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Drug Information for Thiothixene Capsules, USP (Sandoz Inc.): PRECAUTIONS
- ADVERSE REACTIONS
- HOW SUPPLIED
- Diseases/Conditions Related to Thiothixene Capsules, USP (Sandoz Inc.)
- Liens externes liés à Thiothixene Capsules, USP (Sandoz Inc.)
An antiemetic effect was observed in animal studies with thiothixene; since this effect may also occur in man, it is possible that thiothixene may mask signs of overdosage of toxic drugs and may obscure conditions such as intestinal obstruction and brain tumor.
In consideration of the known capability of thiothixene and certain other psychotropic drugs to precipitate convulsions, extreme caution should be used in patients with a history of convulsive disorders or those in a state of alcohol withdrawal, since it may lower the convulsive threshold. Although thiothixene potentiates the actions of the barbiturates, the dosage of the anticonvulsant therapy should not be reduced when thiothixene is administered concurrently.
Though exhibiting rather weak anticholinergic properties, thiothixene should be used with caution in patients who might be exposed to extreme heat or who are receiving atropine or related drugs.
Use with caution in patients with cardiovascular disease.
Caution as well as careful adjustment of the dosages is indicated when thiothixene is used in conjunction with other CNS depressants.
Also, careful observation should be made for pigmentary retinopathy, and lenticular pigmentation (fine lenticular pigmentation has been noted in a small number of patients treated with thiothixene for prolonged periods). Blood dyscrasias (agranulocytosis, pancytopenia, thrombocytopenic purpura), and liver damage (jaundice, biliary stasis), have been reported with related drugs.
Antipsychotic drugs, including thiothixene3, elevate prolactin levels; the elevation persists during chronic administration. Tissue culture experiments indicate that approximately one-third of human breast cancers are prolactin dependent in vitro, 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 antipsychotic drugs. Neither clinical studies nor epidemiologic studies conducted to date, however, have shown an association between chronic administration of these drugs and mammary tumorigenesis; the available evidence is considered too limited to be conclusive at this time.
Information for Patients
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.
Hepatic microsomal enzyme inducing agents, such as carbamazepine, were found to significantly increase the clearance of thiothixene. Patients receiving these drugs should be observed for signs of reduced thiothixene effectiveness.4,5
Due to a possible additive effect with hypotensive agents, patients receiving these drugs should be observed closely for signs of excessive hypotension when thiothixene is added to their drug regimen.6
- Drug Information Provided by National Library of Medicine (NLM).