Dosage Form: Opthalmic solution
Alacot is indicated for the treatment of ocular itching associated with allergic conjunctivitis.
Olopatadine is an inhibitor of the release of histamine from the mast cell and a relatively selective histamine H1‐antagonist that inhibits the in vivo and in vitro type 1 immediate hypersensitivity reaction including inhibition of histamine induced effects on human conjunctival epithelial cells. Olopatadine is devoid of effects on alpha adrenergic, dopamine and muscarinic type 1 and 2 receptors. Following topical ocular administration in human, olopatadine was shown to have low systemic exposure.
One drop in each affected eye two times per day at an interval of 6 to 8 hours.
Route of administration: Intra ocular.
May result in additive CNS depression with CNS depressants.
Olopatadine Hydrochloride ophthalmic solution is contraindicated in persons with a known hypersensitivity to Olopatadine Hydrochloride.
Headaches have been reported at an incidence of 7%. The following adverse experiences have been reported in less than 5% of patients: Asthenia, 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.
Pregnancy & Lactation:
There are no adequate and well controlled studies in pregnant women. Because animal studies are not always predictive of human responses, this drug should be used in pregnant women only if the potential benefit to the mother justifies the potential risk to the fetus.
It is not known whether topical ocular administration could result in sufficient systemic absorption to produce detectable quantities in the human breast milk. Nevertheless, caution should be exercised when Olopatadine Hydrochloride ophthalmic solution is administered to a nursing mother.
Precautions & Warnings:
Alacot HCl ophthalmic solution should not be used to treat contact lens related irritation. Patients who wear soft contact lenses should be instructed to wait at least ten minutes after instilling Alacot ophthalmic solution before they insert their contact lenses.
Ophthalmic Non-Steroid drugs
Store below 30° C in a cool and dry place protected from light. Keep out of reach of children. Do not touch the dropper tip to surfaces since this may contaminate the solution. Do not use after 30 days of first opening.
Manufactured by: Square Pharmaceuticals Ltd.