DailyMed - THIORIDAZINE HYDROCHLORIDE tablet, film coated

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class="content-wide"> <article> <ul class="drug-information"> <li> <strong> <a class="tip" rel="tooltip" title="<b>NDC (National Drug Code)</b> - Each drug product is assigned this unique number which can be found on the drug's outer packaging." href="#" id="anch_dj_103">NDC Code(s):</a> </strong> <span id="item-code-s"> 0378-0612-01, 0378-0614-01, 0378-0616-01, 0378-0618-01 </span> </li> <li><strong>Packager: </strong>Mylan Pharmaceuticals Inc.</li> </ul> <ul class="drug-information"> <li> <strong>Category:</strong> <span id="category" class="orangetext ">HUMAN PRESCRIPTION DRUG LABEL </span> </li> <li> <strong>DEA Schedule:</strong> <span id="dea-schedule">None</span> </li> <li> <strong>Marketing Status:</strong> <span id="marketing-status">Abbreviated New Drug Application</span> </li> </ul> <div id="drug-information" class="toggle"> <h2><a id="druglabel"></a>Drug Label Information</h2> <p class="date">Updated November 14, 2024 </p> <p class="orangetext">If you are a consumer or patient please visit <a class="audience-context-switch consumer" href="/dailymed/drugInfo.cfm?setid=56b3f4c2-52af-4947-b225-6808ae9f26f5&audience=consumer" id="anch_dj_105">this version.</a></p> <ul class="tools"> <li class="download">Download DRUG LABEL INFO: <a download="" class="pdf" href="/dailymed/getFile.cfm?setid=56b3f4c2-52af-4947-b225-6808ae9f26f5&type=pdf" target="_blank" id="anch_dj_106">PDF</a> <a download="" class="xml" href="/dailymed/getFile.cfm?setid=56b3f4c2-52af-4947-b225-6808ae9f26f5&type=zip" target="_blank" id="anch_dj_107">XML</a> </li> <li class="print"> <a href="/dailymed/fda/fdaDrugXsl.cfm?setid=56b3f4c2-52af-4947-b225-6808ae9f26f5&type=display" target="_blank" id="anch_dj_108">Official Label (Printer Friendly)</a> </li> </ul> <div class="drug-label-sections"> <div class="control-nav show-js" style="display: block;"> <a class="open-all" href="#" id="anch_dj_109" style="display: inline;">View All Sections</a><a class="close-all" href="#" id="anch_dj_dj_110" style="display: none;">Close All Sections</a> </div> <ul> <li id="boxedwarning"> <a href="#" id="anch_dj_dj-dj_1" class="">BOXED WARNING</a> <a class="tip" rel="tooltip" href="#" id="anch_dj_dj_dj_1" title="A boxed warning is the strongest warning that the FDA requires, and signifies that medical studies indicate that the drug carries a significant risk of serious or even life-threatening adverse effects.">(What is this?)</a> <div class="Warning toggle-content closed long-content"> <a name="ID_6325ACA8-7498-4765-8F45-A152E1954D12"></a><a name="section-1"></a> <p></p> <h1>WARNING </h1> <p class="First"> <span class="Bold">Thioridazine has been shown to prolong the QTc interval in a dose related manner, and drugs with this potential, including thioridazine, have been associated with Torsades de pointes type arrhythmias and sudden death. Due to its potential for significant, possibly life threatening, proarrhythmic effects, thioridazine should be reserved for use in the treatment of schizophrenic patients who fail to show an acceptable response to adequate courses of treatment with other antipsychotic drugs, either because of insufficient effectiveness or the inability to achieve an effective dose due to intolerable adverse effects from those drugs (see <a href="#ID_C9D0F7E3-BE93-4A69-AE58-1561BDDFFCC0">WARNINGS</a>, <a href="#ID_FA39D9CD-DDE1-4A20-8C2F-11977A67B7E2">CONTRAINDICATIONS</a>, and <a href="#ID_5D4F5C2C-D4AC-46D7-BB30-0459106DDCC2">INDICATIONS</a>).</span> </p> <p> <span class="Bold"><span class="Underline">Increased Mortality in Elderly Patients with Dementia-Related Psychosis</span></span> </p> <p> <span class="Bold">Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Thioridazine hydrochloride is not approved for the treatment of patients with dementia-related psychosis (see <a href="#ID_C9D0F7E3-BE93-4A69-AE58-1561BDDFFCC0">WARNINGS</a>).</span> </p> </div> </li> <li > <a href="#" id="anch_dj_dj-dj_2" class="">DESCRIPTION </a> <div class="Section toggle-content closed long-content" data-sectioncode="34089-3"> <a name="ID_F4390D70-8F32-462C-91D0-7E3CBEB55EE2"></a><a name="section-1"></a> <p></p> <p class="First">Thioridazine hydrochloride is 2-methylmercapto-10-[2-(N-methyl-2-piperidyl) ethyl] phenothiazine. Its structural formula, molecular weight and molecular formula are:</p> <div class="Figure"> <a name="id83897639"></a><img alt="Thioridazine Hydrochloride Structural Formula" src="/dailymed/image.cfm?name=image-01.jpg&setid=56b3f4c2-52af-4947-b225-6808ae9f26f5"/><p class="MultiMediaCaption">C<span class="Sub">21</span>H<span class="Sub">26</span>N<span class="Sub">2</span>S<span class="Sub">2</span> • HCl M.Wt.: 407.05</p> </div> <p>Thioridazine hydrochloride, USP is available as tablets for oral administration containing 10 mg, 25 mg, 50 mg or 100 mg.</p> <p>Each tablet for oral administration contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, FD&C Yellow No. 6 Aluminum Lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium lauryl sulfate and titanium dioxide.</p> </div> </li> <li > <a href="#" id="anch_dj_dj-dj_3" class="">CLINICAL PHARMACOLOGY </a> <div class="Section toggle-content closed long-content" data-sectioncode="34090-1"> <a name="ID_32675B2E-0EA2-4343-B565-1D20611AF21C"></a><a name="section-2"></a> <p></p> <p class="First">The basic pharmacological activity of thioridazine is similar to that of other phenothiazines, but is associated with minimal extrapyramidal stimulation.</p> <p>However, thioridazine has been shown to prolong the QTc interval in a dose dependent fashion. This effect may increase the risk of serious, potentially fatal, ventricular arrhythmias, such as Torsades de pointes type arrhythmias. Due to this risk, thioridazine is indicated only for schizophrenic patients who have not been responsive to or cannot tolerate other antipsychotic agents (see <a href="#ID_C9D0F7E3-BE93-4A69-AE58-1561BDDFFCC0">WARNINGS</a> and <a href="#ID_FA39D9CD-DDE1-4A20-8C2F-11977A67B7E2">CONTRAINDICATIONS</a>). However, the prescriber should be aware that thioridazine has not been systematically evaluated in controlled trials in treatment refractory schizophrenic patients and its efficacy in such patients is unknown.</p> </div> </li> <li > <a href="#" id="anch_dj_dj-dj_4" class="">INDICATIONS AND USAGE </a> <div class="Section toggle-content closed long-content" data-sectioncode="34067-9"> <a name="ID_5D4F5C2C-D4AC-46D7-BB30-0459106DDCC2"></a><a name="section-3"></a> <p></p> <p class="First">Thioridazine hydrochloride tablets are indicated for the management of schizophrenic patients who fail to respond adequately to treatment with other antipsychotic drugs. Due to the risk of significant, potentially life threatening, proarrhythmic effects with thioridazine treatment, thioridazine hydrochloride tablets should be used only in patients who have failed to respond adequately to treatment with appropriate courses of other antipsychotic drugs, either because of insufficient effectiveness or the inability to achieve an effective dose due to intolerable adverse effects from those drugs. Consequently, before initiating treatment with thioridazine hydrochloride tablets, it is strongly recommended that a patient be given at least two trials, each with a different antipsychotic drug product, at an adequate dose, and for an adequate duration (see <a href="#ID_C9D0F7E3-BE93-4A69-AE58-1561BDDFFCC0">WARNINGS</a> and <a href="#ID_FA39D9CD-DDE1-4A20-8C2F-11977A67B7E2">CONTRAINDICATIONS</a>).</p> <p>However, the prescriber should be aware that thioridazine hydrochloride tablets have not been systematically evaluated in controlled trials in treatment refractory schizophrenic patients and its efficacy in such patients is unknown.</p> </div> </li> <li > <a href="#" id="anch_dj_dj-dj_5" class="">CONTRAINDICATIONS </a> <div class="Section toggle-content closed long-content" data-sectioncode="34070-3"> <a name="ID_FA39D9CD-DDE1-4A20-8C2F-11977A67B7E2"></a><a name="section-4"></a> <p></p> <p class="First">Thioridazine hydrochloride tablet use should be avoided in combination with other drugs that are known to prolong the QTc interval and in patients with congenital long QT syndrome or a history of cardiac arrhythmias.</p> <p>Reduced cytochrome P450 2D6 isozyme activity drugs that inhibit this isozyme (e.g., fluoxetine and paroxetine) and certain other drugs (e.g., fluvoxamine, propranolol, and pindolol) appear to appreciably inhibit the metabolism of thioridazine. The resulting elevated levels of thioridazine would be expected to augment the prolongation of the QTc interval associated with thioridazine and may increase the risk of serious, potentially fatal, cardiac arrhythmias, such as Torsades de pointes type arrhythmias. Such an increased risk may result also from the additive effect of coadministering thioridazine with other agents that prolong the QTc interval. Therefore, thioridazine is contraindicated with these drugs as well as in patients, comprising about 7% of the normal population, who are known to have a genetic defect leading to reduced levels of activity of P450 2D6 (see <a href="#ID_C9D0F7E3-BE93-4A69-AE58-1561BDDFFCC0">WARNINGS</a> and <a href="#ID_0D0BCA52-90C9-4168-BCFC-DA0F6EB0258B">PRECAUTIONS</a>).</p> <p>In common with other phenothiazines, thioridazine is contraindicated in severe central nervous system depression or comatose states from any cause including drug induced central nervous system depression (see <span class="Underline"><a href="#ID_C9D0F7E3-BE93-4A69-AE58-1561BDDFFCC0">WARNINGS</a></span>). It should also be noted that hypertensive or hypotensive heart disease of extreme degree is a contraindication of phenothiazine administration.</p> </div> </li> <li > <a href="#" id="anch_dj_dj-dj_6" class="">WARNINGS </a> <div class="Section toggle-content closed long-content" data-sectioncode="34071-1"> <a name="ID_C9D0F7E3-BE93-4A69-AE58-1561BDDFFCC0"></a><a name="section-5"></a> <p></p> <div class="Section" data-sectioncode="42229-5"> <a name="ID_be990007-46d6-4b34-a522-461f0594e212"></a><a name="section-5.1"></a> <p></p> <h2> <span class="Underline">Increased Mortality in Elderly Patients with Dementia-Related Psychosis</span><span class="Underline"></span> </h2> <p class="First"> <span class="Bold">Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Thioridazine hydrochloride is not approved for the treatment of patients with dementia-related psychosis (see <a href="#ID_6325ACA8-7498-4765-8F45-A152E1954D12">BOXED WARNING</a>).</span> </p> </div> <div class="Section" data-sectioncode="42229-5"> <a name="ID_ae1266b3-fcb0-42e7-a174-92cc97e72795"></a><a name="section-5.2"></a> <p></p> <h2>Potential for Proarrhythmic Effects </h2> <p class="First">DUE TO THE POTENTIAL FOR SIGNIFICANT, POSSIBLY LIFE THREATENING, PROARRHYTHMIC EFFECTS WITH THIORIDAZINE TREATMENT, THIORIDAZINE SHOULD BE RESERVED FOR USE IN THE TREATMENT OF SCHIZOPHRENIC PATIENTS WHO FAIL TO SHOW AN ACCEPTABLE RESPONSE TO ADEQUATE COURSES OF TREATMENT WITH OTHER ANTIPSYCHOTIC DRUGS, EITHER BECAUSE OF INSUFFICIENT EFFECTIVENESS OR THE INABILITY TO ACHIEVE AN EFFECTIVE DOSE DUE TO INTOLERABLE ADVERSE EFFECTS FROM THOSE DRUGS. CONSEQUENTLY, BEFORE INITIATING TREATMENT WITH THIORIDAZINE, IT IS STRONGLY RECOMMENDED THAT A PATIENT BE GIVEN AT LEAST TWO TRIALS, EACH WITH A DIFFERENT ANTIPSYCHOTIC DRUG PRODUCT, AT AN ADEQUATE DOSE, AND FOR AN ADEQUATE DURATION. THIORIDAZINE HAS NOT BEEN SYSTEMATICALLY EVALUATED IN CONTROLLED TRIALS IN THE TREATMENT OF REFRACTORY SCHIZOPHRENIC PATIENTS AND ITS EFFICACY IN SUCH PATIENTS IS UNKNOWN.</p> <p>A crossover study in nine healthy males comparing single doses of thioridazine 10 mg and 50 mg with placebo demonstrated a dose related prolongation of the QTc interval. The mean maximum increase in QTc interval following the 50 mg dose was about 23 msec; greater prolongation may be observed in the clinical treatment of unscreened patients.</p> <p>Prolongation of the QTc interval has been associated with the ability to cause Torsades de pointes type arrhythmias, a potentially fatal polymorphic ventricular tachycardia, and sudden death. There are several published case reports of Torsades de pointes and sudden death associated with thioridazine treatment. A causal relationship between these events and thioridazine therapy has not been established but, given the ability of thioridazine to prolong the QTc interval, such a relationship is possible.</p> <p>Certain circumstances may increase the risk of Torsades de pointes and/or sudden death in association with the use of drugs that prolong the QTc interval, including 1) bradycardia, 2) hypokalemia, 3) concomitant use of other drugs that prolong the QTc interval, 4) presence of congenital prolongation of the QT interval, and 5) for thioridazine in particular, its use in patients with reduced activity of P450 2D6 or its coadministration with drugs that may inhibit P450 2D6 or by some other mechanism interfere with the clearance of thioridazine (see <a href="#ID_FA39D9CD-DDE1-4A20-8C2F-11977A67B7E2">CONTRAINDICATIONS</a> and <a href="#ID_0D0BCA52-90C9-4168-BCFC-DA0F6EB0258B">PRECAUTIONS</a>).