Source: Health Products and Food Branch (CA) Revision Year: 2014
LOXAPAC IM (loxapine hydrochloride injection) is indicated in the management of the manifestations of schizophrenia.
Geriatrics (>65years of age): LOXAPAC IM is not indicated in elderly patients with dementia. The safety and efficacy of LOXAPAC IM in patients 65 years of age or older have not been studied (see WARNINGS AND PRECAUTIONS, Serious Warnings and Precautions Box and Special Populations).
Pediatrics (<18 years of age): The safety and efficacy of LOXAPAC IM have not been established in children below the age of 18, and its use is not recommended.
LOXAPAC IM (loxapine hydrochloride injection) is utilized in patients whose symptoms render oral medication temporarily impractical. During clinical trials, there were no reports of significant local tissue reaction.
Geriatrics: Given the higher incidence of concomitant illness (renal, hepatic and cardiovascular) and concomitant medication in the elderly, LOXAPAC IM should be used with caution in this population.
LOXAPAC IM is for intramuscular use only. Not for intravenous use.
LOXAPAC IM is administered by intramuscular (not intravenous) injection in doses of 12.5 mg (¼ mL) to 50 mg (1 mL) at intervals of four to six hours or longer, both dose and interval depending on patient response. Many patients have responded satisfactorily to twice-daily dosage. Attention should be directed to the necessity for dosage adjustment on an individual basis over the early days of loxapine administration.
Once the desired symptomatic control is achieved and the patient is able to take medication orally, loxapine should be administered in tablet or oral concentrate form.
Signs and symptoms of overdosage of LOXAPAC IM would be expected to range from mild depression of the CNS and cardiovascular systems to profound hypotension, respiratory depression and unconsciousness. The possibility of occurrence of extrapyramidal symptoms and/or convulsive seizures should be kept in mind.
Renal failure following loxapine overdosage has also been reported.
No specific antidote is known. The treatment of overdosage would be essentially symptomatic and supportive. Early gastric lavage would be expected to be beneficial as might be extended dialysis. Additional supportive measures include the administration of oxygen and intravenous fluids. Centrally acting emetics may have little effect because of the antiemetic action of LOXAPAC IM. In addition, emesis should be avoided because of the possibility of aspiration of vomit. Avoid analeptics, which may cause convulsions.
Severe hypotension might be expected to respond to the administration of levarterenol or phenylephrine. Epinephrine should not be used since its use in a patient with partial adrenergic blockade may further lower the blood pressure. Severe extrapyramidal reactions should be treated with anticholinergic antiparkinson agents or diphenhydramine hydrochloride, and anticonvulsant therapy should be initiated as indicated.
Renal failure following loxapine overdosage has also been reported.
For management of a suspected drug overdose, contact your regional Poison Control Centre immediately.
Store between 15°C and 30°C.
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