NITROGLYCERIN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Dr. Reddys Laboratories Inc

INN (International Name):

NITROGLYCERIN

Composition:

NITROGLYCERIN 0.3 mg

Administration route:

SUBLINGUAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Nitroglycerin sublingual tablets are indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.  Nitroglycerin sublingual tablets are 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.

Product summary:

Nitroglycerin sublingual tablets are supplied 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.  0.3 mg sublingual tablets are white to off-white, modified rectangle shaped tablets debossed with "CL" on one side and "3" on the other side and are supplied in bottles of 100 tablets.   Bottle of 100 NDC 43598-435-01 0.4 mg sublingual tablets are white to off-white, modified rectangle shaped tablets debossed with "CL" on one side and "4" on the other side and are supplied in bottles of 25 and 100 tablets.   Bottle of 100 NDC 43598-436-01 Convenience Package NDC 43598-436-11 0.6 mg sublingual tablets are white to off-white, modified rectangle shaped tablets debossed with "CL" on one side and "6" on the other side and are supplied in bottles of 100 tablets.   Bottle of 100 NDC 43598-437-01 Store at 20°-25°C (68°-77°F) [see USP Controlled Room Temperature].   Rx only Manufactured by: Ingenus Pharmaceuticals NJ, LLC Fairfield, NJ 07004, USA Manufactured for: Dr. Reddy’s Laboratories Inc . Princeton, New Jersey 08540, USA Revised: 0217

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NITROGLYCERIN- NITROGLYCERIN TABLET
DR. REDDYS LABORATORIES INC
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NITROGLYCERIN SUBLINGUAL TABLETS USP
DESCRIPTION
Nitroglycerin is a stabilized sublingual compressed nitroglycerin
tablet that contains 0.3 mg, 0.4 mg, or
0.6 mg nitroglycerin USP; as well as calcium stearate powder,
colloidal silicon dioxide, hydrogenated
vegetable oil, lactose monohydrate, and pregelatinized starch.
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)