</p> <p>It is recommended that patients being considered for thioridazine treatment have a baseline ECG performed and serum potassium levels measured. Serum potassium should be normalized before initiating treatment and patients with a QTc interval greater than 450 msec should not receive thioridazine treatment. It may also be useful to periodically monitor ECG’s and serum potassium during thioridazine treatment, especially during a period of dose adjustment. Thioridazine should be discontinued in patients who are found to have a QTc interval over 500 msec.</p> <p>Patients taking thioridazine who experience symptoms that may be associated with the occurrence of Torsades de pointes (e.g., dizziness, palpitations, or syncope) may warrant further cardiac evaluation; in particular, Holter monitoring should be considered.</p> </div> <div class="Section" data-sectioncode="42229-5"> <a name="ID_63ae8051-ef5c-4642-bd72-d207d5611662"></a><a name="section-5.3"></a> <p></p> <h2>Tardive Dyskinesia </h2> <p class="First">Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with antipsychotic drugs. Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the inception of antipsychotic treatment, which patients are likely to develop the syndrome. Whether antipsychotic drug products differ in their potential to cause tardive dyskinesia is unknown.</p> <p>Both the risk of developing the syndrome and the likelihood that it will become irreversible are believed to increase as the duration of treatment and the total cumulative dose of antipsychotic drugs administered to the patient increase. However, the syndrome can develop, although much less commonly, after relatively brief treatment periods at low doses.</p> <p>There is no known treatment for established cases of tardive dyskinesia, although the syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn. Antipsychotic treatment itself, however, may suppress (or partially suppress) the signs and symptoms of the syndrome and thereby may possibly mask the underlying disease process. The effect that symptomatic suppression has upon the long-term course of the syndrome is unknown.</p> <p>Given these considerations, antipsychotics should be prescribed in a manner that is most likely to minimize the occurrence of tardive dyskinesia. Chronic antipsychotic treatment should generally be reserved for patients who suffer from a chronic illness that, 1) is known to respond to antipsychotic drugs, and, 2) for whom alternative, equally effective, but potentially less harmful treatments are <span class="Italics">not </span>available or appropriate. In patients who do require chronic treatment, the smallest dose and the shortest duration of treatment producing a satisfactory clinical response should be sought. The need for continued treatment should be reassessed periodically.</p> <p>If signs and symptoms of tardive dyskinesia appear in a patient on antipsychotics, drug discontinuation should be considered. However, some patients may require treatment despite the presence of the syndrome.</p> <p>(For further information about the description of tardive dyskinesia and its clinical detection, please refer to the sections on <a href="#ID_62bbcc8d-dec8-4c20-9a09-0d6b2c6ccced">Information for Patients</a> and <a href="#ID_AF86C656-4AB7-4D67-8470-123DA832F20C">ADVERSE REACTIONS</a>.)</p> <p>It has been suggested in regard to phenothiazines in general, that people who have demonstrated a hypersensitivity reaction (e.g., blood dyscrasias, jaundice) to one may be more prone to demonstrate a reaction to others. Attention should be paid to the fact that phenothiazines are capable of potentiating central nervous system depressants (e.g., anesthetics, opiates, alcohol, etc.) as well as atropine and phosphorus insecticides. Physicians should carefully consider benefit versus risk when treating less severe disorders.</p> <p>Reproductive studies in animals and clinical experience to date have failed to show a teratogenic effect with thioridazine. However, in view of the desirability of keeping the administration of all drugs to a minimum during pregnancy, thioridazine should be given only when the benefits derived from treatment exceed the possible risks to mother and fetus.</p> </div> <div class="Section" data-sectioncode="42228-7"> <a name="ID_49c1cbc5-410e-40f0-83e6-a4b84d02500a"></a><a name="section-5.4"></a> <p></p> <h2>Pregnancy </h2> <div class="Section" data-sectioncode="34078-6"> <a name="ID_118a2f39-dc83-4a24-953d-d1f593c89f73"></a><a name="section-5.4.1"></a> <p></p> <h3> <span class="Bold"><span class="Italics">Nonteratogenic Effects</span></span><span class="Bold"><span class="Italics"></span></span> </h3> <p class="First">Neonates exposed to antipsychotic drugs, during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates. These complications have varied in severity; while in some cases symptoms have been self-limited, in other cases neonates have required intensive care unit support and prolonged hospitalization.</p> <p>Thioridazine hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.</p> </div> </div> <div class="Section" data-sectioncode="42229-5"> <a name="ID_ba14d54f-27b9-49ca-8b14-96472acb31ff"></a><a name="section-5.5"></a> <p></p> <h2>Neuroleptic Malignant Syndrome (NMS) </h2> <p class="First">A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with antipsychotic drugs. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmias).</p> <p>The diagnostic evaluation of patients with this syndrome is complicated. In arriving at a diagnosis, it is important to identify cases where the clinical presentation includes both serious medical illness (e.g., pneumonia, systemic infection, etc.) and untreated or inadequately treated extrapyramidal signs and symptoms (EPS). Other important considerations in the differential diagnosis include central anticholinergic toxicity, heat stroke, drug fever, and primary central nervous system (CNS) pathology.</p> <p>The management of NMS should include, 1) immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy, 2) intensive symptomatic treatment and medical monitoring, and 3) treatment of any concomitant serious medical problems for which specific treatments are available. There is no general agreement about specific pharmacological treatment regimens for uncomplicated NMS.</p> <p>If a patient requires antipsychotic drug treatment after recovery from NMS, the potential reintroduction of drug therapy should be carefully considered. The patient should be carefully monitored, since recurrences of NMS have been reported.</p> </div> <div class="Section" data-sectioncode="42229-5"> <a name="ID_3c8f60c6-34d6-458b-af0a-3685325f5c04"></a><a name="section-5.6"></a> <p></p> <h2>Falls </h2> <p class="First">Thioridazine hydrochloride tablets may cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls and, consequently, fractures or other injuries. For patients with diseases, conditions, or medications that could exacerbate these effects, complete fall risk assessments when initiating antipsychotic treatment and recurrently for patients on long-term antipsychotic therapy.</p> </div> <div class="Section" data-sectioncode="42229-5"> <a name="ID_0364995a-bd7b-49d2-946c-31cc5b3cbc42"></a><a name="section-5.7"></a> <p></p> <h2>Central Nervous System Depressants </h2> <p class="First">As in the case of other phenothiazines, thioridazine is capable of potentiating central nervous system depressants (e.g., alcohol, anesthetics, barbiturates, narcotics, opiates, other psychoactive drugs, etc.) as well as atropine and phosphorus insecticides. Severe respiratory depression and respiratory arrest have been reported when a patient was given a phenothiazine and a concomitant high dose of a barbiturate. </p> </div> </div> </li> <li > <a href="#" id="anch_dj_dj-dj_7" class="">PRECAUTIONS </a> <div class="Section toggle-content closed long-content" data-sectioncode="42232-9"> <a name="ID_0D0BCA52-90C9-4168-BCFC-DA0F6EB0258B"></a><a name="section-6"></a> <p></p> <p class="First">Leukopenia and/or agranulocytosis and convulsive seizures have been reported but are infrequent. In schizophrenic patients with epilepsy, anticonvulsant medication should be maintained during treatment with thioridazine. Pigmentary retinopathy, which has been observed primarily in patients taking larger than recommended doses, is characterized by diminution of visual acuity, brownish coloring of vision, and impairment of night vision; examination of the fundus discloses deposits of pigment. The possibility of this complication may be reduced by remaining within the recommended limits of dosage.</p> <p>Where patients are participating in activities requiring complete mental alertness (e.g., driving) it is advisable to administer the phenothiazines cautiously and to increase the dosage gradually. Female patients appear to have a greater tendency to orthostatic hypotension than male patients. The administration of epinephrine should be avoided in the treatment of drug-induced hypotension in view of the fact that phenothiazines may induce a reversed epinephrine effect on occasion. Should a vasoconstrictor be required, the most suitable are levarterenol and phenylephrine.</p> <p>Antipsychotic drugs elevate prolactin levels; the elevation persists during chronic administration. Tissue culture experiments indicate that approximately one-third of human breast cancers are prolactin dependent <span class="Italics">in vitro</span>, a factor of potential importance if the prescription of these drugs is contemplated in a patient with a previously detected breast cancer. Although disturbances such as galactorrhea, amenorrhea, gynecomastia, and impotence have been reported, the clinical significance of elevated serum prolactin levels is unknown for most patients. An increase in mammary neoplasms has been found in rodents after chronic administration of neuroleptic drugs. Published epidemiologic studies have shown inconsistent results when exploring the association between hyperprolactinemia and breast cancer.</p> <div class="Section" data-sectioncode="34073-7"> <a name="ID_2d16b5cd-f8e9-40e1-8ff4-59b44af4e165"></a><a name="section-6.1"></a> <p></p> <h2>Drug Interactions </h2> <p class="First">Reduced cytochrome P450 2D6 isozyme activity, drugs which inhibit this isozyme (e.g., fluoxetine and paroxetine), and certain other drugs (e.g., fluvoxamine, propranolol, and pindolol) appear to appreciably inhibit the metabolism of thioridazine. The resulting elevated levels of thioridazine would be expected to augment the prolongation of the QTc interval associated with thioridazine and may increase the risk of serious, potentially fatal, cardiac arrhythmias, such as Torsades de pointes type arrhythmias. Such an increased risk may result also from the additive effect of coadministering thioridazine with other agents that prolong the QTc interval. Therefore, thioridazine is contraindicated with these drugs as well as in patients, comprising about 7% of the normal population, who are known to have a genetic defect leading to reduced levels of activity of P450 2D6 (see <a href="#ID_C9D0F7E3-BE93-4A69-AE58-1561BDDFFCC0">WARNINGS</a> and <a href="#ID_FA39D9CD-DDE1-4A20-8C2F-11977A67B7E2">CONTRAINDICATIONS</a>).</p> <div class="Section" data-sectioncode="42229-5"> <a name="ID_e3a70fc3-b96c-4142-9b03-883f7c8fa766"></a><a name="section-6.1.1"></a> <p></p> <h3> <span class="Bold"><span class="Italics">Drugs That Inhibit Cytochrome P450 2D6</span></span><span class="Bold"><span class="Italics"></span></span> </h3> <p class="First">In a study of 19 healthy male subjects, which included 6 slow and 13 rapid hydroxylators of debrisoquin, a single 25 mg oral dose of thioridazine produced a 2.4-fold higher C<span class="Sub">max</span> and a 4.5-fold higher AUC for thioridazine in the slow hydroxylators compared to rapid hydroxylators. The rate of debrisoquin hydroxylation is felt to depend on the level of cytochrome P450 2D6 isozyme activity. Thus, this study suggests that drugs that inhibit P450 2D6 or the presence of reduced activity levels of this isozyme will produce elevated plasma levels of thioridazine. Therefore, the coadministration of drugs that inhibit P450 2D6 with thioridazine and the use of thioridazine in patients known to have reduced activity of P450 2D6 are contraindicated.</p> </div> <div class="Section" data-sectioncode="42229-5"> <a name="ID_aff13a19-7730-4832-b770-3ddf735242ac"></a><a name="section-6.1.2"></a> <p></p> <h3> <span class="Bold"><span class="Italics">Drugs That Reduce the Clearance of Thioridazine Through Other Mechanisms</span></span><span class="Bold"><span class="Italics"></span></span> </h3> <div class="Section" data-sectioncode="42229-5"> <a name="ID_5ff2abdd-78cb-4956-b504-015349844c0e"></a><a name="section-6.1.2.1"></a> <p></p> <h4>Fluvoxamine </h4> <p class="First">The effect of fluvoxamine (25 mg b.i.d. for one week) on thioridazine steady-state concentration was evaluated in ten male inpatients with schizophrenia. Concentrations of thioridazine and its two active metabolites, mesoridazine and sulforidazine, increased 3-fold following coadministration of fluvoxamine. Fluvoxamine and thioridazine should not be coadministered.