Composition: Isosorbide Mononitrate 10 mg; Isosorbide 5-Mononitrate BP 20 mg (M-Trate)
Usage: Prevention of angina-related chest pain
Category: Anti-cardiovascular drugs
Therapeutic category: Cardiovascular agent / anti-anginal
Manufacturer: Healthy Life Pharma Pvt. Ltd. (WHO-GMP certification claimed; verify current certificate)
Exporter: Healthy Inc (Star Export House status claimed; verify)
Categories: Contract Manufacturer, Formulations Exporter India, Manufacturing Pharmaceutical Company India, Pharmaceutical Exporter India, Pharmaceutical Formulations India, Tablets Manufacturer, WHO GMP Certified Formulations
Isosorbide Mononitrate Tablets 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.
Isosorbide Mononitrate Tablets are nitrate vasodilators used for prevention of angina (chest pain) associated with coronary artery disease. Healthy Life Pharma Pvt. Ltd. is identified as the manufacturer and Healthy Inc as the exporter in the supplied product information.
The supplied product labels confirm 10 mg Isosorbide Mononitrate and 20 mg Isosorbide 5-Mononitrate BP (M-Trate). The separately listed isosorbide dinitrate tablets contain a different active ingredient and are not mononitrate strengths. Claims about 40 mg and sustained-release variants require product-label confirmation.
| Parameter | Specification |
|---|---|
| Product | Isosorbide Mononitrate Tablets |
| Active ingredient | Isosorbide Mononitrate / Isosorbide 5-Mononitrate |
| Confirmed strengths | 10 mg (uncoated); 20 mg BP (M-Trate, uncoated) |
| CAS number | 16051-77-7 |
| Therapeutic class | Anti-anginal / nitrate vasodilator |
| Primary use | Prevention of angina; not for immediate relief of an ongoing attack |
| Other proposed strengths | 40 mg / SR: listed in narrative only; verify approved product labels |
| Shelf life / packaging | 36 months; blister or bulk packaging proposed — verify approved specification |
Isosorbide Dinitrate IP 5 mg, IP 10 mg and BP 5 mg are not Isosorbide Mononitrate and must be listed separately.
Manufacturing of nitrate tablets requires appropriate controls for ingredient compatibility, blend uniformity, moisture exposure, tablet compression and stability. Sustained-release products, where specifically approved, require validated release-controlling excipients and processes. The use of HPMC matrices or particular machinery must be confirmed against the actual manufacturing dossier before being represented as product-specific.
Quality assessment may include identity, assay, content uniformity, impurities, dissolution, microbial limits where applicable, packaging integrity and stability, according to the relevant approved specification. Immediate-release and sustained-release tablets have different dissolution requirements. Numerical acceptance criteria must follow the applicable monograph and approved product specification.
Isosorbide mononitrate promotes nitric-oxide-mediated relaxation of vascular smooth muscle, principally reducing venous return and myocardial oxygen demand. It is used to prevent angina episodes. It is not suitable for treating sudden, ongoing chest pain.
Isosorbide dinitrate is a different medicine and must not be substituted dose-for-dose without prescriber review.
For export enquiries, Healthy Inc may be contacted about market-specific registration requirements, product dossiers, certificates of analysis, manufacturing documentation, packaging configurations and shipping terms. Availability of CTD/ACTD dossiers, FSC, COPP, WHO-GMP certificates and specific export arrangements should be verified for the destination market and product.
Q: What strengths are listed on the supplied mononitrate labels?
A: 10 mg Isosorbide Mononitrate and 20 mg Isosorbide 5-Mononitrate BP (M-Trate).
Q: Is Isosorbide Mononitrate the same as Dinitrate?
A: No. They are distinct active ingredients with different pharmacokinetic and dosing characteristics.
Q: Can it stop a sudden angina attack?
A: No. Seek urgent medical guidance for new, severe or persistent chest pain and follow the prescribed rescue plan.
Q: Can SR tablets be crushed or split?
A: Do not crush or chew sustained-release tablets. Splitting depends on the specific approved product instructions.
Use only as prescribed. Dose and frequency depend on whether the formulation is immediate-release or extended-release, the approved label, the indication and patient response. A planned low-nitrate interval is often needed to reduce tolerance; the exact schedule is formulation-specific. Do not apply an SR dosing schedule to the supplied uncoated 10 mg or 20 mg tablets without verification.
Common effects include headache, flushing, dizziness and low blood pressure; fainting may occur. Do not combine nitrates with PDE5 inhibitors such as sildenafil or tadalafil, or with riociguat, because profound hypotension can occur. Patients with significant hypotension or low circulating blood volume require careful medical assessment. Seek emergency care for severe or persistent chest pain.
Keep in the original, tightly closed container, protected from moisture and excessive heat. Follow the temperature range on the approved pack label; the supplied draft suggests storage below 30°C, which requires confirmation. Keep out of reach of children.