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Nitroglycerin Sublingual Tablets USP

Composition: Each sublingual tablet contains dilute nitroglycerin USP equivalent to nitroglycerin 0.5 mg; excipients q.s.

Dosage form: Sublingual tablet — intended to dissolve under the tongue, not a controlled-release tablet.

Usage: Relief of angina (chest pain) episodes and, when prescribed, prevention immediately before a known trigger.

Category: Generic Drugs and Medicine / Cardiovascular Drugs

Therapeutic category: Organic nitrate vasodilator / Antianginal

SKU: Nitroglycerin Tablets

Categories: Pharmaceutical Exporter India, Pharmaceutical Formulations India, WHO GMP Certified Formulations

Product Information

Nitroglycerin Sublingual Tablets USP is listed in our pharmaceutical product portfolio for business-to-business enquiries. Product-specific formulation details, available strengths, dosage form, pack configuration and supply terms should be confirmed against the current product specification before ordering.

For distributor, wholesaler, hospital procurement and export enquiries, please request the applicable product specifications, batch documentation, shelf-life information, packaging options and regulatory documents. Availability and documentation depend on the product and destination market.

Description

Manufacturer: Healthy Life Pharma Pvt. Ltd. (certification subject to verification). Exporter: Healthy Inc (export credentials subject to verification).

1. Product Introduction

Nitroglycerin, also called glyceryl trinitrate (GTN), is a short-acting organic nitrate vasodilator. The supplied formulation is a USP 0.5 mg sublingual tablet intended for relief of angina episodes. It is placed under the tongue to dissolve and should not be confused with extended-release or controlled-release tablets used for longer-term angina prevention. Claims in the supplied marketing description about 2.6 mg and 6.4 mg controlled-release formulations are not supported by this product's composition.

2. Product Specifications

ParameterSpecification
Product nameNitroglycerin Sublingual Tablets
Active ingredientDilute Nitroglycerin USP equivalent to Nitroglycerin 0.5 mg per tablet
ExcipientsQuantity sufficient (q.s.)
Dosage formSublingual tablet (rapid acting)
Pharmacopoeial standard as suppliedUSP (finished-product compliance to be verified)
Therapeutic classOrganic nitrate / antianginal vasodilator
CAS number55-63-0 (nitroglycerin)
Packaging / shelf lifeConfirm using approved product-specific label and stability records

3. Manufacturing Technology

Nitroglycerin is a potent, volatile and stability-sensitive substance. Manufacture requires appropriately licensed facilities, controlled handling, validated content uniformity, and packaging demonstrated to maintain sublingual-tablet potency. Specific claims about explosion-proof suites, proprietary stabilization processes, or controlled-release matrices have not been independently verified and should not be attributed to this 0.5 mg product.

4. Quality Assurance

Relevant quality controls may include identity, assay, content uniformity, impurities, disintegration or dissolution as required by the applicable monograph, container-closure integrity, and stability testing. Acceptance limits and shelf life must come from approved specifications and supporting test records; no unverified numerical release targets are claimed.

5. Pharmacology and Clinical Use

Nitroglycerin is converted to nitric oxide-related signaling species that relax vascular smooth muscle, especially veins, reducing cardiac preload and myocardial oxygen demand. Sublingual nitroglycerin is used for acute relief of angina and may be prescribed before activities that predictably provoke angina. Persistent, new, or worsening chest pain can be a medical emergency and requires immediate medical evaluation. Controlled-release tablets are different formulations and are not interchangeable with this product.

6. Export and Regulatory Support

Country-specific marketing authorization, manufacturing licences, pharmacopoeial compliance, and import/export permissions should be checked before supply. Availability of COA, COPP, FSC, CTD/ACTD dossiers, WHO-GMP certification and Star Export House credentials must be verified with the responsible organizations. This page does not assert unconfirmed regulatory approvals.

7. Frequently Asked Questions

Is this a controlled-release tablet? No. The provided composition is for a 0.5 mg sublingual tablet. The 2.6 mg and 6.4 mg controlled-release strengths in the marketing description describe a different dosage form.

Can it be swallowed like an ordinary tablet? Sublingual tablets are intended to dissolve under the tongue according to the approved patient instructions; swallowing may reduce or delay the intended rapid effect.

Can it be combined with sildenafil or tadalafil? No. Nitrates with PDE5 inhibitors can cause a dangerous fall in blood pressure. Riociguat is also contraindicated with nitrates.

8. Dosage and Administration

Use strictly according to the approved label and prescriber's instructions. At the onset of angina, the prescribed sublingual tablet is placed under the tongue and allowed to dissolve; sit down before use because dizziness or fainting may occur. Do not chew or swallow it as an ordinary tablet. Seek emergency medical assistance for chest pain that persists, worsens or is unusual; do not delay calling emergency services to take repeated doses. Exact dose limits and repeat intervals must follow the product's approved labeling.

9. Side Effects and Precautions

Common effects include headache, flushing, dizziness and low blood pressure. Serious hypotension or fainting can occur. Do not use with phosphodiesterase-5 inhibitors (such as sildenafil, tadalafil or vardenafil) or riociguat. Alcohol and other blood-pressure-lowering medicines may increase hypotension risk. Patients with certain cardiovascular conditions require particular caution. Ask a healthcare professional about contraindications, pregnancy, breastfeeding and drug interactions.

10. Storage Instructions

Nitroglycerin sublingual tablets can lose potency if stored improperly. Keep in the original manufacturer-approved container, tightly closed, and protect from heat, moisture and light as specified on the label. Do not transfer to unsuitable pill organizers. Follow the labeled expiry and replacement instructions; keep away from children.

For product identification and healthcare-professional reference only. Not individualized medical advice. Packaging, claims, certification and availability must be verified before publication or purchase.