</p> </div> <div class="Section" data-sectioncode="42229-5"> <a name="ID_936c97d8-207e-4c3c-82a7-14f2fa49ee3e"></a><a name="section-6.1.2.2"></a> <p></p> <h4>Propranolol </h4> <p class="First">Concurrent administration of propranolol (100 mg to 800 mg daily) has been reported to produce increases in plasma levels of thioridazine (approximately 50% to 400%) and its metabolites (approximately 80% to 300%). Propranolol and thioridazine should not be coadministered.</p> </div> <div class="Section" data-sectioncode="42229-5"> <a name="ID_5b55b867-2e38-453e-ae13-c3f589184cab"></a><a name="section-6.1.2.3"></a> <p></p> <h4>Pindolol </h4> <p class="First">Concurrent administration of pindolol and thioridazine have resulted in moderate, dose related increases in the serum levels of thioridazine and two of its metabolites, as well as higher than expected serum pindolol levels. Pindolol and thioridazine should not be coadministered.</p> </div> </div> <div class="Section" data-sectioncode="42229-5"> <a name="ID_6d0182cd-e903-4aea-928a-6d532d390288"></a><a name="section-6.1.3"></a> <p></p> <h3> <span class="Bold"><span class="Italics">Drugs That Prolong the QTc Interval</span></span><span class="Bold"><span class="Italics"></span></span> </h3> <p class="First">There are no studies of the coadministration of thioridazine and other drugs that prolong the QTc interval. However, it is expected that such coadministration would produce additive prolongation of the QTc interval and, thus, such use is contraindicated.</p> </div> </div> <div class="Section" data-sectioncode="34076-0"> <a name="ID_62bbcc8d-dec8-4c20-9a09-0d6b2c6ccced"></a><a name="section-6.2"></a> <p></p> <h2>Information for Patients </h2> <p class="First">Patients should be informed that thioridazine has been associated with potentially fatal heart rhythm disturbances. The risk of such events may be increased when certain drugs are given together with thioridazine. Therefore, patients should inform the prescriber that they are receiving thioridazine treatment before taking any new medication.</p> <p>Given the likelihood that some patients exposed chronically to antipsychotics will develop tardive dyskinesia, it is advised that all patients in whom chronic use is contemplated be given, if possible, full information about this risk. The decision to inform patients and/or their guardians must obviously take into account the clinical circumstances and the competency of the patient to understand the information provided.</p> </div> <div class="Section" data-sectioncode="34081-0"> <a name="ID_b9ccdf37-c26f-4265-9ae0-6aacee7ee1d6"></a><a name="section-6.3"></a> <p></p> <h2>Pediatric Use </h2> <p class="First">See <a href="#ID_edf2ae54-cf2f-4268-8dbe-58ffd4950eeb">DOSAGE AND ADMINISTRATION: Pediatric Patients</a>.</p> </div> <div class="Section" data-sectioncode="42229-5"> <a name="ID_8efb5f4d-c66c-4476-82dd-f98e7a5fbf4b"></a><a name="section-6.4"></a> <p></p> <h2>Leukopenia, Neutropenia and Agranulocytosis </h2> <p class="First">In clinical trial and post-marketing experience, events of leukopenia/neutropenia and agranulocytosis have been reported temporally related to antipsychotic agents.</p> <p>Possible risk factors for leukopenia/neutropenia include preexisting low white blood cell count (WBC) and history of drug induced leukopenia/neutropenia. Patients with a preexisting low WBC or a history of drug induced leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy and should discontinue Thioridazine Hydrochloride Tablets at the first sign of a decline in WBC in the absence of other causative factors.</p> <p>Patients with neutropenia should be carefully monitored for fever or other symptoms or signs of infection and treated promptly if such symptoms occur. Patients with severe neutropenia (absolute neutrophil count < 1000/mm<span class="Sup">3</span>) should discontinue Thioridazine Hydrochloride Tablets and have their WBC followed until recovery. </p> </div> </div> </li> <li > <a href="#" id="anch_dj_dj-dj_8" class="">ADVERSE REACTIONS </a> <div class="Section toggle-content closed long-content" data-sectioncode="34084-4"> <a name="ID_AF86C656-4AB7-4D67-8470-123DA832F20C"></a><a name="section-7"></a> <p></p> <p class="First">In the recommended dosage ranges with thioridazine hydrochloride most side effects are mild and transient.</p> <div class="Section" data-sectioncode="42229-5"> <a name="ID_5ff33e58-cd0a-4c20-8e35-9d399832a16b"></a><a name="section-7.1"></a> <p></p> <h2>Central Nervous System </h2> <p class="First">Drowsiness may be encountered on occasion, especially where large doses are given early in treatment. Generally, this effect tends to subside with continued therapy or a reduction in dosage. Pseudoparkinsonism and other extrapyramidal symptoms may occur but are infrequent. Nocturnal confusion, hyperactivity, lethargy, psychotic reactions, restlessness, and headache have been reported but are extremely rare.</p> </div> <div class="Section" data-sectioncode="42229-5"> <a name="ID_918006e1-daa2-4cc5-bd4d-0384160724fa"></a><a name="section-7.2"></a> <p></p> <h2>Autonomic Nervous System </h2> <p class="First">Dryness of mouth, blurred vision, constipation, nausea, vomiting, diarrhea, nasal stuffiness, and pallor have been seen.</p> </div> <div class="Section" data-sectioncode="42229-5"> <a name="ID_1d48fbde-5bd5-4c7a-b88d-9a6fe9c96cca"></a><a name="section-7.3"></a> <p></p> <h2>Endocrine System </h2> <p class="First">Galactorrhea, breast engorgement, amenorrhea, inhibition of ejaculation, and peripheral edema have been described.</p> </div> <div class="Section" data-sectioncode="42229-5"> <a name="ID_f839dfa7-c8ce-40f2-b215-1bb13bdf2381"></a><a name="section-7.4"></a> <p></p> <h2>Skin </h2> <p class="First">Dermatitis and skin eruptions of the urticarial type have been observed infrequently. Photosensitivity is extremely rare.</p> </div> <div class="Section" data-sectioncode="42229-5"> <a name="ID_cc75136f-a67c-48b3-bb21-23b66a3944bb"></a><a name="section-7.5"></a> <p></p> <h2>Cardiovascular System </h2> <p class="First">Thioridazine produces a dose related prolongation of the QTc interval, which is associated with the ability to cause Torsades de pointes type arrhythmias, a potentially fatal polymorphic ventricular tachycardia, and sudden death (see <a href="#ID_C9D0F7E3-BE93-4A69-AE58-1561BDDFFCC0">WARNINGS</a>). Both Torsades de pointes type arrhythmias and sudden death have been reported in association with thioridazine. A causal relationship between these events and thioridazine therapy has not been established but, given the ability of thioridazine to prolong the QTc interval, such a relationship is possible. Other ECG changes have been reported (see <a href="#ID_80c2a5cd-ed7a-4511-8316-f5c014c341bb">Phenothiazine Derivatives: Cardiovascular Effects</a>).</p> </div> <div class="Section" data-sectioncode="42229-5"> <a name="ID_98642644-17e8-450b-b594-c2a954431465"></a><a name="section-7.6"></a> <p></p> <h2>Other </h2> <p class="First">Rare cases described as parotid swelling have been reported following administration of thioridazine.</p> </div> <div class="Section" data-sectioncode="42229-5"> <a name="ID_da929090-e5df-4af7-be88-ffeb575fb24c"></a><a name="section-7.7"></a> <p></p> <h2>Post Introduction Reports </h2> <p class="First">These are voluntary reports of adverse events temporally associated with thioridazine that were received since marketing, and there may be no causal relationship between thioridazine use and these events: priapism.</p> </div> <div class="Section" data-sectioncode="42229-5"> <a name="ID_80c2a5cd-ed7a-4511-8316-f5c014c341bb"></a><a name="section-7.8"></a> <p></p> <h2>Phenothiazine Derivatives </h2> <p class="First">It should be noted that efficacy, indications, and untoward effects have varied with the different phenothiazines. It has been reported that old age lowers the tolerance for phenothiazines. The most common neurological side effects in these patients are parkinsonism and akathisia. There appears to be an increased risk of agranulocytosis and leukopenia in the geriatric population. The physician should be aware that the following have occurred with one or more phenothiazines and should be considered whenever one of these drugs is used:</p> <p> <span class="Bold"><span class="Italics">Autonomic Reactions: </span></span>Miosis, obstipation, anorexia, paralytic ileus.</p> <p> <span class="Bold"><span class="Italics">Cutaneous Reactions: </span></span>Erythema, exfoliative dermatitis, contact dermatitis.</p> <p> <span class="Bold"><span class="Italics">Blood Dyscrasias: </span></span>Agranulocytosis, leukopenia, eosinophilia, thrombocytopenia, anemia, aplastic anemia, pancytopenia.</p> <p> <span class="Bold"><span class="Italics">Allergic Reactions: </span></span>Fever, laryngeal edema, angioneurotic edema, asthma.</p> <p> <span class="Italics"><span class="Bold">Hepatotoxicity:</span> </span>Jaundice, biliary stasis.</p> <p> <span class="Bold"><span class="Italics">Cardiovascular Effects: </span></span>Changes in the terminal portion of the electrocardiogram to include prolongation of the QT interval, depression and inversion of the T wave, and the appearance of a wave tentatively identified as a bifid T wave or a U wave have been observed in patients receiving phenothiazines, including thioridazine. To date, these appear to be due to altered repolarization, not related to myocardial damage, and reversible. Nonetheless, significant prolongation of the QT interval has been associated with serious ventricular arrhythmias and sudden death (see <a href="#ID_C9D0F7E3-BE93-4A69-AE58-1561BDDFFCC0">WARNINGS</a>). Hypotension, rarely resulting in cardiac arrest, has been reported.</p> <p> <span class="Bold"><span class="Italics">Extrapyramidal Symptoms: </span></span>Akathisia, agitation, motor restlessness, dystonic reactions, trismus, torticollis, opisthotonus, oculogyric crises, tremor, muscular rigidity, akinesia.</p> <p> <span class="Bold"><span class="Italics">Tardive Dyskinesia: </span></span>Chronic use of antipsychotics may be associated with the development of tardive dyskinesia. The salient features of this syndrome are described in the <a href="#ID_C9D0F7E3-BE93-4A69-AE58-1561BDDFFCC0">WARNINGS</a> section and subsequently.</p> <p>The syndrome is characterized by involuntary choreoathetoid movements which variously involve the tongue, face, mouth, lips, or jaw (e.g., protrusion of the tongue, puffing of cheeks, puckering of the mouth, chewing movements), trunk, and extremities. The severity of the syndrome and the degree of impairment produced vary widely.</p> <p>The syndrome may become clinically recognizable either during treatment, upon dosage reduction, or upon withdrawal of treatment. Movements may decrease in intensity and may disappear altogether if further treatment with antipsychotics is withheld. It is generally believed that reversibility is more likely after short rather than long-term antipsychotic exposure. Consequently, early detection of tardive dyskinesia is important. To increase the likelihood of detecting the syndrome at the earliest possible time, the dosage of antipsychotic drug should be reduced periodically (if clinically possible) and the patient observed for signs of the disorder. This maneuver is critical, for antipsychotic drugs may mask the signs of the syndrome.</p> <p> <span class="Bold"><span class="Italics">Neuroleptic Malignant Syndrome (NMS): </span></span>Chronic use of antipsychotics may be associated with the development of Neuroleptic Malignant Syndrome. The salient features of this syndrome are described in the <a href="#ID_C9D0F7E3-BE93-4A69-AE58-1561BDDFFCC0">WARNINGS</a> section and subsequently. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmias).</p> <p> <span class="Bold"><span class="Italics">Endocrine Disturbances: </span></span>Menstrual irregularities, altered libido, gynecomastia, lactation, weight gain, edema. False positive pregnancy tests have been reported.</p> <p> <span class="Bold"><span class="Italics">Urinary Disturbances: </span></span>Retention, incontinence.</p> <p> <span class="Bold"><span class="Italics">Others: </span></span>Hyperpyrexia. Behavioral effects suggestive of a paradoxical reaction have been reported. These include excitement, bizarre dreams, aggravation of psychoses, and toxic confusional states. More recently, a peculiar skin-eye syndrome has been recognized as a side effect following long-term treatment with phenothiazines. This reaction is marked by progressive pigmentation of areas of the skin or conjunctiva and/or accompanied by discoloration of the exposed sclera and cornea. Opacities of the anterior lens and cornea described as irregular or stellate in shape have also been reported. Systemic lupus erythematosus-like syndrome. </p> </div> </div> </li> <li > <a href="#" id="anch_dj_dj-dj_9" class="">OVERDOSAGE </a> <div class="Section toggle-content closed long-content" data-sectioncode="34088-5"> <a name="ID_416EE654-13A3-4903-883C-48051E7333A8"></a><a name="section-8"></a> <p></p> <p class="First">Many of the symptoms observed are extensions of the side effects described under <a href="#ID_AF86C656-4AB7-4D67-8470-123DA832F20C">ADVERSE REACTIONS</a>. Thioridazine can be toxic in overdose, with cardiac toxicity being of particular concern. Frequent ECG and vital sign monitoring of overdosed patients is recommended. Observation for several days may be required because of the risk of delayed effects.