Molindone Hydrochloride

INDICATIONS AND USAGE Molindone Hydrochloride Tablets, USP are indicated for the management of schizophrenia. The efficacy of Molindone Hydrochloride Tablets, USP in schizophrenia was established in clinical studies which enrolled newly hospitalized and chronically hospitalized, acutely ill, schizophrenic patients as subjects.

ADVERSE REACTIONS CNS Effects The most frequently occurring effect is initial drowsiness that generally subsides with continued usage of the drug or lowering of the dose. Noted less frequently were depression, hyperactivity and euphoria. Neurological Extrapyramidal Symptoms Extrapyramidal symptoms noted below may occur in susceptible individuals and are usually reversible with appropriate management. Akathisia Motor restlessness may occur early. Parkinson Syndrome Akinesia, characterized by rigidity, immobility and reduction of voluntary movements and tremor, have been observed. Occurrence is less frequent than akathisia.

Pregnancy Studies in pregnant patients have not been carried out. Reproduction studies have been performed in the following animals: Pregnant Rats oral dose— no adverse effect 20 mg/kg/day - 10 days no adverse effect 40 mg/kg/day - 10 days Pregnant Mice oral dose— slight increase resorptions 20 mg/kg/day - 10 days slight increase resorptions 40 mg/kg/day - 10 days Pregnant Rabbits oral dose— no adverse effect 5 mg/kg/day - 12 days no adverse effect 10 mg/kg/day - 12 days no adverse effect 20 mg/kg/day - 12 days Animal reproductive studies have not demonstrated a teratogenic potential.

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. WARNINGS 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. Molindone Hydrochloride Tablets are not approved for the treatment of patients with dementia-related psychosis (see BOXED WARNING ). Tardive Dyskinesia Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with antipsychotic drugs. Although the prevalence of the syndrome appears to be highest among the elderly, especially elderly women, it is impossible to rely upon prevalence estimates to predict, at the inception of antipsychotic treatment, which patients are likely to develop the syndrome. CONTRAINDICATIONS Molindone Hydrochloride Tablets are contraindicated in severe central nervous system depression (alcohol, barbiturates, narcotics, etc.) or comatose states, and in patients with known hypersensitivity to the drug.