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Loxapine

Also known as: Loxapine

Route: Oral

2 interactions on record⛔ Black Box Warning

Loxapine has 2 known drug interactions based on U.S. FDA drug labeling data. 2 are classified as major interactions requiring close medical supervision. Notable interactions include combinations with Carbamazepine, Lorazepam. Patients taking Loxapine should inform their healthcare provider of all current medications — including over-the-counter drugs and supplements — to avoid potentially harmful combinations. Data sourced from OpenFDA and the NIH National Library of Medicine.

Total: 2
Major: 2

Major (2)

Loxapine + Carbamazepine— Epoxide hydrolase inhibitor; increases carbamazepine-10,11-epoxide plasma concentrations. Dosage adjustment and plasma l…
Loxapine + Lorazepam— Rare reports of significant respiratory depression, stupor, and/or hypotension with concomitant use of loxapine and lora…

Loxapine + Carbamazepine⚠️Major

Epoxide hydrolase inhibitor; increases carbamazepine-10,11-epoxide plasma concentrations. Dosage adjustment and plasma level monitoring required.

Loxapine + Lorazepam⚠️Major

Rare reports of significant respiratory depression, stupor, and/or hypotension with concomitant use of loxapine and lorazepam.

⛔ FDA Black Box Warning

WARNING Increased Mortality in Elderly Patients with Dementia-Related Psychosis Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Loxapine is not approved for the treatment of patients with dementia-related psychosis ( see WARNINGS ).

Contraindications

CONTRAINDICATIONS Loxapine is contraindicated in comatose or severe drug-induced depressed states (alcohol, barbiturates, narcotics, etc.). Loxapine is contraindicated in individuals with known hypersensitivity to dibenzoxazepines.

Pregnancy & Breastfeeding

Pregnancy 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. Loxapine Succinate should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Safe use of loxapine during pregnancy or lactation has not been established; therefore, its use in pregnancy, in nursing mothers, or in women of childbearing potential requires that the benefits of treatment be weighed against the possible risks to mother and child. No embryotoxicity or teratogenicity was observed in studies in rats, rabbits, or dogs although, with the exception of one rabbit study, the highest dosage was only two times the maximum recommended human dose and in some studies it was below this dose. Perinatal studies have shown renal papillary abnormalities in offspring of rats treated from mid-pregnancy with doses of 0.6 and 1.8 mg/kg, doses which approximate the usual human dose but which are considerably below the maximum recommended human dose.

Data sourced from U.S. FDA drug labeling via openFDA and the NIH National Library of Medicine. For informational purposes only. Always consult your pharmacist or physician.