Land: Kanada
Språk: engelska
Källa: Health Canada
LOXAPINE (LOXAPINE SUCCINATE)
PHARMEL INC
N05AH01
LOXAPINE
5MG
TABLET
LOXAPINE (LOXAPINE SUCCINATE) 5MG
ORAL
100/500
Prescription
MISCELLANEOUS ANTIPSYCHOTICS
Active ingredient group (AIG) number: 0111557002; AHFS:
CANCELLED POST MARKET
2016-10-25
PRODUCT MONOGRAPH PR PHL-LOXAPINE Loxapine Succinate Tablets 2.5, 5, 10, 25, and 50 mg Oral Concentrate (Loxapine Hydrochloride Solution) 25 mg/ml ANTIPSYCHOTIC PHARMEL INC. DATE OF PREPARATION: 8699 8th Avenue February 25, 1997 Montréal, Canada DATE OF REVISION: H1Z 2X4 June 17, 2004 Control # : 092228, 092229 PRODUCT MONOGRAPH 2 PR PHL-LOXAPINE Loxapine Succinate Tablets Oral Concentrate (Loxapine Hydrochloride Solution) THERAPEUTIC CLASSIFICATION Antipsychotic ACTION AND CLINICAL PHARMACOLOGY Loxapine succinate, a tricyclic dibenzoxazepine antipsychotic agent, which is clinically distinct from the phenothiazines, thioxanthenes and butyrophenones, produces pharmacologic responses in various animal species which are characteristic of those seen with the majority of anti-psychotic drugs. Loxapine succinate is an antipsychotic drug which exhibits many of the actions common to this broad class of drugs. Loxapine succinate has proven to be of value in the management of both acute and chronic schizophrenia. As in the case of other antipsychotics, the mode of action has not been clearly established, but is postulated to involve changes in synaptic transmission at the subcortical level of the brain, resulting in strong inhibition of spontaneous motor activity. Absorption of orally administered loxapine succinate tablets and oral concentrate in man is rapid and virtually complete following a single 25 mg dose. After administration of the oral concentrate somewhat higher and earlier peak serum levels may be expected initially than after tablet administration. The mean serum concentrations of unmetabolized loxapine succinate during the period of 1 to 4 hours after oral dosage were approximately half the concentrations following intramuscular injection of 25 mg. Signs of sedation in normal volunteers appear generally within 30 minutes for oral and parenteral administration. Duration of sedation with the tablets may last through a 12-hour period; the average was found to be close to three hours. When multiple doses were gi Läs hela dokumentet