Nitrostat Nitroglycerin Sublingual Tablets

Brand Name: 耐较咛®(Nitrostat®)
Generic Name: Nitroglycerin Sublingual
Strength: 0.6mg per tablet, 25 tablets per bottle
Manufacturer: Viatris Pharmaceuticals
Marketing Authorization Holder: Viatris Pharmaceuticals
Approval Date in China: 2019‑02‑18
Registration Number: HJ20190008
Storage: Store in a tightly‑closed container, protected from light.

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1. Indications and Usage
Acute Angina Relief: Indicated for the rapid relief of angina pectoris attacks.
Prophylaxis: Can be used prophylactically 5–10 minutes before activities likely to precipitate an anginal attack.
2. Dosage and Administration
Standard Dose: 0.3–0.6 mg (1–2 tablets) placed under the tongue (sublingual) at the onset of an attack.
Administration: Do not swallow or chew. The tablet dissolves quickly under the tongue.
Emergency Protocol: If pain is not relieved after 1 tablet within 5 minutes, a second dose may be administered. A third dose can be given after another 5 minutes. If pain persists after 3 doses, emergency medical services should be contacted immediately.
3. Mechanism of Action
Nitric Oxide Donor: Nitroglycerin is metabolized to release nitric oxide (NO) in vascular smooth muscle cells.
Vasodilation: NO increases intracellular cyclic GMP, causing relaxation of vascular smooth muscle.
Hemodynamic Effects: It predominantly dilates large veins (reducing preload) and coronary arteries (improving myocardial blood supply), rapidly alleviating myocardial ischemia and angina.
4. Safety and Warnings
Hypotension: The most common risk is severe hypotension and reflex tachycardia.
Contraindications: Contraindicated in patients with severe hypotension, hypovolemia, right ventricular infarction, or known hypersensitivity.
PDE5 Inhibitors: Absolute contraindication with phosphodiesterase-5 (PDE5) inhibitors (e.g., sildenafil) within 24 hours due to the risk of life-threatening hypotension.
Storage: Tablets are volatile and must be stored in their original glass container, tightly closed, and kept away from light and heat.
5. Adverse Reactions and Clinical Research
Common Adverse Reactions: Headache (very common, often severe initially), dizziness, lightheadedness, flushing, and sweating.
Serious Adverse Reactions: Severe hypotension, syncope, bradycardia, and methemoglobinemia (rare).
Clinical Findings: Rapid onset of action (1–3 minutes) makes it the gold standard for acute angina relief.
6. Drug Interactions
PDE5 Inhibitors: Concomitant use with sildenafil, tadalafil, or vardenafil is strictly contraindicated.
Antihypertensives: May potentiate the hypotensive effects of other antihypertensive agents.
Alcohol: Can enhance vasodilation and hypotensive effects.
7. Pharmaceutical Information
Active Ingredient: Nitroglycerin.
Strengths: Typically available as 0.3 mg (1/200 grain) and 0.6 mg (1/100 grain) tablets.
Appearance: White tablets or sugar-coated tablets.
Storage: Store below 30°C in the original amber glass container, tightly closed. Discard 3–6 months after opening the bottle as potency declines.

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