Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
PROCHLORPERAZINE
SANOFI-AVENTIS CANADA INC
N05AB04
PROCHLORPERAZINE
10MG
SUPPOSITORY
PROCHLORPERAZINE 10MG
RECTAL
10
Prescription
PHENOTHIAZINES
Active ingredient group (AIG) number: 0106181001; AHFS:
CANCELLED POST MARKET
2006-07-28
Page 1 of 19 PRODUCT MONOGRAPH STEMETIL ® PROCHLORPERAZINE MESYLATE INJECTION 10 MG/2 ML_ _PROCHLORPERAZINE AS PROCHLORPERAZINE MESYLATE PROCHLORPERAZINE SUPPOSITORIES 10 MG ANTIPSYCHOTIC - ANTIEMETIC sanofi-aventis Canada Inc. Revision Date: 2150 St. Elzear Blvd. West October 13, 2006 Laval, Quebec H7L 4A8 Submission Control No.: 107337 s-a version 3.0 dated Page 2 of 19 PRODUCT MONOGRAPH NAME OF DRUG STEMETIL PROCHLORPERAZINE MESYLATE INJECTION _ _ PROCHLORPERAZINE SUPPOSITORIES _ _ THERAPEUTIC CLASSIFICATION Antipsychotic - Antiemetic ACTION Stemetil (prochlorperazine) is a piperazine phenothiazine derivative with antipsychotic, antiemetic and weak sedative activity. Stemetil has actions similar to those of other phenothiazine derivatives but 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 Stemetil (prochlorperazine) is indicated in the management of manifestations of psychotic disorders such as agitation, confusion, delusion, tension and anxiety. It is also effective in controlling nausea and vomiting due to stimulation of the chemoreceptor trigger zone. In selected patients, Stemetil may be of value for the relief of excessive anxiety, accompanied by severe tension and agitation, associated with psychoneurotic or somatic conditions. Page 3 of 19 CONTRAINDICATIONS Stemetil (prochlorperazine) 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 history of hypersensitivity to phenothiazine derivatives. As with other phenothiazines, Stemetil is contraindicate Soma hati kamili