Description

Sulphadiazine Tablets (500mg)

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 Sulphadiazine Tablets in India. This is a short-acting Sulfonamide Antibiotic that inhibits bacterial growth by interfering with folic acid synthesis. While historically used for urinary tract infections, its primary modern clinical value lies in the treatment of Toxoplasmosis (in combination with Pyrimethamine) and for the prophylaxis of Rheumatic Fever.

We offer Contract Manufacturing (Third Party) services for this essential antibiotic. Sulphadiazine requires precise formulation to ensure it does not crystallize in the kidneys, a known risk of the sulfonamide class. Our WHO-GMP certified facility in Mumbai ensures high-purity API sourcing and optimal disintegration profiles. Healthy Inc manages the export logistics, supplying infectious disease centers and hospitals across Africa, Latin America, and Southeast Asia.

2. Product Specifications

3. Manufacturing Technology

Ensuring bioavailability while managing solubility is key.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Wet Granulation: Sulphadiazine powder has poor flow properties. We use advanced wet granulation techniques with specific binders to create uniform granules that compress into hard, durable tablets.

  • Disintegration: Quick disintegration is vital for absorption. We formulate the tablet to break down rapidly in the stomach to establish therapeutic blood levels quickly.

  • Purity: We strictly source API with low levels of heavy metals and impurities to minimize toxicity risks.

• The Exporter: Healthy Inc

  • Bulk Supply: We specialize in supplying this product in bulk jars for hospital dispensing, which is common for rheumatic fever prophylaxis programs.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Dissolution: We test release profiles to ensure >70% of the drug releases within 90 minutes.

• Assay: We confirm the potency is strictly within 90-110% of the label claim.

• Related Substances: We monitor for degradation products like sulfanilamide to ensure safety.

5. Why Use Sulphadiazine?

It is a niche but life-saving antibiotic.

• Mechanism: It is a competitive inhibitor of the bacterial enzyme dihydropteroate synthase. This blocks the production of dihydrofolic acid, a precursor to DNA, effectively stopping bacterial reproduction (bacteriostatic).

• Key Indications:

  • Toxoplasmosis: The drug of choice (combined with Pyrimethamine) for treating Toxoplasma gondii encephalitis, especially in HIV/AIDS patients.

  • Rheumatic Fever: Used for the prevention of recurrence in patients allergic to penicillin.

  • Nocardiosis: Treatment of infections caused by Nocardia species.

6. Export and Regulatory Support

We streamline the registration process for our B2B partners:

• Dossier Support: We offer CTD and ACTD Dossiers for quick registration.

• Certificates: Free Sale Certificate (FSC), COPP (WHO-GMP), and COA.

• Logistics: Efficient shipping via Air or Sea (FOB Mumbai / CIF).

7. Frequently Asked Questions

• Q: Who manufactures Sulphadiazine Tablets?

  A: Healthy Life Pharma Pvt. Ltd. manufactures them in India.

• Q: Why must I drink water with this?

  A: Sulphadiazine has low solubility in acidic urine and can form crystals (kidney stones). Drinking plenty of water (alkalizing the urine) prevents this “crystalluria.”

• Q: Can I take this if I am allergic to Bactrim?

  A: NO. Both drugs are sulfonamides (“sulfa drugs”). If you are allergic to one, you are likely allergic to the other.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Toxoplasmosis (Adults): 1g to 1.5g four times daily (combined with Pyrimethamine).

• Rheumatic Fever Prophylaxis: 500mg once daily (for patients <30kg) or 1g once daily (for patients >30kg).

• Administration: Take with a full glass of water. Maintain high fluid intake (2-3 liters/day) throughout therapy.

9. Side Effects and Precautions

• Hypersensitivity: Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) are rare but life-threatening reactions. Discontinue at the first sign of a rash.

• Renal: Crystalluria (crystals in urine) causing kidney damage.

• Hematologic: Agranulocytosis or aplastic anemia. Periodic blood counts are recommended during long-term therapy.

• Contraindications: Sulfa allergy, severe renal failure, pregnancy at term (kernicterus risk).

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from light.