Dosing & Uses
Dosage Forms & Strengths
tablet
- 5mg
- 10mg
- 25mg
- 50mg
Schizophrenia
Indicated for the management of schizophrenia
Initial: 50-75 mg PO qDay; increase to 100 mg/day in 3-4 days; may titrate up or down based on severity of symptomatology and individual patient response
Maintenance
- Mild: 5-15 mg PO q6-8hr
- Moderate: 10-25 mg PO q6-8hr
- Severe: 225 mg/day PO may be required
Dosage Modifications
- Initiate at lower dose in elderly patients and debilitated patients
Dosing Considerations
- When stopping antipsychotics, gradually taper dose over 6-24 months to avoid withdrawal
Safety and efficacy not established
Use lower initial doses
Interactions
Interaction Checker
No Results

Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor

Adverse Effects
Frequency Not Defined
Drowsiness
Depression
Hyperactivity
Euphoria
Extrapyramidal symptoms
Akathisia
Parkinson syndrome
Dystonia
Tardive dyskineisa
Tachycardia
Nausea
Dry mouth
Salivation
Urinary retention
Constipation
Priapism
Amenorrhea
Gynecomastia
Galactorrhea
Libido increased
Leukopenia
Alteration in liver function tests
T-wave changes (transient, rare)
Lens opacities and pigmentary retinopathy
Rash
Warnings
Black Box Warnings
Patients with dementia-related psychosis who are treated with antipsychotic drugs are at an increased risk for death, as shown in short-term controlled trials; deaths in trials appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature
Not approved for treatment of patients with dementia-related psychosis
Contraindications
Documented hypersensitivity
Severe CNS depression (eg, alcohol, barbiturates, narcotics) or comatose states
Cautions
Tardive dyskinesia, a syndrome consisting of potentially irreversible, involuntary, dyskinetic movements, may develop in patients treated with antipsychotic drugs; if signs and symptoms of tardive dyskinesia appear in patients on antipsychotics, consider drug discontinuation; however, some patients may require treatment despite presence of the syndrome
May cause somnolence, postural hypotension, motor instability and sensory instability, which may lead to falls and, consequently, fractures or other injuries; complete fall-risk assessments for patients with diseases, conditions, or medications that could exacerbate these effects, when initiating antipsychotic treatment and recurrently for patients on long-term antipsychotic therapy
Neuroleptic malignant syndrome (NMS) reported with antipsychotic drug use; immediately discontinue therapy if it occurs along with nonessential concurrent therapy and administer intensive symptomatic treatment and monitor carefully; if patient requires antipsychotic drug treatment after recovery from NMS, it should be considered carefully and the patient monitored closely since recurrences of NMS have been reported
May cause drowsiness initially; advise patient against activities requiring mental alertness until response to the drug has been established
Convulsive seizures reported with use
Preparation contains calcium sulfate as an excipient; calcium ions may interfere with absorption of preparations containing phenytoin sodium and tetracyclines
Therapy may obscure signs of intestinal obstruction or brain tumor
Antipsychotic drugs elevate prolactin levels; elevation persists during long-term administration; although disturbances such as galactorrhea, amenorrhea, gynecomastia, and impotence have been reported, clinical significance of elevated serum prolactin levels is unknown for most patients
Therapy has not been shown effective in the management of behavioral complications in patients with mental retardation
In clinical trial and/or postmarketing experience, events of leukopenia/neutropenia and agranulocytosis have been reported temporally related to antipsychotic agents; possible risk factors for leukopenia/neutropenia include preexisting low white blood cell (WBC) count and history of drug-induced leukopenia/neutropenia; patients with clinically significant neutropenia should be carefully monitored for fever or other symptoms or signs of infection and treated promptly if such symptoms or signs occur; patients with severe neutropenia (absolute neutrophil count <1000/mm3) should discontinue therapy and have their WBC count followed until recovery
Pregnancy & Lactation
Pregnancy
Studies in pregnant patients have not been performed; animal reproductive studies have not demonstrated a teratogenic potential; anticipated benefits must be weighed against unknown risks to fetus if used in pregnant patients
Neonates exposed to antipsychotic drugs during third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery; agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress, and feeding disorder reported in neonates; complications have varied in severity; while in some cases symptoms have been self-limited, in other cases neonates have required intensive care unit support and prolonged hospitalization
Lactation
Data not available on content of molindone hydrochloride in milk of nursing mothers
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Dihydroindolone derivative, which is not structurally related to phenothiazines, butyrophenones, or thioxanthenes; blocks postsynaptic dopaminergic receptors in the nucleus accumbens, striatum, and ventral tegmental area; has negligible affinity for the alpha-1 adrenergic receptor and the histamine H1 receptor in the frontal cortex; lacks affinity for the muscarinic acetylcholine receptor in the caudate nucleus and intermediate affinity for the alpha-2 adrenergic receptor in the frontal cortex
Absorption
Rapidly absorbed
Peak serum time: 1.5 hr
Duration: 24-36 hr
Distribution
Protein bound: 76%
Metabolism
Hepatic
Elimination
Half-life: 1.5 hr
Excretion: Urine and feces (2-3% unmetabolized)
Administration
Oral Administration
Initial and maintenance doses should be individualized
Storage
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F)
Keep tightly closed in light-resistant container
Images
Patient Handout
Formulary
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