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(molindone hydrochloride) Tablets, USP
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. MOBAN (molindone hydrochloride tablets) is not approved for the treatment of patients with dementia-related psychosis (see WARNINGS).
MOBAN (molindone hydrochloride) is a dihydroindolone compound which is not structurally related to the phenothiazines, the butyrophenones or the thioxanthenes.
MOBAN (molindone hydrochloride tablets) is 3-ethyl-6, 7-dihydro-2-methyl-5-(morpholinomethyl) indol-4 (5H)-one hydrochloride. It is a white to off-white crystalline powder, freely soluble in water and alcohol.
MOBAN (molindone hydrochloride tablets) Tablets contain the following inactive ingredients:
Calcium sulfate, lactose, magnesium stearate, microcrystalline cellulose and povidone.
The 5 mg strength also contains alginic acid, colloidal silicon dioxide and FD&C Yellow 6.
The 10 mg strength also contains alginic acid, colloidal silicon dioxide, FD&C Blue 2 and FD&C Red 40.
The 25 mg strength also contains alginic acid, colloidal silicon dioxide, D&C Yellow 10, FD&C Blue 2, and FD&C Yellow 6.
The 50 mg strength also contains FD&C Blue 2 and sodium starch glycolate.
Molindone Hydrochloride is represented by the following structural formula:
The empirical formula is C16H24N2O2 •HCl representing a molecular weight of 312.83.
What are the possible side effects of molindone (Moban)?
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop taking molindone and call your doctor at once if you have a serious side effect such as:
- very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, feeling like you might pass out;
- restless muscle movements in your eyes, tongue, jaw, or neck;
- tremor (uncontrolled shaking);
- trouble swallowing;
- seizure (convulsions);
- easy bruising or bleeding,...
Last reviewed on RxList: 1/13/2011
This monograph has been modified to include the generic and brand name in many instances.
Additional Moban Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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