</p> <div class="Section" data-sectioncode="42229-5"> <a name="ID_0ec09a8f-91d1-4361-bbd1-1f7ebb858779"></a><a name="section-8.1"></a> <p></p> <h2>Signs and Symptoms </h2> <p class="First">Effects and clinical complications of acute overdose involving phenothiazines may include:</p> <p> <span class="Bold"><span class="Italics">Cardiovascular: </span></span>Cardiac arrhythmias, hypotension, shock, ECG changes, increased QT and PR intervals, non-specific ST and T wave changes, bradycardia, sinus tachycardia, atrioventricular block, ventricular tachycardia, ventricular fibrillation, Torsades de pointes, myocardial depression.</p> <p> <span class="Bold"><span class="Italics">Central Nervous System: </span></span>Sedation, extrapyramidal effects, confusion, agitation, hypothermia, hyperthermia, restlessness, seizures, areflexia, coma.</p> <p> <span class="Bold"><span class="Italics">Autonomic Nervous System: </span></span>Mydriasis, miosis, dry skin, dry mouth, nasal congestion, urinary retention, blurred vision.</p> <p> <span class="Bold"><span class="Italics">Respiratory: </span></span>Respiratory depression, apnea, pulmonary edema.</p> <p> <span class="Bold"><span class="Italics">Gastrointestinal: </span></span>Hypomotility, constipation, ileus.</p> <p> <span class="Bold"><span class="Italics">Renal: </span></span>Oliguria, uremia.</p> <p>Toxic dose and blood concentration ranges for the phenothiazines have not been firmly established. It has been suggested that the toxic blood concentration range for thioridazine begins at 1 mg/dL, and 2 to 8 mg/dL is the lethal concentration range.</p> </div> <div class="Section" data-sectioncode="42229-5"> <a name="ID_3b182322-036d-4d0b-9ab8-db899a167259"></a><a name="section-8.2"></a> <p></p> <h2>Treatment </h2> <p class="First">An airway must be established and maintained. Adequate oxygenation and ventilation must be ensured.</p> <p>Cardiovascular monitoring should commence immediately and should include continuous electrocardiographic monitoring to detect possible arrhythmias. Treatment may include one or more of the following therapeutic interventions: correction of electrolyte abnormalities and acid-base balance, lidocaine, phenytoin, isoproterenol, ventricular pacing, and defibrillation. Disopyramide, procainamide, and quinidine may produce additive QT-prolonging effects when administered to patients with acute overdosage of thioridazine and should be avoided (see <a href="#ID_C9D0F7E3-BE93-4A69-AE58-1561BDDFFCC0">WARNINGS</a> and <a href="#ID_FA39D9CD-DDE1-4A20-8C2F-11977A67B7E2">CONTRAINDICATIONS</a>). Caution must be exercised when administering lidocaine, as it may increase the risk of developing seizures.</p> <p>Treatment of hypotension may require intravenous fluids and vasopressors. Phenylephrine, levarterenol, or metaraminol are the appropriate pressor agents for use in the management of refractory hypotension. The potent α adrenergic blocking properties of the phenothiazines makes the use of vasopressors with mixed α and ß adrenergic agonist properties inappropriate, including epinephrine and dopamine. Paradoxical vasodilation may result. In addition, it is reasonable to expect that the α adrenergic-blocking properties of bretylium might be additive to those of thioridazine, resulting in problematic hypotension.</p> <p>In managing overdosage, the physician should always consider the possibility of multiple drug involvement. Gastric lavage and repeated doses of activated charcoal should be considered. Induction of emesis is less preferable to gastric lavage because of the risk of dystonia and the potential for aspiration of vomitus. Emesis should not be induced in patients expected to deteriorate rapidly, or those with impaired consciousness.</p> <p>Acute extrapyramidal symptoms may be treated with diphenhydramine hydrochloride or benztropine mesylate.</p> <p>Avoid the use of barbiturates when treating seizures, as they may potentiate phenothiazine-induced respiratory depression.</p> <p>Forced diuresis, hemoperfusion, hemodialysis and manipulation of urine pH are of unlikely benefit in the treatment of phenothiazine overdose due to their large volume of distribution and extensive plasma protein binding.</p> <p>Up-to-date information about the treatment of overdose can often be obtained from a certified Regional Poison Control Center. Telephone numbers of certified Regional Poison Control Centers are listed in the Physicians’ Desk Reference<span class="Sup">®</span>**.</p> </div> </div> </li> <li > <a href="#" id="anch_dj_dj-dj_10" class="">DOSAGE AND ADMINISTRATION </a> <div class="Section toggle-content closed long-content" data-sectioncode="34068-7"> <a name="ID_EC882A2D-8B1F-45A8-A911-4162A1F4B6ED"></a><a name="section-9"></a> <p></p> <p class="First">Since thioridazine hydrochloride tablets are associated with a dose related prolongation of the QTc interval, which is a potentially life threatening event, its use should be reserved for schizophrenic patients who fail to respond adequately to treatment with other antipsychotic drugs. Dosage must be individualized and the smallest effective dosage should be determined for each patient (see <a href="#ID_5D4F5C2C-D4AC-46D7-BB30-0459106DDCC2">INDICATIONS</a> and <a href="#ID_C9D0F7E3-BE93-4A69-AE58-1561BDDFFCC0">WARNINGS</a>).</p> <div class="Section" data-sectioncode="42229-5"> <a name="ID_99c3b660-a717-4175-b248-09822f55b53d"></a><a name="section-9.1"></a> <p></p> <h2>Adults </h2> <p class="First">The usual starting dose for adult schizophrenic patients is 50 mg to 100 mg three times a day, with a gradual increment to a maximum of 800 mg daily if necessary. Once effective control of symptoms has been achieved, the dosage may be reduced gradually to determine the minimum maintenance dose. The total daily dosage ranges from 200 mg to 800 mg, divided into two to four doses.</p> </div> <div class="Section" data-sectioncode="42229-5"> <a name="ID_edf2ae54-cf2f-4268-8dbe-58ffd4950eeb"></a><a name="section-9.2"></a> <p></p> <h2>Pediatric Patients </h2> <p class="First">For pediatric patients with schizophrenia who are unresponsive to other agents, the recommended initial dose is 0.5 mg/kg/day given in divided doses. Dosage may be increased gradually until optimum therapeutic effect is obtained or the maximum dose of 3 mg/kg/day has been reached. </p> </div> </div> </li> <li > <a href="#" id="anch_dj_dj-dj_11" class="">HOW SUPPLIED </a> <div class="Section toggle-content closed long-content" data-sectioncode="34069-5"> <a name="ID_DEDD13D0-035C-483E-8F84-A61B5A75387A"></a><a name="section-10"></a> <p></p> <p class="First">Thioridazine Hydrochloride Tablets, USP are available containing 10 mg, 25 mg, 50 mg or 100 mg of thioridazine hydrochloride, USP.</p> <p>The 10 mg tablets are orange film-coated, round, unscored tablets debossed with <span class="Bold">M</span> over <span class="Bold">54</span> on one side and <span class="Bold">10</span> on the other side. They are available as follows:</p> <p>NDC 0378-0612-01<br/>bottles of 100 tablets</p> <p>The 25 mg tablets are orange film-coated, round, unscored tablets debossed with <span class="Bold">M</span> over <span class="Bold">58</span> on one side and <span class="Bold">25</span> on the other side. They are available as follows:</p> <p>NDC 0378-0614-01<br/>bottles of 100 tablets</p> <p>The 50 mg tablets are orange film-coated, round, unscored tablets debossed with <span class="Bold">M</span> over <span class="Bold">59</span> on one side and <span class="Bold">50</span> on the other side. They are available as follows:</p> <p>NDC 0378-0616-01<br/>bottles of 100 tablets</p> <p>The 100 mg tablets are orange film-coated, round, unscored tablets debossed with <span class="Bold">M</span> over <span class="Bold">61</span> on one side and <span class="Bold">100</span> on the other side. They are available as follows:</p> <p>NDC 0378-0618-01<br/>bottles of 100 tablets</p> <p> <span class="Bold">Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]</span> </p> <p> <span class="Bold">Protect from light.</span> </p> <p>Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.</p> <p>**Trademark of Medical Economics Company, Inc.</p> <p>Manufactured for:<br/> <span class="Bold">Mylan Pharmaceuticals Inc.<br/> </span>Morgantown, WV 26505 U.S.A.</p> <p>Manufactured by:<br/> <span class="Bold">Mylan Laboratories Limited<br/> </span>Hyderabad — 500 096, India</p> <p>750XXXXX</p> <p>Revised: 11/2024<br/>MX:THIO:RX1</p> </div> </li> <li > <a href="#" id="anch_dj_dj-dj_12" class="">PRINCIPAL DISPLAY PANEL – 10 mg </a> <div class="Section toggle-content closed long-content" data-sectioncode="51945-4"> <a name="ID_4D812EF0-58D6-4173-A398-465D07815877"></a><a name="section-11"></a> <p></p> <p class="First"> <span class="Bold">NDC 0378-0612-01</span> </p> <p> <span class="Bold">Thioridazine<br/>Hydrochloride<br/>Tablets, USP<br/>10 mg</span> </p> <p> <span class="Bold">Rx only 100 Tablets</span> </p> <p>Each film-coated tablet contains:<br/>Thioridazine hydrochloride, USP 10 mg</p> <p> <span class="Bold">Usual Dosage:</span> See accompanying<br/>prescribing information.</p> <p> <span class="Bold">Keep this and all medication out of<br/>the reach of children.</span> </p> <p> <span class="Bold">Store at 20° to 25°C (68° to 77°F). [See<br/>USP Controlled Room Temperature.]</span> </p> <p> <span class="Bold">Protect from light.</span> </p> <p>Manufactured for:<br/> <span class="Bold">Mylan Pharmaceuticals Inc.</span> <br/>Morgantown, WV 26505 U.S.A.</p> <p>Made in India</p> <p> <span class="Bold">RMX0612A</span> </p> <p>Dispense in a tight, light-resistant<br/>container as defined in the USP<br/>using a child-resistant closure.</p> <p>Keep container tightly closed.</p> <p>Code No.: MH/DRUGS/25/NKD/89</p> <div class="Figure"> <a name="id-746257163"></a><img alt="Thioridazine Hydrochloride Tablets 10 mg Bottle Label" src="/dailymed/image.cfm?name=image-02.jpg&setid=56b3f4c2-52af-4947-b225-6808ae9f26f5"/></div> </div> </li> <li > <a href="#" id="anch_dj_dj-dj_13" class="">PRINCIPAL DISPLAY PANEL – 25 mg </a> <div class="Section toggle-content closed long-content" data-sectioncode="51945-4"> <a name="ID_c891d28e-f65e-405e-86de-9f3080b4daca"></a><a name="section-12"></a> <p></p> <p class="First"> <span class="Bold">NDC 0378-0614-01</span> </p> <p> <span class="Bold">Thioridazine<br/>Hydrochloride<br/>Tablets, USP<br/>25 mg</span> </p> <p> <span class="Bold">Rx only 100 Tablets</span> </p> <p>Each film-coated tablet contains:<br/>Thioridazine hydrochloride, USP 25 mg</p> <p> <span class="Bold">Usual Dosage:</span> See accompanying<br/>prescribing information.</p> <p> <span class="Bold">Keep this and all medication out of<br/>the reach of children.</span> </p> <p> <span class="Bold">Store at 20° to 25°C (68° to 77°F). [See<br/>USP Controlled Room Temperature.]</span> </p> <p> <span class="Bold">Protect from light.</span> </p> <p>Manufactured for:<br/> <span class="Bold">Mylan Pharmaceuticals Inc.</span> <br/>Morgantown, WV 26505 U.S.A.</p> <p>Made in India</p> <p> <span class="Bold">RMX0614A</span> </p> <p>Dispense in a tight, light-resistant<br/>container as defined in the USP<br/>using a child-resistant closure.</p> <p>Keep container tightly closed.</p> <p>Code No.: MH/DRUGS/25/NKD/89</p> <div class="Figure"> <a name="id-2124760443"></a><img alt="Thioridazine Hydrochloride Tablets 25 mg Bottle Label" src="/dailymed/image.cfm?name=image-03.jpg&setid=56b3f4c2-52af-4947-b225-6808ae9f26f5"/></div> </div> </li> <li > <a href="#" id="anch_dj_dj-dj_14" class="">PRINCIPAL DISPLAY PANEL – 50 mg </a> <div class="Section toggle-content closed long-content" data-sectioncode="51945-4"> <a name="ID_46ec0fb7-e064-4971-99df-1dd3f82b8985"></a><a name="section-13"></a> <p></p> <p class="First"> <span class="Bold">NDC 0378-0616-01</span> </p> <p> <span class="Bold">Thioridazine<br/>Hydrochloride<br/>Tablets, USP<br/>50 mg</span> </p> <p> <span class="Bold">Rx only 100 Tablets</span> </p> <p>Each film-coated tablet contains:<br/>Thioridazine hydrochloride, USP 50 mg</p> <p> <span class="Bold">Usual Dosage:</span> See accompanying<br/>prescribing information.</p> <p> <span class="Bold">Keep this and all medication out of<br/>the reach of children.</span> </p> <p> <span class="Bold">Store at 20° to 25°C (68° to 77°F). [See<br/>USP Controlled Room Temperature.]</span> </p> <p> <span class="Bold">Protect from light.</span> </p> <p>Manufactured for:<br/> <span class="Bold">Mylan Pharmaceuticals Inc.</span> <br/>Morgantown, WV 26505 U.S.A.</p> <p>Made in India</p> <p> <span class="Bold">RMX0616A</span> </p> <p>Dispense in a tight, light-resistant<br/>container as defined in the USP<br/>using a child-resistant closure.</p> <p>Keep container tightly closed.