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NITROSTAT® (nitroglycerin) Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

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

NITROSTAT (nitroglycerin) sublingual tablet
Initial U.S. Approval: 1981

INDICATIONS AND USAGE

NITROSTAT is a nitrate vasodilator indicated for 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 tablet under the tongue or buccal pouch. One additional tablet may be administered every 5 minutes as needed. No more than 3 total tablets are recommended within a 15 minute period. (2)
  • If chest pain persists after three tablets, seek prompt medical attention. (2)
  • May be used prophylactically 5 to 10 minutes prior to engaging in activities that might precipitate an acute attack. (2)

DOSAGE FORMS AND STRENGTHS

Sublingual tablets, 0.3 mg; 0.4 mg; 0.6 mg (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 NITROSTAT 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, dizziness and paresthesia. (6)


To report SUSPECTED ADVERSE REACTIONS, contact Pfizer, Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Ergotamine: increased bioavailability of ergotamine. Avoid concomitant use. (7.2)

See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.

Revised: 2/2018

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Contact Pfizer Safety to report an adverse event, side effect or concern about the quality of a Pfizer product: (800) 438-1985

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns at 1-800-FDA-1088 or www.fda.gov/MedWatch

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