- Loxapine is not approved for patients with dementia-related psychosis
- Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death [US Black Box Warning]
- Tardive dyskinesia, a syndrome of potentially irreversible, involuntary, dyskinetic movements, may occur in patients treated with antipsychotic agents; incidence appears to be highest among the elderly
- Discontinuation of the drug should be considered if signs and symptoms of tardive dyskinesia appear
- Antipsychotic drugs may cause neuroleptic malignant syndrome (NMS), which is clinically manifestated as hyperpyrexia, muscle rigidity, altered mental status, and autonomic instability. Discontinue the drug immediately and provide intensive symptomatic treatment and medical monitoring
- If a patient requires antipsychotic drug treatment after recovery from NMS, reintroduction of drug therapy should be carefully considered with careful patient monitoring as recurrences have been reported
- Patients should be warned against performing activities requiring alertness and about concomitant use of alcohol and other CNS depressants because loxapine may impair mental and/or physical abilities, especially during the first few days of therapy
- Not recommended in patients with mental retardation
- Leukopenia/neutropenia and agranulocytosis may occur with antipsychotic agents. Monitor CBC count frequently during the first few months of therapy and discontinue the drug at the first sign of a decrease in WBC
- Patients with neutropenia should be observed carefully for fever or other signs or symptoms of infection; institute appropriate treatment if such reactions occur
- Ocular toxicity may occur during therapy. Carefully observe/monitor patients for pigmentary retinopathy and lenticular pigmentation
- Loxapine may mask signs of overdosage of toxic drugs and may obscure conditions such as brain tumor and intestinal obstruction owing to its antiemetic effect
- Increase in prolactin levels may occur on chronic administration of antipsychotic drugs
Cautions: Use cautiuosly in
- Hepatic impairment
- Cardiovascular disease
- Glaucoma
- Co-administration of anticholinergic-type antiparkinson medications
- Concomitant use of CNS-active drugs
- Predisposition for urinary retention
- History of drug-induced leukopenia/neutropenia
- History of seizure disorder
Pregnancy Category:C
Breastfeeding: An alternate drug may be preferred, especially while nursing a newborn or preterm infant. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 29 March 2011). As per manufacturer's data, loxapine administration in nursing mothers should be avoided if clinically possible.
