NITROGLYCERIN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Rebel Distributors Corp

INN (International Name):

NITROGLYCERIN

Composition:

NITROGLYCERIN 0.4 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Nitroglycerin is indicated for the acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease. 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 USP is contraindicated in patients who are using Viagra® (sildenafil citrate). Viagra® has been shown to potentiate the hypotensive effects of organic nitrates.

Product summary:

Nitroglycerin Tablets, USP are supplied as follows: 0.4 mg - White tablet embossed with a "4". 4 x Bottles of 25: NDC 21695-697-25 Bottle of 100: NDC 21695-810-00

Authorization status:

unapproved drug other

Summary of Product characteristics

NITROGLYCERIN- NITROGLYCERIN TABLET
REBEL DISTRIBUTORS CORP
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this labeling has not been_
_approved by FDA. For further information about unapproved drugs,
click here._
----------
NITROGLYCERIN TABLETS, USP
RX ONLY
DESCRIPTION
Nitroglycerin, an organic nitrate, is a vasodilating agent. The
chemical name for nitroglycerin is 1,2,3-
propanetriol trinitrate. The chemical structure is:
Nitroglycerin tablets USP are compressed sublingual nitroglycerin
tablets containing the non-volatile
nitroglycerin fixing agent polyethylene glycol. The tablets contain
0.3 mg (1/200 grain), 0.4 mg (1/150
grain), and 0.6 mg (1/100 grain) nitroglycerin. Also contains lactose
NF, polyethylene glycol 3350 NF,
microcrystalline cellulose NF, colloidal silicon dioxide NF, and
magnesium stearate NF.
CLINICAL PHARMACOLOGY
Relaxation of vascular smooth muscle is the principal pharmacologic
action of nitroglycerin. The
mechanism by which nitroglycerin produces relaxation of smooth muscle
is unknown. Although venous
effects predominate, nitroglycerin produces, in a dose-related manner,
dilation of both arterial and
venous beds. Dilation of the postcapillary vessels, including large
veins, promotes peripheral pooling
of blood and decreases venous return to the heart, reducing left
ventricular end-diastolic pressure
(preload). Arteriolar relaxation reduces systemic vascular resistance
and arterial pressure (afterload).
Myocardial oxygen consumption or demand (as measured by the
pressure-rate product, tension-time
index and stroke-work index) is decreased by both the arterial and
venous effects of nitroglycerin, and
amore favorable supply-demand ratio can be achieved.
Nitroglycerin also dilates large epicardial coronary arteries;
however, the extent to which this 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 usual