Levocetirizine

DRUG INFORMATION

  ADULT
    - Some patients may be adequately controlled by 2.5 mg (1/2 tablet) once daily in
      the evening.
      Source: US FDA label for levocetirizine (levocetirizine dihydrochloride), section
      'dosage and administration', retrieved 2026-08-29
    - The 2.5 mg dose should not be exceeded because the systemic exposure with 5 mg is
      approximately twice that of adults [see Clinical Pharmacology (12.3) ].
      Source: US FDA label for levocetirizine (levocetirizine dihydrochloride), section
      'dosage and administration', retrieved 2026-08-29
    - Levocetirizine dihydrochloride tablets are available as 5 mg breakable (scored)
      tablets, allowing for the administration of 2.5 mg, if needed. Levocetirizine
      dihydrochloride tablets can be taken without regard to food consumption.
      Source: US FDA label for levocetirizine (levocetirizine dihydrochloride), section
      'dosage and administration', retrieved 2026-08-29

  CHILD
    - The recommended dose of levocetirizine dihydrochloride for the treatment of the
      uncomplicated skin manifestations of chronic idiopathic urticaria in patients 6
      months to 17 years of age is based on extrapolation of efficacy from adults 18
      years of age and older [see Clinical Studies (14) ].
      Source: US FDA label for levocetirizine (levocetirizine dihydrochloride), section
      'pediatric use', retrieved 2026-08-29
    - Levocetirizine dihydrochloride tablets are available as 5 mg breakable (scored)
      tablets, allowing for the administration of 2.5 mg, if needed. Levocetirizine
      dihydrochloride tablets can be taken without regard to food consumption.
      Source: US FDA label for levocetirizine (levocetirizine dihydrochloride), section
      'dosage and administration', retrieved 2026-08-29
    - The safety of levocetirizine dihydrochloride 5 mg once daily was evaluated in 243
      pediatric patients 6 to 12 years of age in two placebo-controlled clinical trials
      lasting 4 and 6 weeks.
      Source: US FDA label for levocetirizine (levocetirizine dihydrochloride), section
      'pediatric use', retrieved 2026-08-29

  RENAL IMPAIRMENT
    - In patients with both hepatic impairment and renal impairment, adjustment of the
      dose is recommended.
      Source: US FDA label for levocetirizine (levocetirizine dihydrochloride), section
      'dosage and administration', retrieved 2026-08-29
    - Renal Impairment Because levocetirizine dihydrochloride is substantially excreted
      by the kidneys, the risk of adverse reactions to this drug may be greater in
      patients with impaired renal function ( 8.6 and 12.3 ).
      Source: US FDA label for levocetirizine (levocetirizine dihydrochloride), section
      'use in specific populations', retrieved 2026-08-29
    - In general, dose selection for an elderly patient should be cautious, usually
      starting at the low end of the dosing range reflecting the greater frequency of
      decreased hepatic, renal, or cardiac function and of concomitant disease or other
      drug therapy.
      Source: US FDA label for levocetirizine (levocetirizine dihydrochloride), section
      'use in specific populations', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - No dose adjustment is needed in patients with solely hepatic impairment.
      Source: US FDA label for levocetirizine (levocetirizine dihydrochloride), section
      'dosage and administration', retrieved 2026-08-29
    - In patients with both hepatic impairment and renal impairment, adjustment of the
      dose is recommended.
      Source: US FDA label for levocetirizine (levocetirizine dihydrochloride), section
      'dosage and administration', retrieved 2026-08-29
    - Because elderly patients are more likely to have decreased renal function, care
      should be taken in dose selection and it may be useful to monitor renal function
      [see Dosage and Administration (2) and Clinical Pharmacology (12.3) ].
      Source: US FDA label for levocetirizine (levocetirizine dihydrochloride), section
      'use in specific populations', retrieved 2026-08-29

  PREGNANCY   [ CAUTION ]
    The label allows it only when the benefit is judged to outweigh the risk. Read the
      quote below.
    - Pregnancy Category B There are no adequate and well-controlled studies in pregnant
      women.
      Source: US FDA label for levocetirizine (levocetirizine dihydrochloride), section
      'pregnancy', retrieved 2026-08-29
    - Because animal reproduction studies are not always predictive of human response,
      levocetirizine dihydrochloride should be used during pregnancy only if clearly
      needed.
      Source: US FDA label for levocetirizine (levocetirizine dihydrochloride), section
      'pregnancy', retrieved 2026-08-29
    - Teratogenic Effects In rats and rabbits, levocetirizine was not teratogenic at
      oral doses approximately 320 and 390, respectively, times the maximum recommended
      daily oral dose in adults on a mg/m 2 basis.
      Source: US FDA label for levocetirizine (levocetirizine dihydrochloride), section
      'pregnancy', retrieved 2026-08-29

  BREASTFEEDING
    - No peri- and post-natal animal studies have been conducted with levocetirizine.
      Source: US FDA label for levocetirizine (levocetirizine dihydrochloride), section
      'nursing mothers', retrieved 2026-08-29
    - In mice, cetirizine caused retarded pup weight gain during lactation at an oral
      dose in dams that was approximately 40 times the maximum recommended daily oral
      dose in adults on a mg/m 2 basis.
      Source: US FDA label for levocetirizine (levocetirizine dihydrochloride), section
      'nursing mothers', retrieved 2026-08-29
    - Studies in beagle dogs indicated that approximately 3% of the dose of cetirizine
      was excreted in milk.
      Source: US FDA label for levocetirizine (levocetirizine dihydrochloride), section
      'nursing mothers', retrieved 2026-08-29