Product Description

Indications: Nitrocard SR is indicated for the rapid relief of acute anginal attacks and for the prevention of angina pectoris associated with coronary artery disease.

Pharmacology: Nitrocard SR contains nitroglycerin, an organic nitrate that relaxes vascular smooth muscle, producing vasodilation of both arteries and veins, with a greater effect on veins. This leads to reduced venous return (preload) and decreased cardiac workload, as well as reduced systemic vascular resistance (afterload). Nitroglycerin releases nitric oxide (NO), which activates guanylate cyclase and increases cyclic GMP levels, resulting in smooth muscle relaxation. It is rapidly absorbed, widely distributed, metabolized in the liver into active metabolites, and primarily excreted via the kidneys.

Dosage & Administration: For sublingual tablets, one 0.5 mg tablet should be placed under the tongue at the onset of chest pain and may be repeated every 5 minutes if needed, up to a maximum of 3 doses within 15 minutes. Sustained-release tablets should be taken as prescribed, typically 2.6 mg twice daily before meals or 6.4 mg twice daily, with dose adjustments based on response. For spray, one or two metered doses should be administered under the tongue at the onset of an attack and may be repeated every 5 minutes if necessary, up to 3 sprays within 15 minutes. It may also be used prophylactically 5–10 minutes before activities likely to trigger angina.

Administration: The spray should be primed before first use by pressing the actuator several times. Hold the container upright and spray under the tongue while sitting or resting. Avoid swallowing immediately after use and do not exceed recommended doses. The spray should not be inhaled, shaken, or used near flames.

Interaction: Concomitant use with antihypertensive agents, beta-blockers, or phenothiazines may enhance hypotensive effects. Alcohol may further increase the risk of hypotension. Aspirin may enhance the vasodilatory effects of nitroglycerin.

Contraindications: Contraindicated in patients using PDE5 inhibitors such as sildenafil, tadalafil, or vardenafil, as well as in those with severe anemia, increased intracranial pressure, hypersensitivity to nitrates, or acute circulatory failure or shock.

Side Effects: Common adverse effects include headache, flushing, and hypotension.

Pregnancy & Lactation: Safety in pregnancy and lactation has not been established. It should be used only if clearly necessary and under medical supervision. It is not known whether nitroglycerin is excreted in breast milk.

Precautions & Warnings: Use the lowest effective dose to avoid tolerance. Caution is advised in patients with hypotension or volume depletion. Excessive use may reduce effectiveness over time.

Use in Special Populations: Safety and effectiveness in pediatric patients have not been established.

Overdose Effects: Overdose may result in symptoms such as hypotension, tachycardia, cyanosis, restlessness, vomiting, syncope, and methemoglobinemia. Management is supportive and symptomatic.

Therapeutic Class: Nitrates; coronary vasodilators

Storage Conditions: Store below 25°C in a dry place, protected from light. Keep out of reach of children.