NITROSTAT- nitroglycerin tablet

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

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

Fáanlegur frá:

Proficient Rx LP

INN (Alþjóðlegt nafn):

NITROGLYCERIN

Samsetning:

NITROGLYCERIN 0.4 mg

Stjórnsýsluleið:

SUBLINGUAL

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

Nitroglycerin is 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 NITROSTAT 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 NITROSTAT in patients who are taking the soluble guanylate cyclase stimulator riociguat. Concomitant use can cause hypotension.

Vörulýsing:

NITROSTAT is supplied as white, round, flat-faced tablets in 3 strengths (0.3 mg, 0.4 mg, and 0.6 mg) in bottles containing 100 tablets each, with color-coded labels, and in color-coded Patient Convenience Packages of 4 bottles of 25 tablets each. 0.4 mg: Coded "N" on one side and "4" on the other. NDC 63187-884-25—Bottle of 25 Store at Controlled Room Temperature 20°–25°C (68°–77°F) [see USP].

Leyfisstaða:

New Drug Application

Vara einkenni

NITROSTAT- NITROGLYCERIN TABLET
PROFICIENT RX LP
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NITROS TAT
(NITROGLYCERIN SUBLINGUAL TABLETS, USP)
DESCRIPTION
NITROSTAT is a stabilized sublingual compressed nitroglycerin tablet
that contains 0.3 mg, 0.4 mg ,
or 0.6 mg nitroglycerin; as well as lactose monohydrate, NF; glyceryl
monostearate, NF; pregelatinized
starch, NF; calcium stearate, NF powder; and silicon dioxide,
colloidal, NF.
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