Country: Kanada
Bahasa: Inggeris
Sumber: Health Canada
ISOSORBIDE DINITRATE
AA PHARMA INC
C01DA08
ISOSORBIDE DINITRATE
10MG
TABLET
ISOSORBIDE DINITRATE 10MG
ORAL
100/1000/5000
Ethical
NITRATES AND NITRITES
Active ingredient group (AIG) number: 0103176001; AHFS:
APPROVED
2010-07-02
PRODUCT MONOGRAPH ISDN Isosorbide Dinitrate Tablets USP 5, 10 and 30 mg Coronary Vasodilator AA PHARMA INC. DATE OF PREPARATION: 1165 Creditstone Road, Unit #1 June 18, 2010 Vaughan, Ontario L4K 4N7 Control:# 139535 1 PRODUCT MONOGRAPH ISDN Isosorbide Dinitrate Tablets USP 5, 10 and 30 mg THERAPEUTIC CLASSIFICATION Coronary Vasodilator ACTIONS AND CLINICAL PHARMACOLOGY The basic action of isosorbide dinitrate is the relaxation of smooth muscle. Relaxation of peripheral vascular smooth muscle and pooling results in the reduction of preload and afterload on the left ventricle. The effect of the long acting nitrate appears to be mainly peripheral. Although isosorbide dinitrate dilates the coronary arteries there is no incontrovertible evidence that it relieves ischemic heart pain by increasing coronary blood flow. When administered sublingually, isosorbide dinitrate has an onset of action of 2 to 5 minutes and lasts 1 to 2 hours. After oral administration, relief of angina pectoris begins in 30 minutes and lasts 4 to 6 hours. Isosorbide dinitrate is metabolized to 2-isosorbide mononitrate and 5-isosorbide mononitrate. After a single oral dose, 80 to 100% of the amount absorbed is excreted in the urine within 24 hours, chiefly as metabolites. INDICATIONS AND CLINICAL USE ISDN (isosorbide dinitrate) is indicated for the prophylaxis of ischemic heart pain 2 associated with coronary insufficiency. Isosorbide dinitrate may reduce the number, duration and severity of anginal attacks, exercise tolerance may be increased and nitroglycerin requirements curtailed. CONTRAINDICATIONS Although isosorbide dinitrate may be used for the control of angina pectoris occurring after myocardial infarction, it is suggested that treatment be withheld in the presence of cardiogenic shock, or if there is a risk of shock developing. Hypersensitivity to isosorbide dinitrate. Concomitant use of ISDN (isosorbide dinitrate) either regularly and/or intermittently, with VIAGRA® (sildenafil citrate), is absolutely contraindicated. WARNINGS Data su Baca dokumen lengkap