Molindone

Drug Interactions Potentiation of drugs administered concurrently with Molindone Hydrochloride has not been reported. Additionally, animal studies have not shown increased toxicity when Molindone Hydrochloride is given concurrently with representative members of three classes of drugs (i.e., barbiturates, chloral hydrate and antiparkinson drugs).

Pregnancy Studies in pregnant patients have not been carried out. Reproduction studies have been performed in the following animals: Pregnant Rats oral dose— no adverse effect 20 mg/kg/day - 10 days no adverse effect 40 mg/kg/day - 10 days Pregnant Mice oral dose— slight increase resorptions 20 mg/kg/day - 10 days slight increase resorptions 40 mg/kg/day - 10 days Pregnant Rabbits oral dose— no adverse effect 5 mg/kg/day - 12 days no adverse effect 10 mg/kg/day - 12 days no adverse effect 20 mg/kg/day - 12 days Animal reproductive studies have not demonstrated a teratogenic potential.

The anticipated benefits must be weighed against the unknown risks to the fetus if used in pregnant patients. Non-teratogenic Effects Neonates exposed to antipsychotic drugs, during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates. These 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.

Molindone Hydrochloride should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers Data are not available on the content of Molindone Hydrochloride in the milk of nursing mothers.