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Betoptic Eye Drops Solution


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10.21.2017 | Logan Miers
Betoptic
Betoptic Eye Drops Solution

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. While Betoptic has demonstrated a low potential for systemic effects, it should be used with caution in patients suspected of developing thyrotoxicosis.

Choroidal detachment: Choroidal detachment has been reported with administration of aqueous suppressant therapy (e.g. timolol, acetazolamide) after filtration procedures.

Skin and subcutaneous tissue disorders.

Additional adverse reactions have been seen with ophthalmic beta-blockers and may potentially occur with BETOPTIC SOLUTION: System Organ Classification.

Respiratory, thoracic and mediastinal disorders.

Frequency unknown: nightmares, memory loss, hallucinations, psychoses, confusion. Nervous system disorders:.

In clinical trials with Betaxolol eye drops the most common adverse reaction was ocular discomfort, occurring in 12.0% of patients.

Muscle weakness: Beta adrenergic blocking agents have been reported to potentiate muscle weakness consistent with certain myasthenic symptoms (e.g. diplopia, ptosis and generalised weakness).

Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR.

There is a potential for additive effects resulting in hypotension and/or marked bradycardia when ophthalmic beta-blockers solution is administered concomitantly with oral calcium channel blockers, beta-adrenergic blocking agents, anti-arrhythmics (including amiodarone), digitalis glycosides, parasympathomimetics and guanethidine. Close observation of the patient is recommended.

If overdose with Betaxolol Eye Drops occurs, treatment should be symptomatic and supportive.

Common: vision blurred, lacrimation increased.

Do not store above 25°C.

Betoptic is not recommended for use in children.

However, at therapeutic doses of betaxolol in eye drops, it is not likely that sufficient amounts would be present in breast milk to produce clinical symptoms of beta-blockade in the infant. Beta-blockers are excreted in breast milk, having the potential to cause serious undesirable effects in the infant of the nursing mother. To reduce systemic absorption, see section 4.2.

Musculoskeletal and connective tissue disorders: Frequency unknown: Myalgia.

Reproductive system and breast disorders:

Lactation. Epidemiological studies have not revealed malformative effects but show a risk for intra-uterine growth retardation when beta-blockers are administered by the oral route. In addition, signs and symptoms of beta-blockade (e.g. bradycardia, hypotension, respiratory distress and hypoglycaemia) have been observed in the neonate when beta-blockers have been administered until delivery. If BETOPTIC SOLUTION is administered until delivery, the neonate should be carefully monitored during the first days of life.

Disodium edetate, sodium chloride, benzalkonium chloride, sodium hydroxide, hydrochloric acid, purified water. None known.

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.

Due to its negative effect on conduction time, beta-blockers should only be given with caution to patients with first degree heart block.

For a full list of excipients see Section 6.1 Eye Drops, Solution.

• Reactive airway disease including severe bronchial asthma or a history of severe bronchial asthma, severe chronic obstructive pulmonary disease.

Frequency unknown: Sexual dysfunction, impotence.

Betoptic Eye Drops Solution (PIL).

MedDRA Preferred Term (V13.0) Immune system disorders:

Skin and subcutaneous tissue disorders:

No specific drug interaction studies have been performed with betaxolol.

A topical overdose of Betoptic may be flushed from the eye(s) with warm tap water.

Rare: dermatitis, rash, alopecia.

Frequency unknown: Systemic allergic reactions including angioedema, urticaria, localized and generalized rash, pruritus, anaphylactic reaction.

• Sinus bradycardia, sick sinus syndrome, sino-atrial block, second or third degree atrioventricular block not controlled with pace-maker. Overt cardiac failure, cardiogenic shock.

Summary of the safety profile.

There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

Frequency unknown: cerebrovascular accident, cerebral ischemia, increases in signs and symptoms of myasthenia gravis, paraesthesia Eye disorders:

General disorders and administration site conditions: Frequency unknown: fatigue.

Very common: ocular discomfort.

Fertility. Eye ointments should be administered last. If more than one topical ophthalmic medicinal product is being used, the medicines must be administered at least 5 minutes apart.

POM - Prescription Only Medicine.

The usual dose is one drop to be instilled into the affected eye(s) twice daily. Children.

Contact lenses: Betaxolol Eye Drops contain benzalkonium chloride which may cause irritation and is known to discolour soft contact lenses. Avoid contact with soft contact lenses. Patients must be instructed to remove contact lenses prior to application of Betaxolol Eye Drops and wait at least 15 minutes before reinsertion.

Betaxolol 0.5% w/v (as hydrochloride).

Why? betaxolol hydrochloride. Please check that this is the correct company before contacting them. Before you contact this company : often several companies will market medicines with the same active ingredient.

Unopened 36 months, after opening 28 days.

Mydriasis resulting from concomitant use of ophthalmic beta-blockers and adrenaline (epinephrine) has been reported occasionally.

