BETOPTIC S- betaxolol hydrochloride suspension/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Betaxolol Hydrochloride (UNII: 6X97D2XT0O) (Betaxolol - UNII:O0ZR1R6RZ2)

Available from:

Alcon Laboratories, Inc.

INN (International Name):

Betaxolol Hydrochloride

Composition:

Betaxolol Hydrochloride 2.8 mg in 1 mL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

BETOPTIC S® (betaxolol hydrochloride ophthalmic suspension) 0.25% is indicated for the treatment of elevated intraocular pressure (IOP) in patients with chronic open-angle glaucoma or ocular hypertension. BETOPTIC S is contraindicated in patients with: - sinus bradycardia - greater than a first degree atrioventricular (AV) block - cardiogenic shock - patients with overt cardiac failure - hypersensitivity to any component of this product Risk Summary There are no adequate and well-controlled studies of BETOPTIC S administration in pregnant women to inform a drug-associated risk. There are limited data with the use of betaxolol eye drops in pregnant women. Epidemiological studies have not revealed malformative effects but show a risk for intrauterine growth retardation when beta-blockers are administered by the oral route. In animal reproductive studies, no drug-induced maternal toxicity or teratogenicity was observed at clinically relevant doses (see Data) . Because animal reproductive studies are not always

Product summary:

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 0065-0246-10 15 mL NDC 0065-0246-15 Storage and Handling 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.

Authorization status:

New Drug Application

Summary of Product characteristics

BETOPTIC S - BETAXOLOL HYDROCHLORIDE SUSPENSION/ DROPS
ALCON LABORATORIES, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
BETOPTIC S SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR BETOPTIC S.
BETOPTIC S (BETAXOLOL HYDROCHLORIDE OPHTHALMIC SUSPENSION), 0.25% AS
BASE, FOR TOPICAL
OPHTHALMIC USE
INITIAL U.S. APPROVAL: 1985
INDICATIONS AND USAGE
BETOPTIC S is a beta-adrenergic receptor inhibitor indicated for the
treatment of elevated intraocular
pressure (IOP) in patients with chronic open-angle glaucoma or ocular
hypertension (1)
DOSAGE AND ADMINISTRATION
Instill one drop in the affected eye(s) twice daily (2)
DOSAGE FORMS AND STRENGTHS
Ophthalmic suspension: 2.5 mg/mL of betaxolol as base (0.25%) (3)
CONTRAINDICATIONS
Hypersensitivity to any component of this product (4)
Sinus bradycardia, second or third degree atrioventricular (AV) block,
overt cardiac failure, and
cardiogenic shock (4)
WARNINGS AND PRECAUTIONS
Systemic Absorption: Same adverse reactions found with systemic
administration of beta-adrenergic
receptor inhibitors may occur with topical ophthalmic administration
(5.1)
Cardiac Failure: Discontinue treatment at the first signs of cardiac
failure (5.2)
Diabetes Mellitus: Beta-adrenergic receptor inhibitors may mask the
signs and symptoms of acute
hypoglycemia. Administer with caution in diabetic patients subject to
hypoglycemia (5.3)
Thyrotoxicosis: Beta-adrenergic receptor inhibitors may mask certain
clinical signs (e.g., tachycardia) or
hyperthyroidism (5.4)
ADVERSE REACTIONS
The most frequent adverse reaction is transient ocular discomfort
(6.1)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT NOVARTIS
PHARMACEUTICALS CORPORATION
AT 1-888-669-6682 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
DRUG INTERACTIONS
Oral beta-adrenergic receptor inhibitors may have additive effects
(7.1)
Catecholamine-depleting drugs may have additive effects (7.2)
Concomitant adrenergic psychotropic drugs may have additive effects
(7