# Sulphasalazine

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DRUG INFORMATION

  ADULT
    - Ulcerative Colitis Initial Therapy: Adults: 3 to 4 g daily in evenly divided doses
      with dosage intervals not exceeding eight hours.
      Source: US FDA label for sulfasalazine (Sulfasalazine), section 'dosage and
      administration', retrieved 2026-08-29
    - It may be advisable to initiate therapy with a lower dosage, e.g., 1 to 2 g daily,
      to reduce possible gastrointestinal intolerance.
      Source: US FDA label for sulfasalazine (Sulfasalazine), section 'dosage and
      administration', retrieved 2026-08-29
    - If daily doses exceeding 4 g are required to achieve the desired therapeutic
      effect, the increased risk of toxicity should be kept in mind.
      Source: US FDA label for sulfasalazine (Sulfasalazine), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - The dosage of SULFASALAZINE DELAYED RELEASE Tablets, USP should be adjusted to
      each individual's response and tolerance. Patients should be instructed to take
      SULFASALAZINE DELAYED RELEASE Tablets, USP in evenly divided doses, preferably
      after meals, and to swallow the tablets whole. Ulcerative Colitis Initial Therapy:
      Adults: 3 to 4 g daily in evenly divided doses with dosage intervals not exceeding
      eight hours.
      Source: US FDA label for sulfasalazine (Sulfasalazine), section 'dosage and
      administration', retrieved 2026-08-29
    - Children, six years of age and older: 40 to 60 mg/kg of body weight in each
      24-hour period, divided into 3 to 6 doses.
      Source: US FDA label for sulfasalazine (Sulfasalazine), section 'dosage and
      administration', retrieved 2026-08-29
    - Children, six years of age and older: 30 mg/kg of body weight in each 24-hour
      period, divided into 4 doses.
      Source: US FDA label for sulfasalazine (Sulfasalazine), 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 sulfasalazine (Sulfasalazine),
      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 sulfasalazine (Sulfasalazine),
      retrieved 2026-08-29

  PREGNANCY   [ CAUTION ]
    The label allows it only when the benefit is judged to outweigh the risk. Read the
      quote below.
    - There are no adequate and well-controlled studies of sulfasalazine in pregnant
      women.
      Source: US FDA label for sulfasalazine (Sulfasalazine), section 'pregnancy',
      retrieved 2026-08-29
    - Reproduction studies have been performed in rats and rabbits at doses up to 6
      times the human maintenance dose of 2 g/day based on body surface area and have
      revealed no evidence of impaired female fertility or harm to the fetus due to
      sulfasalazine.
      Source: US FDA label for sulfasalazine (Sulfasalazine), section 'pregnancy',
      retrieved 2026-08-29
    - Because animal reproduction studies are not always predictive of human response,
      this drug should be used during pregnancy only if clearly needed.
      Source: US FDA label for sulfasalazine (Sulfasalazine), section 'pregnancy',
      retrieved 2026-08-29

  BREASTFEEDING
    - Sulfonamides, including sulfasalazine, are present in human milk (see Pregnancy,
      Clinical Considerations ).
      Source: US FDA label for sulfasalazine (Sulfasalazine), section 'nursing mothers',
      retrieved 2026-08-29
    - Insignificant amounts of sulfasalazine have been found in milk, whereas levels of
      the active metabolite sulfapyridine in milk are about 30 to 60 percent of those in
      the maternal serum.
      Source: US FDA label for sulfasalazine (Sulfasalazine), section 'nursing mothers',
      retrieved 2026-08-29
    - Caution should be exercised when SULFASALAZINE DELAYED RELEASE Tablets, USP are
      administered to a nursing mother.
      Source: US FDA label for sulfasalazine (Sulfasalazine), section 'nursing mothers',
      retrieved 2026-08-29
```

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Dawaa Reference is a reference for prescribers, not a medical device, and does not replace clinical judgement.

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