Description

Co-Trimoxazole Tablets (480mg / 960mg DS)

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 Co-Trimoxazole Tablets in India. This is a fixed-dose combination antibiotic containing Sulfamethoxazole (a sulfonamide) and Trimethoprim in a precise 5:1 ratio. This combination transforms two bacteriostatic drugs into a powerful Bactericidal (bacteria-killing) agent through synergistic action.

We offer Contract Manufacturing (Third Party) services for this essential medicine, widely known by the brand names Bactrim or Septra. It is a cornerstone of the WHO Model List of Essential Medicines, particularly vital for treating Urinary Tract Infections (UTIs), respiratory infections, and opportunistic infections in HIV/AIDS patients. Our WHO-GMP certified facility in Mumbai utilizes advanced Dual-Granulation Technology to ensure the two active ingredients are perfectly blended, preventing segregation and ensuring every tablet delivers the exact therapeutic ratio. Healthy Inc manages the export logistics, serving government tenders and hospital formularies across Africa, Southeast Asia, and Latin America.

2. Product Specifications

3. Manufacturing Technology

The power of synergy through precision mixing.

• The Manufacturer: Healthy Life Pharma Pvt. Ltd.

  • Segregation Control: Sulfamethoxazole is a bulky powder, while Trimethoprim is used in smaller quantities. To prevent them from separating during compression (which would lead to variable dosing), we use Wet Granulation with specific binders to lock the two particles together in a uniform granule before tableting.

  • Dissolution Synchronization: For synergy to work, both drugs must enter the blood at the same time. We engineer the tablet matrix so that both components release simultaneously (>75% in 60 mins), ensuring maximum bacterial kill rates.

  • Taste Masking: Sulfonamides have a bitter, metallic aftertaste. We offer Film Coated versions to improve patient compliance.

• The Exporter: Healthy Inc

  • HIV Program Supplies: We are experienced in supplying bulk Cotrim Prophylaxis Packs (1000s jars) used in national HIV/AIDS care programs for the prevention of PCP pneumonia.

4. Quality Assurance

We adhere to strict Pharmacopoeial standards:

• Assay: We confirm the potency of both ingredients is strictly within 93-107% of the label claim.

• Dissolution: Tested in 0.1N Hydrochloric Acid to verify rapid release.

• Related Substances: We strictly monitor for degradation products (Sulfanilamide) to ensure safety.

5. Why Use Co-Trimoxazole?

Blocking the path to survival.

• Mechanism: Bacteria need Folic Acid to make DNA. Co-Trimoxazole performs a Sequential Blockade of the folate pathway:

  1. Sulfamethoxazole mimics PABA and inhibits the enzyme dihydropteroate synthase.

  2. Trimethoprim inhibits the next enzyme, dihydrofolate reductase.

  By blocking two steps in the same chain, it kills bacteria that might survive one drug alone.

• Key Indications:

  • Urinary Tract Infections: Effective against E. coli (though resistance is monitoring).

  • Respiratory: Chronic Bronchitis exacerbations.

  • PCP Pneumonia: The drug of choice for treating and preventing Pneumocystis jirovecii pneumonia in immunocompromised patients.

  • Typhoid & Cholera: Used as an alternative in specific resistant cases.

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 Co-Trimoxazole Tablets?

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

• Q: Is it Bactrim?

  A: Bactrim and Septra are brand names. We manufacture the Generic Equivalent, which contains the exact same active ingredients.

• Q: What is “DS”?

  A: DS stands for Double Strength (960mg). It allows patients to take one tablet twice a day instead of two tablets.

• Q: Can I take it if I have a “Sulfa Allergy”?

  A: NO. This drug contains Sulfonamides. If you are allergic to sulfa drugs, taking this can cause a severe, life-threatening skin reaction (Stevens-Johnson Syndrome).

• Q: Do I need to drink water?

  A: Yes. Sulfa drugs can crystallize in the kidneys. Drink plenty of water to prevent kidney stones.

CLINICAL PHARMACOLOGY & SAFETY INFORMATION

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Adults (Standard): One DS tablet (960mg) every 12 hours.

• PCP Treatment: High dose based on weight (15-20 mg/kg TMP daily) in divided doses every 6 hours.

• PCP Prophylaxis: One DS tablet daily or three times a week.

• Administration: Take with a full glass of water.

9. Side Effects and Precautions

• Dermatologic: WARNING: Risk of Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN). Stop immediately at the first sign of a rash.

• Hematologic: Can cause low white blood cell counts (Neutropenia) or low platelets. Monitor blood counts in long-term use.

• Renal: Crystalluria (crystals in urine). Hydration is key.

• Contraindications: Sulfa allergy, G6PD deficiency (risk of hemolysis), severe renal failure.

10. Storage Instructions

• Store below 25°C in a dry place.

• Protect from light.