Molindone

DEA Class;  Rx

Common Brand Names; Moban

Documented hypersensitivity

Severe CNS depression (eg, alcohol, barbiturates, narcotics) or comatose states

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

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

Data not available on content of molindone hydrochloride in milk of nursing mothers