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Thiothixene (Capsule)

Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/959

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SubjectPredicateObjectContext
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dailymed-drugs:959rdfs:labelThiothixene (Capsule)lld:dailymed
dailymed-drugs:959dailymed-instance:dosageDosage of thiothixene should be individually adjusted depending on the chronicity and severity of the schizophrenia. In general, small doses should be used initially and gradually increased to the optimal effective level, based on patient response. Some patients have been successfully maintained on once a day thiothixene therapy. The use of thiothixene in children under 12 years of age is not recommended because safe conditions for its use have not been established. In milder conditions, an initial dose of 2 mg three times daily. If indicated, a subsequent increase to 15 mg/day total daily dose is often effective. In more severe conditions, an initial dose of 5 mg twice daily. The usual optimal dose is 20 to 30 mg daily. If indicated, an increase to 60 mg/day total daily dose is often effective. Exceeding a total daily dose of 60 mg rarely increases the beneficial response.lld:dailymed
dailymed-drugs:959dailymed-instance:descripti...Thiothixene is a thioxanthene derivative. Specifically, it is the cis isomer of N,N-dimethyl-9-[3-(4-methyl-1-piperazinyl)-propylidene] thioxanthene-2-sulfonamide. It may be represented by the following structural formula: The thioxanthenes differ from the phenothiazines by the replacement of nitrogen in the central ring with a carbon-linked side chain fixed in space in a rigid structural configuration. An N,N-dimethyl sulfonamide functional group is bonded to the thioxanthene nucleus. Each capsule contains 1 mg, 2 mg, 5 mg or 10 mg of thiothixene and the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, powdered cellulose, pregelatinized starch and sodium lauryl sulfate. In addition, each of the empty gelatin capsulescontains gelatin and titanium dioxide and the following colorant agents: 1 mg - FD&C Blue No. 1, D&C Red No. 28, FD&C Red No. 40, FD&C Yellow No. 6 2 mg - FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6, D&C Yellow No. 10 5 mg - FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6 10 mg - FD&C Blue No. 1, FD&C Red No. 40, FD&C Yellow No. 6 The imprinting ink contains the following: black iron oxide, D&C Yellow No. 10 Aluminum Lake, FD&C Blue No. 1 Aluminum Lake, FD&C Blue No. 2 Aluminum Lake, FD&C Red No. 40 Aluminum Lake, propylene glycol and shellac glaze.lld:dailymed
dailymed-drugs:959dailymed-instance:clinicalP...Thiothixene is an antipsychotic of the thioxanthene series. Thiothixene possesses certain chemical and pharmacological similarities to the piperazine phenothiazines and differences from the aliphatic group of phenothiazines.lld:dailymed
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dailymed-drugs:959dailymed-instance:contraind...Thiothixene is contraindicated in patients with circulatory collapse, comatose states, central nervous system depression due to any cause, and blood dyscrasias. Thiothixene is contraindicated in individuals who have shown hypersensitivity to the drug. It is not known whether there is a cross sensitivity between the thioxanthenes and the phenothiazine derivatives, but this possibility should be considered.lld:dailymed
dailymed-drugs:959dailymed-instance:supplyThiothixene Capsules, USP are available containing 1 mg, 2 mg, 5 mg or 10 mg of thiothixene. The 1 mg product is a caramel and powder blue capsule imprinted in black ink with MYLAN 1001 on both body and cap. It is available as follows: NDC 0378-1001-01bottles of 100 capsules The 2 mg product is a caramel and yellow capsule imprinted in black ink with MYLAN 2002 on both body and cap. It is available as follows: NDC 0378-2002-01bottles of 100 capsules NDC 0378-2002-10bottles of 1000 capsules The 5 mg product is a caramel and white capsule imprinted in black ink with MYLAN 3005 on both body and cap. It is available as follows: NDC 0378-3005-01bottles of 100 capsules NDC 0378-3005-10bottles of 1000 capsules The 10 mg product is a caramel and peach capsule imprinted in black ink with MYLAN 5010 on both body and cap. It is available as follows: NDC 0378-5010-01bottles of 100 capsules NDC 0378-5010-10bottles of 1000 capsules Store at 20��to 25��C (68��to 77��F). [See USP for Controlled Room Temperature.] Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.lld:dailymed
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dailymed-drugs:959dailymed-instance:overdosag...Manifestations include muscular twitching, drowsiness and dizziness. Symptoms of gross overdosage may include CNS depression, rigidity, weakness, torticollis, tremor, salivation, dysphagia, hypotension, disturbances of gait, or coma.<br/>Treatment: Essentially symptomatic and supportive. Early gastric lavage is helpful. Keep patient under careful observation and maintain an open airway, since involvement of the extrapyramidal system may produce dysphagia and respiratory difficulty in severe overdosage. If hypotension occurs, the standard measures for managing circulatory shock should be used (I.V. fluids and/or vasoconstrictors). If a vasoconstrictor is needed, norepinephrine and phenylephrine are the most suitable drugs. Other pressor agents, including epinephrine, are not recommended, since phenothiazine derivatives may reverse the usual pressor action of these agents and cause further lowering of blood pressure. If CNS depression is marked, symptomatic treatment is indicated. Extrapyramidal symptoms may be treated with antiparkinson drugs. There are no data on the use of peritoneal or hemodialysis, but they are known to be of little value in phenothiazine intoxication.lld:dailymed
dailymed-drugs:959dailymed-instance:genericMe...Thiothixenelld:dailymed
dailymed-drugs:959dailymed-instance:fullNameThiothixene (Capsule)lld:dailymed
