Sulfamethoxazole; Trimethoprim
Visa No.: VD-23221-15
Product: Pymeprim forte 960
API: Sulfamethoxazole; Trimethoprim
Product Category: Antibiotics
Version approved leaflet: 33648e/QLD - ĐK_22/09/2025
INDICATIONS
Indicated in adults and children over 12 years of age for the treatment of the following infections caused by susceptible organisms:
- Hypersensitivity to Fexofenadine or to any component of the product.
- Hypersensitivity to Fexofenadine or to any component of the product.
- Hypersensitivity to Fexofenadine or to any component of the product.
Also indicated for the treatment of the following infections when there is evidence of bacterial susceptibility to Co-trimoxazole and when there is a reason to prefer the combination over a single antibiotic:
- Acute uncomplicated urinary tract infections.
- Acute otitis media.
- Acute exacerbations of chronic bronchitis.
DOSAGE AND ADMINISTRATION
Dosage
Recommended dose for acute infections
- Adult (> 18 years old): 1 tablet every 12 hours.
- Children (> 12 years old đến < 18 years old): The recommended pediatric dose is approximately (6 mg trimethoprim + 30 mg sulfamethoxazole)/kg/day, pided into two doses.
- For children over 12 years of age, 1 tablet every 12 hours may be used.
Treatment should be continued until the patient has been symptom-free for 2 days. Most patients will require treatment for at least 5 days. If clinical improvement is not evident after 7 days, the patient should be reassessed.
In acute uncomplicated lower urinary tract infections, as an alternative to the standard regimen, a short course of 1–3 days has been shown to be effective.
- Elderly: Refer to Warnings and Precautions. The usual adult dose applies unless otherwise specified.
- Patients with hepatic impairment: No dosage data are available for patients with hepatic impairment.
- Patients with renal impairment: The recommended dose for adults and children over 12 years of age with renal impairment is provided in the table below.
| Creatinine clearnace (ml/min) | Recommended doses |
| > 30 | 1 tablet every 12 hours |
| 15 - 30 | 1 tablet once daily |
| < 15 | Not recommended |
No dosing data are available for children 12 years of age and under with renal impairment
Plasma sulfamethoxazole concentrations should be measured 12 hours after dosing with Co-trimoxazole during 2–3 consecutive days. If the sulfamethoxazole level exceeds 150 µg/mL, treatment should be interrupted until the value falls below 120 µg/mL.
Pneumocystis jirovecii Pneumonia (PJP)
Treatment:
Adult and children > 12 years old: A higher dose is recommended: (20 mg trimethoprim + 100 mg sulfamethoxazole)/kg/day, pided into 2 or more doses for 14 days. The aim is to achieve peak plasma trimethoprim concentrations of ≥5 µg/mL.
Prophylaxis
- Adults (>18 years old): One of the following regimens may be used:
- 160 mg trimethoprim / 800 mg sulfamethoxazole once daily, 7 days per week.
- 160 mg trimethoprim / 800 mg sulfamethoxazole three times per week, on alternate days.
- 320 mg trimethoprim / 1600 mg sulfamethoxazole per day, pided into two doses, three times per week on alternate days.
- Children (> 12 to < 18 years old): The recommended pediatric dose is approximately (6 mg trimethoprim + 30 mg sulfamethoxazole)/kg/day, pided into two doses. Age-based regimens for prophylaxis during high-risk periods are provided in the table below:
| Age group | Recommended dose |
| > 12 to < 18 years old | 1 tablet every 12 hours, 7 days per week |
| > 12 to < 18 years old | 1 tablet every 12 hours, 3 days per week, on alternate days |
| > 12 to < 18 years old | 1 tablet every 12 hours, 3 days per week, on consecutive days |
| > 12 to < 18 years old | 2 tablets per day (pided doses), 3 days per week, on consecutive days |
The average daily dose is approximately 150 mg trimethoprim/m²/day and 750 mg sulfamethoxazole/m²/day. The total daily dose should not exceed 320 mg trimethoprim and 1600 mg sulfamethoxazole.
Nocardia Infections
- Adults (>18 years): There is no established consensus on the optimal dose. Adult doses of 3–4 tablets per day have been used for a duration of 3 months.
Toxoplasma Infections
There is no consensus on the optimal dose for treatment or prophylaxis. Dosage should be guided by clinical experience. For prophylaxis, the dosing regimen recommended for Pneumocystis jirovecii pneumonia (PJP) prophylaxis may be used.
Method of Administration: For oral use. Taking the medicine with meals may help reduce gastrointestinal irritation.
CONTRAINDICATIONS
- Hypersensitivity to sulfonamides, trimethoprim, Co-trimoxazole, or any component of the product.
- Severe hepatic parenchymal damage.
- Severe renal impairment when repeated measurement of plasma drug concentrations is not possible.
- Use in infants during the first 6 weeks of life.
- History of drug-induced immune thrombocytopenia associated with trimethoprim and/or sulfonamides.
- Patients with acute porphyria.
WARNINGS AND PRECAUTIONS
Prescription only medicine. Read the instructions before use. Consult a physician or pharmacist if needed. Keep out of reach of children.
