NITROGLYCERIN tablet

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

A-S Medication Solutions

Az alkalmazás módja:

SUBLINGUAL

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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 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% 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 mg/kg/day 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.

Termék összefoglaló:

Product: 50090-4874 NDC: 50090-4874-0 25 TABLET in a BOTTLE / 4 in a CARTON NDC: 50090-4874-1 25 TABLET in a BOTTLE

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

NITROGLYCERIN- NITROGLYCERIN TABLET
A-S MEDICATION SOLUTIONS
----------
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 ALVOGEN, INC. AT
1-866-770-3024 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 INFORMA