Co-Trimethoprim Sulphamethoxazole Tablets

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. Co-trimoxazole is a fixed-dose antibacterial combination of Sulfamethoxazole and Trimethoprim, conventionally formulated in a 5:1 dose ratio. The two components inhibit sequential steps in bacterial folate metabolism. It is used for specific susceptible bacterial and opportunistic infections according to local resistance patterns, approved labeling and clinical guidance.

2. Product Specifications

3. Manufacturing Technology

• Blend Uniformity: Validated granulation and blending processes help maintain uniform distribution of both active ingredients despite their different dose quantities and physical properties.
• Dissolution Control: Release of both components is tested against the applicable pharmacopoeial or registered specifications.
• Film Coating: Film-coated presentations may be used where included in the registered formulation to improve handling and palatability.
• Institutional Packaging: High-count packs can be supported where permitted by destination-market registration and stability data.

4. Quality Assurance

• Assay & Uniformity: Both Trimethoprim and Sulfamethoxazole are tested against approved finished-product specifications.
• Dissolution: Testing follows the applicable pharmacopoeial/registered method and acceptance criteria.
• Related Substances: Relevant impurities and degradation products are monitored using validated analytical procedures.

5. Pharmacology and Clinical Uses

Sulfamethoxazole inhibits bacterial dihydropteroate synthase, while Trimethoprim inhibits bacterial dihydrofolate reductase. Sequential inhibition of folate synthesis produces enhanced antibacterial activity against susceptible organisms.

• Urinary Tract Infections: May be used for susceptible infections when local resistance patterns and patient factors support its use.
• Respiratory Infections: Used for selected susceptible respiratory infections according to approved indications.
• Pneumocystis jirovecii Pneumonia (PJP/PCP): Has an established role in treatment and prophylaxis for appropriate at-risk patients under medical supervision.
• Traveller's Diarrhea: May be appropriate in selected bacterial cases, but empiric use depends on destination, resistance patterns and current treatment guidance.
• Antimicrobial Stewardship: Co-trimoxazole should be used only for susceptible or strongly suspected bacterial infections where clinically indicated.

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 Co-Trimoxazole Tablets?
A: Healthy Life Pharma Pvt. Ltd. manufactures Sulfamethoxazole + Trimethoprim tablet formulations in India.

Q: Is Co-Trimoxazole sold under different brands?
A: Yes. Sulfamethoxazole + Trimethoprim is marketed under multiple brands worldwide. Generic equivalence should only be claimed for a specific product when supported by applicable regulatory requirements.

Q: What does DS mean?
A: DS means Double Strength; a common DS presentation contains Trimethoprim 160mg plus Sulfamethoxazole 800mg.

Q: Can people with a sulfonamide allergy take it?
A: Patients with a history of serious hypersensitivity to Sulfamethoxazole, Trimethoprim or relevant sulfonamide medicines should discuss this with a clinician and follow the product contraindications.

Clinical Pharmacology & Safety Information

(For Registered Medical Practitioners & Patient Reference)

8. Dosage and Administration

• Dose: Dose and treatment duration vary by infection, age/weight, renal function, susceptibility and product labeling.
• PJP/PCP: Treatment and prophylaxis use indication-specific regimens that should be prescribed and monitored by qualified clinicians.
• Renal Function: Dose adjustment or avoidance may be required with impaired kidney function.
• Administration: Take exactly as prescribed and maintain adequate fluid intake unless a clinician has advised fluid restriction.

9. Side Effects and Precautions

• Serious Skin Reactions: Rare but potentially life-threatening reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis can occur. New rash, blistering, mucosal sores or systemic symptoms require urgent medical assessment.
• Hematologic: Blood dyscrasias, including thrombocytopenia, leukopenia and megaloblastic changes, can occur; monitoring may be required in higher-risk or prolonged treatment.
• Hyperkalemia: Trimethoprim can increase potassium, particularly in renal impairment or with interacting medicines.
• Renal: Kidney injury and crystalluria can occur; renal function and hydration require appropriate consideration.
• G6PD Deficiency: Hemolysis can occur in susceptible patients; this is a precaution requiring clinical assessment rather than a universal absolute contraindication.
• Interactions: Important interactions can occur with medicines including warfarin and some potassium-raising or antifolate therapies.

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.