</p> <p>Code No.: MH/DRUGS/25/NKD/89</p> <div class="Figure"> <a name="id-132641590"></a><img alt="Thioridazine Hydrochloride Tablets 50 mg Bottle Label" src="/dailymed/image.cfm?name=image-04.jpg&setid=56b3f4c2-52af-4947-b225-6808ae9f26f5"/></div> </div> </li> <li > <a href="#" id="anch_dj_dj-dj_15" class="">PRINCIPAL DISPLAY PANEL – 100 mg </a> <div class="Section toggle-content closed long-content" data-sectioncode="51945-4"> <a name="ID_c649bdf3-dbe6-43e6-a4ae-219fb7654f3d"></a><a name="section-14"></a> <p></p> <p class="First"> <span class="Bold">NDC 0378-0618-01</span> </p> <p> <span class="Bold">Thioridazine<br/>Hydrochloride<br/>Tablets, USP<br/>100 mg</span> </p> <p> <span class="Bold">Rx only 100 Tablets</span> </p> <p>Each film-coated tablet contains:<br/>Thioridazine hydrochloride, USP 100 mg</p> <p> <span class="Bold">Usual Dosage:</span> See accompanying<br/>prescribing information.</p> <p> <span class="Bold">Keep this and all medication out of<br/>the reach of children.</span> </p> <p> <span class="Bold">Store at 20° to 25°C (68° to 77°F). [See<br/>USP Controlled Room Temperature.]</span> </p> <p> <span class="Bold">Protect from light.</span> </p> <p>Manufactured for:<br/> <span class="Bold">Mylan Pharmaceuticals Inc.</span> <br/>Morgantown, WV 26505 U.S.A.</p> <p>Made in India</p> <p> <span class="Bold">RMX0618A</span> </p> <p>Dispense in a tight, light-resistant<br/>container as defined in the USP<br/>using a child-resistant closure.</p> <p>Keep container tightly closed.</p> <p>Code No.: MH/DRUGS/25/NKD/89</p> <div class="Figure"> <a name="id-288293349"></a><img alt="Thioridazine Hydrochloride Tablets 100 mg Bottle Label" src="/dailymed/image.cfm?name=image-05.jpg&setid=56b3f4c2-52af-4947-b225-6808ae9f26f5"/></div> </div> </li> <div class="scrollingtable"> <li > <a href="#" id="anch_dj_dj-dj_16" class="">INGREDIENTS AND APPEARANCE</a> <div class="DataElementsTables toggle-content closed long-content scrollingtable"> <table cellpadding="3" cellspacing="0" class="contentTablePetite" width="100%"> <tbody> <tr> <td class="contentTableTitle"><strong>THIORIDAZINE HYDROCHLORIDE </strong> <br/> <span class="contentTableReg">thioridazine hydrochloride tablet, film coated</span></td> </tr> <tr> <td> <table cellpadding="5" cellspacing="0" class="formTablePetite" width="100%"> <tr> <td class="formHeadingTitle" colspan="4">Product Information</td> </tr> <tr class="formTableRowAlt"> <td class="formLabel">Product Type</td><td class="formItem">HUMAN PRESCRIPTION DRUG</td><td class="formLabel">Item Code (Source)</td><td class="formItem">NDC:0378-0612</td> </tr> <tr class="formTableRow"> <td class="formLabel" width="30%">Route of Administration</td><td class="formItem">ORAL</td> </tr> </table> </td> </tr> <tr> <td> <table cellpadding="3" cellspacing="0" class="formTablePetite" width="100%"> <tr> <td class="formHeadingTitle" colspan="3">Active Ingredient/Active Moiety</td> </tr> <tr> <th class="formTitle" scope="col">Ingredient Name</th><th class="formTitle" scope="col">Basis of Strength</th><th class="formTitle" scope="col">Strength</th> </tr> <tr class="formTableRowAlt"> <td class="formItem"><strong>THIORIDAZINE HYDROCHLORIDE</strong> (UNII: 4WCI67NK8M) (THIORIDAZINE - UNII:N3D6TG58NI) </td><td class="formItem">THIORIDAZINE HYDROCHLORIDE</td><td class="formItem">10 mg</td> </tr> </table> </td> </tr> <tr> <td> <table cellpadding="3" cellspacing="0" class="formTablePetite" width="100%"> <tr> <td class="formHeadingTitle" colspan="2">Inactive Ingredients</td> </tr> <tr> <th class="formTitle" scope="col">Ingredient Name</th><th class="formTitle" scope="col">Strength</th> </tr> <tr class="formTableRowAlt"> <td class="formItem"><strong>SILICON DIOXIDE</strong> (UNII: ETJ7Z6XBU4) </td><td class="formItem"> </td> </tr> <tr class="formTableRow"> <td class="formItem"><strong>CROSCARMELLOSE SODIUM</strong> (UNII: M28OL1HH48) </td><td class="formItem"> </td> </tr> <tr class="formTableRowAlt"> <td class="formItem"><strong>FD&C YELLOW NO. 6</strong> (UNII: H77VEI93A8) </td><td class="formItem"> </td> </tr> <tr class="formTableRow"> <td class="formItem"><strong>HYDROXYPROPYL CELLULOSE, UNSPECIFIED</strong> (UNII: 9XZ8H6N6OH) </td><td class="formItem"> </td> </tr> <tr class="formTableRowAlt"> <td class="formItem"><strong>HYPROMELLOSE, UNSPECIFIED</strong> (UNII: 3NXW29V3WO) </td><td class="formItem"> </td> </tr> <tr class="formTableRow"> <td class="formItem"><strong>MAGNESIUM STEARATE</strong> (UNII: 70097M6I30) </td><td class="formItem"> </td> </tr> <tr class="formTableRowAlt"> <td class="formItem"><strong>MICROCRYSTALLINE CELLULOSE</strong> (UNII: OP1R32D61U) </td><td class="formItem"> </td> </tr> <tr class="formTableRow"> <td class="formItem"><strong>POLYETHYLENE GLYCOL, UNSPECIFIED</strong> (UNII: 3WJQ0SDW1A) </td><td class="formItem"> </td> </tr> <tr class="formTableRowAlt"> <td class="formItem"><strong>SODIUM LAURYL SULFATE</strong> (UNII: 368GB5141J) </td><td class="formItem"> </td> </tr> <tr class="formTableRow"> <td class="formItem"><strong>TITANIUM DIOXIDE</strong> (UNII: 15FIX9V2JP) </td><td class="formItem"> </td> </tr> </table> </td> </tr> <tr> <td> <table cellpadding="3" cellspacing="0" class="formTablePetite" width="100%"> <tr> <td class="formHeadingTitle" colspan="4">Product Characteristics</td> </tr> <tr class="formTableRowAlt"> <td class="formLabel">Color</td><td class="formItem">ORANGE</td><td class="formLabel">Score</td><td class="formItem">no score</td> </tr> <tr class="formTableRow"> <td class="formLabel">Shape</td><td class="formItem">ROUND</td><td class="formLabel">Size</td><td class="formItem">6mm</td> </tr> <tr class="formTableRowAlt"> <td class="formLabel">Flavor</td><td class="formItem"></td><td class="formLabel">Imprint Code</td><td class="formItem"> M;54;10 </td> </tr> <tr class="formTableRow"> <td class="formLabel">Contains</td><td class="formItem"> </td> </tr> </table> </td> </tr> <tr> <td> <table cellpadding="3" cellspacing="0" class="formTablePetite" width="100%"> <tr> <td class="formHeadingTitle" colspan="5">Packaging</td> </tr> <tr> <th class="formTitle" scope="col" width="1">#</th><th class="formTitle" scope="col">Item Code</th><th class="formTitle" scope="col">Package Description</th><th class="formTitle" scope="col">Marketing Start Date</th><th class="formTitle" scope="col">Marketing End Date</th> </tr> <tr class="formTableRowAlt"> <th class="formItem" scope="row">1</th><td class="formItem">NDC:0378-0612-01</td><td class="formItem">100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product</td><td class="formItem">03/15/1983</td><td class="formItem"></td> </tr> </table> </td> </tr> <tr> <td></td> </tr> <tr> <td class="normalizer"> <table cellpadding="3" cellspacing="0" class="formTableMorePetite" width="100%"> <tr> <td class="formHeadingReg" colspan="4"><span class="formHeadingTitle">Marketing Information</span></td> </tr> <tr> <th class="formTitle" scope="col">Marketing Category</th><th class="formTitle" scope="col">Application Number or Monograph Citation</th><th class="formTitle" scope="col">Marketing Start Date</th><th class="formTitle" scope="col">Marketing End Date</th> </tr> <tr class="formTableRowAlt"> <td class="formItem">ANDA</td><td class="formItem">ANDA088004</td><td class="formItem">03/15/1983</td><td class="formItem"></td> </tr> </table> </td> </tr> </tbody> </table> <table cellpadding="3" cellspacing="0" class="contentTablePetite" width="100%"> <tbody> <tr> <td class="contentTableTitle"><strong>THIORIDAZINE HYDROCHLORIDE </strong> <br/> <span class="contentTableReg">thioridazine hydrochloride tablet, film coated</span></td> </tr> <tr> <td> <table cellpadding="5" cellspacing="0" class="formTablePetite" width="100%"> <tr> <td class="formHeadingTitle" colspan="4">Product Information</td> </tr> <tr class="formTableRowAlt"> <td class="formLabel">Product Type</td><td class="formItem">HUMAN PRESCRIPTION DRUG</td><td class="formLabel">Item Code (Source)</td><td class="formItem">NDC:0378-0614</td> </tr> <tr class="formTableRow"> <td class="formLabel" width="30%">Route of Administration</td><td class="formItem">ORAL</td> </tr> </table> </td> </tr> <tr> <td> <table cellpadding="3" cellspacing="0" class="formTablePetite" width="100%"> <tr> <td class="formHeadingTitle" colspan="3">Active Ingredient/Active Moiety</td> </tr> <tr> <th class="formTitle" scope="col">Ingredient Name</th><th class="formTitle" scope="col">Basis of Strength</th><th class="formTitle" scope="col">Strength</th> </tr> <tr class="formTableRowAlt"> <td class="formItem"><strong>THIORIDAZINE HYDROCHLORIDE</strong> (UNII: 4WCI67NK8M) (THIORIDAZINE - UNII:N3D6TG58NI) </td><td class="formItem">THIORIDAZINE HYDROCHLORIDE</td><td class="formItem">25 mg</td> </tr> </table> </td> </tr> <tr> <td> <table cellpadding="3" cellspacing="0" class="formTablePetite" width="100%"> <tr> <td class="formHeadingTitle" colspan="2">Inactive Ingredients</td> </tr> <tr> <th class="formTitle" scope="col">Ingredient Name</th><th class="formTitle" scope="col">Strength</th> </tr> <tr class="formTableRowAlt"> <td class="formItem"><strong>SILICON DIOXIDE</strong> (UNII: ETJ7Z6XBU4) </td><td class="formItem"> </td> </tr> <tr class="formTableRow"> <td class="formItem"><strong>CROSCARMELLOSE SODIUM</strong> (UNII: M28OL1HH48) </td><td class="formItem"> </td> </tr> <tr class="formTableRowAlt"> <td class="formItem"><strong>FD&C YELLOW NO. 6</strong> (UNII: H77VEI93A8) </td><td class="formItem"> </td> </tr> <tr class="formTableRow"> <td class="formItem"><strong>HYDROXYPROPYL CELLULOSE, UNSPECIFIED</strong> (UNII: 9XZ8H6N6OH) </td><td class="formItem"> </td> </tr> <tr class="formTableRowAlt"> <td class="formItem"><strong>HYPROMELLOSE, UNSPECIFIED</strong> (UNII: 3NXW29V3WO) </td><td class="formItem"> </td> </tr> <tr class="formTableRow"> <td class="formItem"><strong>MAGNESIUM STEARATE</strong> (UNII: 70097M6I30) </td><td class="formItem"> </td> </tr> <tr class="formTableRowAlt"> <td class="formItem"><strong>MICROCRYSTALLINE CELLULOSE</strong> (UNII: OP1R32D61U) </td><td class="formItem"> </td> </tr> <tr class="formTableRow"> <td class="formItem"><strong>POLYETHYLENE GLYCOL, UNSPECIFIED</strong> (UNII: 3WJQ0SDW1A) </td><td class="formItem"> </td> </tr> <tr class="formTableRowAlt"> <td class="formItem"><strong>SODIUM LAURYL SULFATE</strong> (UNII: 368GB5141J) </td><td class="formItem"> </td> </tr> <tr class="formTableRow"> <td class="formItem"><strong>TITANIUM DIOXIDE</strong> (UNII: 15FIX9V2JP) </td><td class="formItem"> </td> </tr> </table> </td> </tr> <tr> <td> <table cellpadding="3" cellspacing="0" class="formTablePetite" width="100%"> <tr> <td class="formHeadingTitle" colspan="4">Product Characteristics</td> </tr> <tr class="formTableRowAlt"> <td class="formLabel">Color</td><td class="formItem">ORANGE</td><td class="formLabel">Score</td><td class="formItem">no score</td> </tr> <tr class="formTableRow"> <td class="formLabel">Shape</td><td class="formItem">ROUND</td><td class="formLabel">Size</td><td class="formItem">7mm</td> </tr> <tr class="formTableRowAlt"> <td class="formLabel">Flavor</td><td class="formItem"></td><td class="formLabel">Imprint Code</td><td class="formItem"> M;58;25 </td> </tr> <tr class="formTableRow"> <td class="formLabel">Contains</td><td class="formItem"> </td> </tr> </table> </td> </tr> <tr> <td> <table cellpadding="3" cellspacing="0" class="formTablePetite" width="100%"> <tr> <td class="formHeadingTitle" colspan="5">Packaging</td> </tr> <tr> <th class="formTitle" scope="col" width="1">#</th><th class="formTitle" scope="col">Item Code</th><th class="formTitle" scope="col">Package Description</th><th class="formTitle" scope="col">Marketing Start Date</th><th class="formTitle" scope="col">Marketing End Date</th> </tr> <tr class="formTableRowAlt"> <th class="formItem" scope="row">1</th><td class="formItem">NDC:0378-0614-01</td><td class="formItem">100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product</td><td class="formItem">03/15/1983</td><td class="formItem"></td> </tr> </table> </td> </tr> <tr> <td></td> </tr> <tr> <td class="normalizer"> <table cellpadding="3" cellspacing="0" class="formTableMorePetite" width="100%"> <tr> <td class="formHeadingReg" colspan="4"><span class="formHeadingTitle">Marketing Information</span></td> </tr> <tr> <th class="formTitle" scope="col">Marketing Category</th><th class="formTitle" scope="col">Application Number or Monograph Citation</th><th class="formTitle" scope="col">Marketing Start Date</th><th class="formTitle" scope="col">Marketing End Date</th> </tr> <tr class="formTableRowAlt"> <td class="formItem">ANDA</td><td class="formItem">ANDA088004</td><td class="formItem">03/15/1983</td><td class="formItem"></td> </tr> </table> </td> </tr> </tbody> </table> <table cellpadding="3" cellspacing="0" class="contentTablePetite" width="100%"> <tbody> <tr> <td class="contentTableTitle"><strong>THIORIDAZINE HYDROCHLORIDE </strong> <br/> <span class="contentTableReg">thioridazine hydrochloride tablet, film coated</span></td> </tr> <tr> <td> <table cellpadding="5" cellspacing="0" class="formTablePetite" width="100%"> <tr> <td class="formHeadingTitle" colspan="4">Product Information</td> </tr> <tr class="formTableRowAlt"> <td class="formLabel">Product Type</td><td