NITROGLYCERIN aerosol, metered

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Rouses Point Pharm

INN (International Name):

NITROGLYCERIN

Composition:

NITROGLYCERIN 400 ug

Administration route:

SUBLINGUAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Nitroglycerin Lingual Aerosol is indicated for acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease. Administration of Nitroglycerin Lingual Aerosol is contraindicated in patients who are using a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5), as PDE5 inhibitors such as sildenafil, vardenafil, and tadalafil have been shown to potentiate the hypotensive effects of organic nitrates. Do not use Nitroglycerin Lingual Aerosol in patients who are taking the soluble guanylate cyclase (sGC) stimulator riociguat. Concomitant use can cause hypotension. [see DRUG INTERACTIONS (7.1) ]. Nitroglycerin Lingual Aerosol is contraindicated in patients with severe anemia. Nitroglycerin Lingual Aerosol is contraindicated in patients with increased intracranial pressure Nitroglycerin Lingual Aerosol is contraindicated in patients who have shown hypersensitivity to it or to other nitrates or nitrites. Skin reactions consistent with

Product summary:

Each box of Nitroglycerin Lingual Aerosol contains one glass bottle coated with red/orange transparent plastic which assists in containing the glass and medication should the bottle be shattered. Nitroglycerin Lingual Aerosol is available as an 8.5 g (Net Content) of nitroglycerin lingual aerosol that will deliver 200 metered sprays containing 400 mcg of nitroglycerin per actuation or as a 4.1 g (Net Content) of nitroglycerin lingual aerosol that will deliver 60 metered sprays containing 400 mcg of nitroglycerin per actuation. 200 metered sprays: NDC 43478-410-07 60 metered sprays: NDC 43478-410-03 Store at room temperature (25o C, 77o F); excursions permitted to 15o     to 30o C (59o  to 85 o F) Nitroglycerin Lingual Aerosol contains a highly flammable propellant (butane). Do not forcefully open a Nitroglycerin Lingual Aerosol bottle, do not have the container burned after use, and do not spray directly toward flames.

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

NITROGLYCERIN- NITROGLYCERIN AEROSOL, METERED
ROUSES POINT PHARM
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NITROGLYCERIN LINGUAL AEROSOL SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NITROGLYCERIN
LINGUAL AEROSOL.
NITROGLYCERIN LINGUAL AEROSOL
INITIAL U.S. APPROVAL: 2006
INDICATIONS AND USAGE
Nitroglycerin Lingual Aerosol is a nitrate vasodilator indicated for
acute relief of an attack or acute prophylaxis of angina
pectoris due to coronary artery disease (1).
DOSAGE AND ADMINISTRATION
At the onset of an attack, one metered spray or two metered sprays
should be administered on or under the tongue. A
spray may be repeated approximately every 5 minutes as needed (2).
Maximum of 3 metered sprays are recommended within a 15-minute period.
If chest pain persists after a total of 3
sprays, prompt medical attention is recommended (2).
May be used prophylactically 5 minutes to 10 minutes before engaging
in activities that might precipitate an acute
attack (2).
DOSAGE FORMS AND STRENGTHS
Lingual aerosol, 400 mcg per spray is available in either 200 metered
sprays or 60 metered sprays per container (3)
CONTRAINDICATIONS
Use of a selective inhibitor of cyclic guanosine monophosphate
(cGMP)-specific phosphodiesterase type 5 (PDE5
inhibitors), such as sildenafil, vardenafil, and tadalafil (4.1)
Use of the soluble guanylate stimulator riociguat (4.1)
Severe anemia (4.2)
Increased intracranial pressure (4.3)
History of hypersensitivity to Nitroglycerin Lingual Aerosol or to
other nitrates or nitrites (4.4)
WARNINGS AND PRECAUTIONS
Tolerance: Excessive use may lead to tolerance (5.1).
ADVERSE REACTIONS
Most common adverse reactions are headache, flushing, hypotension, and
syncope (6).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ROUSES POINT
PHARMACEUTICALS AT 1-877-567-0862 OR
FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH/REPORT.HTM.
DRUG INTERACTIONS
PDE5 inhibitors: Concomitant use contraindicated (4.1, 7.1)
Soluble guanylate cyclase sti