See Supplemental Patient Information
- Elderly patients with dementia-related psychosis are at an increased risk of death when treated with antipsychotic drugs [US Black Box Warning]
- This drug is not approved for the treatment of patients with dementia-related psychosis [US Black Box Warning]
- Risk of developing irreversible tardive dyskinesia increases as the duration of treatment and the total cumulative dose of antipsychotic drugs administered to the patient increases. Elderly women are more prone to the syndrome of potentially irreversible, involuntary, dyskinetic movements. Syndrome may remit, partially or completely, if antipsychotic treatment is withdrawn
- Antipsychotic treatment may suppress (or partially suppress) the signs and symptoms of the syndrome and thereby may possibly mask the underlying process
- Prescribe this drug in a manner that is most likely to minimize the risk of tardive dyskinesia. Discontinue therapy on occurrence of signs and symptoms of tardive dyskinesia. Reserve chronic antipsychotic treatment for patients who suffer from a chronic illness that is known to respond to antipsychotic drugs, and for whom alternative, equally effective, but potentially less harmful therapy is not available or appropriate. Prescribe the smallest dose and the shortest course of therapy producing a satisfactory clinical response in patients who do require chronic therapy. Periodically reassessed need for continued treatment
- Consider discontinuation of therapy on development of signs and symptoms of tardive dyskinesia; however, some patients may require therapy despite the presence of the syndrome
- Potentially fatal symptom complex such as neuroleptic malignant syndrome (NMS) has occurred in association with administration of antipsychotic drugs. Manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability
- Immediately discontinue antipsychotic drugs and other drugs not essential for concomitant therapy. Provide intensive symptomatic treatment, carefully monitor patients and provide treatment for concomitant serious medical problems for management of NMS
- Carefully consider potential reintroduction of drug therapy in patients recovered from NMS as recurrences of NMS may occur
- Risk for extrapyramidal and/or withdrawal symptoms following delivery, may occur in neonates exposed to antipsychotic drugs during the third trimester of pregnancy. Agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder have been reported in neonates
- Therapy may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery, especially during the first few days of therapy; patient should be cautioned accordingly
- Antiemetic effects may occur which may mask signs and symptoms of overdosage with certain drugs or of manifestations such as intestinal obstruction, and brain tumor
- Therapy should be use cautiously in patients with a history of convulsive disorders or those in a state of alcohol withdrawal, exposed to extreme heat or who are receiving atropine or related drugs, and in cardiovascular disease
- Pigmentary retinopathy, lenticular pigmentation, blood dyscrasias, and liver damage have been reported with this therapy
- Leukopenia, neutropenia, and agranulocytosis have occurred in association with this therapy. Pre-existing low white blood cell count (WBC) and history of drug-induced leukopenia/neutropenia are possible risk factors for leukopenia/neutropenia. Monitor CBC frequently during the first few months of therapy in patients having history of a clinically significant low WBC or a drug-induced leukopenia/neutropenia. Consider discontinuation of therapy at the first sign of a clinically significant decline in WBC in the absence of other causative factors. Monitor patients with clinically significant neutropenia for fever or other symptoms or signs of infection and treat promptly on occurrence of such symptoms or signs. Discontinue this drug in patients having severe neutropenia (ANC <1000/mm3; follow their WBC count until recovery
Cautions: Use cautiously in
- Elderly patients (dose reduction recommended)
- Dementia (increased risk of mortality)
- Cerebrovascular disease
- Cardiovascular disease
- CNS depressant use
- Seizure history or risk of seizures
- Alcohol withdrawal
- Hx of drug-induced leukopenia or neutropenia
- Leukopenia
Supplemental Patient Information
- Caution patients about operating hazardous machinery, including automobiles, until they are reasonably certain that therapy with this drug does not affect them adversely
- Advise patients to notify their physician if they become pregnant or are planning to become pregnant during therapy
- Advise patients to avoid alcohol while taking this drug
Pregnancy Category:NR
Breastfeeding: No published experience with thiothixene, hence other agents are preferred. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 10 June 2011).
Pricing data from www.DrugStore.com in U.S.A.
- Thiothixene 1 MG CAPS [Bottle] (SANDOZ)
90 mg = $22.99
270 mg = $49.97 - Thiothixene 5 MG CAPS [Bottle] (MYLAN)
90 mg = $37.99
270 mg = $93.97 - Navane 10 MG CAPS [Bottle] (PFIZER U.S.)
90 mg = $207.09
270 mg = $616.88 - Thiothixene 2 MG CAPS [Bottle] (MYLAN)
90 mg = $29.69
270 mg = $79.16 - Navane 2 MG CAPS [Bottle] (PFIZER U.S.)
90 mg = $101.36
270 mg = $291.02 - Navane 20 MG CAPS [Bottle] (PFIZER U.S.)
90 mg = $289.94
270 mg = $850.17 - Navane 5 MG CAPS [Bottle] (PFIZER U.S.)
90 mg = $139.99
270 mg = $409.96
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
