NITROGLYCERIN tablet, orally disintegrating

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Physicians Total Care, Inc.

INN (International Name):

NITROGLYCERIN

Composition:

NITROGLYCERIN 0.4 mg

Administration route:

SUBLINGUAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Nitroglycerin is indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease. Allergic reactions to organic nitrates are extremely rare, but they do occur. 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 tablets is contraindicated in patients who are using sildenafil citrate since sildenafil citrate has been shown to potentiate the hypotensive effects of organic nitrates.

Product summary:

Nitroglycerin tablets are supplied as white, round, flat-faced tablets in 0.4 mg strength in bottles containing 100 tablets each, with color-coded labels, and in color-coded Patient Convenience Packages of 4 bottles of 25 tablets each. Store at Controlled Room Temperature 20°–25°C (68°–77°F) [see USP].

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

NITROGLYCERIN - NITROGLYCERIN TABLET, ORALLY DISINTEGRATING
PHYSICIANS TOTAL CARE, INC.
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DESCRIPTION
Nitroglycerin tablets are stabilized sublingual compressed tablets
that contain 0.3 mg (1/200 grain), 0.4
mg (1/150 grain), or 0.6 mg (1/100 grain) 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:
C H N 0
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, te