NITROGLYCERIN tablet

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

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

から入手可能:

Zydus Pharmaceuticals (USA) Inc.

投与経路:

SUBLINGUAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

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 are 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.

製品概要:

Nitroglycerin Sublingual Tablets USP, 0.3 mg are white to off-white, round, flat face, uncoated tablets, debossed with "3" on one side & "T" on other side and are supplied as: NDC 68382-1018-1 in bottle of 100 sublingual tablets Nitroglycerin Sublingual Tablets USP, 0.4 mg are white to off-white, round, flat face, uncoated tablets, debossed with "4" on one side and "T" on other side and are supplied as: NDC 70710-1019-1 in bottle of 100 sublingual tablets NDC 70710-1019-4 in patient convenience package of 100 tablets (4 bottles of 25 sublingual tablets) Nitroglycerin Sublingual Tablets USP, 0.6 mg are white to off-white, round, flat face, uncoated tablets, debossed with "6" on one side and "T" on other side and are supplied as: NDC 70710-1020-1 in bottle of 100 sublingual tablets Store between 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature].

認証ステータス:

Abbreviated New Drug Application

製品の特徴

NITROGLYCERIN - NITROGLYCERIN TABLET
ZYDUS PHARMACEUTICALS (USA) INC.
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NITROGLYCERIN SUBLINGUAL TABLETS, USP
DESCRIPTION
Nitroglycerin sublingual tablets, USP are stabilized sublingual
compressed nitroglycerin
tablets that contains 0.3 mg, 0.4 mg, or 0.6 mg nitroglycerin; as well
as calcium
stearate, colloidal silicon dioxide, glyceryl monostearate, lactose
monohydrate and
pregelatinized starch (botanical source: maize).
Nitroglycerin, USP is white crystalline powder.
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: 227.1
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