ISOSORBIDE DINITRATE- isosorbide dinitrate tablet

Country: Сједињене Америчке Државе

Језик: Енглески

Извор: NLM (National Library of Medicine)

Активни састојак:

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

Доступно од:

American Health Packaging

INN (Међународно име):

ISOSORBIDE DINITRATE

Састав:

ISOSORBIDE DINITRATE 5 mg

Пут администрације:

ORAL

Тип рецептора:

PRESCRIPTION DRUG

Терапеутске индикације:

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.

Резиме производа:

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: Unit dose packages of 30 (5 x 6) NDC 68084-894-25 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. FOR YOUR PROTECTION: Do not use if blister is torn or broken.

Статус ауторизације:

Abbreviated New Drug Application

Карактеристике производа

ISOSORBIDE DINITRATE- ISOSORBIDE DINITRATE TABLET
AMERICAN HEALTH PACKAGING
----------
ISOSORBIDE DINITRATE
TABLETS, USP (ORAL)
RX ONLY
8289421/0618F
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