NITROSTAT- nitroglycerin tablet

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Parke-Davis Div of Pfizer Inc

INN (International namn):

NITROGLYCERIN

Sammansättning:

NITROGLYCERIN 0.3 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 nitrates or nitrites or any excipient. NITROSTAT is 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 Data] . 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 2–4% and 15–20%, 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 7–17, and at intravenous doses in pregnant rabbits up to 4 mg/kg/day from gestation day 6–18. 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 NITROSTAT 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.

Produktsammanfattning:

NITROSTAT is supplied as white, round, flat-faced tablets in 3 strengths (0.3 mg, 0.4 mg, and 0.6 mg) in bottles containing 100 tablets each, with color-coded labels, and in color-coded Patient Convenience Packages of 4 bottles of 25 tablets each. 0.3 mg: Coded "N" on one side and "3" on the other. NDC 0071-0417-24—Bottle of 100 tablets 0.4 mg: Coded "N" on one side and "4" on the other. NDC 0071-0418-13—Convenience Package NDC 0071-0418-24—Bottle of 100 tablets 0.6 mg: Coded "N" on one side and "6" on the other. NDC 0071-0419-24—Bottle of 100 tablets 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
PARKE-DAVIS DIV OF PFIZER 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: 2/2018
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND A