NITROGLYCERIN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Glenmark Pharmaceuticals Inc., USA

INN (International Name):

NITROGLYCERIN

Composition:

NITROGLYCERIN 0.3 mg

Administration route:

SUBLINGUAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Nitroglycerin sublingual tablets are indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease. Do not use nitroglycerin sublingual tablets in patients who are taking PDE-5 Inhibitors, such as avanafil, sildenafil, tadalafil, vardenafil hydrochloride. Concomitant use can cause severe hypotension, syncope, or myocardial ischemia [see Drug Interactions (7.1)]. Do not use nitroglycerin sublingual tablets in patients who are taking the soluble guanylate cyclase stimulators, such as riociguat. Concomitant use can cause hypotension. Nitroglycerin sublingual tablets are contraindicated in patients with severe anemia (large doses of nitroglycerin may cause oxidation of hemoglobin to methemoglobin and could exacerbate anemia). Nitroglycerin sublingual tablets 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 sublingual tablets are contraindicated in patients who are allergic to nitroglycerin, other nitrates or nitrites or any excipient. Nitroglycerin sublingual tablets are contraindicated in patients with acute circulatory failure or shock. Risk Summary Limited published data on the use of nitroglycerin are insufficient to determine a drug associated risk of major birth defects or miscarriage. In animal reproduction studies, there were no adverse developmental effects when nitroglycerin was administered intravenously to rabbits or intraperitoneally to rats during organogenesis at doses greater than 64-times the human dose [see Error! Hyperlink reference not valid. ] . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data No embryotoxic or postnatal development effects were observed with transdermal application in pregnant rabbits and rats at doses up to 80 and 240 mg/kg/day, respectively, at intraperitoneal doses in pregnant rats up to 20 mg/kg/day from gestation day 7 to 17, and at intravenous doses in pregnant rabbits up to 4 mg/kg/day from gestation day 6 to 18. Risk Summary Sublingual nitroglycerin has not been studied in lactating women. It is not known if nitroglycerin is present in human milk or if nitroglycerin has effects on milk production. The safety and effectiveness of nitroglycerin in pediatric patients have not been established. Clinical studies of nitroglycerin sublingual tablets did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Product summary:

Nitroglycerin Sublingual Tablets, USP are supplied as white to off white, round, flat-faced tablets in 3 strengths (0.3 mg, 0.4 mg, and 0.6 mg) in bottles containing 100 tablets each. The 0.4 mg strength is also supplied in Patient Convenience Packages of 4 bottles of 25 tablets each. 0.3 mg: Debossed with “1” on one side and “C” on the other NDC 68462-638-01—Bottle of 100 tablets 0.4 mg: Debossed with “2” on one side and “C” on the other NDC 68462-639-45—Convenience Package NDC 68462-639-01—Bottle of 100 tablets 0.6 mg: Debossed with “3” on one side and “C” on the other NDC 68462-640-01—Bottle of 100 tablets Store at 20°C to 25°C (68°F to 77°F) [see USP Controlled Room Temperature]. Nitroglycerin should be kept in the original glass container and must be tightly capped after each use to prevent loss of tablet potency.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

NITROGLYCERIN- NITROGLYCERIN TABLET
GLENMARK PHARMACEUTICALS INC., USA
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
NITROGLYCERIN
SUBLINGUAL TABLETS SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING
INFORMATION FOR
NITROGLYCERIN SUBLINGUAL TABLETS
NITROGLYCERIN SUBLINGUAL TABLETS, FOR ORAL USE
INITIAL U.S. APPROVAL: 1981
INDICATIONS AND USAGE
Nitroglycerin sublingual tablets are nitrate vasodilator indicated for
relief of an attack or prophylaxis of
angina pectoris due to coronary artery disease. (1)
DOSAGE AND ADMINISTRATION
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•
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DOSAGE FORMS AND STRENGTHS
Sublingual tablets, 0.3 mg; 0.4 mg; 0.6 mg (3)
CONTRAINDICATIONS
•
•
•
•
•
WARNINGS AND PRECAUTIONS
•
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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 GLENMARK
PHARMACEUTICALS INC., USA AT
1 [phone] 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: 10/2021
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
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)
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 nitroglycerin sublin