ISOSORBIDE DINITRATE tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ISOSORBIDE DINITRATE (UNII: IA7306519N) (ISOSORBIDE DINITRATE - UNII:IA7306519N)

Available from:

Sandoz Inc.

INN (International Name):

ISOSORBIDE DINITRATE

Composition:

ISOSORBIDE DINITRATE 5 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Isosorbide dinitrate tablets are indicated for the prevention of angina pectoris due to coronary artery disease. The onset of action of immediate-release oral isosorbide dinitrate is not sufficiently rapid for this product to be useful in aborting an acute anginal episode. Isosorbide dinitrate tablets are contraindicated in patients who are allergic to isosorbide dinitrate or any of its ingredients. Do not use isosorbide dinitrate tablets in patients who are taking certain drugs for erectile dysfunction (phosphodiesterase inhibitors), such as sildenafil, tadalafil, or vardenafil. Concomitant use can cause severe hypotension, syncope, or myocardial ischemia. Do not use isosorbide dinitrate tablets in patients who are taking the soluble guanylate cyclase stimulator riociguat. Concomitant use can cause hypotension.

Product summary:

Isosorbide dinitrate tablets, USP are supplied as: 5 mg: Round, pink, scored tablets, debossed GG 259 on one side and plain on the reverse side, and supplied as: NDC 0781-1635-01 bottles of 100 NDC 0781-1635-10 bottles of 1000 10 mg: Round, white, scored tablets, debossed GG 26 on one side and plain on the reverse side, and supplied as: NDC 0781-1556-01 bottles of 100 NDC 0781-1556-10 bottles of 1000 20 mg: Round, green, scored tablets, debossed GG 227 on one side and plain on the reverse side, and supplied as: NDC 0781-1695-01 bottles of 100 NDC 0781-1695-10 bottles of 1000 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

ISOSORBIDE DINITRATE- ISOSORBIDE DINITRATE TABLET
SANDOZ INC.
----------
ISOSORBIDE DINITRATE TABLETS, USP (ORAL)
RX ONLY
DESCRIPTION
Isosorbide dinitrate (ISDN) is 1,4:3,6-dianhydro-D-glucitol
2,5-dinitrate, an organic nitrate
whose structural formula is:
The organic nitrates are vasodilators, active on both arteries and
veins.
Isosorbide dinitrate is a white, crystalline, odorless compound which
is stable in air and
in solution, has a melting point of 70°C and has an optical rotation
of +134° (c=1,
alcohol, 20°C). Isosorbide dinitrate is freely soluble in organic
solvents such as acetone,
alcohol, and ether, but is only sparingly soluble in water.
Isosorbide dinitrate is available as 5 mg, 10 mg, and 20 mg tablets
for oral
administration. Inactive ingredients: lactose (monohydrate), magnesium
stearate,
microcrystalline cellulose. The 5 MG also contains FD & C Red #40
Aluminum Lake. The
20 MG also contains D & C Yellow #10 Aluminum Lake, FD & C Blue #1
Aluminum Lake,
and FD & C Yellow #6 Aluminum Lake.
CLINICAL PHARMACOLOGY
The principal pharmacological action of isosorbide dinitrate is
relaxation of vascular
smooth muscle and consequent dilatation of peripheral arteries and
veins, especially the
latter. Dilatation of the veins promotes peripheral pooling of blood
and decreases venous
return to the heart, thereby reducing left ventricular end-diastolic
pressure and
pulmonary capillary wedge pressure (preload). Arteriolar relaxation
reduces systemic
vascular resistance, systolic arterial pressure, and mean arterial
pressure (afterload).
Dilatation of the coronary arteries also occurs. The relative
importance of preload
reduction, afterload reduction, and coronary dilatation remains
undefined.
Dosing regimens for most chronically used drugs are designed to
provide plasma
concentrations that are continuously greater than a minimally
effective concentration.
This strategy is inappropriate for organic nitrates. Several
well-controlled clinical trials
have used exercise testing to assess the anti-anginal efficacy o