BETOPTIC S

Instill one drop of BETOPTIC S in the affected eye(s) twice daily. Shake well before using.

BETOPTIC S may be used alone or in combination with other IOP lowering medications. Advise patients requiring concomitant topical ophthalmic medications to administer these at least 10 minutes before instilling BETOPTIC S.

Ophthalmic suspension containing 2.5 mg/mL of betaxolol as base (0.25%) in 10 mL and 15 mL bottles.

BETOPTIC S is contraindicated in patients with:

No information is available on overdosage in humans. The oral LD

A topical overdose of BETOPTIC S may be flushed from the eye(s) with warm tap water. If overdose occurs, treatment should be symptomatic and supportive.

BETOPTIC S contains betaxolol hydrochloride, a cardioselective beta-adrenergic receptor inhibitor, in a sterile resin suspension formulation. Betaxolol hydrochloride is a white, crystalline powder, with a molecular weight of 343.89 g/mol. The chemical structure is presented below.

Empirical Formula: C

Each mL of BETOPTIC S contains:

BETOPTIC S has pH of approximately 7.6 and an osmolality of approximately 290 mOsmol/kg.

In controlled double-masked studies, the magnitude and duration of the ocular hypotensive effect of BETOPTIC S (betaxolol hydrochloride ophthalmic suspension) 0.25% and BETOPTIC (betaxolol hydrochloride ophthalmic solution) 0.5% were clinically equivalent.

BETOPTIC S (betaxolol hydrochloride ophthalmic suspension), 0.25% is supplied as follows: 10 mL and 15 mL in plastic ophthalmic dispensers. Tamper evidence is provided with a shrink band around the closure and neck area of the package.

10 mL NDC 0078-0729-10

15 mL NDC 0078-0729-15

Store upright at 2°C to 25°C (36°F to 77°F).

Shake well before using.

After opening, BETOPTIC S can be used until the expiration date on the bottle.

Instruct patients to avoid allowing the tip of the dispensing container to contact the eye(s) or surrounding structures. Also instruct patients that ocular solutions, if handled improperly, could become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye(s) and subsequent loss of vision may result from using contaminated solutions.

Advise patients that if they have ocular surgery or develop an intercurrent ocular condition (e.g., trauma or infection), they should immediately seek their physician’s advice concerning the continued use of the present multi-dose container.

Advise patients requiring concomitant topical ophthalmic medications to administer these at least 10 minutes before instilling BETOPTIC S.

Vision may be temporarily blurred following dosing with BETOPTIC S. Care should be exercised in operating machinery or driving a motor vehicle.

The preservative in BETOPTIC S, benzalkonium chloride, may be absorbed by soft contact lenses. Remove contact lenses during instillation of BETOPIC S. Contact lenses may be reinserted 15 minutes after instillation.

Distributed by:

© Novartis

T2021-95

NDC 0078-0729-10

Betoptic S

(betaxolol HCI ophthalmic suspension) 0.25% as base

10 mL Sterile

NOVARTIS