ISDN TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

ISOSORBIDE DINITRATE

Available from:

AA PHARMA INC

ATC code:

C01DA08

INN (International Name):

ISOSORBIDE DINITRATE

Dosage:

5MG

Pharmaceutical form:

TABLET

Composition:

ISOSORBIDE DINITRATE 5MG

Administration route:

SUBLINGUAL

Units in package:

100/500

Prescription type:

Ethical

Therapeutic area:

NITRATES AND NITRITES

Product summary:

Active ingredient group (AIG) number: 0103176002; AHFS:

Authorization status:

APPROVED

Authorization date:

2010-07-02

Summary of Product characteristics

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