class="formItem">HUMAN PRESCRIPTION DRUG</td><td class="formLabel">Item Code (Source)</td><td class="formItem">NDC:0378-0616</td> </tr> <tr class="formTableRow"> <td class="formLabel" width="30%">Route of Administration</td><td class="formItem">ORAL</td> </tr> </table> </td> </tr> <tr> <td> <table cellpadding="3" cellspacing="0" class="formTablePetite" width="100%"> <tr> <td class="formHeadingTitle" colspan="3">Active Ingredient/Active Moiety</td> </tr> <tr> <th class="formTitle" scope="col">Ingredient Name</th><th class="formTitle" scope="col">Basis of Strength</th><th class="formTitle" scope="col">Strength</th> </tr> <tr class="formTableRowAlt"> <td class="formItem"><strong>THIORIDAZINE HYDROCHLORIDE</strong> (UNII: 4WCI67NK8M) (THIORIDAZINE - UNII:N3D6TG58NI) </td><td class="formItem">THIORIDAZINE HYDROCHLORIDE</td><td class="formItem">50 mg</td> </tr> </table> </td> </tr> <tr> <td> <table cellpadding="3" cellspacing="0" class="formTablePetite" width="100%"> <tr> <td class="formHeadingTitle" colspan="2">Inactive Ingredients</td> </tr> <tr> <th class="formTitle" scope="col">Ingredient Name</th><th class="formTitle" scope="col">Strength</th> </tr> <tr class="formTableRowAlt"> <td class="formItem"><strong>SILICON DIOXIDE</strong> (UNII: ETJ7Z6XBU4) </td><td class="formItem"> </td> </tr> <tr class="formTableRow"> <td class="formItem"><strong>CROSCARMELLOSE SODIUM</strong> (UNII: M28OL1HH48) </td><td class="formItem"> </td> </tr> <tr class="formTableRowAlt"> <td class="formItem"><strong>FD&C YELLOW NO. 6</strong> (UNII: H77VEI93A8) </td><td class="formItem"> </td> </tr> <tr class="formTableRow"> <td class="formItem"><strong>HYDROXYPROPYL CELLULOSE, UNSPECIFIED</strong> (UNII: 9XZ8H6N6OH) </td><td class="formItem"> </td> </tr> <tr class="formTableRowAlt"> <td class="formItem"><strong>HYPROMELLOSE, UNSPECIFIED</strong> (UNII: 3NXW29V3WO) </td><td class="formItem"> </td> </tr> <tr class="formTableRow"> <td class="formItem"><strong>MAGNESIUM STEARATE</strong> (UNII: 70097M6I30) </td><td class="formItem"> </td> </tr> <tr class="formTableRowAlt"> <td class="formItem"><strong>MICROCRYSTALLINE CELLULOSE</strong> (UNII: OP1R32D61U) </td><td class="formItem"> </td> </tr> <tr class="formTableRow"> <td class="formItem"><strong>POLYETHYLENE GLYCOL, UNSPECIFIED</strong> (UNII: 3WJQ0SDW1A) </td><td class="formItem"> </td> </tr> <tr class="formTableRowAlt"> <td class="formItem"><strong>SODIUM LAURYL SULFATE</strong> (UNII: 368GB5141J) </td><td class="formItem"> </td> </tr> <tr class="formTableRow"> <td class="formItem"><strong>TITANIUM DIOXIDE</strong> (UNII: 15FIX9V2JP) </td><td class="formItem"> </td> </tr> </table> </td> </tr> <tr> <td> <table cellpadding="3" cellspacing="0" class="formTablePetite" width="100%"> <tr> <td class="formHeadingTitle" colspan="4">Product Characteristics</td> </tr> <tr class="formTableRowAlt"> <td class="formLabel">Color</td><td class="formItem">ORANGE</td><td class="formLabel">Score</td><td class="formItem">no score</td> </tr> <tr class="formTableRow"> <td class="formLabel">Shape</td><td class="formItem">ROUND</td><td class="formLabel">Size</td><td class="formItem">9mm</td> </tr> <tr class="formTableRowAlt"> <td class="formLabel">Flavor</td><td class="formItem"></td><td class="formLabel">Imprint Code</td><td class="formItem"> M;59;50 </td> </tr> <tr class="formTableRow"> <td class="formLabel">Contains</td><td class="formItem"> </td> </tr> </table> </td> </tr> <tr> <td> <table cellpadding="3" cellspacing="0" class="formTablePetite" width="100%"> <tr> <td class="formHeadingTitle" colspan="5">Packaging</td> </tr> <tr> <th class="formTitle" scope="col" width="1">#</th><th class="formTitle" scope="col">Item Code</th><th class="formTitle" scope="col">Package Description</th><th class="formTitle" scope="col">Marketing Start Date</th><th class="formTitle" scope="col">Marketing End Date</th> </tr> <tr class="formTableRowAlt"> <th class="formItem" scope="row">1</th><td class="formItem">NDC:0378-0616-01</td><td class="formItem">100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product</td><td class="formItem">03/15/1983</td><td class="formItem"></td> </tr> </table> </td> </tr> <tr> <td></td> </tr> <tr> <td class="normalizer"> <table cellpadding="3" cellspacing="0" class="formTableMorePetite" width="100%"> <tr> <td class="formHeadingReg" colspan="4"><span class="formHeadingTitle">Marketing Information</span></td> </tr> <tr> <th class="formTitle" scope="col">Marketing Category</th><th class="formTitle" scope="col">Application Number or Monograph Citation</th><th class="formTitle" scope="col">Marketing Start Date</th><th class="formTitle" scope="col">Marketing End Date</th> </tr> <tr class="formTableRowAlt"> <td class="formItem">ANDA</td><td class="formItem">ANDA088004</td><td class="formItem">03/15/1983</td><td class="formItem"></td> </tr> </table> </td> </tr> </tbody> </table> <table cellpadding="3" cellspacing="0" class="contentTablePetite" width="100%"> <tbody> <tr> <td class="contentTableTitle"><strong>THIORIDAZINE HYDROCHLORIDE </strong> <br/> <span class="contentTableReg">thioridazine hydrochloride tablet, film coated</span></td> </tr> <tr> <td> <table cellpadding="5" cellspacing="0" class="formTablePetite" width="100%"> <tr> <td class="formHeadingTitle" colspan="4">Product Information</td> </tr> <tr class="formTableRowAlt"> <td class="formLabel">Product Type</td><td class="formItem">HUMAN PRESCRIPTION DRUG</td><td class="formLabel">Item Code (Source)</td><td class="formItem">NDC:0378-0618</td> </tr> <tr class="formTableRow"> <td class="formLabel" width="30%">Route of Administration</td><td class="formItem">ORAL</td> </tr> </table> </td> </tr> <tr> <td> <table cellpadding="3" cellspacing="0" class="formTablePetite" width="100%"> <tr> <td class="formHeadingTitle" colspan="3">Active Ingredient/Active Moiety</td> </tr> <tr> <th class="formTitle" scope="col">Ingredient Name</th><th class="formTitle" scope="col">Basis of Strength</th><th class="formTitle" scope="col">Strength</th> </tr> <tr class="formTableRowAlt"> <td class="formItem"><strong>THIORIDAZINE HYDROCHLORIDE</strong> (UNII: 4WCI67NK8M) (THIORIDAZINE - UNII:N3D6TG58NI) </td><td class="formItem">THIORIDAZINE HYDROCHLORIDE</td><td class="formItem">100 mg</td> </tr> </table> </td> </tr> <tr> <td> <table cellpadding="3" cellspacing="0" class="formTablePetite" width="100%"> <tr> <td class="formHeadingTitle" colspan="2">Inactive Ingredients</td> </tr> <tr> <th class="formTitle" scope="col">Ingredient Name</th><th class="formTitle" scope="col">Strength</th> </tr> <tr class="formTableRowAlt"> <td class="formItem"><strong>SILICON DIOXIDE</strong> (UNII: ETJ7Z6XBU4) </td><td class="formItem"> </td> </tr> <tr class="formTableRow"> <td class="formItem"><strong>CROSCARMELLOSE SODIUM</strong> (UNII: M28OL1HH48) </td><td class="formItem"> </td> </tr> <tr class="formTableRowAlt"> <td class="formItem"><strong>FD&C YELLOW NO. 6</strong> (UNII: H77VEI93A8) </td><td class="formItem"> </td> </tr> <tr class="formTableRow"> <td class="formItem"><strong>HYDROXYPROPYL CELLULOSE, UNSPECIFIED</strong> (UNII: 9XZ8H6N6OH) </td><td class="formItem"> </td> </tr> <tr class="formTableRowAlt"> <td class="formItem"><strong>HYPROMELLOSE, UNSPECIFIED</strong> (UNII: 3NXW29V3WO) </td><td class="formItem"> </td> </tr> <tr class="formTableRow"> <td class="formItem"><strong>MAGNESIUM STEARATE</strong> (UNII: 70097M6I30) </td><td class="formItem"> </td> </tr> <tr class="formTableRowAlt"> <td class="formItem"><strong>MICROCRYSTALLINE CELLULOSE</strong> (UNII: OP1R32D61U) </td><td class="formItem"> </td> </tr> <tr class="formTableRow"> <td class="formItem"><strong>POLYETHYLENE GLYCOL, UNSPECIFIED</strong> (UNII: 3WJQ0SDW1A) </td><td class="formItem"> </td> </tr> <tr class="formTableRowAlt"> <td class="formItem"><strong>SODIUM LAURYL SULFATE</strong> (UNII: 368GB5141J) </td><td class="formItem"> </td> </tr> <tr class="formTableRow"> <td class="formItem"><strong>TITANIUM DIOXIDE</strong> (UNII: 15FIX9V2JP) </td><td class="formItem"> </td> </tr> </table> </td> </tr> <tr> <td> <table cellpadding="3" cellspacing="0" class="formTablePetite" width="100%"> <tr> <td class="formHeadingTitle" colspan="4">Product Characteristics</td> </tr> <tr class="formTableRowAlt"> <td class="formLabel">Color</td><td class="formItem">ORANGE</td><td class="formLabel">Score</td><td class="formItem">no score</td> </tr> <tr class="formTableRow"> <td class="formLabel">Shape</td><td class="formItem">ROUND</td><td class="formLabel">Size</td><td class="formItem">10mm</td> </tr> <tr class="formTableRowAlt"> <td class="formLabel">Flavor</td><td class="formItem"></td><td class="formLabel">Imprint Code</td><td class="formItem"> M;61;100 </td> </tr> <tr class="formTableRow"> <td class="formLabel">Contains</td><td class="formItem"> </td> </tr> </table> </td> </tr> <tr> <td> <table cellpadding="3" cellspacing="0" class="formTablePetite" width="100%"> <tr> <td class="formHeadingTitle" colspan="5">Packaging</td> </tr> <tr> <th class="formTitle" scope="col" width="1">#</th><th class="formTitle" scope="col">Item Code</th><th class="formTitle" scope="col">Package Description</th><th class="formTitle" scope="col">Marketing Start Date</th><th class="formTitle" scope="col">Marketing End Date</th> </tr> <tr class="formTableRowAlt"> <th class="formItem" scope="row">1</th><td class="formItem">NDC:0378-0618-01</td><td class="formItem">100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product</td><td class="formItem">11/18/1983</td><td class="formItem"></td> </tr> </table> </td> </tr> <tr> <td></td> </tr> <tr> <td class="normalizer"> <table cellpadding="3" cellspacing="0" class="formTableMorePetite" width="100%"> <tr> <td class="formHeadingReg" colspan="4"><span class="formHeadingTitle">Marketing Information</span></td> </tr> <tr> <th class="formTitle" scope="col">Marketing Category</th><th class="formTitle" scope="col">Application Number or Monograph Citation</th><th class="formTitle" scope="col">Marketing Start Date</th><th class="formTitle" scope="col">Marketing End Date</th> </tr> <tr class="formTableRowAlt"> <td class="formItem">ANDA</td><td class="formItem">ANDA088004</td><td class="formItem">11/18/1983</td><td class="formItem"></td> </tr> </table> </td> </tr> </tbody> </table> <table cellpadding="3" cellspacing="0" class="formTableMorePetite" width="100%"> <tr> <td class="formHeadingReg" colspan="4"><span class="formHeadingTitle">Labeler - </span>Mylan Pharmaceuticals Inc. (059295980) </td> </tr> </table> </div> </li> </div> </ul> <div class="control-nav"> <a class="open-all" href="#" id="anch_dj_dj_460" style="display: inline;">View All Sections</a><a class="close-all" href="#" id="anch_dj_dj_461" style="display: none;">Close All Sections</a> </div> </div> </div> </article> <div class="articlefooternav"> <h2>Find additional resources</h2> <strong>(also available in the <a href="#leftmenu" id="anch_dj_dj_462">left menu</a>)</strong> <h3>Safety</h3> <p> <a href="#boxedwarning" id="anch_dj_462">Boxed Warnings</a>, <a href="//www.accessdata.fda.gov/scripts/medwatch/ " target="_blank" rel="noopener noreferrer" id="anch_dj_463">Report Adverse Events</a>, <a href="https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts" target="_blank" rel="noopener noreferrer" id="anch_dj_464">FDA Safety Recalls</a>, <a href="https://ncbi.nlm.nih.gov/books/n/lactmed/LM255" target="_blank" rel="noopener noreferrer" id="anch_dj_465">Presence in Breast Milk</a> </p> <h3>Related Resources</h3> <p> <a href="//vsearch.nlm.nih.gov/vivisimo/cgi-bin/query-meta?v:project=medlineplus&query=THIORIDAZINE" target="_blank" rel="noopener noreferrer" id="anch_dj_466">Medline Plus</a>, <a href="//www.clinicaltrials.gov/ct/search?submit=Search&term=THIORIDAZINE" target="_blank" rel="noopener noreferrer" id="anch_dj_467">Clinical Trials</a>, <a href="#pubmed-menu" id="pubmed-bottom">PubMed</a>, <a href="https://www.drugbank.ca/search?utf8=%E2%9C%93&query=APRD00596&search_type=drugs&button=" target="_blank" rel="noopener noreferrer" id="anch_dj_468">Biochemical Data Summary</a> </p> <h3>More Info on this Drug</h3> <p> <a href="#modal-label-archives" class="modal-open" id="anch_dj_470">View Labeling Archives</a>, <a href="#modal-rx-norm" class="modal-open" id="anch_dj_471">RxNorm</a>, <a href="#modal-label-rss" class="modal-open" id="anch_dj_472">Get Label RSS Feed</a>, <a href="#modal-codes" class="modal-open" id="anch_dj_473">View NDC Code(s)</a><span class="tag">NEW!</span> </p> </div> </div> <div class="divider"></div>  <div class="mfp-hide modal" id="modal-label-archives"> <div class="modal-wrapper"> <header><h2>View Labeling Archives for this drug</h2></header> <div class="top"> <h3 class="long-title">THIORIDAZINE HYDROCHLORIDE tablet, film coated<br></h3> <h4>Number of versions: 13</h4> </div> <div class="modal-content"> <table class="modal"> <tbody> <tr> <th>Published Date <a class="tip" rel="tooltip" href="#" title="<b>Published Date</b> - The date that a drug label is published on DailyMed for public view. This is distinct from <b>Updated Date</b>*. <br><br> *<b>Updated Date</b> (also known as <b>Effective Time</b>) - The label revision date included in the SPL.">(What is this?)