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Molindone Hydrochloride

Drug Approvals

(BANM, US Adopted Name, rINNM)

Synonyms: EN-1733A; Molindona, hidrocloruro de
BAN: Molindone Hydrochloride [BANM]
USAN: Molindone Hydrochloride
INN: Molindone Hydrochloride [rINNM (en)]
INN: Hidrocloruro de molindona [rINNM (es)]
INN: Molindone, Chlorhydrate de [rINNM (fr)]
INN: Molindoni Hydrochloridum [rINNM (la)]
INN: Молиндона Гидрохлорид [rINNM (ru)]
Chemical name: 3-Ethyl-1,5,6,7-tetrahydro-2-methyl-5-(morpholinomethyl)indol-4-one hydrochloride
Molecular formula: C16H24N2O2,HCl =312.8
CAS: 7416-34-4 (molindone); 15622-65-8 (molindone hydrochloride)
ATC code: N05AE02

Pharmacopoeias. In US.

The United States Pharmacopeia 31, 2008 (Molindone Hydrochloride). pHof a 1 % solution in water is between 4.0 and 5.0. Store in airtight containers. Protect from light.

Molindone Hydrochloride 5mg / 10mg / 25mg

Adverse Effects, Treatment, and Precautions

As for Chlorpromazine. Molindone hydrochloride is less likely to cause hypotension than chlorpromazine, and extrapyramidal effects may be frequent but less severe. The incidence of sedation is intermediate between that of chlorpromazine and of phenothiazines with a piperazine side-chain. Weight gain or loss may occur, but weight loss appears to be more prominent.

Effects on the liver. A report of hepatotoxicity, associated with a flu-like syndrome, in a patient given molindone. Symptoms and liver-enzyme values returned to normal on stopping the drug and recurred on rechallenge with low doses. The effect was probably due to a hypersensitivity reaction.

Interactions

As for Chlorpromazine.

Pharmacokinetics

Molindone is readily absorbed after oral doses, with peak concentrations of unchanged molindone occurring within about 1.5 hours. It is rapidly and extensively metabolised and a large number of metabolites have been identified. It is excreted in the urine and faeces mainly as metabolites and less than 2 to 3% as unchanged drug. The pharmacological effect from a single oral dose is reported to last for 24 to 36 hours.

Uses and Administration

Molindone is an indole derivative with general properties similar to those of the phenothiazine, chlorpromazine. It is given as the hydrochloride for the treatment of psychoses including schizophrenia.

The usual oral dose of molindone hydrochloride is 50 to 75 mg daily initially, increased in 3 or 4 days to 100 mg daily in severe or resistant conditions doses of up to 225 mg daily may be required. The maintenance dose can range from 15 to 225 mg daily according to severity of symptoms. The daily dose is usually divided into 3 or 4 portions.

Molindone should be given in reduced dosage to elderly or debilitated patients.

Psychiatric disorders. A systematic review found that, based on limited data, molindone appeared to be effective in schizophrenia and other severe psychoses but evidence of differences from other classical antipsychotics was lacking.

Preparations

The United States Pharmacopeia 31, 2008: Molindone Hydrochloride Tablets.

Proprietary Preparations

USA: Moban

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