NITROSTAT- nitroglycerin tablet

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 0.3 mg

Administration route:

ORAL

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 Nitrostat (nitroglycerin tablets, USP) is contraindicated in patients who are using Viagra® since Viagra has been shown to potentiate the hypotensive effects of organic nitrates.

Product summary:

Nitrostat is supplied as white, round, flat-faced tablets in 3 strengths (0.3 mg, 0.4 mg, and 0.6 mg) in LAB-0180-2.0 December 2005 Relabeling of "Additional" label by: Physicians Total Care, Inc. Tulsa, OK    74146

Authorization status:

New Drug Application

Summary of Product characteristics

NITROSTAT - NITROGLYCERIN TABLET
PHYSICIANS TOTAL CARE, INC.
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NITROSTAT (NITROGLYCERIN)0.4 MG USP 25 TABLETS BOTTLE
DES CRIPTION
Nitrostat is a stabilized sublingual compressed nitroglycerin tablet
that contains 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:
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
pr