Product Description.:
Drops , white
White to off-white
Each mL of BETOPTIC S? Ophthalmic
Suspension 0.25% contains: Active: betaxolol HCl 2.8 mg equivalent to 2.5 mg of betaxolol base. Preservative: benzalkonium chloride 0.01%. Inactive(s): Mannitol, Poly(Styrene-Divinyl Benzene) sulfonic acid, Carbomer 934P, edetate disodium, hydrochloric acid or sodium hydroxide (to adjust pH) and purified water.
BETOPTIC S? Ophthalmic Suspension 0.25% has a pH of approximately 7.6 and an osmolality of approximately 290 mOsmol/kg.
INDICATIONS
BETOPTIC S? Ophthalmic Suspension 0.25% is indicated for the treatment of elevated intraocular pressure in patients with chronic open-angle glaucoma or ocular hypertension.
DOSAGE AND ADMINISTRATION
Instill one drop of BETOPTIC S? Ophthalmic Suspension 0.25% in the affected eye twice daily. It may be used alone or in combination with other intraocular pressure lowering medications.
HOW SUPPLIED
Dosage Forms And Strengths
Bottle filled with 2.5, 5, 10, and 15 mL of 0.25% sterile ophthalmic suspension
BETOPTIC S? Ophthalmic Suspension 0.25% is supplied as follows: 2.5, 5, 10 and 15 mL in plastic ophthalmic DROP-TAINER? dispensers. Tamper evidence is provided with a shrink band around the closure and neck area of the DROP-TAINER package.
Storage and Handling
Store upright at 2?- 25?C (36?- 77?F). Shake well before using.
Alcon Laboratories, Inc. Fort Worth, Texas 76134. FDA Rev date: 5/8/2008