dailymed-drugs:959dailymed-instance:adverseRe...NOTE: Not all of the following adverse reactions have been reported with thiothixene. However, since thiothixene has certain chemical and pharmacologic similarities to the phenothiazines, all of the known side effects and toxicity associated with phenothiazine therapy should be borne in mind when thiothixene is used.<br/>Cardiovascular Effects: Tachycardia, hypotension, light-headedness, and syncope. In the event hypotension occurs, epinephrine should not be used as a pressor agent since a paradoxical further lowering of blood pressure may result. Nonspecific EKG changes have been observed in some patients receiving thiothixene. These changes are usually reversible and frequently disappear on continued thiothixene therapy. The incidence of these changes is lower than that observed with some phenothiazines. The clinical significance of these changes is not known.<br/>CNS Effects: Drowsiness, usually mild, may occur although it usually subsides with continuation of thiothixene therapy. The incidence of sedation appears similar to that of the piperazine group of phenothiazines but less than that of certain aliphatic phenothiazines. Restlessness, agitation and insomnia have been notedwith thiothixene. Seizures and paradoxical exacerbation of psychotic symptoms have occurred with thiothixene infrequently. Hyperreflexia has been reported in infants delivered from mothers having received structurally related drugs. In addition, phenothiazine derivatives have been associated with cerebral edema and cerebrospinal fluid abnormalities. Extrapyramidal symptoms, such as pseudoparkinsonism, akathisia and dystonia have been reported. Management of these extrapyramidal symptoms depends upon the type and severity. Rapid relief of acute symptoms may require the use of an injectable antiparkinson agent. More slowly emerging symptoms may be managed by reducing the dosage of thiothixene and/or administering an oral antiparkinson agent.<br/>Dystonia: Class Effect: Symptoms of dystonia, prolonged abnormal contractions of muscle groups, may occur in susceptible individuals during the first few days of treatment. Dystonic symptoms include: spasm of the neck muscles, sometimes progressing to tightness of the throat, swallowing difficulty, difficulty breathing, and/or protrusion of the tongue. While these symptoms can occur at low doses, they occur more frequently and with greater severity with highpotency and at higher doses of first generation antipsychotic drugs. An elevated risk of acute dystonia is observed in males and younger age groups.<br/>Persistent Tardive Dyskinesia: As with all antipsychotic agents, tardive dyskinesia may appear in some patients on long-term therapy or may occur after drug therapy has been discontinued. The syndrome is characterized by rhythmical involuntary movements of the tongue, face, mouth or jaw (e.g., protrusion of tongue, puffing of cheeks, puckering of mouth, chewing movements). Sometimes these may be accompanied by involuntary movements of extremities. Since early detection of tardive dyskinesia is important, patients should be monitored on an ongoing basis. It has been reported that fine vermicular movement of the tongue may be an early sign of the syndrome. If this or any other presentation of the syndrome is observed, the clinician should consider possible discontinuation of antipsychotic medication.<br/>Hepatic Effects: Elevations of serum transaminase and alkaline phosphatase, usually transient, have been infrequently observed in some patients. No clinically confirmed cases of jaundice attributable to thiothixene have been reported.<br/>Hematologic Effects: As is true with certain other psychotropic drugs, leukopenia and leucocytosis which are usually transient, can occur occasionally with thiothixene. Other antipsychotic drugs have been associated with agranulocytosis, eosinophilia, hemolytic anemia, thrombocytopenia and pancytopenia.<br/>Allergic Reactions: Rash, pruritus, urticaria, photosensitivity and rare cases of anaphylaxis have been reported with thiothixene. Undue exposure to sunlight should be avoided. Although not experienced with thiothixene, exfoliative dermatitis and contact dermatitis (in nursing personnel) have been reported with certain phenothiazines.<br/>Endocrine Disorders: Lactation, moderate breast enlargement and amenorrhea have occurred in a small percentage of females receiving thiothixene. If persistent, this may necessitate a reduction in dosage or the discontinuation of therapy. Phenothiazines have been associated with false positive pregnancy tests, gynecomastia, hypoglycemia, hyperglycemia and glycosuria.<br/>Autonomic Effects: Dry mouth, blurred vision, nasal congestion, constipation, increased sweating, increased salivation and impotence have occurred infrequently with thiothixene therapy. Phenothiazines have been associated with miosis, mydriasis, and adynamic ileus.<br/>Other Adverse Reactions: Hyperpyrexia, anorexia, nausea, vomiting, diarrhea, increase in appetite and weight, weakness or fatigue, polydipsia, and peripheral edema. Although not reported with thiothixene, evidence indicates there is a relationship between phenothiazine therapy and the occurrence of a systemic lupus erythematosus-like syndrome.<br/>Neuroleptic Malignant Syndrome (NMS): Please refer to the text regarding NMS in the WARNINGS section. NOTE: Sudden deaths have occasionally been reported in patients who have received certain phenothiazine derivatives. In some cases the cause of death was apparently cardiac arrest or asphyxia due to failure of the cough reflex. In others, the cause could not be determined nor could it be established that death was due to phenothiazine administration.lld:dailymed
dailymed-drugs:959dailymed-instance:indicatio...Thiothixene is effective in the management of schizophrenia. Thiothixene has not been evaluated in the management of behavioral complications in patients with mental retardation.lld:dailymed
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