Страна: Канада
Язык: английский
Источник: Health Canada
METHOTRIMEPRAZINE (METHOTRIMEPRAZINE MALEATE)
SANOFI-AVENTIS CANADA INC
N05AA02
LEVOMEPROMAZINE
25MG
TABLET
METHOTRIMEPRAZINE (METHOTRIMEPRAZINE MALEATE) 25MG
ORAL
100/500
Prescription
PHENOTHIAZINES
Active ingredient group (AIG) number: 0134080002; AHFS:
CANCELLED POST MARKET
2007-07-18
PRODUCT MONOGRAPH NOZINAN ® METHOTRIMEPRAZINE MALEATE TABLETS 5, 25, 50 MG METHOTRIMEPRAZINE AS METHOTRIMEPRAZINE MALEATE METHOTRIMEPRAZINE HYDROCHLORIDE INJECTION 25 MG/ML METHRORIMEPRAZINE AS METHOTRIMEPRAZINE HYDROCHLORIDE NEUROLEPTIC sanofi-aventis Canada Inc. Date of Revision: 2150 St. Elzear Blvd. West May 18, 2007 Laval, Quebec H7L 4A8 Submission Control No.: 111761 s-a Version 4.0 dated Page 2 of 15 P RODUCT M ONOGRAPH N AME OF D RUG NOZINAN ® _ _ Methotrimeprazine Maleate Tablets Methotrimeprazine Hydrochloride Injection T HERAPEUTIC C LASSIFICATION Neuroleptic A CTION AND C LINICAL P HARMACOLOGY Nozinan possesses antipsychotic, tranquilizing, anxiolytic, sedative and analgesic properties and it is also a potent potentiator of anesthetics. I NDICATIONS AND C LINICAL U SE Psychotic disturbances: acute and chronic schizophrenias, senile psychoses, manic-depressive syndromes. Conditions associated with anxiety and tension: autonomic disturbances, personality disturbances, emotional troubles secondary to such physical conditions as resistant pruritus, etc. Nozinan is also employed: - As an analgesic: In pain due to cancer, zona, trigeminal neuralgia and neurocostal neuralgia and in phantom limb pains and muscular discomforts. - As a potentiator of anesthetics: In general anesthesia where it can be used as both a pre- and post-operative sedative and analgesic. - As an antiemetic: For the treatment of nausea and vomiting of central origin. - As a sedative: For the management of insomnia. C ONTRAINDICATIONS In cases of coma or CNS depression due to alcohol, hypnotics, analgesics or narcotics. It is also contraindicated in patients with blood dyscrasia, hepatic troubles or a sensitivity to phenothiazines. Page 3 of 15 W ARNINGS _Occupational Hazards_ : Nozinan can reduce psychomotor activity especially during the first few days of treatment. Patients should therefore be cautioned not to drive a motor vehicle or to participate in activities requiring total mental alertness. As with other neuroleptics, very rare Прочитать полный документ