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:

Sina Health 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. 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 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 in patients who are taking the soluble guanylate cyclase stimulator riociguat. Concomitant use can cause hypotension.

Product summary:

Nitroglycerin tablets are supplied as white, round, flat-faced tablets 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. Store at Controlled Room Temperature 20°–25°C (68°–77°F) [see USP].

Authorization status:

New Drug Application Authorized Generic

Patient Information leaflet

NITROGLYCERIN- NITROGLYCERIN TABLET, ORALLY DISINTEGRATING
Sina Health Inc
----------
NITROGLYCERIN SUBLINGUAL TABLETS, USP
Read this information carefully before you start Nitroglycerin and
each time you refill your prescription.
There may be new information. This information does not replace
talking with your doctor. If you have
any questions about Nitroglycerin, ask your doctor. Your doctor will
know if Nitroglycerin is right for
you.
What is Nitroglycerin?
Nitroglycerin is a type of medicine known as an organic nitrate and is
a vasodilating agent. It is used to
treat a type of chest pain called angina.
What is Angina?
Angina is a pain or discomfort that keeps coming back when part of
your heart does not get enough
blood. Angina feels like a pressing or squeezing pain, usually in your
chest under the breastbone.
Sometimes you can feel it in your shoulders, arms, neck, jaws, or
back. Nitroglycerin can relieve this
pain.
Who should not use Nitroglycerin?
Do not use Nitroglycerin if you are allergic to organic nitrates (like
the active ingredient in Nitroglycerin).
You should not take Nitroglycerin if you have the following
conditions:
•
very recent heart attack
•
severe anemia
•
increased pressure in the head
Do not take Nitroglycerin with drugs for erectile dysfunction, like
VIAGRA ® (sildenafil citrate),
CIALIS ® (tadalafil), or LEVITRA ® (vardenafil hydrochloride), as
this may lead to extreme lowering of
your blood pressure .
What should I tell my doctor before taking Nitroglycerin?
Before using Nitroglycerin, tell your doctor if:
•
You are taking any medicines that are used to treat angina, heart
failure, or an irregular heartbeat.
•
You are taking any medicines that reduce blood pressure.
•
You are taking any diuretics (water pills).
•
You are taking medications to treat depression or psychiatric illness.
•
You are taking ergotamine or similar drugs for migraine headaches.
•
You are taking aspirin.
•
You are taking the blood thinner medicine heparin.
•
You are taking any medicines f

Summary of Product characteristics

NITROGLYCERIN- NITROGLYCERIN TABLET, ORALLY DISINTEGRATING
SINA HEALTH INC
----------
NITROGLYCERIN SUBLINGUAL TABLETS, USP
DESCRIPTION
Nitroglycerin tablets are stabilized sublingual compressed tablets
that contain 0.3 mg, 0.4 mg, or 0.6 mg
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
pressure-rate product, tension-time index, and st