{
  "schema_version": 1,
  "kind": "drug_profile",
  "generic": "paracetamol",
  "review_status": "reviewed",
  "sections": {
    "adult": [
      {
        "text": "Adult: 1 g 3 or 4 times daily (max. 4 g daily)",
        "source": "MSF Essential Drugs 2024, PARACETAMOL = ACETAMINOPHEN oral (last updated October 2024)",
        "cached_file": "msf-paracetamol-oral.txt",
        "verbatim": true
      },
      {
        "text": "One or two tablets every 4-6 hours , if you need to. Do not take more than 8 tablets in any 24 hours.",
        "source": "eMC SmPC, Paracetamol 500 mg tablets (emc 12154), section 4.2",
        "cached_file": "emc-51da1d1b3f663864.txt",
        "verbatim": true
      }
    ],
    "child": [
      {
        "text": "Child under 1 month: 10 mg/kg 3 or 4 times daily (max. 40 mg/kg daily)",
        "source": "MSF Essential Drugs 2024, PARACETAMOL = ACETAMINOPHEN oral (last updated October 2024)",
        "cached_file": "msf-paracetamol-oral.txt",
        "verbatim": true
      },
      {
        "text": "Child 1 month and over: 15 mg/kg 3 or 4 times daily (max. 60 mg/kg daily)",
        "source": "MSF Essential Drugs 2024, PARACETAMOL = ACETAMINOPHEN oral (last updated October 2024)",
        "cached_file": "msf-paracetamol-oral.txt",
        "verbatim": true
      },
      {
        "text": "Reduce the dose in: children with severe acute malnutrition: 10 mg/kg up to 3 times maximum per 24 hours",
        "source": "MSF Essential Drugs 2024, PARACETAMOL = ACETAMINOPHEN oral (last updated October 2024)",
        "cached_file": "msf-paracetamol-oral.txt",
        "verbatim": true
      },
      {
        "text": "patients with dengue with warning sign(s): Child: 10 mg/kg 3 to 4 times daily",
        "source": "MSF Essential Drugs 2024, PARACETAMOL = ACETAMINOPHEN oral (last updated October 2024)",
        "cached_file": "msf-paracetamol-oral.txt",
        "verbatim": true
      },
      {
        "text": "Do not give children under 10 years of age.",
        "source": "eMC SmPC, Paracetamol 500 mg tablets (emc 12154), section 4.2 - a restriction on THIS 500 mg tablet, not on paracetamol: MSF doses younger children with the 100 mg tablet and the 120 mg/5 ml suspension, below",
        "cached_file": "emc-51da1d1b3f663864.txt",
        "verbatim": true
      }
    ],
    "renal": [
      {
        "text": "No dose reduction is published for oral paracetamol in kidney impairment. Give the ordinary dose, and watch for the warning below in severe impairment.",
        "source": "Read and found silent on renal dosing: eMC 12154 sections 4.2 and 4.4; MSF Essential Drugs 2024 paracetamol oral. The intravenous label does state an interval by creatinine clearance; carrying an IV interval across to an oral dose is an extrapolation this project does not make without a ruling.",
        "verbatim": false
      },
      {
        "text": "Cases of high anion gap metabolic acidosis (HAGMA) due to pyroglutamic acidosis have been reported in patients with severe illness such as severe renal impairment and sepsis, or in patients with malnutrition or other sources of glutathione deficiency (e.g. chronic alcoholism) who were treated with paracetamol at therapeutic dose for a prolonged period or a combination of paracetamol and flucloxacillin.",
        "source": "eMC SmPC, Paracetamol 500 mg tablets (emc 12154), section 4.4",
        "cached_file": "emc-51da1d1b3f663864.txt",
        "verbatim": true
      }
    ],
    "hepatic": [
      {
        "text": "No reduced dose is published. Both sources say to use paracetamol with caution in liver disease without naming a lower figure.",
        "source": "Read and found silent on a reduced hepatic dose: eMC 12154 sections 4.2 and 4.4; MSF Essential Drugs 2024 paracetamol oral",
        "verbatim": false
      },
      {
        "text": "Administer with caution to patients with hepatic impairment.",
        "source": "MSF Essential Drugs 2024, PARACETAMOL = ACETAMINOPHEN oral (last updated October 2024)",
        "cached_file": "msf-paracetamol-oral.txt",
        "verbatim": true
      },
      {
