Betathalmic

Trade Name: Betathalmic0.5 %

                Generic Name: Betaxolol Hydrochloride               

Composition:Each 5 ml contains :

Active:Betaxolol Hydrochloride  28 mg / 5 ml Eq .to Betaxolol 25 mg / 5 ml

Inactive: Sodium Chloride , Sodium Hydroxide , Disodium Edetate , Water for Injection , Benzalkonium Chloride

 

DESCRIPTION:

Betaxolol Hydrochloride Ophthalmic Solution contains betaxolol hydrochloride, a cardioselective beta-adrenergic receptor blocking agent, in a sterile isotonic solution.

 

CLINICAL PHARMACOLOGY:

Betaxolol Hydrochloride 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-adrenergicblocking agents reduce cardiac output in healthy subjects and patients with heart disease. In patientswith severe impairment of myocardial function, beta-adrenergic receptor antagonists may inhibit thesympathetic stimulatory effect necessary to maintain adequate cardiac function.

When instilled in the eye, Betaxolol Hydrochloride Ophthalmic Solution has the action of reducingelevated as well as normal intraocular pressure, whether or not accompanied by glaucoma.

Ophthalmic betaxolol has minimal effect on pulmonary and cardiovascular parameters.

Optic nerve head damage and visual field loss are the result of a sustained elevated

intraocular pressure and poor ocular perfusion. Betaxolol Hydrochloride Ophthalmic Solution has the action of reducing elevated as well as normal intraocular pressure, and the mechanism of ocular hypotensive action appears to be a reduction of aqueous production as demonstrated by tonography and aqueous fluorophotometry. The onset of action with Betaxolol Hydrochloride Ophthalmic Solution can generally be noted within 30 minutes and the maximal effect can usually be detected 2 hours after topical administration. A single dose provides a 12-hour reduction in intraocular pressure.

Clinical observation of glaucoma patients treated with Betaxolol Hydrochloride Ophthalmic Solution for up to three years shows that the intraocular pressure lowering effect is well maintained.

Betaxolol Hydrochloride Ophthalmic Solution has also been used successfully in glaucoma patients who have undergone a laser trabeculoplasty and have needed additional long-term ocular hypotensive therapy.

Betaxolol Hydrochloride Ophthalmic Solution has been well tolerated in glaucoma patients wearinghard or soft contact lenses and in aphakic patients.

 

INDICATIONS AND USAGE:

Betaxolol Hydrochloride Ophthalmic Solution has been shown to beeffective in lowering intraocular pressure and is indicated in the treatment of ocular hypertension andchronic open-angle glaucoma. It may be used alone or in combination with other anti-glaucoma drugs.

 

CONTRAINDICATIONS:

Hypersensitivity to any component of this product Betaxolol

 

 

 

WARNING:

Topically applied beta-adrenergic blocking agents may be absorbed systemically. The

same adverse reactions found with systemic administration of beta-adrenergic blocking agents mayoccur 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 withcardiac failure, have been reported with topical application of beta-adrenergic blocking agents.

Betaxolol Hydrochloride Ophthalmic Solution has been shown to have a minor effect on heart rate andblood pressure in clinical studies. Caution should be used in treating patients with a history of cardiacfailure or heat block. Treatment with Betaxolol Hydrochloride Ophthalmic Solution should bediscontinued at the first signs of cardiac failure.

 

PRECAUTIONS:

General: Information for Patients.

Do not touch dropper tip to any surface as this may contaminate

the solution.

Diabetes Mellitus:

Beta-adrenergic blocking agents should be administered with caution in patients

subject to spontaneous hypoglycemia or to diabetic patients (especially those with labile diabetes) whoare receiving insulin or oral hypoglycemic agents. Beta-adrenergic receptor blocking agents may maskthe signs and symptoms of acute hypoglycemia.

 

Thyrotoxicosis:

Beta-adrenergic blocking agents may mask certain clinical signs (e.g., tachycardia) of

hyperthyroidism. Patients suspected of developing thyrotoxicosis should be managed carefully to

avoid abrupt withdrawal of beta-adrenergic blocking agents, which might precipitate a thyroid storm.

 

 

 

 

Muscle Weakness:

Beta-adrenergic blockade has been reported to potentiate muscle weakness

consistent with certain myasthenic symptoms (e.g., diplopia, ptosis, and generalized weakness).

 

Major Surgery:

Consideration should be given to the gradual withdraw of beta-adrenergic blocking

agents prior to general anesthesia because of the reduced ability of the heart to respond to betaadrenergicallymediated sympathetic reflex stimuli.

