Nitrostat (Nitroglycerin)

NITROSTAT™

Parke-Davis

Nitroglycerin

Coronary Vasodilator

Indications And Clinical Uses: For the prophylaxis, treatment and management of patients with angina pectoris.

Contra-Indications: In patients with early myocardial infarction, severe anemia, increased intracranial pressure and those with a known hypersensitivity to nitroglycerin.

Manufacturers’ Warnings In Clinical States: The use of nitroglycerin during the early course of acute myocardial infarction requires particular attention to hemodynamic monitoring and clinical status because of the possibility of hypotension.

Precautions: Only the smallest dose required for effective relief of the acute anginal attack should be used. Excessive use may lead to the development of tolerance. Nitrostat tablets are intended for sublingual or buccal administration and should not be swallowed. The drug should be discontinued if blurring of vision or drying of the mouth occurs. Excessive dosage of nitroglycerin may produce severe headaches.

Severe hypotension particularly with upright posture, may occur even with small doses of nitroglycerin. The drug should be used cautiously in patients with volume depletion or low systolic blood pressure.

Paradoxical bradycardia and increased angina pectoris may accompany nitroglycerin-induced hypotension.

Nitratre therapy may aggravate angina caused by hypertrophic cardiomyopathy.

Tolerance to the vascular and antianginal effects of nitroglycerin and cross-tolerance to other nitrates and nitrites may occur.

Drug Interactions: Concomitant use of nitrates and alcohol may cause hypotension. Patients receiving antihypertensive drugs, beta-adrenergic blockers or phenothiazines and nitrates should be observed for possible additive hypotensive effects.

Marked orthostatic hypotension has been reported when calcium channel blockers and organic nitrates were used concomitantly. Dose adjustment of either drug may be necessary.

ASA may decrease the clearance and enhance the hemodynamic effects of sublingual nitroglycerin.

A decrease in the therapeutic effect of sublingual nitroglycerin may result from use of long-acting nitrates.

Drug/Laboratory Test Interactions : Nitrates may interfere with the Zlatkis-Zak color reaction, causing a false report of decreased serum cholesterol.

Pregnancy: Nitroglycerin should be given to a pregnant woman only if clearly needed.

Lactation: Caution should be exercised when nitroglycerin is administered to a nursing woman.

Children: Safety and effectiveness in children have not been established.

Information for the Patient: If possible, patients should sit down when taking Nitrostat tablets. This eliminates the possibility of falling due to lightheadedness or dizziness.

Nitroglycerin may produce a burning or tingling sensation when administered sublingually; however, the ability to produce a burning or tingling sensation should not be considered a reliable method for determining the potency of the tablets.

Nitrostat should be kept in the original glass container, tightly capped. The cotton should be discarded once the bottle is opened.

Adverse Reactions: Headache, which may be severe and persistent, may occur immediately after use. Vertigo, 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 vasodilation has been reported. Flushing, drug rash and exfoliative dermatitis have been reported in patients receiving nitrate therapy.

Symptoms And Treatment Of Overdose: Symptoms and Treatment: Nitrate overdose may result in severe hypotension, tachycardia, bradycardia, heart block, palpitation, death due to circulatory collapse, syncope, persistent throbbing headache, vertigo, visual disturbance, increased intracranial pressure, paralysis and coma. These may be followed by convulsions, flushing and diaphoresis, nausea and vomiting, colic and diarrhea, dyspnea and methemoglobinemia.

Since hypotension from nitroglycerin overdose results from venodilation and arterial hypovolemia, therapy should be directed towards central volume expansion. Elevation of extremities may be sufficient, but i.v. infusion may also be necessary. Use of arterial vasoconstrictors may do more harm than good. Management of nitroglycerin overdose in patients with renal disease or congestive heart failure may require invasive monitoring.

If methemoglobinemia is present, i.v. administration of methylene blue (1 to 2 mg/kg) may be required.

No specific antidote is available. Treatment should be symptomatic and supportive.

Dosage And Administration: Usual adult dosage range 0.3 to 0.6 mg. One tablet should be dissolved under the tongue or in the buccal pouch at the first sign of an acute anginal attack. The dose may be repeated approximately every 5 minutes until relief is obtained. If the pain persists after a total of 3 tablets in a 15-minute period, prompt medical attention is recommended. Nitrostat may be used prophylactically 5 to 10 minutes prior to engaging in activities that might precipitate an acute attack.

No dosage adjustment is required in patients with renal failure.

Availability And Storage: 0.3 mg: Each sublingual tablet contains: nitroglycerin 0.3 mg. Nonmedicinal ingredients: alcohol, lactose, polyethylene glycol and sucrose. Energy: 0.13 kJ (0.54 kcal). Gluten-, paraben-, sodium-, sulfite- and tartrazine-free. Bottles of 100.

0.6 mg: Each sublingual tablet contains: nitroglycerin 0.6 mg. Nonmedicinal ingredients: alcohol, lactose, polyethylene glycol and sucrose. Energy: 0.13 kJ (0.54 kcal). Gluten-, paraben-, sodium-, sulfite- and tartrazine-free. Bottles of 100. (Shown in Product Recognition Section)

NITROSTAT™ Parke-Davis Nitroglycerin Coronary Vasodilator

Connected Diseases :

Angina Pectoris

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