国: カナダ
言語: 英語
ソース: Health Canada
TRIMIPRAMINE (TRIMIPRAMINE MALEATE)
SANOFI-AVENTIS CANADA INC
N06AA06
TRIMIPRAMINE
50MG
TABLET
TRIMIPRAMINE (TRIMIPRAMINE MALEATE) 50MG
ORAL
100
Prescription
TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS
Active ingredient group (AIG) number: 0102479003; AHFS:
CANCELLED POST MARKET
2006-07-28
PRODUCT MONOGRAPH SURMONTIL ® (Trimipramine) 25 mg and 50 mg Tablets Tricyclic Antidepressant sanofi-aventis Canada Inc. Date of Preparation: 2150 St. Elzear Blvd. West June 12, 2006 Laval, Quebec H7L 4A8 Submission Control No. 106414 s-a Version 1.0 dated 2 ACTION SURMONTIL (trimipramine) is a tricyclic antidepressant with sedative properties. It has also anticholinergic properties and potentiates the sympathetic responses, presumably by blocking the re-uptake of norepinephrine which has been released by the presynaptic neurones. Trimipramine has a quinidine-like effect on the heart and produces E.K.G and E.E.G. changes similar to those of other tricyclic antidepressants. INDICATIONS SURMONTIL (trimipramine) is indicated in the drug treatment of depressive illness. It is particularly effective in endogenous depression. It may also be useful in some patients with neurotic depression. CONTRAINDICATIONS SURMONTIL (trimipramine) is contraindicated in cases of known hypersensitivity to the drug. The possibility of cross-sensitivity with other dibenzazepine compounds should also be kept in mind. Monoamine oxidase inhibitors should not be administered concomitantly with SURMONTIL and a two-week delay is recommended before using the drug in patients who have received an MAO inhibitor. Treatment with SURMONTIL should be started with small doses and increased progressively, depending on tolerance and response. Because of its anticholinergic properties, SURMONTIL is contraindicated in patients with narrow angle glaucoma and prostatic hypertrophy. It is also contraindicated during the acute recovery phase following myocardial infarction and in the presence of acute congestive heart failure. WARNINGS Tricyclic antidepressants, particularly in high doses, have been reported to produce arrhythmias, sinus tachycardia, and prolongation of conduction time. A few instances of unexpected death have been reported in patients with cardiovascular disorders. Myocardial infarction and stroke have also been reported with drugs of this c 完全なドキュメントを読む