Molindone Hydrochloride (2 brand names, 3 dosage forms, 1 route)
Available dosage forms: TABLET, CAPSULE, CONCENTRATE.
Routes of administration: ORAL.
Brand Names
- MOBAN
- MOLINDONE HYDROCHLORIDE
Boxed 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. Molindone Hydrochloride Tablets, USP are not approved for the treatment of patients with dementia-related psychosis (see WARNINGS).
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.
Dosage and Administration
Initial and maintenance doses of Molindone Hydrochloride Tablets should be individualized.
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.
Drug Interactions
Potentiation of drugs administered concurrently with Molindone Hydrochloride has not been reported. Additionally, animal studies have not shown increased toxicity when Molindone Hydrochloride is given concurrently with representative members of three classes of drugs (i.e., barbiturates, chloral hydrate and antiparkinson drugs).
Overdosage
Symptomatic, supportive therapy should be the rule. Gastric lavage is indicated for the reduction of absorption of Molindone Hydrochloride which is freely soluble in water. Since the adsorption of Molindone Hydrochloride by activated charcoal has not been determined, the use of this antidote must be considered of theoretical value. Emesis in a comatose patient is contraindicated. Additionally, while the emetic effect of apomorphine is blocked by Molindone Hydrochloride in animals, this blocking effect has not been determined in humans. A significant increase in the rate of removal of unmetabolized Molindone Hydrochloride from the body by forced diuresis, peritoneal or renal dialysis would not be expected. (Only 2% of a single ingested dose of Molindone Hydrochloride is excreted unmetabolized in the urine). However, poor response of the patient may justify use of these procedures. While the use of laxatives or enemas might be based on general principles, the amount of unmetabolized Molindone Hydrochloride in feces is less than 1%. Extrapyramidal symptoms have responded to the use of Diphenhydramine (Benadryl®)*, Amantadine HCl (Symmetrel®)† and the synthetic anticholinergic antiparkinson agents, (i.e., Artane®‡, Cogentin®§, Akineton®¶).