Nitrostad 0.6

Rx

Indications

• For the acute relief of an attack or acute prophylaxis of angina pectoris due to coronary artery disease.

Dosage

• 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.
• Nitrostad may be used prophylactically 5 to 10 minutes prior to engaging in activities that might precipitate an acute attack.

Usage

• 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 Nitrostad at rest, preferably in the sitting position.

• Do not use nitroglycerin in patients who are taking PDE-5 inhibitors, such as avanafil, sildenafil, tadalafil, vardenafil hydrochloride.
• Do not use nitroglycerin in patients who are taking the soluble guanylate cyclase stimulators, such as riociguat. Concomitant use can cause hypotension.
• Nitroglycerin is contraindicated in patients with severe anemia.
• Nitroglycerin 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 is contraindicated in patients who are allergic to nitroglycerin, other nitrates or nitrites or any excipient.
• Nitroglycerin is contraindicated in patients with acute circulatory failure or shock.

Common

• Hypotension,
• Headache,
• Vertigo,
• Palpitation,
• Flushing,
• Exfoliative dermatitis.

• 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 volumedepleted, or are already hypotensive.
• 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.
• The safety and effectiveness of nitroglycerin in pediatric patients have not been established.
• Geriatric use
  Clinical studies of nitroglycerin 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.
• Because the safety of nitroglycerin for pregnant and breastfeeding women has not been established, the drug should not be used in pregnant women (especially during the first trimester of pregnancy) and breastfeeding women, unless the benefits outweigh the risks.
• There is no evidence that nitroglycerin affects the ability to drive or to operate machinery.