Source: FDA, National Drug Code (US) Revision Year: 2020
PATANOL (olopatadine hydrochloride ophthalmic solution) 0.1% 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. 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 PATANOL (olopatadine hydrochloride ophthalmic solution) 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 purified water.
It has a pH of approximately 7 and an osmolality of approximately 300 mOsm/kg.
How Supplied |
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PATANOL (olopatadine hydrochloride ophthalmic solution) 0.1% is supplied as follows: 5 mL in plastic DROP-TAINER dispenser. 5 mL: NDC 0065-0271-05 Distributed by: ALCON LABORATORIES, INC., Fort Worth, Texas 76134 Alcon, A Novartis company |
Drug | Countries | |
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PATANOL | Brazil, Canada, Ecuador, Israel, Japan, Mexico, New Zealand, Singapore, Turkey, United States, South Africa |
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