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Isosorbide Tablets product photograph

Isosorbide Dinitrate Tablets

Composition: Isosorbide Dinitrate IP 5 mg / 10 mg; BP 5 mg (each uncoated tablet).

Additional separate products: Isosorbide Mononitrate 10 mg and M-Trate Isosorbide 5-Mononitrate BP 20 mg.

Usage: Prevention of angina-related chest pain.

Category: Anti Cardiovascular Drugs

Therapeutic Category: Cardiovascular Agent / Anti-anginal Nitrate

SKU: Isosorbide Tablets

Categories: Contract Manufacturer, Formulations Exporter India, Manufacturing Pharmaceutical Company India, Pharmaceutical Exporter India, Pharmaceutical Formulations India, Tablets Manufacturer, WHO GMP Certified Formulations

Product Information

Isosorbide Dinitrate 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.

Description

Isosorbide Dinitrate Tablets IP / BP 5 mg and 10 mg

1. Product Introduction

Healthy Life Pharma Pvt. Ltd. presents Isosorbide Dinitrate Tablets for the prevention of angina (chest pain). Isosorbide dinitrate is an organic nitrate vasodilator that relaxes blood vessels and reduces cardiac workload. The supplied catalogue also includes isosorbide mononitrate products; these contain a different active ingredient and are clearly identified separately.

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

2. Product Specifications

ProductComposition per tabletDosage form
Isosorbide Dinitrate Tablets IP 5 mgDiluted Isosorbide Dinitrate IP equivalent to Isosorbide Dinitrate 5 mgUncoated
Isosorbide Dinitrate Tablets IP 10 mgDiluted Isosorbide Dinitrate IP equivalent to Isosorbide Dinitrate 10 mgUncoated
Isosorbide Dinitrate Tablets BP 5 mgDiluted Isosorbide Dinitrate BP equivalent to Isosorbide Dinitrate 5 mgUncoated
Isosorbide Mononitrate Tablets 10 mgDiluted Isosorbide Mononitrate equivalent to Isosorbide Mononitrate 10 mgUncoated; separate active ingredient
M-Trate / Isosorbide 5-Mononitrate BP 20 mgDiluted Isosorbide 5-Mononitrate BP equivalent to 20 mgUncoated; separate active ingredient

Isosorbide dinitrate CAS: 87-33-2. Therapeutic class: Anti-anginal / organic nitrate vasodilator. Confirmed dinitrate strengths: 5 mg and 10 mg. 20 mg: confirmed only for the separate isosorbide 5-mononitrate M-Trate product, not for dinitrate. All supplied products are uncoated; no sublingual dosage form has been confirmed. Shelf life, pack sizes and pharmacopoeial compliance require product-specific verification.

3. Manufacturing Technology

Low-dose nitrate formulations require careful handling of the specified diluted active ingredient, controlled blending, content uniformity and validated compression. Processing methods, excipient compatibility and packaging selection should follow the approved formulation and safety procedures. A particular granulation method, sublingual performance or dangerous-goods classification should not be assumed without documented product evidence.

4. Quality Assurance

Appropriate release testing may include identity, assay, uniformity of dosage units, disintegration or dissolution, related substances and stability testing against the applicable approved IP/BP monograph and registration specifications. Exact numeric acceptance limits must be verified for each product.

5. Pharmacology and Clinical Use

Isosorbide dinitrate is converted to nitric oxide-related signaling species, promoting vascular smooth-muscle relaxation and reducing myocardial oxygen demand. It is used for angina prevention; some prescribed regimens may include it in heart-failure treatment with other agents. Isosorbide mononitrate is not interchangeable milligram-for-milligram with dinitrate. These listed oral tablets should not be presented as a verified emergency sublingual treatment for sudden chest pain.

6. Export and Regulatory Support

For contract manufacturing and exports, request the product-specific certificate of analysis, approved composition, stability data, packaging details and registration dossier where available. FSC, COPP, CTD/ACTD documentation and country-specific approvals should be confirmed before commercial claims are made.

7. Frequently Asked Questions

Q: Which isosorbide dinitrate strengths are listed?
A: IP 5 mg, IP 10 mg and BP 5 mg.

Q: Is M-Trate the same as isosorbide dinitrate?
A: No. The supplied M-Trate composition contains isosorbide 5-mononitrate 20 mg.

Q: Can these tablets treat a sudden angina attack?
A: Do not assume so. The supplied formulations are listed as uncoated oral tablets, not confirmed sublingual rescue products. Follow the patient’s emergency plan and seek urgent medical help for new, severe or persistent chest pain.

Q: Can nitrates be taken with sildenafil or tadalafil?
A: No. This combination can cause dangerous, potentially life-threatening hypotension.

8. Dosage and Administration

Use only according to a qualified prescriber and the approved label. Dose, schedule and any nitrate-free interval depend on the exact formulation and indication. Do not substitute mononitrate for dinitrate or use an oral tablet under the tongue unless specifically approved for that route. Do not stop or change therapy without medical advice.

9. Side Effects and Precautions

  • Common: Headache, flushing, dizziness and low blood pressure.
  • Serious interactions: Never combine with PDE5 inhibitors such as sildenafil, tadalafil or vardenafil, or with riociguat.
  • Other cautions: Fainting, dehydration, low blood pressure, and use with other antihypertensives or alcohol may increase risks.
  • Chest pain: Sudden, worsening or persistent pain requires urgent medical assessment.

10. Storage Instructions

Store in the original packaging, protected from excess heat, moisture and light as specified on the approved pack label. Keep out of reach of children.