Molindone

What it is used for

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.

How to take it

Initial and maintenance doses of Molindone Hydrochloride Tablets should be individualized.

Who should not take it

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.

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 ).

Other medicines and 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).

General

Some patients receiving Molindone Hydrochloride may note drowsiness initially and they should be advised against activities requiring mental alertness until their response to the drug has been established.

Increased activity has been noted in patients receiving Molindone Hydrochloride. Caution should be exercised where increased activity may be harmful.

Molindone Hydrochloride does not lower the seizure threshold in experimental animals to the degree noted with more sedating antipsychotic drugs. However, in humans convulsive seizures have been reported in a few instances.

The physician should be aware that this tablet preparation contains calcium sulfate as an excipient and that calcium ions may interfere with the absorption of preparations containing phenytoin sodium and tetracyclines.

Molindone Hydrochloride has an antiemetic effect in animals. A similar effect may occur in humans and may obscure signs of intestinal obstruction or brain tumor.

Antipsychotic drugs elevate prolactin levels; the elevation persists during chronic administration. Tissue culture experiments indicate that approximately one-third of human breast cancers are prolactin dependent in vitro, a factor of potential importance if the prescription of these drugs is contemplated in a patient with a previously detected breast cancer. Although disturbances such as galactorrhea, amenorrhea, gynecomastia, and impotence have been reported, the clinical significance of elevated serum prolactin levels is unknown for most patients. An increase in mammary neoplasms has been found in rodents after chronic administration of antipsychotic drugs. Some epidemiologic studies have indicated a potential association between chronic administration of prolactin- increasing antipsychotics and breast cancer.

Molindone Hydrochloride has not been shown effective in the management of behavioral complications in patients with mental retardation.