Drug profile
Sulphamethoxazole+Trimethoprim
Adult, child, renal, hepatic, pregnancy and breastfeeding information, with the source named on every line.
DRUG INFORMATION
ADULT
- Pneumocystis jirovecii Pneumonia: Treatment: Adults and Children: The recommended
dosage for treatment of patients with documented Pneumocystis jirovecii pneumonia
is 75 to 100 mg/kg sulfamethoxazole and 15 to 20 mg/kg trimethoprim per 24 hours
given in equally divided doses every 6 hours for 14 to 21 days.
Source: US FDA label for sulfamethoxazole and trimethoprim (Sulfamethoxazole and
Trimethoprim), section 'dosage and administration', retrieved 2026-08-29
- Prophylaxis: Adults: The recommended dosage for prophylaxis in adults is 1
sulfamethoxazole and trimethoprim DS (double strength) tablet daily. 13 Children:
For children, the recommended dose is 750 mg/m 2 /day sulfamethoxazole with 150
mg/m 2 /day trimethoprim given orally in equally divided doses twice a day, on 3
consecutive days per week.
Source: US FDA label for sulfamethoxazole and trimethoprim (Sulfamethoxazole and
Trimethoprim), section 'dosage and administration', retrieved 2026-08-29
- Sulfamethoxazole and trimethoprim tablets are contraindicated in pediatric
patients less than 2 months of age. Urinary Tract Infections and Shigellosis in
Adults and Pediatric Patients, and Acute Otitis Media in Children: Adults: The
usual adult dosage in the treatment of urinary tract infections is 1
sulfamethoxazole and trimethoprim DS (double strength) tablet or 2
sulfamethoxazole and trimethoprim tablets every 12 hours for 10 to 14 days.
Source: US FDA label for sulfamethoxazole and trimethoprim (Sulfamethoxazole and
Trimethoprim), section 'dosage and administration', retrieved 2026-08-29
CHILD
- Sulfamethoxazole and trimethoprim is contraindicated for infants younger than 2
months of age (see INDICATIONS AND USAGE and CONTRAINDICATIONS sections).
Source: US FDA label for sulfamethoxazole and trimethoprim (Sulfamethoxazole and
Trimethoprim), section 'pediatric use', retrieved 2026-08-29
- Sulfamethoxazole and trimethoprim tablets are contraindicated in pediatric
patients less than 2 months of age. Urinary Tract Infections and Shigellosis in
Adults and Pediatric Patients, and Acute Otitis Media in Children: Adults: The
usual adult dosage in the treatment of urinary tract infections is 1
sulfamethoxazole and trimethoprim DS (double strength) tablet or 2
sulfamethoxazole and trimethoprim tablets every 12 hours for 10 to 14 days.
Source: US FDA label for sulfamethoxazole and trimethoprim (Sulfamethoxazole and
Trimethoprim), section 'dosage and administration', retrieved 2026-08-29
- Children: The recommended dose for children with urinary tract infections or acute
otitis media is 40 mg/kg sulfamethoxazole and 8 mg/kg trimethoprim per 24 hours,
given in two divided doses every 12 hours for 10 days.
Source: US FDA label for sulfamethoxazole and trimethoprim (Sulfamethoxazole and
Trimethoprim), section 'dosage and administration', retrieved 2026-08-29
RENAL IMPAIRMENT
- No kidney-impairment dose in this label. Not a statement that none is needed.
Source: Read and found silent: the US FDA label for sulfamethoxazole and
trimethoprim (Sulfamethoxazole and Trimethoprim), retrieved 2026-08-29
HEPATIC IMPAIRMENT
- No liver-impairment dose in this label. Not a statement that none is needed.
Source: Read and found silent: the US FDA label for sulfamethoxazole and
trimethoprim (Sulfamethoxazole and Trimethoprim), retrieved 2026-08-29
PREGNANCY
- While there are no large, well-controlled studies on the use of sulfamethoxazole
and trimethoprim in pregnant women, Brumfitt and Pursell, 11 in a retrospective
study, reported the outcome of 186 pregnancies during which the mother received
either placebo or sulfamethoxazole and trimethoprim.
Source: US FDA label for sulfamethoxazole and trimethoprim (Sulfamethoxazole and
Trimethoprim), section 'pregnancy', retrieved 2026-08-29
- The incidence of congenital abnormalities was 4.5% (3 of 66) in those who received
placebo and 3.3% (4 of 120) in those receiving sulfamethoxazole and trimethoprim.
Source: US FDA label for sulfamethoxazole and trimethoprim (Sulfamethoxazole and
Trimethoprim), section 'pregnancy', retrieved 2026-08-29
- There were no abnormalities in the 10 children whose mothers received the drug
during the first trimester.
Source: US FDA label for sulfamethoxazole and trimethoprim (Sulfamethoxazole and
Trimethoprim), section 'pregnancy', retrieved 2026-08-29
BREASTFEEDING [ CAUTION ]
The label allows it only when the benefit is judged to outweigh the risk. Read the
quote below.
- Levels of sulfamethoxazole and trimethoprim in breast milk are approximately 2 to
5% of the recommended daily dose for infants over 2 months of age.
Source: US FDA label for sulfamethoxazole and trimethoprim (Sulfamethoxazole and
Trimethoprim), section 'nursing mothers', retrieved 2026-08-29
- Caution should be exercised when sulfamethoxazole and trimethoprim is administered
to a nursing woman, especially when breastfeeding, jaundiced, ill, stressed, or
premature infants because of the potential risk of bilirubin displacement and
kernicterus.
Source: US FDA label for sulfamethoxazole and trimethoprim (Sulfamethoxazole and
Trimethoprim), section 'nursing mothers', retrieved 2026-08-29