NITROGLYCERIN- nitroglycerin tablet
Bryant Ranch Prepack
1 INDICATIONS AND USAGE
Nitroglycerin sublingual tablets are indicated for the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.
2 DOSAGE AND ADMINISTRATION
Administer one tablet under the tongue or in the buccal pouch at the first sign of an acute anginal attack. Allow tablet to dissolve without swallowing. One additional tablet may be administered every 5 minutes until relief is obtained. No more than three tablets are recommended within a 15-minute period. If the pain persists after a total of 3 tablets in a 15-minute period, or if the pain is different than is typically experienced, seek prompt medical attention.
Nitroglycerin sublingual tablets may be used prophylactically 5 minutes to 10 minutes prior to engaging in activities that might precipitate an acute attack.
For patients with xerostomia, a small sip of water prior to placing the tablet under the tongue may help maintain mucosal hydration and aid dissolution of the tablet.
Administer nitroglycerin sublingual tablets at rest, preferably in the sitting position.
3 DOSAGE FORMS AND STRENGTHS
Nitroglycerin sublingual tablets, USP are supplied as white, round, flat-faced tablets in three strengths:
0.3 mg (Coded with “V” on one side and “3” on the other)
0.4 mg (Coded with “V” on one side and “4” on the other)
0.6 mg (Coded with “V” on one side and “6” on the other)
4.1 PDE-5-Inhibitors and sGC-Stimulators
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.
4.2 Severe Anemia
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).
4.3 Increased Intracranial Pressure
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.
4.5 Circulatory Failure and Shock
Nitroglycerin sublingual tablets are contraindicated in patients with acute circulatory failure or shock.
5 WARNINGS AND PRECAUTIONS
Excessive use may lead to the development of tolerance. Only the smallest dose required for effective relief of the acute angina attack should be used. A decrease in therapeutic effect of sublingual nitroglycerin may result from use of long-acting nitrates.
Severe hypotension, particularly with upright posture, may occur with small doses of nitroglycerin particularly in patients with constrictive pericarditis, aortic or mitral stenosis, patients who may be volume-depleted, or are already hypotensive. Hypotension induced by nitroglycerin may be accompanied by paradoxical bradycardia and increased angina pectoris. Symptoms of severe hypotension (nausea, vomiting, weakness, pallor, perspiration and collapse/syncope) may occur even with therapeutic doses.
5.3 Hypertrophic Obstructive Cardiomyopathy
Nitrate therapy may aggravate the angina caused by hypertrophic cardiomyopathy.
Nitroglycerin produces dose-related headaches, especially at the start of nitroglycerin therapy, which may be severe and persist but usually subside with continued use.
6 ADVERSE REACTIONS
The following adverse reactions are discussed in more detail elsewhere in the label:
• Hypotension [see Warnings and Precautions (5.2)]
• Headache [see Warnings and Precautions (5.4)]
• Hypersensitivity [see Contraindications (4.4)]
Vertigo, dizziness, weakness, palpitation, and other manifestations of postural hypotension may develop occasionally, particularly in erect, immobile patients. Marked sensitivity to the hypotensive effects of nitrates (manifested by nausea, vomiting, weakness, diaphoresis, pallor, and collapse) may occur at therapeutic doses. Syncope due to nitrate vasodilatation has been reported.
Flushing, drug rash, and exfoliative dermatitis have been reported in patients receiving nitrate therapy.
7 DRUG INTERACTIONS
7.1 PDE-5-Inhibitors and sGC-Stimulators
Nitroglycerin sublingual tablets are contraindicated in patients who are using a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE-5). PDE-5-Inhibitors such as avanafil, sildenafil, vardenafil, and tadalafil have been shown to potentiate the hypotensive effects of organic nitrates.
Nitroglycerin sublingual tablets are contraindicated in patients who are taking soluble guanylate cyclase (sGC) stimulators. Concomitant use can cause hypotension.
The time course and dose dependence of these interactions have not been studied, and use within a few days of one another is not recommended. Appropriate supportive care for the severe hypotension has not been studied, but it seems reasonable to treat this as a nitrate overdose, with elevation of the extremities and with central volume expansion.
Oral administration of nitroglycerin markedly decreases the first-pass metabolism of dihydroergotamine and subsequently increases its oral bioavailability. Ergotamine is known to precipitate angina pectoris. Therefore, patients receiving sublingual nitroglycerin should avoid ergotamine and related drugs or be monitored for symptoms of ergotism if this is not possible.
8 USE IN SPECIFIC POPULATIONS
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.
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 summarySublingual 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.
8.4 Pediatric Use
The safety and effectiveness of nitroglycerin in pediatric patients have not been established.
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