Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
OLOPATADINE HYDROCHLORIDE (UNII: 2XG66W44KF) (OLOPATADINE - UNII:D27V6190PM)
Cipla USA Inc.
OPHTHALMIC
PRESCRIPTION DRUG
Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1% is indicated for the treatment of the signs and symptoms of allergic conjunctivitis. Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1% is contraindicated in persons with a known hypersensitivity to olopatadine hydrochloride or any components of Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1%.
Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1% is supplied as follows: 5 mL in white opaque low density polyethylene bottle with translucent low density polyethylene dropper and white opaque high density polyethylene cap. 5 mL: NDC 69097-275-35 Storage: Store between 4°C-25°C (39°F-77°F), Protect from light. Rx Only Manufactured by: Cipla Ltd., India Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300, Warren, NJ 07059 Revised Date: 6/2020
Abbreviated New Drug Application
OLOPATADINE HYDROCHLORIDE- OLOPATADINE HYDROCHLORIDE SOLUTION/ DROPS CIPLA USA INC. ---------- OLOPATADINE HYDROCHLORIDE OPHTHALMIC SOLUTION USP 0.1% DESCRIPTION Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1% is a sterile ophthalmic solution containing olopatadine, a relatively selective H -receptor antagonist and inhibitor of histamine release from the mast cell for topical administration to the eyes. Olopatadine hydrochloride is a white, crystalline, water- soluble powder with a molecular weight of 373.88. The chemical structure is presented below: CHEMICAL NAME: 11-[(Z)-3-(Dimethylamino) propylidene] -6-11-dihydrodibenz [b, e] oxepin-2-acetic acid hydrochloride Each mL of Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1% contains: ACTIVE: 1.11 mg olopatadine hydrochloride equivalent to 1 mg olopatadine. PRESERVATIVE: benzalkonium chloride 0.01 %. INACTIVES: dibasic sodium phosphate; sodium chloride; hydrochloric acid/sodium hydroxide (adjust pH); and water for injection. It has a pH of approximately 7 and an osmolality of approximately 300 mOsm/kg. CLINICAL PHARMACOLOGY Olopatadine is an inhibitor of the release of histamine from the mast cell and a relatively selective histamine H -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 e Perskaitykite visą dokumentą