Valsts: Kanāda
Valoda: angļu
Klimata pārmaiņas: Health Canada
PIPOTIAZINE PALMITATE
SANOFI-AVENTIS CANADA INC
N05AC04
PIPOTIAZINE
50MG
SOLUTION
PIPOTIAZINE PALMITATE 50MG
INTRAMUSCULAR
5X2ML
Prescription
PHENOTHIAZINES
Active ingredient group (AIG) number: 0112633001; AHFS:
CANCELLED POST MARKET
2017-03-30
1 PRODUCT MONOGRAPH PR PIPORTIL ® L 4 (PIPOTIAZINE PALMITATE INJECTION) 25 MG/ML AND 50 MG/ML ANTIPSYCHOTIC AGENT sanofi-aventis Canada Inc. 2150 St. Elzear Blvd. West Laval, Quebec H7L 4A8 Date of Revision: OCTOBER 31, 2011 Submission Control No.: 149573 s-a Version 6.0 dated 2 NAME OF DRUG PR PIPORTIL ® L 4 (PIPOTIAZINE PALMITATE INJECTION) THERAPEUTIC CLASSIFICATION ANTIPSYCHOTIC AGENT ACTION Piportil ® L 4 (pipotiazine palmitate) is the palmitic ester of pipotiazine, a piperidine phenothiazine with antipsychotic properties and weak sedative activity. The esterification of pipotiazine is responsible for its prolonged duration of action. The onset of action appears usually within the first 2 to 3 days after injection and the effects of the drug on psychotic symptoms are significant within one week. Improvement in symptomatology lasts from 3 to 6 weeks, but adequate control may frequently be maintained with one injection every 4 weeks. However, in view of the variations in individual response, careful supervision is required throughout treatment. Piportil L 4 has actions similar to those of other phenothiazines. Among the different phenothiazine derivatives, Piportil L 4 appears to be less sedating and to have a weak propensity for causing hypotension or potentiating the effects of CNS depressants and anesthetics. However, it produces a high incidence of extrapyramidal reactions. _ _ INDICATIONS Piportil L 4 (pipotiazine palmitate) is indicated in the maintenance treatment of chronic non-agitated schizophrenic patients. CONTRAINDICATIONS Piportil L 4 (pipotiazine palmitate) should not be administered in the presence of circulatory collapse, altered states of consciousness or comatose states, particularly when these are due to intoxication with central depressant drugs (alcohol, hypnotics, narcotics, etc.). It is contraindicated in severely depressed patients, in the presence of blood dyscrasias, liver disease, renal insufficiency, pheochromocytoma, or in patients with severe cardiovascular disorders or a hist Izlasiet visu dokumentu