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BETAGAN
®
(levobunolol hydrochloride ophthalmic solution USP) with C Cap
®
Compliance Cap
DESCRIPTION : BETAGAN® (levobunolol hydrochloride ophthalmic solution USP) sterile is a
noncardioselective beta-adrenoceptor blocking agent for ophthalmic use.
CHEMICAL NAME: LevobunololHCl: (-)-5-[3-(tert-Butylamino)-2-hydroxypropoxy]-3,4-dihydro-1(2H)-
naphthalenone hydrochloride.
STRUCTURAL FORMULA: Levobunolol HCl
Contains:
Active: levobunolol HCl 0.25% or 0.5%.
Preservative: benzalkonium chloride (0.004%).
Inactives: polyvinyl alcohol1.4%; edetate disodium; sodium metabisulfite; sodium phosphate, dibasic;
potassium phosphate, monobasic; sodium chloride; hydrochloric acid or sodium hydroxide to adjust the
pH; and purified water.
CLINICAL PHARMACOLOGY : Levobunolol HCl is a noncardioselective beta-adrenoceptor blocking
agent, equipotent at both beta 1 and beta 2 receptors. Levobunolol HCl is greater than 60 times more
potent than its dextro isomer in its beta-blocking activity, yet equipotent in its potential for direct
myocardial depression. Accordingly, the levo isomer, levobunolol HCl, is used. Levobunolol HCl does not
have significant local anesthetic (membrane-stabilizing) or intrinsic sympathomimetic activity.
Beta-adrenergic receptor blockade reduces cardiac output in both healthy subjects and patients with
heart disease. In patients with severe impairment of myocardial function, beta-adrenergic receptor
blockade may inhibit the stimulatory effect of the sympathetic nervous system necessary to maintain
adequate cardiac function.
Beta-adrenergic receptor blockade in the bronchi and bronchioles results in increased airway resistance
from unopposed para-sympathetic activity. Such an effect in patients with asthma or other bronchospastic
conditions is potentially dangerous.
BETAGAN® (levobunolol HCl ophthalmic solution USP) has been shown to be an active agent in
lowering elevated as well as normal intraocular pressure (IOP) whether or not accompanied by glaucoma.
Elevated IOP presents a major risk factor in glaucomatous field loss. The higher the level of IOP, the
greater the likelihood of optic nerve damage and visual field loss.
The onset of action with one drop of BETAGAN
®
can be detected within one hour after treatment, with
maximum effect seen between 2 and 6 hours.
A significant decrease in IOP can be maintained for up to 24 hours following a single dose.
In two separate, controlled studies (one three month and one up to 12 months duration) BETAGAN®
ophthalmic solution 0.25% b.i.d. controlled the IOP of approximately 64% and 70% of the subjects.
The overall No Prescription Viagra Texas Houston mean decrease from baseline was 5.4 mm Hg and 5.1 mm Hg respectively. In an open-label
study, BETAGAN® ophthalmic solution 0.25% q.d. controlled the IOP of 72% of the subjects while
achieving an overall mean decrease of 5.9 mm Hg.
In controlled clinical studies of approximately two years duration, intraocular pressure was well-controlled
in approximately 80% of subjects treated with BETAGAN® Ophthalmic Solution 0.5% b.i.d. The meanIOP decrease from baseline was between 6.87 mm Hg and 7.81 mm Hg. No significant effects on pupil
size, tear production or corneal sensitivity were observed. BETAGAN® ophthalmic solution at the
concentrations tested, when applied topically, decreased heart rate and blood pressure in some patients.
The IOP-lowering effect of BETAGAN® was well maintained over the course of these studies.
In a three month clinical study, a single daily application of 0.5% BETAGAN® ophthalmic solution
controlled the IOP of 72% of subjects achieving an overall mean decrease in IOP of 7.0 mm Hg.
The primary mechanism of the ocular hypotensive action of levobunolol HCl in reducing IOP is most likely
a decrease in aqueous humor production. BETAGAN® reduces IOP with little or no effect on pupil size or
accommodation in contrast to the miosis which cholinergic agents are known to produce. The blurred
vision and night blindness often associated with miotics would not be expected and have not been
reported with the use of BETAGAN
®
This is particularly important in cataract patients with central lens .
opacities who would experience decreased visual acuity with pupillary constriction.
INDICATIONS AND USAGE : BETAGAN
®
ophthalmic solution has been shown to be effective in
lowering intraocular pressure and may be used in patients with chronic open-angle glaucoma or ocular
hypertension.
CONTRAINDICATIONS : BETAGAN
®
ophthalmic solution is contraindicated in those individuals with
bronchial asthma or with a history of bronchial asthma, or severe chronic obstructive pulmonary disease
(see WARNINGS ); sinus bradycardia; second and third degree atrioventricular block; overt cardiac failure
(see WARNINGS); cardiogenic shock; or hypersensitivity to any component of these products.
WARNINGS : As with other topically applied ophthalmic drugs, BETAGAN
®
may be absorbed
systemically. The same adverse reactions found with systemic administration of beta-adrenergic blocking
agents may occur with topical administration. For example, severe respiratory reactions and cardiac
reactions, including death due to bronchospasm in patients with asthma, and rarely death in association
with cardiac failure, have been reported with topical application of beta-adrenergic blocking agents (see
CONTRAINDICATIONS ).
Cardiac Failure: Sympathetic stimulation may be essential for support of the circulation in individuals
with diminished myocardial contractility, and its inhibition by beta-adrenergic receptor blockade may
precipitate more severe failure.
In Patients Without a History of Cardiac Failure: Continued depression of the myocardium with betablocking agents over a period of time can, in some cases, lead to cardiac failure. At the first sign or
symptom of cardiac failure, BETAGAN
®
ophthalmic solution should be discontinued.
Obstructive Pulmonary Disease:
PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (e.g., CHRONIC BRONCHITIS,
EMPHYSEMA) OF MILD OR MODERATE SEVERITY, BRONCHOSPASTIC DISEASE OR A HISTORY
OF BRONCHOSPASTIC DISEASE (OTHER THAN BRONCHIAL ASTHMA OR A HISTORY OF
BRONCHIAL ASTHMA, IN WHICH BETAGAN® IS CONTRAINDICATED, See CONTRAINDICATIONS ),
SHOULD IN GENERAL NOT RECEIVE BETA BLOCKERS, INCLUDING BETAGAN®. However, if
BETAGAN
®
is deemed necessary in such patients, then it should be administered cautiously since it may
block bronchodilation produced by endogenous and exogenous catecholamine stimulation of beta 2
receptors.
Major Surgery: The necessity or desirability of withdrawal of beta-adrenergic blocking agents prior to
major surgery is controversial. Beta-adrenergic receptor blockade impairs the ability of the heart to
respond to beta-adrenergically mediated reflex stimuli. This may augment the risk of general anesthesia
in surgical procedures. Some patients receiving beta-adrenergic receptor blocking agents have been
subject to protracted severe hypotension during anesthesia. Difficulty in restarting and maintaining the
heartbeat has also been reported. For these reasons, in patients undergoing elective surgery, gradual
withdrawal of beta-adrenergic receptor blocking agents may be appropriate.
If necessary during surgery, the effects of beta-adrenergic blocking agents may be reversed by sufficient
doses of such agonists as isoproterenol, dopamine, dobutamine or levarterenol (See OVERDOSAGE ).