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XALACOM (latanoprost and timolol ophthalmic solution (as timolol maleate) Dosage Forms, Composition And Packaging

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Dosage Forms, Composition And Packaging

XALACOM (latanoprost and timolol maleate) is a sterile, isotonic, buffered, clear and colorless aqueous solution. One drop contains approximately 1.5 mcg of latanoprost and 150 mcg of timolol.

XALACOM is intended for topical administration on the eye.

XALACOM is supplied in a 5 mL plastic ophthalmic dispenser bottle with a dropper tip, screw cap and tamper proof polyethylene overcap.

Each bottle contains 2.5 mL of XALACOM corresponding to approximately 80 drops of solution.

XALACOM is supplied as a sterile, isotonic, buffered, clear and colorless aqueous solution with a pH of approximately 6.0 and an osmolality of approximately 290 mOsmol/kg. Each mL contains 50 micrograms (mcg) of latanoprost and 5 mg of timolol (6.83 mg timolol maleate).

Non-medicinal ingredients: sodium chloride, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate anhydrous, and water for injection. Benzalkonium chloride 0.02% is added as a preservative. If required, the pH of the solution is adjusted with hydrochloric acid and/or sodium hydroxide.

 

Control #: 237590
May 7, 2020

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