NITROGLYCERIN tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Advagen Pharma Ltd

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 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 in patients who are taking the soluble guanylate cyclase stimulators, such as riociguat. Concomitant use can cause hypotension. Nitroglycerin is contraindicated in patients with severe anemia (large doses of nitroglycerin may cause oxidation of hemoglobin to methemoglobin and could exacerbate anemia). Nitroglycerin 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 is contraindicated in patients who are allergic to nitrog

Product summary:

Nitroglycerin sublingual tablets, USP are supplied as white to off white , round, flat-faced tablets in three strengths (0.3 mg, 0.4 mg, and 0.6 mg) in bottles containing 100 tablets each, additionally 0.4 mg strength is available in bottles of 25 tablets also. 0.3 mg:         "Ʌ6" debossed on one side and plain on the other side.                      NDC 72888-138-01- Bottle of 100 tablets 0.4 mg:         "Ʌ7" debossed on one side and plain on the other side.                      NDC 72888-139-01- Bottle of 100 tablets                            NDC 72888-139-33- Patient Convenience Package of 4 Bottles of 25 tablets. 0.6 mg:         "Ʌ8" debossed on one side and plain on the other side.                      NDC 72888-140-01- Bottle of 100 tablets Store at Controlled Room Temperature 20°–25°C (68°–77°F) [see USP]. Nitroglycerin sublingual tablets 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
ADVAGEN PHARMA LTD
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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
INITIAL U.S. APPROVAL: 1981
INDICATIONS AND USAGE
Nitroglycerin 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 nitroglycerin 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 ADVAGEN PHARMA LTD, AT
866-488-0312
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: 9/2023
FULL PRESCRIBING INFORMA