Olopatadine

DRUG INFORMATION

  ADULT
    - Recommended dosages: • Adults and Adolescents ≥ 12 Years : Two sprays per nostril
      (665 mcg per spray) twice daily ( 2.1 ). • Pediatric Patients 6 to 11 Years : One
      spray per nostril (665 mcg per spray) twice daily ( 2.2 ). • Priming Information :
      Prime olopatadine hydrochloride nasal solution (nasal spray) before initial use
      and when olopatadine hydrochloride nasal solution (nasal spray) has not been used
      for more than 7 days ( 2.3 ).
      Source: US FDA label for olopatadine (olopatadine hydrochloride), section 'dosage
      and administration', retrieved 2026-08-29
    - For nasal use only. Recommended dosages: • Adults and Adolescents ≥ 12 Years : Two
      sprays per nostril (665 mcg per spray) twice daily ( 2.1 ). • Pediatric Patients 6
      to 11 Years : One spray per nostril (665 mcg per spray) twice daily ( 2.2 ). •
      Priming Information : Prime olopatadine hydrochloride nasal solution (nasal spray)
      before initial use and when olopatadine hydrochloride nasal solution (nasal spray)
      has not been used for more than 7 days ( 2.3 ).
      Source: US FDA label for olopatadine (olopatadine hydrochloride), section 'dosage
      and administration', retrieved 2026-08-29

  CHILD
    - The safety and effectiveness of olopatadine hydrochloride nasal solution (nasal
      spray) for the relief of symptoms of seasonal allergic rhinitis have been
      established in pediatric patients aged 6 years and older. The safety and
      effectiveness of olopatadine hydrochloride nasal solution (nasal spray) in
      pediatric patients 6 to 11 years of age are supported by 3 vehicle-controlled
      2-week studies in 870 patients [ see Adverse Reactions ( 6.1 ) ].
      Source: US FDA label for olopatadine (olopatadine hydrochloride), section
      'pediatric use', retrieved 2026-08-29
    - For nasal use only. Recommended dosages: • Adults and Adolescents ≥ 12 Years : Two
      sprays per nostril (665 mcg per spray) twice daily ( 2.1 ). • Pediatric Patients 6
      to 11 Years : One spray per nostril (665 mcg per spray) twice daily ( 2.2 ). •
      Priming Information : Prime olopatadine hydrochloride nasal solution (nasal spray)
      before initial use and when olopatadine hydrochloride nasal solution (nasal spray)
      has not been used for more than 7 days ( 2.3 ).
      Source: US FDA label for olopatadine (olopatadine hydrochloride), section 'dosage
      and administration', retrieved 2026-08-29
    - Recommended dosages: • Adults and Adolescents ≥ 12 Years : Two sprays per nostril
      (665 mcg per spray) twice daily ( 2.1 ). • Pediatric Patients 6 to 11 Years : One
      spray per nostril (665 mcg per spray) twice daily ( 2.2 ). • Priming Information :
      Prime olopatadine hydrochloride nasal solution (nasal spray) before initial use
      and when olopatadine hydrochloride nasal solution (nasal spray) has not been used
      for more than 7 days ( 2.3 ).
      Source: US FDA label for olopatadine (olopatadine hydrochloride), section 'dosage
      and administration', retrieved 2026-08-29

  RENAL IMPAIRMENT
    - No kidney-impairment dose in this label. Not a statement that none is needed.
      Source: Read and found silent: the US FDA label for olopatadine (olopatadine
      hydrochloride), retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - No liver-impairment dose in this label. Not a statement that none is needed.
      Source: Read and found silent: the US FDA label for olopatadine (olopatadine
      hydrochloride), retrieved 2026-08-29

  PREGNANCY
    - Risk Summary Published data from postmarketing experience with antihistamines,
      with similar mechanism of action to olopatadine hydrochloride nasal solution
      (nasal spray), have not identified a drug-associated risk of major birth defects,
      miscarriage, or adverse maternal or fetal outcomes.
      Source: US FDA label for olopatadine (olopatadine hydrochloride), section
      'pregnancy', retrieved 2026-08-29
    - However, there are no published human data specific to olopatadine hydrochloride
      nasal solution (nasal spray).
      Source: US FDA label for olopatadine (olopatadine hydrochloride), section
      'pregnancy', retrieved 2026-08-29
    - In animal reproductive studies, oral administration of olopatadine hydrochloride
      to pregnant rats and rabbits caused a decrease in the number of live fetuses at
      maternal doses approximately 110 and 1460 times the maximum recommended human
      daily intranasal dose (MRHDID) on a mg/m 2 basis, respectively (see Data) .
      Source: US FDA label for olopatadine (olopatadine hydrochloride), section
      'pregnancy', retrieved 2026-08-29

  BREASTFEEDING
    - In peri-/postnatal toxicity studies, pregnant rats received oral doses of
      olopatadine up to 600 mg/kg/day during late gestation and throughout the lactation
      period.
      Source: US FDA label for olopatadine (olopatadine hydrochloride), section 'use in
      specific populations', retrieved 2026-08-29
    - These effects appeared attributable to exposure of pups via the milk as
      demonstrated in a cross-fostered study in which pups of untreated dams cross-
      fostered to dams treated with 60 mg/kg/day olopatadine orally during the lactation
      period exhibited decreased body weight gain. 8.2 Lactation Risk Summary There are
      no data on the presence of olopatadine in human milk, the effects on the breastfed
      infant, or the effects on milk production.
      Source: US FDA label for olopatadine (olopatadine hydrochloride), section 'use in
      specific populations', retrieved 2026-08-29
    - It is not known whether topical nasal administration could result in sufficient
      systemic absorption to produce detectable quantities in human breast milk.
      Source: US FDA label for olopatadine (olopatadine hydrochloride), section 'use in
      specific populations', retrieved 2026-08-29