molindone (Rx)

Brand and Other Names:Moban
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Dosing & Uses

AdultPediatricGeriatric

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

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Interactions

Interaction Checker

and molindone

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      Serious - Use Alternative

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            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

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            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

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            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.

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            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)

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            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

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            Images

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.