Drug Information for Thiothixene Capsules, USP (Sandoz Inc.): ADVERSE REACTIONS

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  • 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.

  • Cardiovascular Effects

  • Tachycardia, hypotension, lightheadedness, 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.

  • 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 noted with 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

  • Extrapyramidal symptoms, such as pseudo-parkinsonism, akathisia and dystonia have been reported (see Dystonia: Class Effect). 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.

  • 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 high potency and at higher doses of first generation antipsychotic drugs. An elevated risk of acute dystonia is observed in males and younger age groups.

  • Persistent Tardive Dyskinesia

  • As with all antipsychotic agents, tardive dyskinesia may appear in some patients on long term therapy with thiothixene1 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. (See WARNINGS Section.)

  • 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.

  • 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.

  • 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.

  • Endocrine/Reproductive

  • Hyperprolactinemia3; lactation, menstrual irregularities, 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.

  • 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.

  • 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.

  • 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.

  • DOSAGE AND ADMINISTRATION

  • Dosage of thiothixene capsules should be individually adjusted depending on the chronicity and severity of the symptoms of 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 capsules 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 is recommended. 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 is recommended.

    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.

  • Drug Information Provided by National Library of Medicine (NLM).
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