Therapeutic Category:Ophthalmic drugs
Pharmacologic Category:Histamine H1; Antagonist - Second Generation
Pharmaceutical Form:Eye Drops
Olopatadine HCl is a relatively selective H1 receptor antagonist and inhibitor of histamine release, that inhibits immediate hypersensitivity reaction including inhibition of histamine induced effects on human conjunctival epithelial cells.
Olopatadine is absorbed systematically. However systemic absorption of topically applied olopatadine is minimal with plasma concentration ranging from below the assay quantitation limit.
PATALERG opthalamic solution is indicated for the treatment of signs and symptoms of allergic conjunctivitis.
PATALERG eye drops is contraindicated in persons with a known hypersensitivity to Olopatadine hydrochloride or any components of the formulation.
4-WARNINGS & PRECAUTIONS:
-Only for topical use and not for injection or oral use.
-Patients who wear soft contact lenses should be instructed to wait at least ten minutes after instilling PATALERG before they insert their contact lenses.
-PATALERG should not be used to treat contact lens related irritation.
5-PREGNANCY & LACTATION:
Olopatadine should be used in pregnant woman only if there is potential benefit to mother.
Caution should be exercised when PATALERG is administered to a nursing mothers.
Headaches, blurred vision, burning or stinging, cold syndrome, dry eye, foreign body sensation, hyperemia, hypersensitivity, keratitis, lid edema, nausea, pharyngitis, pruritus, rhinitis, sinusitis, and taste perversion.
7-DOSAGE & ADMINISTRATION:
The recommended dose of PATALERG 1 is one drop in each affected eye twice a day at an interval of 6 to 8 hours, or once a day using PATALERG 2
8-PACKAGING & COMPOSITION:
-PATALERG 1 - Eye Drops: A pack of plastic container of 5 or 10 mL sterile solution contains Olopatadine Hydrochloride equivalent to 1mg Olopatadine per mL.
-PATALERG 2 - Eye Drops: A pack of plastic container of 5 or 10 mL sterile solution contains Olopatadine Hydrochloride equivalent to 2mg Olopatadine per mL.
Store at (4-25)°C.