NITROSTAT- nitroglycerin tablet

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

REMEDYREPACK INC.

INN (International namn):

NITROGLYCERIN

Sammansättning:

NITROGLYCERIN 0.4 mg

Administreringssätt:

SUBLINGUAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

NITROSTAT is indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease. Do not use NITROSTAT 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 NITROSTAT in patients who are taking the soluble guanylate cyclase stimulators, such as riociguat. Concomitant use can cause hypotension. NITROSTAT is contraindicated in patients with severe anemia (large doses of nitroglycerin may cause oxidation of hemoglobin to methemoglobin and could exacerbate anemia). NITROSTAT 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). NITROSTAT is contraindicated in patients who are allergic to nitroglycerin, other nitrat

Produktsammanfattning:

NITROSTAT is supplied as white, round, flat-faced tablets in 4 mg strength 0.4 mg: Coded "N" on one side and "4" on the other. NDC: 70518-0105-00 PACKAGING: 25 in 1 BOTTLE Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762 Store at Controlled Room Temperature 20°–25°C (68°–77°F) [see USP]. Nitroglycerin should be kept in the original glass container and must be tightly capped after each use to prevent loss of tablet potency.

Bemyndigande status:

New Drug Application

Produktens egenskaper

NITROSTAT- NITROGLYCERIN TABLET
REMEDYREPACK INC.
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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: 2/2020
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND