May 24, 2017
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"Feb. 22, 2011 -- The FDA has issued a safety announcement notifying health care professionals that it has updated the pregnancy section of drug labels for the entire class of antipsychotic medications.

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Navane (thiothixene hcl) is effective in the management of schizophrenia. Navane (thiothixene hcl) has not been evaluated in the management of behavioral complications in patients with mental retardation.


Dosage of Navane (thiothixene hcl) 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 Navane (thiothixene hcl) therapy.

The use of Navane (thiothixene hcl) 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.


Navane (thiothixene) Capsules

Bottles of 100's:

1 mg (NDC 0049-5710-66)
2 mg (NDC 0049-5720-66)
5 mg (NDC 0049-5730-66)
10 mg (NDC 0049-5740-66)
20 mg (NDC 0049-5770-66)

Distributed by Roerig Division of Pfizer Inc,NY,NY,10017. Revised: December 2010


1. Worldwide Labeling Safety Report: Dyskinesia and Dyskinesia Tardive and Thiothixene, (16 Apr 02).

2. Worldwide Labeling Safety Report: Neuroleptic Malignant Syndrome and Thiothixene, (16 Apr 02).

3. Worldwide Labeling Safety Report: Hyperprolactinemia and Thiothixene, (16 Apr 02).

4. Ereshefsky L, Saklad SR, Watanabe MD, et al. Thiothixene Pharmacokinetic Interactions: A Study of Hepatic Enzyme Inducers, Clearance Inhibitors, and Demographic Variables. Journal of Clinical Psychopharmacology, 11(5):296-301, (1991).

5. Worldwide Labeling Safety Report: Drug Interaction and Thiothixene, (09 May 02).

6. McEvoy GK, Miller JL, Snow EK, et al. AHFS Drug Information. American Society of Health-System Pharmacists, Inc., p. 2334-2336, (2002).

7. Worldwide Labeling Safety Report: Menstrual Disorder and Thiothixene, (16 Apr 02).

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 1/3/2017

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