NITROGLYCERIN LINGUAL spray metered

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

nitroglycerin (UNII: G59M7S0WS3) (nitroglycerin - UNII:G59M7S0WS3)

Dostupno od:

Wilshire Pharmaceuticals, Inc.

INN (International ime):

nitroglycerin

Sastav:

nitroglycerin 400 ug

Tip recepta:

PRESCRIPTION DRUG

Status autorizacije:

New Drug Application

Svojstava lijeka

NITROGLYCERIN LINGUAL- NITROGLYCERIN SPRAY, METERED
WILSHIRE PHARMACEUTICALS, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NITROGLYCERIN LINGUAL SPRAY SAFELY
AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR NITROGLYCERIN
LINGUAL SPRAY.
NITROGLYCERIN LINGUAL SPRAY
INITIAL U.S. APPROVAL: 1997
INDICATIONS AND USAGE
Nitroglycerin Lingual Spray is a nitrate vasodilator indicated for
acute relief of an attack or prophylaxis of angina pectoris
due to coronary artery disease (1).
DOSAGE AND ADMINISTRATION
At the onset of an attack, administer onto or under the tongue. Repeat
every 5 minutes as needed (2.1).
Do up to three metered sprays within a 15-minute period. If chest pain
persists, advise prompt medical attention (2.1).
May be used prophylactically 5 to 10 minutes prior to engaging in
activities that might precipitate an acute attack (2.1).
DOSAGE FORMS AND STRENGTHS
Lingual spray, 400 mcg per spray, available in 60 or 200 metered
sprays per container (3).
CONTRAINDICATIONS
Use of phosphodiesterase type 5 (PDE5) inhibitors, such as avanafil,
sildenafil, tadalafil, or vardenafil, or soluble
guanylate cyclase (sGC) stimulator (riociguat). (4.1)
Severe anemia. (4.2)
Increased intracranial pressure. (4.3)
History of hypersensitivity to Nitroglycerin Lingual Spray or to other
nitrates or nitrites or any excipient. (4.4)
WARNINGS AND PRECAUTIONS
Tolerance: Excessive use may lead to tolerance. (5.1)
Hypotension: Severe hypotension may occur. (5.2)
ADVERSE REACTIONS
Most common adverse reactions occurring at a frequency greater than 2
% are headache, dizzinesss and paresthesia (6).
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT WILSHIRE
PHARMACEUTICALS, INC. AT 1-877-495-6856 OR
FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Antihypertensives: Possible additive hypotensive effects. (7.2)
Ergotamine: increased bioavailability of ergotamine. Avoid concomitant
use (7.3)
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PA