Molindone Hydrochloride

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

Mechanism of Action

Pharmacology

Unknown. Exerts its effect on ascending reticular activating system.

Pharmacokinetics

Absorption

Molindone is rapidly absorbed.

Metabolism

Metabolism is rapid.

Elimination

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

Peak

Time to peak is 1.5 hr.

Duration

Duration is 24 to 36 hr.

Indications and Usage

Management of schizophrenia.

Contraindications

Comatose or severe drug-induced depressed states (eg, barbiturates); hypersensitivity to the drug.

Dosage and Administration

PO 50 to 75 mg/day, increasing dose 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.

PO 5 to 15 mg tid or qid.

PO 10 to 25 mg tid or qid.

PO 225 mg/day may be required.

Storage/Stability

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

Drug Interactions

None well documented.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Tachycardia; transient, nonspecific T-wave changes; hypotension.

CNS

Drowsiness; depression; hyperactivity; euphoria; extrapyramidal reactions; akathisia; Parkinson syndrome; dystonic syndrome; tardive dyskinesia; increased libido; seizures.

Dermatologic

Skin rash.

EENT

Blurred vision.

GI

Dry mouth; salivation; constipation; nausea.

Genitourinary

Urinary retention; priapism; amenorrhea; gynecomastia; heavy menses (initially).

Hepatic

Altered liver function.

Metabolic

Galactorrhea.

Precautions

Pregnancy

Safety not established.

Lactation

Undetermined.

Children

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

Elderly

Start therapy with a reduced dosage.

Debilitated patients

Start therapy with a reduced dosage.

Neuroleptic malignant syndrome (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 the elderly, especially elderly women.

Patient Information

• Explain name, dose, action, and potential side effects of drug, including 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 women to notify health care provider if pregnant, planning to become pregnant, or breastfeeding.
• Advise patient to notify health care provider if excessive drowsiness occurs.
• Instruct patient not to take any prescription or OTC medications, herbal preparations, or dietary supplements unless advised by the health care provider.
• Advise patient that follow-up visits will be required to monitor therapy and to keep appointments.
• 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.