Molindone Hydrochloride

Pronunciation: moe-LIN-done HYE-droe-KLOR-ide
Class: Dihydroindolone derivative

Trade Names:
Moban
- Tablets 5 mg
- Tablets 10 mg
- Tablets 25 mg
- Tablets 50 mg

Pharmacology

Unknown. Exerts its effect on ascending reticular activating system.

Pharmacokinetics

Absorption

Rapidly absorbed. T max is 1.5 h.

Metabolism

Metabolism is rapid.

Elimination

Thirty-six metabolites are recognized with less than 2% to 3% unmetabolized molindone excreted in urine and feces.

Indications and Usage

Management of schizophrenia.

Contraindications

Severe CNS depression (eg, alcohol, barbiturates, narcotics) or comatose states; hypersensitivity to the drug.

Dosage and Administration

Adults and Children 12 yr of age and older Initial dose

PO 50 to 75 mg/day, increasing dosage to 100 mg/day in 3 or 4 days. Patients with severe symptoms may require 225 mg/day. Start elderly and debilitated patients on lower dosage.

Maintenance dose Mild symptoms

PO 5 to 15 mg 3 or 4 times daily.

Moderate symptoms

PO 10 to 25 mg 3 or 4 times daily.

Severe symptoms

PO 225 mg/day may be required.

Storage/Stability

Store at controlled room temperature (59° to 86°F). Protect from light.

Drug Interactions

Phenytoin, tetracyclines

This tablet's preparation contains calcium sulfate and may interfere with the absorption of phenytoin sodium and tetracycline.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Hypotension, tachycardia, transient, nonspecific T-wave changes.

CNS

Akathisia; depression; drowsiness; dystonic syndrome; euphoria; extrapyramidal reactions; hyperactivity; increased libido; Parkinson syndrome; seizures; tardive dyskinesia.

Dermatologic

Skin rash.

EENT

Blurred vision.

GI

Constipation; dry mouth; nausea; salivation.

Genitourinary

Amenorrhea; gynecomastia; initial heavy menses; priapism; urinary retention.

Hepatic

Altered liver function.

Lab Tests

Leucopenia, leukocytosis.

Metabolic-Nutritional

Galactorrhea.

Precautions

Warnings

Increased mortality

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death compared with those taking placebo. Over a course of a 10-wk controlled trial, the rate of death in drug-treated patients was about 4.5% compared with 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either CV (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature.


Pregnancy

Category C.

Lactation

Undetermined.

Children

Safety and efficacy not established in children younger than 12 yr of age.

Elderly

Start therapy with a reduced dosage.

Antiemetic effect

Molindone may have an antiemetic effect, which may obscure signs of intestinal obstruction or brain tumor.

Debilitated patients

Start therapy with a reduced dosage.

Increased activity

May occur.

NMS

This potentially fatal condition has been reported in association with antipsychotic agents. Signs and symptoms include hyperpyrexia, muscle rigidity, altered mental status, irregular pulse or BP, tachycardia, diaphoresis, and cardiac arrhythmias.

Prolactin levels

Antipsychotic drugs elevate prolactin levels; elevation persists during chronic administration.

Seizures

Convulsive seizures have been reported.

Tardive dyskinesia

This syndrome of potentially irreversible, involuntary dyskinetic movements has occurred with other antipsychotic agents. Incidence appears to be highest among elderly patients, especially elderly women.

Patient Information

  • Explain the risk of developing tardive dyskinesia.
  • Advise patient that dose may be slowly increased until max benefit is achieved and not to take more than prescribed or increase the dose more rapidly than advised.
  • Instruct patient not to stop taking molindone when symptoms have improved.
  • Tell patient to immediately report high fever, muscle rigidity, involuntary body or facial movements, altered mental status, irregular pulse, or sweating to health care provider.
  • Advise patient to avoid strenuous activity during periods of high temperature or humidity.
  • Advise patient that drug may cause drowsiness and to use caution while driving or performing other tasks requiring mental alertness.
  • Advise patient to notify health care provider if excessive drowsiness occurs.
  • Advise patient, family, or caregiver not to change the dose or stop taking molindone unless advised by health care provider.
  • Instruct patient to avoid alcoholic beverages and other depressants while taking this medication.

Copyright © 2009 Wolters Kluwer Health.

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