Country: মার্কিন যুক্তরাষ্ট্র
ভাষা: ইংরেজি
সূত্র: NLM (National Library of Medicine)
OLOPATADINE HYDROCHLORIDE (UNII: 2XG66W44KF) (OLOPATADINE - UNII:D27V6190PM)
Preferred Pharmaceuticals Inc.
OPHTHALMIC
PRESCRIPTION DRUG
Olopatadine hydrochloride ophthalmic solution 0.1% is indicated for the treatment of the signs and symptoms of allergic conjunctivitis. Olopatadine hydrochloride ophthalmic solution 0.1% is contraindicated in persons with a known hypersensitivity to olopatadine hydrochloride or any components of olopatadine hydrochloride ophthalmic solution 0.1%.
Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1% is supplied as follows: 5mL in a 5mL white, round low-density polyethylene (LDPE) bottle, with a natural LDPE dropper tip, and white colored high-density polyethelene (HDPE) eyedropper cap. A white tamper evident overcap is provided. 5 mL: NDC 68788-6317-5 Storage: Store at 20-25°C (68°F-77°F) [See USP Controlled Room Temperature]. Rx Only
Abbreviated New Drug Application
OLOPATADINE HYDROCHLORIDE- OLOPATADINE HYDROCHLORIDE 0.1% SOLUTION/ DROPS PREFERRED PHARMACEUTICALS INC. ---------- 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 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 purified water. 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 elimination was predominantly through renal excr সম্পূর্ণ নথি পড়ুন