betoptic- 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:

Alcon

INN (International Name):

betaxolol hydrochloride

Pharmaceutical form:

SOLUTION/ DROPS

Composition:

5.6 mg in 1 mL

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

BETOPTIC 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 BETOPTIC 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. BETOPTIC Ophthalmic Solution is contraindicated in patients with sinus bradycardia, greater than a first degree atrioventricular block, cardiogenic shock, or patients with overt cardiac failure.

Product summary:

BETOPTIC Ophthalmic Solution is a sterile, isotonic, aqueous solution of betaxolol hydrochloride. Supplied as follows: 2.5, 5, 10 and 15 mL in plastic ophthalmic DROP-TAINER® dispensers. 2.5 mL: NDC 0065-0245-20   10 mL: NDC 0065-0245-10 5 mL: NDC 0065-0245-05   15 mL: NDC 0065-0245-15 Store at room temperature Rx Only U.S. Patents Nos. 4,252,984; 4,311,708; 4,342,783 ALCON® OPHTHALMIC ALCON LABORATORIES, INC Fort Worth, Texas 76134 USA Printed in USA 236015-0598

Summary of Product characteristics

BETOPTIC- BETAXOLOL HYDROCHLORIDE SOLUTION/ DROPS
ALCON
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DESCRIPTION
BETOPTIC® Sterile 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 of BETOPTIC Ophthalmic Solution (0.5%) contains: ACTIVE: 5.6
mg betaxolol hydrochloride
equivalent to betaxolol base 5 mg. PRESERVATIVE: Benzalkonium Chloride
0.01%. INACTIVE: Edetate
Disodium, Sodium Chloride, Hydrochloric Acid and/or Sodium Hydroxide
(to adjust pH), and Purified
Water. DM-00
CLINICAL PHARMACOLOGY
Betaxolol HCl, 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, BETOPTIC 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.
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 timolol. Betaxolol HCl had no significant
effect on pulmonary function as
measured by F