1. Disclaimer
The information provided in this report is intended solely for educational and professional reference purposes and is not a substitute for medical advice, diagnosis, or treatment. Clinical decisions should always be based on official prescribing information approved by regulatory authorities and the judgment of qualified healthcare professionals.
We do not guarantee the accuracy, currency or completeness of information regarding medications or medical products, and official sources should be verified before making any decisions. By using this blog, you agree to assume personal responsibility for relying on the information provided.
2. Summary
COPRIMASEPT is a fixed-dose combination antibacterial product containing sulfamethoxazole and trimethoprim, collectively known as co-trimoxazole (TMP-SMX). The combination provides synergistic inhibition of bacterial folate synthesis, resulting in bactericidal activity against a broad range of susceptible Gram-positive and Gram-negative organisms, as well as certain opportunistic pathogens. It is commonly used in urinary, respiratory, gastrointestinal, skin, and selected opportunistic infections. Careful monitoring is required due to potential hematologic, renal, electrolyte, and severe cutaneous adverse reactions.
3. Brand Name
COPRIMASEPT®
4. Category
- Systemic Antibacterial
- Sulfonamide + Dihydrofolate Reductase Inhibitor
- Fixed-Dose Combination Antibiotic
5. Active Ingredient
- Sulfamethoxazole
- Trimethoprim
(Standard fixed ratio 5:1)
6. Pharmaceutical Form & Strength
- Tablets: 400 mg sulfamethoxazole / 80 mg trimethoprim
- Oral Suspension: 200 mg sulfamethoxazole / 40 mg trimethoprim per 5 mL
(Exact presentation may vary by market; confirm with local leaflet.)
7. Manufacturer & Marketing Authorization Holder
Manufacturer: Pharopharma A.R.E. (Egypt)
Marketing Authorization Holder: Pharopharma (Pharco Pharmaceuticals Group)
(Local registration details should be verified with the Egyptian Drug Authority or relevant national authority.)
8. Mechanism of Action
COPRIMASEPT acts through sequential blockade of bacterial folate synthesis:
- Sulfamethoxazole inhibits dihydropteroate synthase, preventing dihydrofolic acid formation.
- Trimethoprim inhibits dihydrofolate reductase, blocking tetrahydrofolate synthesis.
This dual inhibition disrupts bacterial DNA, RNA, and protein synthesis, producing a synergistic bactericidal effect.
9. Spectrum of Activity
Active against many susceptible organisms, including:
- Gram-positive: Staphylococcus aureus (including some community MRSA strains), Streptococcus pneumoniae, Nocardia spp.
- Gram-negative: Escherichia coli, Klebsiella spp., Enterobacter spp., Proteus mirabilis, Haemophilus influenzae, Salmonella spp., Shigella spp.
- Other pathogens: Pneumocystis jirovecii, Toxoplasma gondii (adjunct/alternative therapy)
Not active against Pseudomonas aeruginosa, most anaerobes, fungi, or viruses. Resistance patterns vary geographically.
10. Pharmacokinetics
- Absorption: Rapid and nearly complete after oral administration
- Distribution: Wide tissue distribution; penetrates lungs, kidneys, prostate, CSF (with inflamed meninges); crosses placenta and enters breast milk
- Metabolism: Partial hepatic metabolism (sulfamethoxazole mainly acetylated)
- Elimination: Primarily renal (glomerular filtration and tubular secretion)
- Half-life:
- Sulfamethoxazole: ~9–11 hours
- Trimethoprim: ~8–11 hours
Dose adjustment is required in renal impairment.
11. Indications
- Urinary tract infections
- Respiratory tract infections (e.g., acute exacerbations of chronic bronchitis)
- Acute otitis media (selected cases)
- Gastrointestinal infections (e.g., shigellosis, traveler’s diarrhea)
- Skin and soft tissue infections (susceptible organisms)
- Pneumocystis jirovecii pneumonia (treatment and prophylaxis)
- Selected opportunistic infections (e.g., nocardiosis, toxoplasmosis adjunct)
12. Administration
- Administered orally, usually every 12 hours
- Tablets should be taken with a full glass of water
- Oral suspension should be shaken well before use
- Adequate hydration is essential to reduce crystalluria risk
13. Method of Preparation
- Oral suspension: Shake well before each dose
- If supplied as powder, reconstitute according to manufacturer instructions
(No special preparation for tablets.)
14. Contraindications
- Hypersensitivity to sulfonamides or trimethoprim
- History of severe sulfonamide-associated skin reactions (SJS/TEN)
- Severe hepatic impairment
- Severe renal impairment without monitoring
- Megaloblastic anemia due to folate deficiency
- Infants <2 months of age
- Pregnancy near term
15. Warnings & Precautions
- Risk of severe cutaneous adverse reactions (SJS/TEN)
- Bone marrow suppression, especially with prolonged therapy
- Hyperkalemia risk, particularly in elderly or renal impairment
- Use with caution in G6PD deficiency
- Monitor CBC, renal function, and electrolytes during prolonged or high-dose therapy
16. Drug Interactions
- Warfarin: Increased anticoagulant effect
- Methotrexate: Increased hematologic toxicity
- Phenytoin: Increased plasma levels
- ACE inhibitors / ARBs / potassium-sparing diuretics: Hyperkalemia risk
- Sulfonylureas: Enhanced hypoglycemic effect
17. Side Effects
- Common: Nausea, vomiting, diarrhea, rash
- Less common: Photosensitivity, headache, dizziness
- Serious: Blood dyscrasias, severe hypersensitivity reactions, hepatotoxicity, renal impairment, electrolyte disturbances
18. Use in Special Populations
- Pregnancy: Avoid if possible; contraindicated near term
- Breastfeeding: Generally acceptable in healthy full-term infants; avoid in premature or jaundiced infants
- Pediatrics: Contraindicated in neonates <2 months
- Elderly: Increased risk of adverse effects; close monitoring required
- Renal impairment: Dose adjustment mandatory
19. Storage Conditions
- Store below 25°C
- Protect from light and moisture
- Keep out of reach of children
- Do not use after expiration date
20. Additional Sections
- Not effective against viral infections
- Local antimicrobial resistance patterns should guide use
- May interfere with some laboratory tests (e.g., creatinine)
21. Frequently Asked Questions (FAQ)
Q: Is COPRIMASEPT the same as co-trimoxazole?
A: Yes, it contains the same active ingredients in the same ratio.
Q: Can it be taken with food?
A: Yes, food may reduce gastrointestinal discomfort.
Q: Why is hydration important?
A: To prevent crystalluria and renal complications.
22. References
- WHO Model Formulary
- British National Formulary (BNF)
- FDA Prescribing Information for TMP-SMX
- Martindale: The Complete Drug Reference
- IDSA Clinical Practice Guidelines
