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Glyceryl Trinitrate Tablets IP

Glyceryl Trinitrate Tablets IP

Composition: Each sublingual tablet contains Dilute Nitroglycerin IP equivalent to Nitroglycerin 0.5 mg; excipients q.s.

Usage: Rapid relief of angina (chest pain), as prescribed.

Category: Generic Drugs and Medicine

Therapeutic category: Anti-anginal / nitrate vasodilator

SKU: Glyceryl Trinitrate Tablets

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

Product Information

Glyceryl Trinitrate Tablets IP 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

Glyceryl Trinitrate (Nitroglycerin) Sublingual Tablets

Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)
Exported by: Healthy Inc (Star Export House)

1. Product Introduction

Glyceryl trinitrate (GTN), also called nitroglycerin, is an organic nitrate vasodilator used for rapid relief of angina (chest pain caused by reduced oxygen supply to heart muscle). The confirmed product is a 0.5 mg sublingual tablet. It is placed under the tongue and is not an oral sustained-release tablet.

Healthy Life Pharma Pvt. Ltd. is identified as manufacturer and Healthy Inc as exporter. Any product-specific approvals, manufacturing claims and export registrations should be checked against supporting records.

2. Product Specifications

ParameterSpecification
ProductGlyceryl Trinitrate Tablets IP 0.5 mg
Composition per tabletDilute Nitroglycerin IP equivalent to Nitroglycerin 0.5 mg; excipients q.s.
Dosage formSublingual tablet (immediate action)
Pharmacopoeial referenceIP, as supplied
CAS number55-63-0
Therapeutic classNitrate vasodilator / anti-anginal
Strength confirmation0.5 mg sublingual confirmed; 2.6 mg and 6.4 mg sustained-release products not confirmed by supplied composition
Packaging / shelf lifeAccording to approved pack label and stability data

3. Manufacturing Technology

GTN is a potent, volatile substance requiring validated manufacturing, handling and packaging controls. Formulation design must support content uniformity, rapid sublingual performance and stability throughout shelf life. The exact production equipment, processes and explosion-protection arrangements are not established by the supplied product composition and are not claimed here.

4. Quality Assurance

Appropriate quality checks include identification, assay, content uniformity, impurities, disintegration or dissolution where applicable, packaging compatibility and stability. Actual limits and acceptance criteria depend on the approved product specification. Claims of fixed dissolution times or assay ranges require product-specific documentation.

5. Pharmacology and Clinical Use

GTN releases nitric oxide–related signalling that increases cyclic GMP in vascular smooth muscle and promotes vasodilation. Its venodilator action reduces cardiac preload and myocardial oxygen demand. Sublingual GTN is used for prompt symptom relief in angina; it does not treat a heart attack and must not delay emergency assessment of potentially serious chest pain.

6. Export and Regulatory Support

Regulatory dossiers, certificates of analysis, manufacturing certificates, free-sale documents and export documentation may be available subject to verification for the exact registered product and destination country. Packaging and shipping conditions must follow the approved label and applicable transport rules.

7. Frequently Asked Questions

Q: What is the confirmed strength?
A: Glyceryl Trinitrate IP 0.5 mg per sublingual tablet.

Q: Should this tablet be swallowed?
A: No. The confirmed 0.5 mg sublingual tablet is intended to dissolve under the tongue according to its approved instructions.

Q: Are 2.6 mg and 6.4 mg SR tablets included?
A: They appear in the descriptive draft, but no supporting composition was provided. They are separate dosage forms and should not be substituted for sublingual GTN.

Q: Can it be taken with sildenafil or tadalafil?
A: No. Nitrates and PDE5 inhibitors can cause a dangerous fall in blood pressure.

8. Dosage and Administration

Use only as directed by the prescribing clinician and the approved product leaflet. For an angina episode, stop activity and sit down before using the prescribed sublingual dose. Seek emergency medical help immediately for new, severe, unusual or persistent chest pain; do not wait through repeated doses before seeking help. Repeat-dose instructions depend on the prescribed product and local emergency guidance. Do not swallow the sublingual tablet as a routine oral dose.

9. Side Effects and Precautions

  • Common: headache, flushing, dizziness and low blood pressure.
  • Serious: fainting or profound hypotension; use caution with dehydration and other blood-pressure-lowering medicines.
  • Major interaction: do not combine with sildenafil, tadalafil, vardenafil or other PDE5 inhibitors; avoid riociguat. Relevant separation intervals and contraindications are defined by prescribing guidance.
  • Emergency warning: persistent chest pain, breathlessness, sweating or collapse requires urgent medical assessment.

10. Storage Instructions

Keep tablets in the original tightly closed container and follow the product label for temperature, light, moisture and expiry-after-opening requirements. GTN tablets can lose potency if improperly stored. A universal eight-week discard rule should not be applied without checking the actual product leaflet. Keep away from children.