 

Pulmonary:

Caution should be exercised in the treatment of glaucoma patients with excessive

restriction of pulmonary function. There have been reports of asthmatic attacks and pulmonary

distress during betaxolol treatment. Although rechallenges of some such patients with ophthalmicbetaxolol has not adversely affected pulmonary function test results, the possibility of adversepulmonary effects in patients sensitive to beta blockers cannot be ruled out.

 

Risk from Anaphylatic Reaction:

While taking beta-blockers, patients with a history of atopy or ahistory of severe anaphylatic reaction to a variety of allergens may be more reactive to repeatedaccidental, diagnostic, or therapeutic challenge with such allergens. Such patients may beunresponsive to the usual doses of epinephrine used to treat anaphylactic reactions.

 

 

Drug Interactions:

Patients who are receiving a beta-adrenergic blocking agent orally and Betaxolol

Hydrochloride Ophthalmic Solution should be observed for a potential additive effect either on theintraocular pressure or on the known systemic effects of beta blockade.

Close observation of the patient is recommended when a beta blocker is administered to patients

receiving catecholamine-depleting drugs such as reserpine, because of possible additive effects and theproduction of hypotension and/or bradycardia.

Betaxolol is an adrenergic blocking agent; therefore, caution should be exercised in patients usingconcomitant adrenergic psychotropic drugs.

 

Ocular:

In patients with angle-closure glaucoma, the immediate treatment objective is to reopen the

angle by constriction of the pupil with a miotic agent. Betaxolol has little or no effect on the pupil.

When Betaxolol Hydrochloride Ophthalmic Solution is used to reduce elevated intraocular pressure inangle-closure glaucoma, it should be used with a miotic and not alone.

 

Pregnancy: Pregnancy Category C:

 

BetaxololHCl was not shown to be teratogenic, however, and there were no other

adverse effects on reproduction at subtoxic dose levels. There are no adequate and well-controlledstudies in pregnant women. Betaxolol Hydrochloride Ophthalmic Solution should be used duringpregnancy only if the potential benefit justifies the potential risk to the fetus.

 

 

 

Nursing Mothers:

It is not known whether betaxololHCl is excreted in human milk. Because manydrugs are excreted in human milk, caution should be exercised when Betaxolol HydrochlorideOphthalmic Solution is administered to nursing women.

 

Pediatric Use:

Safety and effectiveness in pediatric patients have not been established.

 

Geriatric Use:

No overall differences in safety or effectiveness have been observed between elderly

and younger patients.

 

 

ADVERSE REACTIONS:

 

Ocular:

Discomfort of short duration was experienced by one in four patients, but none discontinued

therapy; occasional tearing has been reported. Rare instances of decreased corneal sensitivity,

erythema, itching sensation, corneal punctate staining, keratitis, anisocoria, edema, and photophobiahave been reported.

Additional medical events reported with other formulations of betaxolol include blurred vision, foreignbody sensation, dryness of the eyes, inflammation, discharge, ocular pain, decreased visual acuity, andcrusty lashes.

 

 

Systemic:

Systemic reactions following administration of Betaxolol Hydrochloride Ophthalmic

Solution 0.5% or Betaxolol Hydrochloride Ophthalmic Suspension 0.25% have been rarely reported.These include:

 

Cardiovascular: Bradycardia, heart block and congestive failure.

 

Pulmonary: Pulmonary distress characterized by dyspnea, bronchospasm, thickened bronchial

secretions, asthma and respiratory failure.

 

Central Nervous System: Insomnia, dizziness, vertigo, headaches, depression, lethargy, and increasein signs and symptoms of myasthenia gravis.

 

Other: Hives, toxic epidermal necrolysis, hair loss and glossitis.

 

 

 

 

 

 

 

 

 

 

Warning of Benzalkonium chloride :

May cause eye irritation

Avoid contact with soft contact lenses

Remove contact lenses prior to application and wait at least 15 minutes before reinsertion

Known to discolour soft contact lenses

 

OVERDOSAGE:

No information is available on overdosage of humans.

 

DOSAGE AND ADMINISTRATION:

The recommended dose is one to two drops of BetaxololHydrochloride Ophthalmic Solution in the affected eye(s) twice daily.

STORAGE:

Store at temperature not exceeding 30 ˚C , And after opening for one month

 

Packing :

Carton box containing Plastic Bottle of 5 ml with a dropper & an inner leaflet