BETAXOLOL- betaxolol hydrochloride solution/ drops

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Akorn

INN (nemzetközi neve):

Betaxolol Hydrochloride

Összetétel:

Betaxolol 5 mg in 1 mL

Az alkalmazás módja:

OPHTHALMIC

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

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

Termék összefoglaló:

Betaxolol Ophthalmic Solution 0.5% is a sterile, isotonic, aqueous solution of betaxolol hydrochloride, USP. Supplied as follows: 2.5 mL, 5 mL, 10 mL and 15 mL in plastic ophthalmic dropper tip bottles. NDC 17478-705-25       2.5 mL Bottle NDC 17478-705-10       5 mL Bottle NDC 17478-705-11       10 mL Bottle NDC 17478-705-12       15 mL Bottle Storage: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Akorn Manufactued by: Akorn, Inc. Lake Forest, IL 60045 BX00N   Rev. 06/16

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

BETAXOLOL- BETAXOLOL HYDROCHLORIDE SOLUTION/ DROPS
AKORN
----------
Rx only
DESCRIPTION
Betaxolol Ophthalmic Solution USP, 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
343.90. The structural formula is presented below:
Molecular Formula: C
H
NO •HCl
Chemical Name:
(±)-1[_p_-[2-(Cyclopropylmethoxy)ethyl]phenoxy]-3-(isopropylamino)-2-
propanol hydrochloride.
Each mL of Betaxolol Ophthalmic Solution for ophthalmic administration
contains:
ACTIVE: 5.6 mg betaxolol hydrochloride equivalent to betaxolol base 5
mg; INACTIVES:
Edetate Disodium, Sodium Chloride, Hydrochloric Acid and/or Sodium
Hydroxide may be
added to adjust pH and Water for Injection; PRESERVATIVE: Benzalkonium
Chloride
0.01%.
CLINICAL PHARMACOLOGY
Betaxolol, 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 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 had no
significant effect on pulmonary function as