NAVANE?
(thiothixene) Capsules
(thiothixene hydrochloride) Concentrate
WARNING
Increased Mortality in Elderly Patients with Dementia-Related Psychosis - Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Navane is not approved for the treatment of patients with dementia-related psychosis
DESCRIPTION
Navane? (thiothixene) is a thioxanthene derivative.
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,Ndimethyl sulfonamide functional group is bonded to the thioxanthene nucleus.
Inert ingredients for the capsule formulations are: hard gelatin capsules (which contain gelatin and titanium dioxide may contain Yellow 10, Yellow 6, Blue 1, Green 3, Red 3, and other inert ingredients) lactose magnesium stearate sodium lauryl sulfate starch.
Inert ingredients for the oral concentrate formulation are: alcohol cherry flavor dextrose passion fruit flavor sorbitol solution water.
INDICATIONS
Navane is effective in the management of schizophrenia. Navane has not been evaluated in the management of behavioral complications in patients with mental retardation.
SIDE EFFECTS
NOTE: Not all of the following adverse reactions have been reported with Navane. However, since Navane 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 Navane is used.
