DESCRIPATION:
Allernil-O Eye Drops (Olopatadine Hydrochloride Ophthalmic Solution) is a sterile ophthalmic solution containing olopatadine, a relatively selective H1-receptor antagonist and inhibitor of histamine release from the mast cell for topical administration to the eyes.
COMPOSITION:
Label Claim: Each mL Contains :
Olopatadine Hydrochloride IP
- Equivalent to Olopatadine
0.1% w/v
- Benzalkonium Chloride Solution IP
.0.01%w/v
- Sterile aqueous Vehicle..
...q.s.
PACKAGING
Primary packing - 5ml Opaque poly bottles White caps & Nozzles.
Secondary Packing - Labels, Cartons, Shrink Pack & Shipper box.
AVAILABILITY
5ml of solution in White poly bottles with white caps & nozzles in properly sealed.
SHELF LIFE:
24 months from the date of manufacturing.
STORAGE:
Keep in a cool & dark place. Below 30ºC.Do not allow to Freeze.
CLINICAL PHARMACOLOGY:
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 man, olopatadine was shown to have low systemic exposure. Two studies in normal volunteers (totaling 24 subjects) dosed bilaterally with olopatadine 0.15% ophthalmic solution once every 12 hours for 2 weeks demonstrated plasma concentrations to be generally below the quantitation limit of the assay (<0.5 ng/mL). Samples in which olopatadine was quantifiable were typically found within 2 hours of dosing and ranged from 0.5 to 1.3 ng/mL. The half-life in plasma was approximately 3 hours, and elimination was predominantly through renal excretion. Approximately 60-70% of the dose was recovered in the urine as parent drug. Two metabolites, the mono-desmethyl and the N-oxide, were detected at low concentrations in the urine.
Results from an environmental study demonstrated that Allernil-O Eye Drops (Olopatadine Hydrochloride Ophthalmic Solution), was effective in the treatment of the signs and symptoms of allergic conjunctivitis when dosed twice daily for up to 6 weeks. Results from conjunctival antigen challenge studies demonstrated that Allernil-O Eye Drops (Olopatadine Hydrochloride Ophthalmic Solution), when subjects were challenged with antigen both initially and up to 8 hours after dosing, was significantly more effective than its vehicle in preventing ocular itching associated with allergic conjunctivitis.
INDICATIONS AND USAGE:
Allernil-O Eye Drops (Olopatadine Hydrochloride Ophthalmic Solution) is indicated for the treatment of the signs and symptoms of allergic conjunctivitis.
CONTRAINDICATIONS:
Allernil-O Eye Drops (Olopatadine Hydrochloride Ophthalmic Solution) is contraindicated in persons with a known hypersensitivity to Olopatadine Hydrochloride or any components of Olopatadine Hydrochloride Ophthalmic Solution.
WARNINGS :
Allernil-O Eye Drops (Olopatadine Hydrochloride Ophthalmic Solution) is for topical use only and not for injection or oral use.
DOSAGE AND ADMINISTRATION:
The recommended dose is one drop in each affected eye two times per day at an interval of 6 to 8 hours.
SUPPLY:
Allernil-O Eye Drops is supplied in one White polethylene Bottle packed with printed labelled & cartons And Such 25 Carton Packed in a Shrink Sleeves & corrugated box.
