{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "mesalazine",
  "review_status": "reviewed",
  "origin": "openfda",
  "sections": {
    "adult": [
      {
        "text": "( 2.1 , 5.7 ) Treatment of Mildly to Moderately Active Ulcerative Colitis: Adults: 800 mg (two 400 mg capsules) three times daily for 6 weeks.",
        "source": "US FDA label for mesalamine (Mesalamine), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/mesalazine.json",
        "verbatim": true
      },
      {
        "text": "( 2.2 ) Maintenance of Remission of Ulcerative Colitis: Adults: 1.6 grams (four 400 mg capsules) daily, in two to four divided doses.",
        "source": "US FDA label for mesalamine (Mesalamine), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/mesalazine.json",
        "verbatim": true
      },
      {
        "text": "Close the container tightly and leave any desiccant pouches present in the bottle along with the capsules. 2.2 Dosage for Treatment of Mildly to Moderately Active Ulcerative Colitis Adults For adults, the recommended dosage of mesalamine delayed-release capsules is 800 mg (two 400 mg capsules) three times daily (total daily dosage of 2.4 grams) for a duration of 6 weeks [see Clinical Studies ( 14.1 )] .",
        "source": "US FDA label for mesalamine (Mesalamine), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/mesalazine.json",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "The safety and effectiveness of mesalamine delayed-release capsules for the treatment of mildly to moderately active ulcerative colitis in pediatric patients 5 to 17 years of age has been established based on adequate and well-controlled studies using mesalamine delayed-release 400 mg tablets.",
        "source": "US FDA label for mesalamine (Mesalamine), section 'pediatric use', retrieved 2026-08-29",
        "cached_file": "labels/mesalazine.json",
        "verbatim": true
      },
      {
        "text": "Important Administration Instructions : Do not substitute two mesalamine delayed-release 400 mg capsules with one mesalamine delayed-release 800 mg tablet. ( 2.1 ) Evaluate renal function prior to initiation of mesalamine delayed-release capsules. ( 2.1 , 5.1 ) Take with or without food. ( 2.1 ) Swallow the capsules whole; do not cut, break, crush or chew.",
        "source": "US FDA label for mesalamine (Mesalamine), section 'dosage and administration', retrieved 2026-08-29",
        "cached_file": "labels/mesalazine.json",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "In general, consider the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy in elderly patients when prescribing mesalamine delayed-release capsules [see Use in Specific Populations ( 8.6 )] . 8.6 Renal Impairment Mesalamine is known to be substantially excreted by the kidney, and the risk of toxic reactions may be greater in patients with impaired renal function.",
        "source": "US FDA label for mesalamine (Mesalamine), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/mesalazine.json",
        "verbatim": true
      },
      {
        "text": "Monitor patients with known renal impairment or history of renal disease or taking nephrotoxic drugs for decreased renal function and mesalamine-related adverse reactions.",
        "source": "US FDA label for mesalamine (Mesalamine), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/mesalazine.json",
        "verbatim": true
      },
      {
        "text": "Renal Impairment: Assess renal function at the beginning of treatment and periodically during treatment.",
        "source": "US FDA label for mesalamine (Mesalamine), section 'warnings and cautions', retrieved 2026-08-29",
        "cached_file": "labels/mesalazine.json",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "( 5.3 ) Hepatic Failure: Evaluate the risks and benefits of using mesalamine delayed-release capsules in patients with known liver impairment.",
        "source": "US FDA label for mesalamine (Mesalamine), section 'warnings and cautions', retrieved 2026-08-29",
        "cached_file": "labels/mesalazine.json",
        "verbatim": true
      },
      {
        "text": "Discontinue mesalamine delayed-release capsules if an alternative etiology for the signs or symptoms cannot be established. 5.4 Hepatic Failure There have been reports of hepatic failure in patients with pre-existing liver disease who have been administered mesalamine.",
        "source": "US FDA label for mesalamine (Mesalamine), section 'warnings and cautions', retrieved 2026-08-29",
        "cached_file": "labels/mesalazine.json",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "Risk Summary There are no adequate and well controlled studies of mesalamine use in pregnant women.",
        "source": "US FDA label for mesalamine (Mesalamine), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/mesalazine.json",
        "verbatim": true
      },
      {
        "text": "Limited published human data on mesalamine show no increase in the overall rate of congenital malformations.",
        "source": "US FDA label for mesalamine (Mesalamine), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/mesalazine.json",
        "verbatim": true
      },
      {
        "text": "Some data show an increased rate of preterm birth, stillbirth, and low birth weight; however, these adverse pregnancy outcomes are also associated with active inflammatory bowel disease.",
        "source": "US FDA label for mesalamine (Mesalamine), section 'pregnancy', retrieved 2026-08-29",
        "cached_file": "labels/mesalazine.json",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "These mesalamine doses were about 1.9 times (rat) and 3.9 times (rabbit) the recommended human dose, based on body surface area. 8.2 Lactation Mesalamine and its N-acetyl metabolite are present in human milk.",
        "source": "US FDA label for mesalamine (Mesalamine), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/mesalazine.json",
        "verbatim": true
      },
      {
        "text": "In published lactation studies, maternal mesalamine doses from various oral and rectal formulations and products ranged from 500 mg to 3 g daily.",
        "source": "US FDA label for mesalamine (Mesalamine), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/mesalazine.json",
        "verbatim": true
      },
      {
        "text": "Based on these concentrations, estimated infant daily doses for an exclusively breastfed infant are 0 mg/kg/day to 0.017 mg/kg/day of mesalamine and 0.75 mg/kg/day to 2.72 mg/kg/day of N-acetyl-5-aminosalicylic acid.",
        "source": "US FDA label for mesalamine (Mesalamine), section 'use in specific populations', retrieved 2026-08-29",
        "cached_file": "labels/mesalazine.json",
        "verbatim": true
      }
    ]
  }
}