</a></th>  <th>Version</th> <th>Files</th> </tr> <tr> <td>Nov 21, 2024</td> <td> 13 (current) </td> <td> <a download target="_blank" class="download-link" href="/dailymed/getArchivalFile.cfm?archive_id=846424">download</a> </td> </tr> <tr> <td>Oct 4, 2024</td> <td> 12 </td> <td> <a download target="_blank" class="download-link" href="/dailymed/getArchivalFile.cfm?archive_id=827891">download</a> </td> </tr> <tr> <td>Oct 27, 2021</td> <td> 11 </td> <td> <a download target="_blank" class="download-link" href="/dailymed/getArchivalFile.cfm?archive_id=605392">download</a> </td> </tr> <tr> <td>Jun 30, 2020</td> <td> 10 </td> <td> <a download target="_blank" class="download-link" href="/dailymed/getArchivalFile.cfm?archive_id=503538">download</a> </td> </tr> <tr> <td>Dec 3, 2018</td> <td> 9 </td> <td> <a download target="_blank" class="download-link" href="/dailymed/getArchivalFile.cfm?archive_id=357976">download</a> </td> </tr> <tr> <td>Nov 30, 2016</td> <td> 8 </td> <td> <a download target="_blank" class="download-link" href="/dailymed/getArchivalFile.cfm?archive_id=238268">download</a> </td> </tr> <tr> <td>Jun 23, 2014</td> <td> 7 </td> <td> <a download target="_blank" class="download-link" href="/dailymed/getArchivalFile.cfm?archive_id=143101">download</a> </td> </tr> <tr> <td>Jan 28, 2014</td> <td> 6 </td> <td> <a download target="_blank" class="download-link" href="/dailymed/getArchivalFile.cfm?archive_id=130021">download</a> </td> </tr> <tr> <td>Jun 28, 2013</td> <td> 5 </td> <td> <a download target="_blank" class="download-link" href="/dailymed/getArchivalFile.cfm?archive_id=111869">download</a> </td> </tr> <tr> <td>Dec 20, 2012</td> <td> 4 </td> <td> <a download target="_blank" class="download-link" href="/dailymed/getArchivalFile.cfm?archive_id=96111">download</a> </td> </tr> <tr> <td>Dec 14, 2010</td> <td> 3 </td> <td> <a download target="_blank" class="download-link" href="/dailymed/getArchivalFile.cfm?archive_id=44183">download</a> </td> </tr> <tr> <td>Mar 22, 2010</td> <td> 2 </td> <td> <a download target="_blank" class="download-link" href="/dailymed/getArchivalFile.cfm?archive_id=17543">download</a> </td> </tr> <tr> <td>Feb 9, 2007</td> <td> 1 </td> <td> <a download target="_blank" class="download-link" href="/dailymed/getArchivalFile.cfm?archive_id=3296">download</a> </td> </tr> </tbody> </table> </div> </div> </div>  <div class="mfp-hide modal" id="modal-rx-norm"> <div class="modal-wrapper"> <header><h2>RxNorm</h2></header> <div class="top"> <h3 class="long-title">THIORIDAZINE HYDROCHLORIDE tablet, film coated<br></h3> </div> <div class="modal-content"> <table class="modal"> <tbody> <tr> <th></th> <th>RxCUI</th> <th>RxNorm NAME</th> <th>RxTTY</th> </tr> <tr class="psn-rxtty"> <td>1</td> <td><a href="/dailymed/search.cfm?searchdb=rxcui&query=198270">198270</a></td> <td>thioridazine HCl 100 MG Oral Tablet</td> <td>PSN</td> </tr> <tr > <td>2</td> <td><a href="/dailymed/search.cfm?searchdb=rxcui&query=198270">198270</a></td> <td>thioridazine 100 MG Oral Tablet</td> <td>SCD</td> </tr> <tr class="psn-rxtty"> <td>3</td> <td><a href="/dailymed/search.cfm?searchdb=rxcui&query=198274">198274</a></td> <td>thioridazine HCl 25 MG Oral Tablet</td> <td>PSN</td> </tr> <tr > <td>4</td> <td><a href="/dailymed/search.cfm?searchdb=rxcui&query=198274">198274</a></td> <td>thioridazine 25 MG Oral Tablet</td> <td>SCD</td> </tr> <tr > <td>5</td> <td><a href="/dailymed/search.cfm?searchdb=rxcui&query=198274">198274</a></td> <td>thioridazine (as thioridazine hydrochloride) 25 MG Oral Tablet</td> <td>SY</td> </tr> <tr class="psn-rxtty"> <td>6</td> <td><a href="/dailymed/search.cfm?searchdb=rxcui&query=198275">198275</a></td> <td>thioridazine HCl 50 MG Oral Tablet</td> <td>PSN</td> </tr> <tr > <td>7</td> <td><a href="/dailymed/search.cfm?searchdb=rxcui&query=198275">198275</a></td> <td>thioridazine 50 MG Oral Tablet</td> <td>SCD</td> </tr> <tr > <td>8</td> <td><a href="/dailymed/search.cfm?searchdb=rxcui&query=198275">198275</a></td> <td>thioridazine (as thioridazine hydrochloride) 50 MG Oral Tablet</td> <td>SY</td> </tr> <tr class="psn-rxtty"> <td>9</td> <td><a href="/dailymed/search.cfm?searchdb=rxcui&query=313354">313354</a></td> <td>thioridazine HCl 10 MG Oral Tablet</td> <td>PSN</td> </tr> <tr > <td>10</td> <td><a href="/dailymed/search.cfm?searchdb=rxcui&query=313354">313354</a></td> <td>thioridazine 10 MG Oral Tablet</td> <td>SCD</td> </tr> </tbody> </table> </div> </div> </div>  <div class="mfp-hide modal" id="modal-label-rss"> <header><h2>Get Label RSS Feed for this Drug</h2></header> <div class="top"> <h3 class="long-title">THIORIDAZINE HYDROCHLORIDE tablet, film coated<br></h3> </div> <div class="modal-content"> <h4>To receive this label RSS feed</h4> <p>Copy the URL below and paste it into your RSS Reader application. <p><a href="/dailymed/labelrss.cfm?setid=56b3f4c2-52af-4947-b225-6808ae9f26f5" target="_blank">https://dailymed.nlm.nih.gov/dailymed/labelrss.cfm?setid=56b3f4c2-52af-4947-b225-6808ae9f26f5</a></p> <h4>To receive all DailyMed Updates for the last seven days</h4> <p>Copy the URL below and paste it into your RSS Reader application.</p> <p><a href="/dailymed/rss.cfm" target="_blank">https://dailymed.nlm.nih.gov/dailymed/rss.cfm</a></p> <h4>What will I get with the DailyMed RSS feed?</h4> <p>DailyMed will deliver notification of updates and additions to Drug Label information currently shown on this site through its RSS feed.</p> <p>DailyMed will deliver this notification to your desktop, Web browser, or e-mail depending on the RSS Reader you select to use. To view updated drug label links, paste the RSS feed address (URL) shown below into a RSS reader, or use a browser which supports RSS feeds, such as Safari for Mac OS X.</p> <h4>How to discontinue the RSS feed</h4> <p>If you no longer wish to have this DailyMed RSS service, simply delete the copied URL from your RSS Reader.</p> <a href="#" class="rss-icon"></a> <a href="/dailymed/rss-updates.cfm">More about getting RSS News & Updates from DailyMed</a> </div> </div>  <div class="mfp-hide modal" id="no-pill-photo-warning-modal">  <div class="modal-content"> <h4>Why is DailyMed no longer displaying pill images on the Search Results and Drug Info pages?</h4> <br> <p> Due to inconsistencies between the drug labels on DailyMed and the pill images provided by <a href="https://rximage.nlm.nih.gov/docs/doku.php?id=rximageapi_support" target="_blank" rel="noopener noreferrer">RxImage</a>, we no longer display the RxImage pill images associated with drug labels. </p> <p> We anticipate reposting the images once we are able identify and filter out images that do not match the information provided in the drug labels. </p> </div> </div>  <div class="mfp-hide modal" id="modal-codes"> <div class="modal-wrapper"> <header> <h2>NDC Codes</h2> </header> <div class="top"> <h3 class="long-title">THIORIDAZINE HYDROCHLORIDE tablet, film coated<br></h3> <h4>If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.</h4> </div> <div class="modal-content"> <table class="modal"> <tbody> <tr> <th></th> <th>NDC</th> </tr> <tr> <td>1</td> <td> 0378-0612-01 </td> </tr> <tr> <td>2</td> <td> 0378-0614-01 </td> </tr> <tr> <td>3</td> <td> 0378-0616-01 </td> </tr> <tr> <td>4</td> <td> 0378-0618-01 </td> </tr> </tbody> </table> </div> </div> </div> </div> </div> <div class="mobilenav no-js"> <ul> <li><a href="/dailymed/index.cfm">Home</a></li> <li>News <ul> <li><a href="/dailymed/dailymed-announcements.cfm">DailyMed Announcements</a></li> <li><a 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AGONIST,,GONADOTROPIN RELEASING HORMONE RECEPTOR AGONISTS,,GONADOTROPIN RELEASING HORMONE RECEPTOR ANTAGONISTS,,GROWTH HORMONE RECEPTOR ANTAGONIST,,GROWTH HORMONE RECEPTOR ANTAGONISTS,,GROWTH HORMONE RELEASING FACTOR ANALOG,,GROWTH HORMONE SECRETAGOGUE RECEPTOR AGONIST,,GROWTH HORMONE SECRETAGOGUE RECEPTOR AGONISTS,,GUANYLATE CYCLASE ACTIVATORS,,GUANYLATE CYCLASE-C AGONIST,,GUANYLATE CYCLASE STIMULATORS,,HCV NS3/4A PROTEASE INHIBITORS,,HEDGEHOG PATHWAY INHIBITOR,,HELICOBACTER PYLORI DIAGNOSTIC,,HEMATOLOGIC ACTIVITY ALTERATION,,HEMATOPOIETIC STEM CELL MOBILIZER,,HEPARIN BINDING ACTIVITY,,HEPARIN REVERSAL AGENT,,HEPATITIS B VIRUS NUCLEOSIDE ANALOG REVERSE TRANSCRIPTASE INHIBITOR,,HEPATITIS C VIRUS NON-NUCLEOSIDE NS5B PALM POLYMERASE INHIBITOR,,HEPATITIS C VIRUS NS3/4A PROTEASE INHIBITOR,,HEPATITIS C VIRUS NS5A INHIBITOR,,HEPATITIS C VIRUS NUCLEOTIDE ANALOG NS5B POLYMERASE INHIBITOR,,HER1 ANTAGONISTS,,HER2/NEU/CERBB2 ANTAGONISTS,,HER2/NEU RECEPTOR ANTAGONIST,,HERPES SIMPLEX VIRUS NUCLEOSIDE ANALOG DNA POLYMERASE INHIBITOR,,HERPESVIRUS NUCLEOSIDE ANALOG DNA POLYMERASE INHIBITOR,,HERPES ZOSTER VIRUS NUCLEOSIDE ANALOG DNA POLYMERASE INHIBITOR,,HISTAMINE-1 RECEPTOR ANTAGONIST,,HISTAMINE-1 RECEPTOR INHIBITOR,,HISTAMINE-2 RECEPTOR ANTAGONIST,,HISTAMINE H1 RECEPTOR ANTAGONISTS,,HISTAMINE H2 RECEPTOR ANTAGONISTS,,HISTAMINE RECEPTOR ANTAGONISTS,,HISTONE DEACETYLASE INHIBITOR,,HISTONE DEACETYLASE INHIBITORS,,HIV INTEGRASE INHIBITORS,,HIV PROTEASE INHIBITORS,,HMG-COA REDUCTASE INHIBITOR,,HUMAN ALPHA-1 PROTEINASE INHIBITOR,,HUMAN ANTIHEMOPHILIC FACTOR,,HUMAN BLOOD COAGULATION FACTOR,,HUMAN C1 ESTERASE INHIBITOR,,HUMAN IMMUNODEFICIENCY VIRUS 1 FUSION INHIBITOR,,HUMAN IMMUNODEFICIENCY VIRUS 1 NON-NUCLEOSIDE ANALOG REVERSE TRANSCRIPTASE INHIBITOR,,HUMAN IMMUNODEFICIENCY VIRUS INTEGRASE STRAND TRANSFER INHIBITOR,,HUMAN IMMUNODEFICIENCY VIRUS NUCLEOSIDE ANALOG REVERSE TRANSCRIPTASE INHIBITOR,,HUMAN IMMUNOGLOBULIN,,HUMAN IMMUNOGLOBULIN G,,HUMANIZED MONOCLONAL ANTIBODY FRAGMENT,,HUMAN PLATELET-DERIVED GROWTH FACTOR,,HUMAN SERUM ALBUMIN,,HYDROLYTIC LYSOSOMAL CHOLESTERYL ESTER-SPECIFIC ENZYME,,HYDROLYTIC LYSOSOMAL GLUCOCEREBROSIDE-SPECIFIC ENZYME,,HYDROLYTIC LYSOSOMAL GLYCOGEN-SPECIFIC ENZYME,,HYDROLYTIC LYSOSOMAL GLYCOSAMINOGLYCAN-SPECIFIC ENZYME,,HYDROLYTIC LYSOSOMAL NEUTRAL GLYCOSPHINGOLIPID-SPECIFIC ENZYME,,HYDROLYTIC LYSOSOMAL N-TERMINAL TRIPEPTIDYL PEPTIDASE,,HYDROLYTIC LYSOSOMAL TRIACYLGLYCEROL-SPECIFIC ENZYME,,HYDROXYMETHYLGLUTARYL-COA REDUCTASE INHIBITORS,,HYDROXYPHENYLPYRUVATE DIOXYGENASE INHIBITORS,,HYPERPOLARIZATION-ACTIVATED CYCLIC NUCLEOTIDE-GATED CHANNEL ANTAGONISTS,,HYPERPOLARIZATION-ACTIVATED CYCLIC NUCLEOTIDE-GATED CHANNEL BLOCKER,,IGE-DIRECTED ANTIBODY INTERACTIONS,,IMMUNOGLOBULIN G,,INACTIVATED BORDETELLA PERTUSSIS VACCINE,,INACTIVATED CLOSTRIDIUM TETANI VACCINE,,INACTIVATED CORYNEBACTERIUM DIPHTHERIAE VACCINE,,INACTIVATED HAEMOPHILUS INFLUENZAE B VACCINE,,INACTIVATED HEPATITIS A VIRUS VACCINE,,INACTIVATED HEPATITIS B VIRUS VACCINE,,INACTIVATED HUMAN PAPILLOMAVIRUS VACCINE,,INACTIVATED INFLUENZA A VIRUS VACCINE,,INACTIVATED JAPANESE ENCEPHALITIS VIRUS VACCINE,,INACTIVATED MENINGOCOCCAL VACCINE,,INACTIVATED PNEUMOCOCCAL VACCINE,,INACTIVATED POLIOVIRUS VACCINE,,INACTIVATED RABIES VIRUS VACCINE,,INACTIVATED SALMONELLA TYPHI VACCINE,,INCREASED ACETYLCHOLINE ACTIVITY,,INCREASED BLOOD PRESSURE,,INCREASED CALCIUM-SENSING RECEPTOR SENSITIVITY,,INCREASED CELLULAR DEATH,,INCREASED COAGULATION ACTIVITY,,INCREASED COAGULATION FACTOR ACTIVITY,,INCREASED COAGULATION FACTOR IX ACTIVITY,,INCREASED COAGULATION FACTOR VIII ACTIVITY,,INCREASED COAGULATION FACTOR VIII CONCENTRATION,,INCREASED COAGULATION FACTOR X ACTIVITY,,INCREASED CYTOKINE ACTIVITY,,INCREASED CYTOKINE PRODUCTION,,INCREASED DIURESIS AT LOOP OF HENLE,,INCREASED DIURESIS,,INCREASED DOPAMINE ACTIVITY,,INCREASED EPITHELIAL PROLIFERATION,,INCREASED ERYTHROID CELL PRODUCTION,,INCREASED FIBRIN POLYMERIZATION ACTIVITY,,INCREASED GHRH ACTIVITY,,INCREASED GLUCONEOGENESIS,,INCREASED GLUTATHIONE CONCENTRATION,,INCREASED GLYCOGENOLYSIS,,INCREASED HEMATOPOIETIC STEM CELL MOBILIZATION,,INCREASED HISTAMINE RELEASE,,INCREASED IGG PRODUCTION,,INCREASED IMMUNOLOGICALLY ACTIVE MOLECULE ACTIVITY,,INCREASED INTRAVASCULAR VOLUME,,INCREASED LARGE INTESTINAL MOTILITY,,INCREASED LYMPHOCYTE ACTIVATION,,INCREASED LYMPHOCYTE CELL PRODUCTION,,INCREASED MACROPHAGE PROLIFERATION,,INCREASED MEDULLARY RESPIRATORY DRIVE,,INCREASED MEGAKARYOCYTE MATURATION,,INCREASED MYELOID CELL PRODUCTION,,INCREASED NOREPINEPHRINE ACTIVITY,,INCREASED ONCOTIC PRESSURE,,INCREASED PLATELET AGGREGATION,,INCREASED PLATELET PRODUCTION,,INCREASED PROSTAGLANDIN ACTIVITY,,INCREASED PROTEIN BREAKDOWN,,INCREASED PROTEIN SYNTHESIS,,INCREASED PROTHROMBIN ACTIVITY,,INCREASED SYMPATHETIC ACTIVITY,,INCREASED THROMBOLYSIS,,INCREASED T LYMPHOCYTE ACTIVATION,,INCREASED T LYMPHOCYTE DESTRUCTION,,INCREASED UTERINE SMOOTH MUSCLE CONTRACTION OR TONE,,INFLUENZA A M2 PROTEIN INHIBITOR,,INHALATION DIAGNOSTIC AGENT,,INHIBITION GASTRIC ACID SECRETION,,INHIBITION LARGE INTESTINE FLUID/ELECTROLYTE ABSORPTION,,INHIBITION SMALL INTESTINE FLUID/ELECTROLYTE ABSORPTION,,INHIBIT OVUM FERTILIZATION,,INSECT PROTEINS,,INSULIN ANALOG,,INSULIN,,INSULIN,,INTEGRIN RECEPTOR ANTAGONIST,,INTEGRIN RECEPTOR ANTAGONISTS,,INTERFERON-ALPHA,,INTERFERON ALPHA,,INTERFERON GAMMA,,INTERFERON INDUCERS,,INTERLEUKIN-12 ANTAGONIST,,INTERLEUKIN-12 ANTAGONISTS,,INTERLEUKIN-17A ANTAGONIST,,INTERLEUKIN-17A ANTAGONISTS,,INTERLEUKIN-17 RECEPTOR A ANTAGONIST,,INTERLEUKIN 17 RECEPTOR A ANTAGONISTS,,INTERLEUKIN-1 RECEPTOR ANTAGONIST,,INTERLEUKIN 1 RECEPTOR ANTAGONISTS,,INTERLEUKIN-23 ANTAGONIST,,INTERLEUKIN-23 ANTAGONISTS,,INTERLEUKIN 2 RECEPTOR ANTAGONISTS,,INTERLEUKIN-2 