Lansoprazole

DRUG INFORMATION

  ADULT
    - Recommended adult starting dose is 60 mg once daily.
      Source: US FDA label for lansoprazole (Lansoprazole), section 'dosage and
      administration', retrieved 2026-08-29
    - Dosages up to 90 mg twice daily have been administered.
      Source: US FDA label for lansoprazole (Lansoprazole), section 'dosage and
      administration', retrieved 2026-08-29
    - Daily dose of greater than 120 mg should be administered in divided doses.
      Source: US FDA label for lansoprazole (Lansoprazole), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - The safety and effectiveness of lansoprazole delayed-release capsules have been
      established in pediatric patients 1 to 17 years of age for short-term treatment of
      symptomatic GERD and erosive esophagitis. Neonate to less than 1 year of age The
      pharmacokinetics of lansoprazole were studied in pediatric patients with GERD aged
      less than 28 days and 1 to 11 months.
      Source: US FDA label for lansoprazole (Lansoprazole), section 'pediatric use',
      retrieved 2026-08-29
    - Lansoprazole is available as a capsule, and is available in 15 mg and 30 mg
      strengths. Directions for use specific to the route and available methods of
      administration is presented below. Lansoprazole delayed-release capsules should be
      taken before eating. Lansoprazole delayed-release capsule products SHOULD NOT BE
      CRUSHED OR CHEWED. In the clinical trials, antacids were used concomitantly with
      lansoprazole delayed-release capsules.
      Source: US FDA label for lansoprazole (Lansoprazole), section 'dosage and
      administration', retrieved 2026-08-29
    - Compared to healthy adults receiving 30 mg, neonates had higher exposure (mean
      weight-based normalized AUC values 2.04-and 1.88-fold higher at doses of 0.5
      mg/kg/day and 1 mg/kg/day, respectively).
      Source: US FDA label for lansoprazole (Lansoprazole), section 'pediatric use',
      retrieved 2026-08-29

  RENAL IMPAIRMENT
    - Patients should be instructed not to take 2 doses at one time to make up for a
      missed dose. 2.2 Special Populations Renal impairment patients and geriatric
      patients do not require dosage adjustment.
      Source: US FDA label for lansoprazole (Lansoprazole), section 'dosage and
      administration', retrieved 2026-08-29
    - The incidence rates of lansoprazole delayed-release capsules-associated adverse
      reactions and laboratory test abnormalities are similar to those seen in younger
      patients. [See Clinical Pharmacology (12.3) ] 8.6 Renal Impairment No dosage
      adjustment of lansoprazole delayed-release capsules is necessary in patients with
      renal impairment.
      Source: US FDA label for lansoprazole (Lansoprazole), section 'use in specific
      populations', retrieved 2026-08-29
    - The pharmacokinetics of lansoprazole in patients with various degrees of renal
      impairment were not substantially different compared to those in subjects with
      normal renal function. [See Clinical Pharmacology (12.3) ] 8.7 Hepatic Impairment
      In patients with various degrees of chronic hepatic impairment, an increase in the
      mean AUC of up to 500% was observed at steady state compared to healthy subjects.
      Source: US FDA label for lansoprazole (Lansoprazole), section 'use in specific
      populations', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - However, consider dose adjustment in patients with severe liver impairment. [See
      Use in Specific Populations (8.5, 8.6 and 8.7 ] 2.3 Important Administration
      Information Administration Options Lansoprazole Delayed-Release Capsules - Oral
      Administration • Lansoprazole delayed-release capsules should be swallowed whole.
      Source: US FDA label for lansoprazole (Lansoprazole), section 'dosage and
      administration', retrieved 2026-08-29
    - • Consider dose adjustment in patients with severe liver impairment ( 8.7 ) •
      Lansoprazole Delayed-Release Capsules are not effective in patients with
      symptomatic GERD 1 month to less than 1 year of age.
      Source: US FDA label for lansoprazole (Lansoprazole), section 'use in specific
      populations', retrieved 2026-08-29
    - The pharmacokinetics of lansoprazole in patients with various degrees of renal
      impairment were not substantially different compared to those in subjects with
      normal renal function. [See Clinical Pharmacology (12.3) ] 8.7 Hepatic Impairment
      In patients with various degrees of chronic hepatic impairment, an increase in the
      mean AUC of up to 500% was observed at steady state compared to healthy subjects.
      Source: US FDA label for lansoprazole (Lansoprazole), section 'use in specific
      populations', retrieved 2026-08-29

  PREGNANCY
    - Teratogenic effects Pregnancy Category B.
      Source: US FDA label for lansoprazole (Lansoprazole), section 'pregnancy',
      retrieved 2026-08-29
    - Reproduction studies have been performed in pregnant rats at oral doses up to 40
      times the recommended human dose and in pregnant rabbits at oral doses up to 16
      times the recommended human dose and have revealed no evidence of impaired
      fertility or harm to the fetus due to lansoprazole.
      Source: US FDA label for lansoprazole (Lansoprazole), section 'pregnancy',
      retrieved 2026-08-29
    - There are, however, no adequate or well-controlled studies in pregnant women.
      Source: US FDA label for lansoprazole (Lansoprazole), section 'pregnancy',
      retrieved 2026-08-29

  BREASTFEEDING
    - Lansoprazole or its metabolites are excreted in the milk of rats.
      Source: US FDA label for lansoprazole (Lansoprazole), section 'nursing mothers',
      retrieved 2026-08-29
    - It is not known whether lansoprazole is excreted in human milk.
      Source: US FDA label for lansoprazole (Lansoprazole), section 'nursing mothers',
      retrieved 2026-08-29
    - Because many drugs are excreted in human milk, because of the potential for
      serious adverse reactions in nursing infants from lansoprazole, and because of the
      potential for tumorigenicity shown for lansoprazole in rat carcinogenicity
      studies, a decision should be made whether to discontinue nursing or to
      discontinue lansoprazole, taking into account the importance of lansoprazole to
      the mother.
      Source: US FDA label for lansoprazole (Lansoprazole), section 'nursing mothers',
      retrieved 2026-08-29