Loperamide

DRUG INFORMATION

  ADULT
    - Acute Diarrhea Adults and Pediatric Patients 13 Years and Older: The recommended
      initial dose is 4 mg (two capsules) followed by 2 mg (one capsule) after each
      unformed stool.
      Source: US FDA label for loperamide (Loperamide Hydrochloride), section 'dosage
      and administration', retrieved 2026-08-29
    - The maximum daily dose is 16 mg (eight capsules).
      Source: US FDA label for loperamide (Loperamide Hydrochloride), section 'dosage
      and administration', retrieved 2026-08-29
    - Chronic Diarrhea Adults The recommended initial dose is 4 mg (two capsule)
      followed by 2 mg (one capsule) after each unformed stool until diarrhea is
      controlled, after which the dosage of loperamide hydrochloride capsules should be
      reduced to meet individual requirements.
      Source: US FDA label for loperamide (Loperamide Hydrochloride), section 'dosage
      and administration', retrieved 2026-08-29

  CHILD
    - Loperamide hydrochloride capsules are contraindicated in pediatric patients less
      than 2 years of age due to the risks of respiratory depression and serious cardiac
      adverse reactions (see CONTRAINDICATIONS ). Postmarketing cases of cardiac arrest,
      syncope, and respiratory depression have been reported in pediatric patients less
      than 2 years of age (see WARNINGS ).
      Source: US FDA label for loperamide (Loperamide Hydrochloride), section 'pediatric
      use', retrieved 2026-08-29
    - Loperamide hydrochloride capsules USP are contraindicated in pediatric patients
      less than 2 years of age due to the risks of respiratory depression and serious
      cardiac adverse reactions (see CONTRAINDICATIONS ). Avoid loperamide hydrochloride
      capsules dosages higher than recommended in adult or pediatric patients 2 years of
      age and older due to the risk of serious cardiac adverse reactions (see WARNINGS ,
      OVERDOSAGE ).
      Source: US FDA label for loperamide (Loperamide Hydrochloride), section 'dosage
      and administration', retrieved 2026-08-29
    - Acute Diarrhea Adults and Pediatric Patients 13 Years and Older: The recommended
      initial dose is 4 mg (two capsules) followed by 2 mg (one capsule) after each
      unformed stool.
      Source: US FDA label for loperamide (Loperamide Hydrochloride), section 'dosage
      and administration', retrieved 2026-08-29

  RENAL IMPAIRMENT
    - Renal Impairment No pharmacokinetic data are available in patients with renal
      impairment.
      Source: US FDA label for loperamide (Loperamide Hydrochloride), section 'dosage
      and administration', retrieved 2026-08-29
    - Since the metabolites and the unchanged drug are mainly excreted in the feces, no
      dosage adjustment is required for patients with renal impairment (see PRECAUTIONS
      ).
      Source: US FDA label for loperamide (Loperamide Hydrochloride), section 'dosage
      and administration', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - Hepatic Impairment The pharmacokinetics of loperamide have not been studied in
      patients with hepatic impairment.
      Source: US FDA label for loperamide (Loperamide Hydrochloride), section 'dosage
      and administration', retrieved 2026-08-29

  PREGNANCY
    - Teratology studies have been performed in rats using oral loperamide hydrochloride
      doses of 2.5 mg/kg/day, 10 mg/kg/day, and 40 mg/kg/day, and in rabbits using oral
      doses of 5 mg/kg/day, 20 mg/kg/day, and 40 mg/kg/day.
      Source: US FDA label for loperamide (Loperamide Hydrochloride), section
      'pregnancy', retrieved 2026-08-29
    - These studies have revealed no evidence of impaired fertility or harm to the fetus
      at doses up to 10 mg/kg/day in rats (5 times the human dose based on body surface
      area comparison) and 40 mg/kg/day in rabbits (43 times the human dose based on
      body surface area comparison).
      Source: US FDA label for loperamide (Loperamide Hydrochloride), section
      'pregnancy', retrieved 2026-08-29
    - Treatment of rats with oral doses of 40 mg/kg/day (21 times the human dose based
      on a body surface area comparison) produced marked impairment of fertility.
      Source: US FDA label for loperamide (Loperamide Hydrochloride), section
      'pregnancy', retrieved 2026-08-29

  BREASTFEEDING
    - Small amounts of loperamide may appear in human breast milk.
      Source: US FDA label for loperamide (Loperamide Hydrochloride), section 'nursing
      mothers', retrieved 2026-08-29
    - Therefore, loperamide hydrochloride capsules are not recommended during breast-
      feeding.
      Source: US FDA label for loperamide (Loperamide Hydrochloride), section 'nursing
      mothers', retrieved 2026-08-29