RECEPTOR BLOCKING ANTIBODY,,INTERLEUKIN 2 RECEPTOR-DIRECTED ANTIBODY INTERACTIONS,,INTERLEUKIN-4 RECEPTOR ALPHA ANTAGONIST,,INTERLEUKIN 4 RECEPTOR ALPHA ANTAGONISTS,,INTERLEUKIN-5 ANTAGONIST,,INTERLEUKIN-5 ANTAGONISTS,,INTERLEUKIN 5 RECEPTOR ALPHA-DIRECTED ANTIBODY INTERACTIONS,,INTERLEUKIN-5 RECEPTOR ALPHA-DIRECTED CYTOLYTIC ANTIBODY,,INTERLEUKIN-6 ANTAGONIST,,INTERLEUKIN-6 ANTAGONISTS,,INTERLEUKIN-6 RECEPTOR ANTAGONIST,,INTERLEUKIN 6 RECEPTOR ANTAGONISTS,,INTESTINAL LIPASE INHIBITOR,,ION EXCHANGE ACTIVITY,,IRON CHELATING ACTIVITY,,IRON CHELATOR,,IRRIGATION,,ISOCITRATE DEHYDROGENASE 2 INHIBITOR,,ISOCITRATE DEHYDROGENASE 2 INHIBITORS,,JANUS KINASE INHIBITOR,,JANUS KINASE INHIBITORS,,KALLIKREIN INHIBITORS,,KETOLIDE ANTIBACTERIAL,,KINASE INHIBITOR,,KINASE INHIBITORS,,LEAD CHELATING ACTIVITY,,LEAD CHELATOR,,LEPTIN ANALOG,,LEPTIN,,LEUKOCYTE GROWTH FACTOR,,LEUKOTRIENE RECEPTOR ANTAGONIST,,LEUKOTRIENE RECEPTOR ANTAGONISTS,,LINCOSAMIDE ANTIBACTERIAL,,LIPASE INHIBITORS,,LIPID-BASED POLYENE ANTIFUNGAL,,LIPID EMULSION,,LIPOGLYCOPEPTIDE ANTIBACTERIAL,,LIPOPEPTIDE ANTIBACTERIAL,,LIVE ATTENUATED BACILLUS CALMETTE-GUERIN IMMUNOTHERAPY,,LIVE ATTENUATED BACILLUS CALMETTE-GUERIN VACCINE,,LIVE ATTENUATED HERPES ZOSTER VIRUS VACCINE,,LIVE ATTENUATED MEASLES VIRUS VACCINE,,LIVE ATTENUATED MUMPS VIRUS VACCINE,,LIVE ATTENUATED ROTAVIRUS VACCINE,,LIVE ATTENUATED RUBELLA VIRUS VACCINE,,LIVE ATTENUATED SALMONELLA TYPHI VACCINE,,LIVE ATTENUATED VARICELLA ZOSTER VIRUS VACCINE,,LIVE ATTENUATED YELLOW FEVER VIRUS VACCINE,,LIVE HUMAN ADENOVIRUS TYPE 4 VACCINE,,LIVE HUMAN ADENOVIRUS TYPE 7 VACCINE,,LIVE ROTAVIRUS VACCINE,,LIVE VACCINIA VIRUS VACCINE,,LOCAL ANESTHESIA,,LOCAL ANESTHETIC,,LOOP DIURETIC,,LOW MOLECULAR WEIGHT HEPARIN,,L-THYROXINE,,L-TRIIODOTHYRONINE,,LYMPHOCYTE FUNCTION ALTERATION,,LYMPHOCYTE FUNCTION-ASSOCIATED ANTIGEN-1 ANTAGONIST,,LYMPHOCYTE FUNCTION-ASSOCIATED ANTIGEN-1 ANTAGONISTS,,LYMPHOCYTE GROWTH FACTOR,,LYSOSOMAL BETA GLUCURONIDASE,,M2 PROTEIN INHIBITORS,,MACROLIDE ANTIBACTERIAL,,MACROLIDE ANTIMICROBIAL,,MACROLIDE,,MACROLIDES,,MAGNESIUM ION EXCHANGE ACTIVITY,,MAGNETIC RESONANCE CONTRAST ACTIVITY,,MAST CELL STABILIZER,,MELANIN SYNTHESIS INHIBITOR,,MELANIN SYNTHESIS INHIBITORS,,MELATONIN RECEPTOR AGONIST,,MELATONIN RECEPTOR AGONISTS,,METAL CHELATING ACTIVITY,,METAL CHELATOR,,METHYLATED SULFONAMIDE ANTIBACTERIAL,,METHYLATING ACTIVITY,,METHYLATING AGENT,,METHYLXANTHINE,,MICROSOMAL TRIGLYCERIDE TRANSFER PROTEIN INHIBITOR,,MICROSOMAL TRIGLYCERIDE TRANSFER PROTEIN INHIBITORS,,MICROTUBULE INHIBITION,,MICROTUBULE INHIBITOR,,MONOAMINE OXIDASE-B INHIBITORS,,MONOAMINE OXIDASE INHIBITOR,,MONOAMINE OXIDASE INHIBITORS,,MONOAMINE OXIDASE TYPE B INHIBITOR,,MONOBACTAM ANTIBACTERIAL,,MOOD STABILIZER,,MTOR INHIBITOR IMMUNOSUPPRESSANT,,MTOR INHIBITORS,,MUCOCUTANEOUS EPITHELIAL CELL GROWTH FACTOR,,MUCOLYTIC,,MULTIDRUG AND TOXIN EXTRUSION TRANSPORTER 1 INHIBITORS,,MU-OPIOID RECEPTOR AGONIST,,MUSCLE RELAXANT,,NATRIURETIC PEPTIDE,,N-CALCIUM CHANNEL RECEPTOR ANTAGONISTS,,NEPRILYSIN INHIBITOR,,NEPRILYSIN INHIBITORS,,NEURAMINIDASE INHIBITOR,,NEURAMINIDASE INHIBITORS,,NEUROKININ 1 ANTAGONISTS,,NEUROMUSCULAR DEPOLARIZING BLOCKADE,,NEUROMUSCULAR NONDEPOLARIZING BLOCKADE,,NICOTINIC ACID,,NITRATE VASODILATOR,,NITROFURAN ANTIBACTERIAL,,NITROGEN BINDING AGENT,,NITROIMIDAZOLE ANTIMICROBIAL,,NMDA RECEPTOR ANTAGONISTS,,N-METHYL-D-ASPARTATE RECEPTOR ANTAGONIST,,NONCOMPETITIVE AMPA GLUTAMATE RECEPTOR ANTAGONIST,,NONDEPOLARIZING NEUROMUSCULAR BLOCKER,,NONERGOT DOPAMINE AGONIST,,NON-NARCOTIC ANTITUSSIVE,,NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS,,NON-STANDARDIZED ANIMAL DANDER ALLERGENIC EXTRACT,,NON-STANDARDIZED ANIMAL HAIR ALLERGENIC EXTRACT,,NON-STANDARDIZED ANIMAL SKIN ALLERGENIC EXTRACT,,NON-STANDARDIZED BACTERIAL ALLERGENIC EXTRACT,,NON-STANDARDIZED CHEMICAL ALLERGEN,,NON-STANDARDIZED FEATHER ALLERGENIC EXTRACT,,NON-STANDARDIZED FOOD ALLERGENIC EXTRACT,,NON-STANDARDIZED FUNGAL ALLERGENIC EXTRACT,,NON-STANDARDIZED HOUSE DUST ALLERGENIC EXTRACT,,NON-STANDARDIZED INSECT ALLERGENIC EXTRACT,,NON-STANDARDIZED INSECT VENOM ALLERGENIC EXTRACT,,NON-STANDARDIZED PLANT ALLERGENIC EXTRACT,,NON-STANDARDIZED PLANT FIBER ALLERGENIC EXTRACT,,NON-STANDARDIZED POLLEN ALLERGENIC EXTRACT,,NONSTEROIDAL ANTI-INFLAMMATORY COMPOUNDS,,NONSTEROIDAL ANTI-INFLAMMATORY DRUG,,NOREPINEPHRINE RELEASING AGENT,,NOREPINEPHRINE REUPTAKE INHIBITOR,,NOREPINEPHRINE UPTAKE INHIBITORS,,N-TYPE CALCIUM CHANNEL ANTAGONIST,,NUCLEIC ACID SYNTHESIS INHIBITORS,,NUCLEOSIDE ANALOG ANTIFUNGAL,,NUCLEOSIDE ANALOG ANTIVIRAL,,NUCLEOSIDE METABOLIC INHIBITOR,,NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITORS,,OMEGA-3 FATTY ACID,,OPIOID AGONIST/ANTAGONIST,,OPIOID AGONIST,,OPIOID AGONISTS,,OPIOID ANTAGONIST,,OPIOID ANTAGONISTS,,OPIOID MU-RECEPTOR AGONISTS,,OREXIN RECEPTOR ANTAGONIST,,OREXIN RECEPTOR ANTAGONISTS,,ORGANIC ANION TRANSPORTER 1 INHIBITORS,,ORGANIC ANION TRANSPORTER 3 INHIBITORS,,ORGANIC ANION TRANSPORTING POLYPEPTIDE 1B1 INHIBITORS,,ORGANIC ANION TRANSPORTING POLYPEPTIDE 1B3 INHIBITORS,,ORGANIC ANION TRANSPORTING POLYPEPTIDE 2B1 INHIBITORS,,ORGANIC CATION TRANSPORTER 1 INHIBITORS,,ORGANIC CATION TRANSPORTER 2 INHIBITORS,,OSMOTIC ACTIVITY,,OSMOTIC DIURETIC,,OSMOTIC LAXATIVE,,OXABOROLE ANTIFUNGAL,,OXAZOLIDINONE ANTIBACTERIAL,,OXIDATION-REDUCTION ACTIVITY,,OXIDATION-REDUCTION AGENT,,OXYTOCIC,,P2Y12 PLATELET INHIBITOR,,P2Y12 RECEPTOR ANTAGONISTS,,PARAMAGNETIC CONTRAST AGENT,,PARATHYROID HORMONE ANALOG,,PARATHYROID HORMONE,,PARATHYROID HORMONE-RELATED PEPTIDE ANALOG,,PARATHYROID HORMONE-RELATED PROTEIN,,PARENTERAL IRON REPLACEMENT,,PARTIAL CHOLINERGIC NICOTINIC AGONIST,,PARTIAL CHOLINERGIC NICOTINIC AGONISTS,,PARTIAL OPIOID AGONIST/ANTAGONIST,,PARTIAL OPIOID AGONIST,,PARTIAL OPIOID AGONISTS,,PASSIVELY ACQUIRED IMMUNITY,,PCSK9 INHIBITOR,,PCSK9 INHIBITORS,,PEDICULICIDE,,PENEM ANTIBACTERIAL,,PENICILLIN-CLASS ANTIBACTERIAL,,PEROXISOME PROLIFERATOR-ACTIVATED RECEPTOR ACTIVITY,,PEROXISOME PROLIFERATOR-ACTIVATED RECEPTOR ALPHA AGONISTS,,PEROXISOME PROLIFERATOR RECEPTOR ALPHA AGONIST,,PEROXISOME PROLIFERATOR RECEPTOR GAMMA AGONIST,,P-GLYCOPROTEIN INDUCERS,,P-GLYCOPROTEIN INHIBITORS,,P-GLYCOPROTEIN INTERACTIONS,,PHENOTHIAZINE,,PHENYLALANINE HYDROXYLASE ACTIVATOR,,PHENYLALANINE HYDROXYLASE ACTIVATORS,,PHOSPHATE BINDER,,PHOSPHATE CHELATING ACTIVITY,,PHOSPHODIESTERASE 3 INHIBITOR,,PHOSPHODIESTERASE 3 INHIBITORS,,PHOSPHODIESTERASE 4 INHIBITOR,,PHOSPHODIESTERASE 4 INHIBITORS,,PHOSPHODIESTERASE 5 INHIBITOR,,PHOSPHODIESTERASE 5 INHIBITORS,,PHOTOABSORPTION,,PHOTOACTIVATED RADICAL GENERATOR,,PHOTOENHANCER,,PHOTOSENSITIZING ACTIVITY,,PLASMA KALLIKREIN INHIBITOR,,PLASMA VOLUME EXPANDER,,PLATELET AGGREGATION INHIBITOR,,PLATELET-REDUCING AGENT,,PLATINUM-BASED DRUG,,PLEUROMUTILIN ANTIBACTERIAL,,POLLEN,,POLY(ADP-RIBOSE) POLYMERASE INHIBITOR,,POLY(ADP-RIBOSE) POLYMERASE INHIBITORS,,POLYENE ANTIFUNGAL,,POLYENE ANTIMICROBIAL,,POLYMERASE ACIDIC ENDONUCLEASE INHIBITOR,,POLYMERASE ACIDIC ENDONUCLEASE INHIBITORS,,POLYMYXIN-CLASS ANTIBACTERIAL,,PORPHYRIN PRECURSOR,,POSITRON EMITTING ACTIVITY,,POTASSIUM BINDER,,POTASSIUM CHANNEL ANTAGONISTS,,POTASSIUM CHANNEL BLOCKER,,POTASSIUM ION BINDING ACTIVITY,,POTASSIUM SALT,,POTASSIUM-SPARING DIURETIC,,PROGESTATIONAL HORMONE RECEPTOR ANTAGONISTS,,PROGESTERONE AGONIST/ANTAGONIST,,PROGESTERONE,,PROGESTIN ANTAGONIST,,PROGESTIN-CONTAINING INTRAUTERINE DEVICE,,PROGESTIN,,PROGRAMMED DEATH LIGAND-1 ANTAGONISTS,,PROGRAMMED DEATH LIGAND-1 BLOCKER,,PROGRAMMED DEATH LIGAND-1-DIRECTED ANTIBODY INTERACTIONS,,PROGRAMMED DEATH RECEPTOR-1 BLOCKING ANTIBODY,,PROGRAMMED DEATH RECEPTOR-1-DIRECTED ANTIBODY INTERACTIONS,,PROSTACYCLINE,,PROSTACYCLINE VASODILATOR,,PROSTACYCLIN RECEPTOR AGONIST,,PROSTACYCLIN RECEPTOR AGONISTS,,PROSTAGLANDIN ANALOG,,PROSTAGLANDIN E1 AGONIST,,PROSTAGLANDIN E1 ANALOG,,PROSTAGLANDIN RECEPTOR AGONISTS,,PROSTAGLANDINS,,PROTEASE-ACTIVATED RECEPTOR-1 ANTAGONIST,,PROTEASE-ACTIVATED RECEPTOR-1 ANTAGONISTS,,PROTEASE INHIBITOR,,PROTEASOME INHIBITOR,,PROTEASOME INHIBITORS,,PROTEIN KINASE INHIBITORS,,PROTEIN SYNTHESIS INHIBITORS,,PROTEOLYTIC ENZYME,,PROTON PUMP INHIBITOR,,PROTON PUMP INHIBITORS,,PROVITAMIN D2 COMPOUND,,PSORALEN,,PURINE ANTIMETABOLITE,,PYRETHROID,,PYRIDONE,,PYRIMIDINE ANALOG,,PYRIMIDINES,,PYRIMIDINE SYNTHESIS INHIBITOR,,PYROPHOSPHATE ANALOG DNA POLYMERASE INHIBITOR,,QUINOLONE ANTIMICROBIAL,,RADIOACTIVE ALPHA-PARTICLE EMITTING THERAPEUTIC AGENT,,RADIOACTIVE DIAGNOSTIC AGENT,,RADIOACTIVE THERAPEUTIC AGENT,,RADIOGRAPHIC CONTRAST AGENT,,RADIOPHARMACEUTICAL ACTIVITY,,RANK LIGAND BLOCKING ACTIVITY,,RANK LIGAND INHIBITOR,,RECEPTOR TYROSINE KINASE INHIBITORS,,RECOMBINANT ANTITHROMBIN,,RECOMBINANT HUMAN DEOXYRIBONUCLEASE 1,,RECOMBINANT HUMAN GROWTH HORMONE,,RECOMBINANT HUMAN INTERFERON BETA,,REDUCING AND COMPLEXING THIOL,,REDUCTION ACTIVITY,,RENAL DEHYDROPEPTIDASE INHIBITOR,,RENIN INHIBITOR,,RENIN INHIBITORS,,RESPIRATORY STIMULANT,,RESPIRATORY SYNCYTIAL VIRUS ANTI-F PROTEIN MONOCLONAL ANTIBODY,,RETINOID,,REVERSED ANTICOAGULATION ACTIVITY,,RHO KINASE INHIBITOR,,RHO KINASE INHIBITORS,,RIFAMYCIN ANTIBACTERIAL,,RIFAMYCIN ANTIMYCOBACTERIAL,,RNA REPLICASE INHIBITORS,,RNA SYNTHETASE INHIBITOR ANTIBACTERIAL,,RNA SYNTHETASE INHIBITORS,,SCLEROSING ACTIVITY,,SCLEROSING AGENT,,SELECTIVE ESTROGEN RECEPTOR MODULATORS,,SELECTIVE PROGESTERONE RECEPTOR MODULATORS,,SELECTIVE T CELL COSTIMULATION BLOCKER,,SELECTIVE T CELL COSTIMULATION MODULATOR,,SEROTONIN-1B AND SEROTONIN-1D RECEPTOR AGONIST,,SEROTONIN 1B RECEPTOR AGONISTS,,SEROTONIN 1D RECEPTOR AGONISTS,,SEROTONIN-2C RECEPTOR AGONIST,,SEROTONIN 2C RECEPTOR AGONISTS,,SEROTONIN-3 RECEPTOR ANTAGONIST,,SEROTONIN 3 RECEPTOR ANTAGONISTS,,SEROTONIN-4 RECEPTOR ANTAGONIST,,SEROTONIN 4 RECEPTOR ANTAGONISTS,,SEROTONIN AND NOREPINEPHRINE REUPTAKE INHIBITOR,,SEROTONIN REUPTAKE INHIBITOR,,SEROTONIN UPTAKE INHIBITORS,,SERUM ALBUMIN,,SIGMA-1 AGONIST,,SIGMA-1 RECEPTOR AGONISTS,,SKELETAL MUSCLE RELAXANT,,SKIN BARRIER ACTIVITY,,SKIN TEST ANTIGEN,,SLAMF7-DIRECTED ANTIBODY INTERACTIONS,,SLAMF7-DIRECTED IMMUNOSTIMULATORY ANTIBODY,,SMOOTHENED RECEPTOR ANTAGONISTS,,SODIUM-GLUCOSE COTRANSPORTER 2 INHIBITOR,,SODIUM-GLUCOSE TRANSPORTER 2 INHIBITORS,,SOLUBLE GUANYLATE CYCLASE STIMULATOR,,SOMATOSTATIN ANALOG,,SOMATOSTATIN RECEPTOR AGONISTS,,SPHINGOSINE 1-PHOSPHATE RECEPTOR MODULATOR,,SPHINGOSINE 1-PHOSPHATE RECEPTOR MODULATORS,,STANDARDIZED ANIMAL HAIR ALLERGENIC EXTRACT,,STANDARDIZED ANIMAL SKIN ALLERGENIC EXTRACT,,STANDARDIZED CHEMICAL ALLERGEN,,STANDARDIZED INSECT ALLERGENIC EXTRACT,,STANDARDIZED INSECT VENOM ALLERGENIC EXTRACT,,STANDARDIZED POLLEN ALLERGENIC EXTRACT,,STIMULANT LAXATIVE,,STIMULATION LARGE INTESTINE FLUID/ELECTROLYTE SECRETION,,STREPTOGRAMIN ANTIBACTERIAL,,SUBSTANCE P/NEUROKININ-1 RECEPTOR ANTAGONIST,,SUCROSE-SPECIFIC ENZYME,,SULFONAMIDE ANTIBACTERIAL,,SULFONAMIDE ANTIMICROBIAL,,SULFONE,,SULFONYLUREA,,SURFACTANT ACTIVITY,,SURFACTANT,,SURVIVAL MOTOR NEURON-2-DIRECTED RNA INTERACTION,,SYMPATHOMIMETIC AMINE ANORECTIC,,SYMPATHOMIMETIC-LIKE AGENT,,TETRACYCLINE-CLASS ANTIBACTERIAL,,TETRACYCLINE-CLASS ANTIMICROBIAL,,TETRACYCLINE-CLASS DRUG,,TETRACYCLINES,,THALIDOMIDE ANALOG,,THIAZIDE DIURETIC,,THIAZIDE-LIKE DIURETIC,,THIAZOLIDINEDIONE,,THROMBIN INHIBITORS,,THROMBOLYTIC AGENT,,THROMBOPOIETIN RECEPTOR AGONIST,,THROMBOPOIETIN RECEPTOR AGONISTS,,THYMIDINE PHOSPHORYLASE INHIBITOR,,THYMIDINE PHOSPHORYLASE INHIBITORS,,THYROID HORMONE SYNTHESIS INHIBITOR,,THYROID HORMONE SYNTHESIS INHIBITORS,,THYROID STIMULATING HORMONE,,TISSUE-NONSPECIFIC ALKALINE PHOSPHATASE,,T LYMPHOCYTE COSTIMULATION ACTIVITY BLOCKADE,,TOPOISOMERASE INHIBITOR,,TOPOISOMERASE INHIBITORS,,TRANSTHYRETIN-DIRECTED RNA INTERACTION,,TRICYCLIC ANTIDEPRESSANT,,TRYPSIN INHIBITORS,,TRYPTOPHAN HYDROXYLASE INHIBITOR,,TRYPTOPHAN HYDROXYLASE INHIBITORS,,TUBERCULOSIS SKIN TEST,,TUBULIN INHIBITING AGENT,,TUMOR NECROSIS FACTOR BLOCKER,,TUMOR NECROSIS FACTOR RECEPTOR BLOCKING ACTIVITY,,TYPICAL ANTIPSYCHOTIC,,TYROSINE KINASE INHIBITORS,,UDP GLUCURONOSYLTRANSFERASES INDUCERS,,UDP GLUCURONOSYLTRANSFERASES INHIBITORS,,UGT1A1 INHIBITORS,,UGT1A3 INHIBITORS,,UGT1A4 INHIBITORS,,UGT1A6 INHIBITORS,,UGT1A9 INHIBITORS,,UGT2B15 INHIBITORS,,UGT2B7 INHIBITORS,,ULTRASOUND CONTRAST ACTIVITY,,UNCOMPETITIVE NMDA RECEPTOR ANTAGONISTS,,UNCOMPETITIVE N-METHYL-D-ASPARTATE RECEPTOR ANTAGONIST,,UNFRACTIONATED HEPARIN,,URATE TRANSPORTER 1 INHIBITOR,,URATE TRANSPORTER 1 INHIBITORS,,UREASE INHIBITOR,,UREASE INHIBITORS,,URIC ACID-SPECIFIC ENZYME,,VACCINES, LIVE, UNATTENUATED,,VASCULAR ENDOTHELIAL GROWTH FACTOR-DIRECTED ANTIBODY INTERACTIONS,,VASCULAR ENDOTHELIAL GROWTH FACTOR INHIBITOR,,VASCULAR ENDOTHELIAL GROWTH FACTOR INHIBITORS,,VASCULAR ENDOTHELIAL GROWTH FACTOR RECEPTOR 2 ANTAGONIST,,VASCULAR SCLEROSING ACTIVITY,,VASOCONSTRICTION,,VASOCONSTRICTOR,,VASODILATION,,VASODILATOR,,VASOPRESSIN ANALOG,,VASOPRESSIN RECEPTOR ANTAGONIST,,VASOPRESSIN RECEPTOR ANTAGONISTS,,VASOPRESSIN V2 RECEPTOR ANTAGONIST,,VASOPRESSIN V2 RECEPTOR ANTAGONISTS,,VEGFR2 INHIBITORS,,VENOM NEUTRALIZATION,,VENOUS VASODILATION,,VESICULAR MONOAMINE TRANSPORTER 2 INHIBITOR,,VESICULAR MONOAMINE TRANSPORTER 2 INHIBITORS,,VINCA ALKALOID,,VIRUS NEUTRALIZATION,,VITAMIN A,,VITAMIN B12,,VITAMIN B6 ANALOG,,VITAMIN B 6,,VITAMIN C,,VITAMIN D2 ANALOG,,VITAMIN D3 ANALOG,,VITAMIN D 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