ISOSORBIDE DINITRATE tablet

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Oceanside Pharmaceuticals

Az alkalmazás módja:

ORAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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 is contraindicated in patients who are allergic to isosorbide dinitrate or any of its ingredients. Do not use Isosorbide Dinitrate 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 in patients who are taking the soluble guanylate cyclase stimulator riociguat. Concomitant use can cause hypotension.

Termék összefoglaló:

Isosorbide Dinitrate tablets are available as follows: 5 mg, round, pink tablets imprinted "BPI 152" on one side and deeply scored on reverse side: NDC 68682-193-01, bottles of 100. 40 mg, round, light green tablets imprinted "BPI 192" on one side and deeply scored on reverse side: NDC 68682-192-01, bottles of 100. Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect from light. Keep bottles tightly closed. Dispense in a light-resistant, tight container. Keep out of reach of children Distributed by: Oceanside Pharmaceuticals, a division of Bausch Health US, LLC Bridgewater, NJ 08807 USA Manufactured by: Bausch Health Companies Inc. Steinbach, MB R5G 1Z7, Canada © 2020 Bausch Health Companies Inc. or its affiliates 9704300 20002849 Rev. 03/2020

Engedélyezési státusz:

New Drug Application

Termékjellemzők

ISOSORBIDE DINITRATE- ISOSORBIDE DINITRATE TABLET
OCEANSIDE PHARMACEUTICALS
----------
ISOSORBIDE DINITRATE
TABLETS
RX ONLY
DESCRIPTION
Isosorbide dinitrate (ISDN) is 1,4:3,6-dianhydro-D-glucitol
2,5-dinitrate, an organic nitrate whose
structural formula is
and whose molecular weight is 236.14. 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=1.0,
alcohol, 20°C). Isosorbide dinitrate
is freely soluble in organic solvents such as acetone, alcohol, and
ether, but is only sparingly soluble in
water.
Each Isosorbide Dinitrate tablet contains 5 mg or 40 mg of isosorbide
dinitrate. The inactive
ingredients in 5 mg tablet are magnesium stearate, lactose
monohydrate, microcrystalline cellulose and
FD&C red 40. The inactive ingredients in 40 mg tablet are magnesium
stearate, microcrystalline
cellulose, FD&C yellow 6, D&C yellow 10, and FD&C blue.
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