Leaflet COTRIM-RATIOPHARM 400mg / 80mg solution for injection

Indicated for: bacterial infections

Route of administration: injectable

Substance: sulfamethoxazole + trimethoprim (antibacterial antibiotics)

ATC: J01EE01 (Antiinfectives for systemic use | Sulfonamides and trimethoprim | Combinations of sulfonamides and trimethoprim, incl. derivatives)

Precautions:
Dose adjustment in renal impairment
Dose adjustment in renal impairment

Dose adjustment may be needed in kidney disease.

Anaphylaxis
Anaphylaxis

Risk of severe allergic reaction. Seek urgent medical help if serious symptoms occur.

Colitis / severe diarrhea
Colitis / severe diarrhea

Seek medical advice if severe or persistent diarrhea occurs.

Sulfamethoxazole + trimethoprim is a combination antibiotic used to treat a wide range of bacterial infections. It is effective against urinary tract infections, respiratory infections, otitis media, gastrointestinal infections (such as traveler's diarrhea), and certain skin infections. It is also used for the prevention and treatment of Pneumocystis jirovecii pneumonia in immunocompromised patients.

This combination works by inhibiting folic acid synthesis in bacteria, a process essential for their growth and reproduction. Sulfamethoxazole and trimethoprim have a synergistic effect, making them more effective together than individually.

Common side effects include nausea, vomiting, diarrhea, and skin rashes. Rarely, severe allergic reactions, Stevens-Johnson syndrome, anemia, leukopenia, or kidney impairment may occur. Patients should inform their doctor of any allergies to sulfonamides or other medications.

Sulfamethoxazole + trimethoprim should be used with caution in patients with renal impairment, liver dysfunction, or glucose-6-phosphate dehydrogenase (G6PD) deficiency. It is essential to follow the prescribed treatment to prevent bacterial resistance.

General data about COTRIM-RATIOPHARM 400mg / 80mg

  • Substance: sulfamethoxazole + trimethoprim
  • Date of latest medicines list: 01-08-2025
  • Product code: W69722001
  • Concentration: 400mg / 80mg
  • Pharmaceutical form: solution for injection
  • Quantity: 5
  • Product type: Generic medicine
  • Prescription status: P-RF - Medicines dispensed with a medical prescription that is retained by the pharmacy and cannot be renewed.

Marketing authorisation

  • Manufacturer: MERCKLE GMBH - GERMANIA
  • Holder: C.N. UNIFARM S.A. - ROMANIA
  • Number: 817/2023/01

Pharmaceutical forms available for sulfamethoxazole + trimethoprim

Concentrations available for sulfamethoxazole + trimethoprim

  • (80mg+16mg)/ml
  • 100mg+20mg
  • 200mg/40mg
  • 200mg/40mg/5ml
  • 25mg/5mg/ml
  • 400mg/80mg
  • 400mg/80mg/5ml
  • 480mg
  • 800mg/160mg