Betoptic 0.25% Eye Drops Suspension (MD) - Summary of Product Characteristics (SPC) by Novartis Pharmaceuticals UK Ltd.
Pregnancy. There are no data on the effects of Betaxolol Eye Drops on human fertility.
If overdose with Betaxolol Eye Drops occurs, treatment should be symptomatic and supportive.
24 months. Hydrochloric acid and/or sodium hydroxide Purified water Not Applicable.
Shake before each use. Discard product 1 month after first opening.
For ocular use only.
Last Updated on eMC 28-Apr-2017 View changes| Novartis Pharmaceuticals UK Ltd Contact details Betoptic Suspension (PIL).
BETOPTIC 0.25% w/v Eye Drops, Suspension.
Rare: cataract, decreased corneal sensitivity, erythema of eyelid Cardiac disorders Uncommon: bradycardia, tachycardia Frequency unknown: arrhythmia Vascular disorders Rare: hypotension.
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Patients with mild/moderate bronchial asthma, a history of mild/moderate bronchial asthma or, mild/moderate chronic obstructive pulmonary disease (COPD) should be treated with caution.
Several Studies have indicated that Betaxolol may have a beneficial effect on visual function for up to 48 months in patients with chronic open angle glaucoma and up to 60 months in patients with ocular hypertension.
BETOPTIC S Ophthalmic Suspension 0.25% contains betaxolol hydrochloride, a cardioselective beta-adrenergic receptor inhibitor, in a sterile resin suspension formulation. BETOPTIC S (betaxolol hydrochloride ophthalmic suspension) Ophthalmic Suspension 0.25% has a pH of.
Ophthalmic betaxolol solution at 1% (one drop each eye) was compared to placebo in a crossover study challenging nine patients with reactive airway disease. The action of isoproterenol, a beta stimulant, administered at the end of the study was not inhibited by ophthalmic betaxolol. Betaxolol HCl had no significant effect on pulmonary function as measured by FEV 1, Forced Vital Capacity (FVC), FEV 1 /FVC and was not significantly different from placebo.
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Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
You are encouraged to report negative side effects of prescription drugs to the FDA.
Betoptic is indicated for the reduction of elevated intraocular pressure in patients with ocular hypertension and chronic open angle glaucoma.
ATC Code: SO1E D02.
Betaxolol is a cardioselective Beta 1 receptor blocker which, when applied topically to the eye, lowers intraocular pressure. It is thought to produce this effect by reducing the rate of production of aqueous humour. Clinical Pharmacology.
Special caution should be exercised in patients with a history of atophy or anaphylaxis. Betablockers can decrease the response to adrenaline use to treat anaphylactic reactions.
Uncommon: punctate keratitis, keratitis, conjunctivitis, blepharitis, visual impairment, photophobia, eye pain, dry eye, asthenopia, blepharospasm, eye pruritus, eye discharge, eyelid margin crusting, eye inflammation, eye irritation, conjunctival disorder, conjunctival oedema, ocular hyperaemia.
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Last Updated on eMC 28-Apr-2017 View changes| Novartis Pharmaceuticals UK Ltd Contact details.
Description of selected adverse reactions.
Rare: anxiety, insomnia, depression Nervous system disorders Common: headache Rare: syncope Frequency unknown: dizziness Eye disorders.
Hypoglycaemia/Diabetes: Beta-blockers should be administered with caution in patients subject to spontaneous hypoglycaemia or to patients with labile diabetes, as beta-blockers may mask the signs and symptoms of acute hypoglycaemia.
Each mL of Betoptic Ophthalmic Solution (0.5%) contains: Active: 5.6 mg betaxolol hydrochloride equivalent to betaxolol base 5 mg. Orally administered beta-adrenergic blocking agents reduce cardiac output in healthy subjects and patients with heart disease. When instilled in the.
In a variety of in vitro and in vivo bacterial and mammalian cell assays, betaxolol HCl was nonmutagenic.
Supplied as follows: 2.5, 5, 10 and 15 mL in plastic ophthalmic DROP-TAINER dispensers. Betoptic Ophthalmic Solution is a sterile, isotonic, aqueous solution of betaxolol hydrochloride.
Betaxolol is an adrenergic blocking agent; therefore, caution should be exercised in patients using concomitant adrenergic psychotropic drugs.
WADA Class WADA Anti-Doping Classification.
5 mL: NDC 15 mL: NDC.
Approval History 10+ years FDA approved 1985.
Betoptic Ophthalmic Solution has been well tolerated in glaucoma patients wearing hard or soft contact lenses and in aphakic patients.
Consideration should be given to the gradual withdrawal of beta-adrenergic blocking agents prior to general anesthesia because of the reduced ability of the heart to respond to beta-adrenergically mediated sympathetic reflex stimuli.
Hypersensitivity to any component of this product.
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Do not rinse the dropper. Replace the dropper cap after each use.
Before using this medicine, consult your doctor or pharmacist if you have: certain types of heart rhythm problems (e.g., sinus bradycardia, second- or third-degree atrioventricular block), certain serious heart conditions (e.g., cardiogenic shock, severe heart failure ). This medication should not be used if you have certain medical conditions.
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