Rx Item-GONITRO nitroglycerin SUBLINGUAL 400MCG PWD 36 BY Allegis Pharma

These highlights do not include all the information needed to use GONITRO safely and effectively. See full prescribing information for GONITRO.

GONITRO (nitroglycerin) sublingual powder
Initial U.S. Approval:1981
INDICATIONS AND USAGE

GONITRO 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 one or two packets (400 mcg each) under the tongue. One additional packet may be administered every 5 minutes as needed. No more than three total packets (1200 mcg) are recommended within a 15 minute period. (2.1)
If chest pain persists after three packets, 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

Sublingual powder, 400 mcg per packet. (3)
CONTRAINDICATIONS

Use of phosphodiesterase type 5 (PDE-5) inhibitors, such as avanafil, sildenafil, tadalafil, or vardenafil, or soluble guanylate cyclase (sGC) stimulators. (4.1, 7.1)
Severe anemia. (4.2)
Increased intracranial pressure. (4.3)
Hypersensitivity to GONITRO or to other nitrates or nitrites or any excipient. (4.4)
Circulatory failure and shock. (4.5)

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 Espero Pharmaceuticals, Inc. at 1-800-235-6520 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 patient labeling.

Revised: 8/2018

GONITRO nitroglycerin SUBLINGU
GONITRO nitroglycerin SUBLINGUAL 400MCG PWD 36 BY Allegis Pharma Item No.:RX598678 598678 NDC No.70007-0400-36 70007-400-36 7000740036 70007040036 UPC/GTIN No. 3-70007-40036-4 370007-400364 37000740

GONITRO nitroglycerin SUBLINGU
GONITRO nitroglycerin SUBLINGUAL 400MCG PWD 36 BY Allegis Pharma Item No.:RX598678 598678 NDC No.70007-0400-36 70007-400-36 7000740036 70007040036 UPC/GTIN No. 3-70007-40036-4 370007-400364 37000740

NITROGLYCERIN SUBLINGUAL
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GONITRO nitroglycerin SUBLINGU
GONITRO nitroglycerin SUBLINGUAL 400MCG PWD 36 BY Allegis Pharma Item No.:RX598678 598678 NDC No.70007-0400-36 70007-400-36 7000740036 70007040036 UPC/GTIN No. 3-70007-40036-4 370007-400364 37000740

GONITRO nitroglycerin SUBLINGU
GONITRO nitroglycerin SUBLINGUAL 400MCG PWD 36 BY Allegis Pharma Item No.:RX598678 598678 NDC No.70007-0400-36 70007-400-36 7000740036 70007040036 UPC/GTIN No. 3-70007-40036-4 370007-400364 37000740