NITROGLYCERIN tablet

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

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

Dostupno od:

Natco Pharma USA LLC

Administracija rute:

SUBLINGUAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

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

Proizvod sažetak:

Nitroglycerin sublingual tablets, USP are supplied in 3 strengths in color-coded labeled bottles containing 100 tablets each (0.3 mg, 0.4 mg, and 0.6 mg), and in one strength in color-coded Patient Convenience Packages of 4 bottles of 25 tablets each (0.4 mg). The 0.3 mg sublingual tablets are a white, round, flat faced tablet debossed with “3” on one side and “V” on other side. They are supplied as:                           NDC 69339-173-01                 Bottle of 100 tablets The 0.4 mg sublingual tablets are a white, round, flat faced tablet debossed with “4” on one side and “V” on other side. They are supplied as:                          NDC 69339-174-01                  Bottle of 100 tablets                          NDC 69339-174-41                  Patient Convenience Package of 4 bottles of 25 tablets (NDC 69339-174-02) The 0.6 mg sublingual tablets are a white, round, flat faced tablet debossed with "6" on one side and "V" on other side. They are supplied as:                         NDC 69339-175-01                   Bottle of 100 tablets Store at 20° to 25°C (68° 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.

Status autorizacije:

Abbreviated New Drug Application

Svojstava lijeka

NITROGLYCERIN - NITROGLYCERIN TABLET
NATCO PHARMA USA LLC
----------
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 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 sublingual tablets 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 NATCO PHARMA USA LLC AT
1-201-786-
6500 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.
REVISED: 7/2023
FULL PRESCRIB