NITROGLYCERIN LINGUAL- nitroglycerin spray

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Padagis Israel Pharmaceuticals Ltd

INN (International Name):

NITROGLYCERIN

Composition:

NITROGLYCERIN 400 ug

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Nitroglycerin Lingual Spray is indicated for acute relief of an attack or prophylaxis of angina pectoris due to coronary artery disease. Do not use Nitroglycerin Lingual Spray in patients who are taking PDE-5-Inhibitors, such as avanafil, sildenafil, tadalafil, or vardenafil. Concomitant use can cause severe hypotension, syncope, or myocardial ischemia [see Drug Interactions (7.1)] . Do not use Nitroglycerin Lingual Spray in patients who are taking soluble guanylate cyclase (sGC) stimulators, such as riociguat. Concomitant use can cause hypotension. Nitroglycerin Lingual Spray is contraindicated in patients with severe anemia (large doses of nitroglycerin may cause oxidation of hemoglobin to methemoglobin and could exacerbate anemia). Nitroglycerin Lingual Spray may precipitate or aggravate increased intracranial pressure and thus should not be used in patients with possible increased intracranial pressure (e.g. cerebral hemorrhage or traumatic brain injury). Nitroglycerin Lingual Spray is contraindicated in

Product summary:

Each box of Nitroglycerin Lingual Spray contains one glass bottle coated with orange transparent plastic which assists in containing the glass and medication should the bottle be shattered. Each bottle contains 4.9 g or 12 g (Net Contents) of nitroglycerin lingual spray which will deliver 60 or 200 metered sprays containing 400 mcg of nitroglycerin per spray after priming. Nitroglycerin Lingual Spray is available as: Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Note: Nitroglycerin Lingual Spray contains 20% alcohol. Do not forcefully open or burn container after use. Do not spray toward flames. Rx Only

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NITROGLYCERIN LINGUAL- NITROGLYCERIN SPRAY
PADAGIS ISRAEL PHARMACEUTICALS LTD
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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). (1)
DOSAGE AND ADMINISTRATION
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•
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DOSAGE FORMS AND STRENGTHS
Lingual spray, 400 mcg per spray, available in 60 or 200 metered
sprays per container (3). (3)
CONTRAINDICATIONS
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•
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WARNINGS AND PRECAUTIONS
Tolerance: Excessive use may lead to tolerance. (5.1) (5)
Hypotension: Severe hypotension may occur. (5.2) (5)
ADVERSE REACTIONS
Most common adverse reactions occurring at a frequency greater than 2%
are headache, dizziness and
paresthesia (6).
To report SUSPECTED ADVERSE REACTIONS, contact Padagis at
1-866-634-9120 or FDA at 1-800-FDA-
1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
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•
SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT
LABELING.
REVISED: 9/2022
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Recommended Dosage
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).
Use of phosphodiesterase type 5 (PDE-5) inhibitors, such as avanafil,
sildenafil, tadalafil, or vardenafil,
or soluble guanylate cyclase (sGC) stimulator (riociguat). (4.1, 7.1)
Severe anemia. (4.2)
Increased intracranial pressure. (4.3)
Hypersensitivity to Nitroglycerin Lingual Spray or to other nitrates
or nitrites or a