NITROGLYCERIN- nitroglycerin tablet

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

NITROGLYCERIN (UNII: G59M7S0WS3) (NITROGLYCERIN - UNII:G59M7S0WS3)

Fáanlegur frá:

NuCare Pharmaceuticals,Inc.

Stjórnsýsluleið:

SUBLINGUAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Nitroglycerin Sublingual Tablets, USP are indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease. Nitroglycerin is contraindicated in patients who are allergic to it. Sublingual nitroglycerin therapy is contraindicated in patients with early myocardial infarction, severe anemia, increased intracranial pressure, and those with a known hypersensitivity to nitroglycerin. Administration of nitroglycerin sublingual tablets is contraindicated in patients who are using a phosphodiesterase-5 (PDE-5) inhibitor (e.g., sildenafil citrate, tadalafil, vardenafil hydrochloride) since these compounds have been shown to potentiate the hypotensive effects of organic nitrates. Do not use nitroglycerin sublingual tablets in patients who are taking the soluble guanylate cyclase stimulator riociguat. Concomitant use can cause hypotension.

Vörulýsing:

Nitroglycerin Sublingual Tablets, USP, 0.3 mg, 0.4 mg and 0.6 mg is supplied as white to off white, round, flat-faced tablets in 3 strengths (0.3 mg, 0.4 mg, and 0.6 mg) Debossed with 2 on one side and C on the other. NDC 68071-4343-5 Bottles of 25 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2 Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Questions? 1 [phone] www.glenmarkpharma.com/usa June 2017

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

NITROGLYCERIN- NITROGLYCERIN TABLET
NUCARE PHARMACEUTICALS,INC.
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NITROGLYCERIN SUBLINGUAL TABLETS, USP
DESCRIPTION
Nitroglycerin Sublingual Tablets, USP are a stabilized sublingual
compressed nitroglycerin tablet that
contains 0.3 mg, 0.4 mg, or 0.6 mg nitroglycerin; as well as calcium
stearate, croscarmellose sodium,
silica dimethyl silylate and lactose monohydrate.
Nitroglycerin, an organic nitrate, is a vasodilating agent. The
chemical name for nitroglycerin is 1, 2, 3
propanetriol trinitrate and the chemical structure is:
Molecular weight: 227.09
CLINICAL PHARMACOLOGY
The principal pharmacological action of nitroglycerin is relaxation of
vascular smooth muscle.
Although venous effects predominate, nitroglycerin produces, in a
dose-related manner, dilation of both
arterial and venous beds. Dilation of postcapillary vessels, including
large veins, promotes peripheral
pooling of blood, decreases venous return to the heart, and reduces
left ventricular end-diastolic
pressure (preload). Nitroglycerin also produces arteriolar relaxation,
thereby reducing peripheral
vascular resistance and arterial pressure (afterload), and dilates
large epicardial coronary arteries;
however, the extent to which this latter effect contributes to the
relief of exertional angina is unclear.
Therapeutic doses of nitroglycerin may reduce systolic, diastolic, and
mean arterial blood pressure.
Effective coronary perfusion pressure is usually maintained, but can
be compromised if blood pressure
falls excessively, or increased heart rate decreases diastolic filling
time.
Elevated central venous and pulmonary capillary wedge pressures, and
pulmonary and systemic vascular
resistance are also reduced by nitroglycerin therapy. Heart rate is
usually slightly increased,
presumably due to a compensatory response to the fall in blood
pressure. Cardiac index may be
increased, decreased, or unchanged. Myocardial oxygen consumption or
demand (as measured by the
pressure-rate product, tension-time index, and stroke-work index) is
decreased an