Source: FDA, National Drug Code (US) Revision Year: 2020
PAZEO is a sterile ophthalmic solution containing olopatadine, which is a mast cell stabilizer, for topical administration to the eyes. Olopatadine hydrochloride is a white, crystalline, water‑soluble powder with a molecular weight of 373.88 and a molecular formula of C21H23NO3•HCl.
The chemical structure is presented below:
Chemical Name: 11-[(Z)-3(dimethylamino) propylidene]-6-11dihydrodibenz[b,e] oxepin-2-acetic acid, hydrochloride.
Each mL of PAZEO solution contains an active ingredient [7.76 mg of olopatadine hydrochloride (7 mg olopatadine)] and the following inactive ingredients: povidone; hydroxypropyl-gamma-cyclodextrin; polyethylene glycol 400; hypromellose; boric acid; mannitol; benzalkonium chloride 0.015% (preservative); hydrochloric acid/sodium hydroxide (to adjust pH); and purified water.
PAZEO solution has a pH of approximately 7.2 and an osmolality of approximately 300 mOsm/kg.
| Dosage Forms and Strengths |
|---|
|
Ophthalmic solution: 7.76 mg of olopatadine hydrochloride in one mL solution (0.7%) in a 4 mL bottle. |
| How Supplied |
|---|
|
PAZEO (olopatadine hydrochloride ophthalmic solution) 0.7% is supplied in a white, oval, low density polyethylene DROP-TAINER* dispenser with a natural low density polyethylene dispensing plug and a white polypropylene cap. Tamper evidence is provided with a shrink band around the closure and neck area of the package. PAZEO is supplied in a 4 mL bottle that contains 2.5 mL of olopatadine hydrochloride ophthalmic solution [7.76 mg of olopatadine hydrochloride in one mL of solution (0.7%)]. NDC 0065-4273-25 ALCON LABORATORIES, INC., Fort Worth, Texas 76134 USA * a Trademark of Novartis |
| Drug | Countries | |
|---|---|---|
| PAZEO | Canada, Ecuador, Singapore, United States |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
