{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "sulphamethoxazole+trimethoprim",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "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",
        "cached_file": "labels/sulphamethoxazole-trimethoprim.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/sulphamethoxazole-trimethoprim.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/sulphamethoxazole-trimethoprim.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "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",
        "cached_file": "labels/sulphamethoxazole-trimethoprim.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/sulphamethoxazole-trimethoprim.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/sulphamethoxazole-trimethoprim.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "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",
        "cached_file": "labels/sulphamethoxazole-trimethoprim.json",
        "verbatim": false
      }
    ],
    "hepatic": [
      {
        "text": "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",
        "cached_file": "labels/sulphamethoxazole-trimethoprim.json",
        "verbatim": false
      }
    ],
    "pregnancy": [
      {
        "text": "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",
        "cached_file": "labels/sulphamethoxazole-trimethoprim.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/sulphamethoxazole-trimethoprim.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/sulphamethoxazole-trimethoprim.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "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",
        "cached_file": "labels/sulphamethoxazole-trimethoprim.json",
        "verbatim": true
      },
      {
        "text": "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",
        "cached_file": "labels/sulphamethoxazole-trimethoprim.json",
        "verbatim": true
      }
    ]
  },
  "verdicts": {
    "lactation": {
      "level": "caution",
      "line": "The label allows it only when the benefit is judged to outweigh the risk. Read the quote below.",
      "set_by": "Set from the label's own words, not from a reading of them: 'Caution should be exercised when sulfamethoxazole and trimethoprim is administered to a nursing'."
    }
  }
}