BETAXOLOL HYDROCHLORIDE solution/ drops

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BETAXOLOL HYDROCHLORIDE (UNII: 6X97D2XT0O) (BETAXOLOL - UNII:O0ZR1R6RZ2)

Available from:

Sandoz Inc

INN (International Name):

BETAXOLOL HYDROCHLORIDE

Composition:

BETAXOLOL HYDROCHLORIDE 5.6 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Betaxolol Hydrochloride Ophthalmic Solution has been shown to be effective in lowering intraocular pressure and is indicated in the treatment of ocular hypertension and chronic open-angle glaucoma. It may be used alone or in combination with other anti-glaucoma drugs. In clinical studies, Betaxolol Hydrochloride Ophthalmic Solution was safely used to lower intraocular pressure in 47 patients with both glaucoma and reactive airway disease who were followed for a mean period of 15 months. However, caution should be used in treating patients with severe reactive airway disease or a history of asthma. Hypersensitivity to any component of this product. Betaxolol Hydrochloride Ophthalmic Solution is contraindicated in patients with sinus bradycardia, greater than a first degree atrioventricular block, cardiogenic shock, or patients with overt cardiac failure. Safety and effectiveness in pediatric patients have not been established. No overall differences in safety or effectiveness have been observed between elderly

Product summary:

Betaxolol Hydrochloride Ophthalmic Solution is a sterile, isotonic, aqueous solution of betaxolol hydrochloride. Supplied as follows: 5, 10 and 15 mL in plastic ophthalmic dispensers.   5 mL: NDC 61314-245-01               15 mL: NDC 61314-245-02 10 mL: NDC 61314-245-03 STORAGE: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Rev. May 2023 300059509-0523 Manufactured by Alcon Laboratories, Inc. Fort Worth, Texas 76134 for Sandoz Inc. Princeton, NJ 08540

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

BETAXOLOL HYDROCHLORIDE- BETAXOLOL HYDROCHLORIDE SOLUTION/ DROPS
SANDOZ INC
----------
BETAXOLOL HYDROCHLORIDE OPHTHALMIC SOLUTION, 0.5% AS BASE
STERILE
RX ONLY
DESCRIPTION
Betaxolol Hydrochloride Ophthalmic Solution contains betaxolol
hydrochloride, a
cardioselective beta-adrenergic receptor blocking agent, in a sterile
isotonic solution.
Betaxolol hydrochloride is a white, crystalline powder, soluble in
water, with a molecular
weight of 343.89. The chemical structure is presented below:
Empirical Formula:
C
H
NO •HCl
Chemical Name:
(±)-1-[p-[2-(Cyclopropylmethoxy)ethyl]phenoxy]-3-(isopropylamino)-2-propanol
hydrochloride.
Each mL contains: ACTIVE: 5.6 mg betaxolol hydrochloride equivalent to
betaxolol base
5 mg. PRESERVATIVE: benzalkonium chloride 0.01%. INACTIVES: edetate
disodium,
purified water, sodium chloride, with hydrochloric acid and/or sodium
hydroxide (to
adjust pH).
CLINICAL PHARMACOLOGY
Betaxolol Hydrochloride, a cardioselective (beta-1-adrenergic)
receptor blocking agent,
does not have significant membrane-stabilizing (local anesthetic)
activity and is devoid of
intrinsic sympathomimetic action. Orally administered beta-adrenergic
blocking agents
reduce cardiac output in healthy subjects and patients with heart
disease. In patients
with severe impairment of myocardial function, beta-adrenergic
receptor antagonists
may inhibit the sympathetic stimulatory effect necessary to maintain
adequate cardiac
function.
When instilled in the eye, Betaxolol Hydrochloride Ophthalmic Solution
has the action of
reducing elevated as well as normal intraocular pressure, whether or
not accompanied
by glaucoma. Ophthalmic betaxolol has minimal effect on pulmonary and
cardiovascular
parameters.
18
29
3
Ophthalmic betaxolol (one drop in each eye) was compared to timolol
and placebo in a
three-way crossover study challenging nine patients with reactive
airway disease who
were selected on the basis of having at least a 15% reduction in the
forced expiratory
volume in one second (FEV ) after administration of ophthalmic