Product Information
Dapsone 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
Dapsone Tablets (25mg / 50mg / 100mg)
Manufactured by: Healthy Life Pharma Pvt. Ltd. (WHO-GMP Certified)
Exported by: Healthy Inc (Star Export House)
1. Product Introduction
Healthy Life Pharma Pvt. Ltd. is a specialized manufacturer of Dapsone Tablets in India. Dapsone (diaminodiphenyl sulfone) is a sulfone antibacterial with anti-inflammatory activity. It has established roles in multidrug treatment of leprosy (Hansen's disease) and in dermatitis herpetiformis. Because systemic Dapsone can cause clinically important hematologic and hypersensitivity reactions, treatment requires appropriate patient assessment and monitoring.
2. Product Specifications
| Parameter | Specification |
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| Product Name | Dapsone Tablets |
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| Generic Name | Dapsone Tablets USP / BP / IP |
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| CAS Number | 80-08-0 |
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| Strength | 25mg / 50mg / 100mg |
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| Dosage Form | Uncoated Tablet; appearance/scoring according to registered formulation |
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| Standard | USP / BP / IP, as applicable |
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| Therapeutic Class | Sulfone Antibacterial / Anti-Leprosy Agent |
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| Shelf Life | Up to 36 months, subject to validated stability data |
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| Packaging | 10×10 Blister / institutional bottle or market-specific pack |
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3. Manufacturing Technology
- API & Particle Control: API particle characteristics and formulation parameters are controlled to achieve the registered dissolution and content-uniformity specifications.
- Cross-Contamination Control: Validated containment, cleaning and line-clearance procedures are applied according to GMP requirements.
- Stability Protection: Packaging is selected according to validated stability data to protect the product from environmental conditions such as excessive light and moisture.
- Program Packaging: Institutional or combination-program packs can be supported only where permitted by destination-market requirements.
4. Quality Assurance
- Dissolution: Tested according to applicable pharmacopoeial or registered finished-product specifications.
- Assay & Uniformity: Dapsone potency and dosage-unit uniformity are verified against approved limits.
- Related Substances: Relevant impurities and degradation products are monitored using validated analytical procedures.
5. Pharmacology and Clinical Use
Dapsone inhibits microbial dihydropteroate synthase and interferes with folate synthesis in susceptible organisms. Its anti-inflammatory actions include effects on neutrophil-mediated inflammatory pathways.
- Leprosy: Used as a component of recommended multidrug therapy; Dapsone should not be used alone for leprosy because of resistance concerns.
- Dermatitis Herpetiformis: Can rapidly control skin symptoms, while a gluten-free diet remains an important part of long-term disease management.
- Pneumocystis jirovecii Pneumonia: Dapsone-containing alternatives may be used for prophylaxis in selected patients when standard options are unsuitable, under specialist guidance.
- Other Uses: Other dermatologic or infectious uses should follow local approved labeling and specialist clinical guidance.
6. Export and Regulatory Support
- Dossier Support: CTD / ACTD documentation where applicable.
- Certificates: FSC, COPP and COA where applicable.
- Logistics: Air or sea shipment via FOB Mumbai / CIF according to destination-market requirements.
7. Frequently Asked Questions
Q: Who manufactures Dapsone Tablets?
A: Healthy Life Pharma Pvt. Ltd. manufactures Dapsone tablet formulations in India.
Q: Why may G6PD testing be considered?
A: Dapsone can cause hemolysis, and risk can be greater in patients with G6PD deficiency. Appropriate baseline assessment and monitoring should follow the product label and clinician guidance.
Q: Can Dapsone cause bluish lips or skin?
A: Methemoglobinemia can reduce oxygen delivery and may cause cyanosis, breathlessness, headache, fatigue or other symptoms. Suspected methemoglobinemia requires prompt medical assessment rather than self-treatment.
Q: Is Dapsone a steroid?
A: No. Dapsone is a sulfone antibacterial with anti-inflammatory properties; it is not a corticosteroid.
Clinical Pharmacology & Safety Information
(For Registered Medical Practitioners & Patient Reference)
8. Dosage and Administration
- Dose: Dosing varies by indication, age, clinical response, comorbidities and the registered product label. It should be prescribed and monitored by a qualified clinician.
- Leprosy: Use as part of an appropriate multidrug regimen rather than monotherapy.
- Dermatitis Herpetiformis: Dose should be individualized to the minimum effective dose while appropriate monitoring is performed.
- Administration: Follow the specific product instructions; do not change the dose without medical advice.
9. Side Effects and Precautions
- Hemolysis / Anemia: Hemolysis can occur and may be more severe in G6PD deficiency. Baseline and follow-up blood testing may be required.
- Methemoglobinemia: Clinically important methemoglobinemia can occur. Cyanosis, unexplained breathlessness, marked fatigue or neurological symptoms require prompt assessment.
- Blood Dyscrasias: Rare serious reactions including agranulocytosis can occur; fever, sore throat or signs of infection require urgent medical review.
- Dapsone Hypersensitivity Syndrome: Fever, rash, lymph-node enlargement, hepatitis or systemic illness can indicate a serious hypersensitivity reaction requiring urgent medical evaluation.
- Neuropathy: Peripheral or motor neuropathy can occur, particularly with prolonged or higher exposure.
- Liver: Hepatic injury is possible; clinical and laboratory monitoring should follow prescribing guidance.
10. Storage Instructions
- Store below 25°C unless otherwise specified on the registered label.
- Keep in a dry place and protect from excessive light and moisture.
- Keep in original packaging and out of reach of children.
- Do not use tablets showing unexpected deterioration; follow the product label and pharmacist/manufacturer guidance.
