Apply topically to the eye as an ophthalmic solution. Not for injection or oral use.
If more than one topical ophthalmic drug is used, administer the drugs at least 5 minutes apart.
Avoid contamination of the solution container.
Dosage
Available as olopatadine hydrochloride; dosage expressed in terms of olopatadine.
Pediatric Patients
Allergic Conjunctivitis
Ophthalmic
Children ≥3 years of age: 1 or 2 drops of a 0.1% solution in the affected eye(s) twice daily (at an interval of 6–8 hours).
Once symptomatic improvement is established, continue therapy for as long as necessary to sustain improvement.
Adults
Allergic Conjunctivitis
Ophthalmic
1 or 2 drops of a 0.1% solution in the affected eye(s) twice daily (at an interval of 6–8 hours).
Once symptomatic improvement is established, continue therapy for as long as necessary to sustain improvement.
Cautions
Contraindications
Known hypersensitivity to olopatadine or any ingredient in the formulation.
Warnings/Precautions
Specific Populations
Pregnancy
Category C.
Lactation
Distributed into milk in rats following oral administration; not known whether distributed into human milk following topical application to the eye. Use with caution.
Pediatric Use
Safety and efficacy not established in children <3 years of age.
Appears to be well-tolerated in children 3–16 years of age.
Geriatric Use
No substantial differences in safety and efficacy relative to younger adults.
Limited systemic exposure following topical application to the eye; plasma concentrations usually are undetectable.
Onset
Rapid onset; symptomatic relief of itching generally occurs within 30 minutes.
Duration
Long duration (≥8 hours).
Distribution
Extent
Distribution into human ocular tissues and fluids not characterized.
Elimination
Metabolism
Metabolized in the liver to monodesmethyl olopatadine and olopatadine N-oxide following topical application to the eyes.
Elimination Route
Eliminated principally by renal excretion; 60–70% of systemically absorbed dose excreted in urine as parent drug.
Half-life
Approximately 3 hours following topical application to the eyes.
Stability
Storage
Ophthalmic
Solution
4–25°C.
Actions
Inhibits type I immediate hypersensitivity reactions in vitro and in vivo.
Suppresses the release of inflammatory mediators (e.g., histamine, prostaglandin D2, tryptase) in response to antigenic stimulation of human conjunctival mast cells in a dose-dependent manner.
Inhibits histamine-stimulated conjunctival vascular permeability response in a concentration-dependent manner.
Potency is comparable to that of levocabastine and exceeds that of pheniramine or antazoline.
Advice to Patients
Importance of learning and adhering to proper administration techniques to avoid contamination of the solution container.
Importance of removing soft contact lenses prior to administration of each dose. Delay reinsertion for 10 minutes after administration if eyes are not red; do not wear contact lenses if eye(s) are red. Not indicated for contact lens-related irritation.
Importance of administering different topical ophthalmic preparations at least 5 minutes apart.
Importance of patients informing clinicians of exisiting or contemplated therapy, including prescription and OTC drugs.
Importance of women informing clinicians if they are or plan to become pregnant or to breast-feed.
Importance of informing patients of other important precautionary information. (See Cautions.)
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