        "text": "Caution in liver disease. Do not combine with other analgesic drugs containing paracetamol (eg combination medicine). Higher doses than recommended may result in very severe liver damage.",
        "source": "eMC SmPC, Paracetamol 500 mg tablets (emc 12154), section 4.4",
        "cached_file": "emc-51da1d1b3f663864.txt",
        "verbatim": true
      }
    ],
    "pregnancy": [
      {
        "text": "Paracetamol may be used during pregnancy if clinically motivated, but it should be used with the lowest effective dose for the shortest possible time and at the lowest possible frequency.",
        "source": "eMC SmPC, Paracetamol 500 mg tablets (emc 12154), section 4.6",
        "cached_file": "emc-51da1d1b3f663864.txt",
        "verbatim": true
      },
      {
        "text": "Pregnancy : no contra-indication",
        "source": "MSF Essential Drugs 2024, PARACETAMOL = ACETAMINOPHEN oral (last updated October 2024)",
        "cached_file": "msf-paracetamol-oral.txt",
        "verbatim": true
      },
      {
        "text": "Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.",
        "source": "TGA pregnancy category A (the definition quoted here) - paracetamol is listed as Category A in the TGA Prescribing medicines in pregnancy database. Australian categorisation system for prescribing medicines in pregnancy, 'Category A' definition (page last updated 28 March 2025), retrieved 2026-08-29",
        "cached_file": "tga-paracetamol-pregnancy-category.txt",
        "verbatim": true
      }
    ],
    "lactation": [
      {
        "text": "Lactation: Paracetamol passes into breast milk but the risk of affecting the child seems unlikely with therapeutic doses.",
        "source": "eMC SmPC, Paracetamol 500 mg tablets (emc 12154), section 4.6",
        "cached_file": "emc-51da1d1b3f663864.txt",
        "verbatim": true
      },
      {
        "text": "Breast-feeding : no contra-indication",
        "source": "MSF Essential Drugs 2024, PARACETAMOL = ACETAMINOPHEN oral (last updated October 2024)",
        "cached_file": "msf-paracetamol-oral.txt",
        "verbatim": true
      }
    ]
  },
  "child_table": {
    "source": "MSF Essential Drugs 2024, PARACETAMOL = ACETAMINOPHEN oral (last updated October 2024)",
    "cached_file": "msf-paracetamol-oral.txt",
    "columns": [
      "Age",
      "Weight",
      "120 mg/5 ml susp.",
      "100 mg tablet",
      "500 mg tablet"
    ],
    "rows": [
      [
        "< 1 month",
        "< 4 kg",
        "1.5 ml x 3",
        "-",
        "-"
      ],
      [
        "1 to < 3 months",
        "4 to < 6 kg",
        "2.5 ml x 3",
        "1/2 tab x 3",
        "-"
      ],
      [
        "3 months to < 1 year",
        "6 to < 10 kg",
        "4 ml x 3",
        "1 tab x 3",
        "-"
      ],
      [
        "1 to < 3 years",
        "10 to < 15 kg",
        "6 ml x 3",
        "1 1/2 tab x 3",
        "-"
      ],
      [
        "3 to < 5 years",
        "15 to < 20 kg",
        "8 ml x 3",
        "2 tab x 3",
        "-"
      ],
      [
        "5 to < 9 years",
        "20 to < 30 kg",
        "12 ml x 3",
        "3 tab x 3",
        "-"
      ],
      [
        "9 to < 14 years",
        "30 to < 50 kg",
        "-",
        "-",
        "1 tab x 3"
      ],
      [
        ">= 14 years and adult",
        ">= 50 kg",
        "-",
        "-",
        "2 tab x 3"
      ]
    ],
    "duration": "According to clinical response"
  },
  "verdicts": {
    "pregnancy": {
      "level": "safe",
      "line": "Can be used - at the lowest effective dose, for the shortest time.",
      "set_by": "Both sources permit it: MSF records no contra-indication, and the UK label says it may be used. The dose-and-duration qualifier is the label's own, and rides on the chip rather than downgrading it."
    },
    "lactation": {
      "level": "safe",
      "line": "Can be used - it reaches the milk, but not in an amount expected to affect the baby.",
      "set_by": "Both sources permit it: MSF records no contra-indication, and the UK label calls harm at therapeutic doses unlikely."
    }
  }
}