Frequency unknown: Bronchospasm (predominantly in patients with pre-existing bronchspastic disease) Gastrointestinal disorders:

Betoptic 0.5% w/v eye drops, solution.

Caution should be exercised in patients using concomitant adrenergic psychotropic drugs.

Within each frequency-grouping, adverse reactions are presented in order of decreasing seriousness. System Organ Classification.

It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard. Reporting suspected adverse reactions after authorisation of the medicinal product is important.

To reduce the systemic absorption, see section 4.2. General: Like other topically applied ophthalmic agents, betaxolol is absorbed systemically. Due to the beta-adrenergic component, betaxolol, the same types of cardiovascular, pulmonary and other adverse reactions seen with systemic beta-adrenergic blocking agents may occur. Incidence of systemic ADRs after topical ophthalmic administration is lower than for systemic administration.

Keep in the outer carton in order to protect from light.

Cardiac disorders: In patients with cardiovascular diseases (e.g. coronary heart disease, Prinzmetal's angina and cardiac failure) and hypotension, therapy with beta-blockers should be critically assessed and the therapy with other active substances should be considered. Patients with cardiovascular diseases should be watched for signs of deterioration of these diseases and of adverse reactions.

To reduce the systemic absorption, see section 4.2. Betaxolol should not be used during pregnancy unless clearly necessary. There are no adequate data for the use of betaxolol in pregnant women.

Reproductive system and breast disorders Rare: libido decreased.

General disorders and administration site conditions Frequency unknown: asthenia.

Do not touch the top of the bottle to any surface as this may contaminate the contents.

Frequency unknown: Raynaud's phenomenon, cold and cyanotic hands and feet, Increase of an existing intermittent claudication.

Reporting of suspected adverse reactions.

Frequency unknown: Chest pain, palpitations, oedema, congestive heart failure, atrioventricular block, cardiac arrest, cardiac failure. A slowed AV-conduction or increase of an existing AV-block Vascular disorders:.

19th August 1986 / 14th November 2001 01 May 2017 POM.

Frequency unknown: dyspepsia, diarrhoea, dry mouth, abdominal pain, vomiting.

Listed adverse reactions include reactions seen within the class of ophthalmic beta-blockers. This may cause similar undesirable effects as seen with systemic beta-blocking agents. Like other topically applied ophthalmic drugs, betaxolol is absorbed into the systemic circulation. Incidence of systemic ADRs after topical ophthalmic administration is lower than for systemic administration.

Ophthalmologicals: Antiglaucoma Preparations & Miotics.

Respiratory disorders: Respiratory reactions, including death due to bronchospasm in patients with asthma have been reported following administration of some ophthalmic beta-blockers.

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Respiratory, thoracic, and mediastinal disorders:

When using nasolacrimal occlusion or closing the eyelids for 2 minutes, the systemic absorption is reduced. This may result in a decrease in systemic side effects and an increase in local activity.

The response of these patients should be closely observed. Other beta-blocking agents: The effect on intra-ocular pressure or the known effects of systemic beta-blockade may be potentiated when betaxolol is given to the patients already receiving a systemic beta-blocking agent. The use of two topical beta-adrenergic blocking agents is not recommended (see section 4.5).

Rare: Cataract, decreased corneal sensitivity, erythema of eyelid Cardiac disorders Uncommon: bradycardia, tachycardia Frequency unknown: arrhythmia Vascular disorders Rare: hypotension.

In case of accidental ingestion, symptoms of overdose from betablockade may include bradycardia, hypotension, cardiac failure and bronchospasm.

• Hypersensitivity to the active substance or to any of the excipients listed in section 6.

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5 ml & 10 ml LDPE bottles (10 ml present in 15 ml container) with natural LDPE plug and blue polystyrene or polypropylene cap.

After cap is removed, if tamper evident snap collar is loose, remove before using product.

There are no data on the effects of Betaxolol Eye Drops on human fertility. Pregnancy.

Anaphylactic reactions: While taking beta-blockers, patients with a history of atopy or a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge with such allergens and unresponsive to the usual dose of adrenaline used to treat anaphylactic reactions.

Cardiac disorders:. Frequency unknown: choroidal detachment following filtration surgery (see 4.4 Special warnings and special precautions for use), corneal erosion, ptosis, diplopia.

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. Moreover there is evidence that betaxolol maintains or increases ocular blood flow/perfusion.

MedDRA Preferred Term (V 13.0) Inmmune system disorders Frequency unknown: hypersensitivity Psychiatric disorders.

Excipients with known effect: 1ml of solution contains 0.1mg benzalkonium chloride.

Ophthalmic beta-blockers may induce dryness of eyes. Caution should be exercised in the use of beta-blocking agents in patients with corneal diseases, Sicca Syndrome or similar tear film abnormalities.

severe forms of Raynaud's disease or Raynaud's syndrome) should be treated with caution. Vascular disorders: Patients with severe peripheral circulatory disturbance/disorders (i.e.

The following adverse reactions have been reported during clinical trials or post marketing surveillance with Betaxolol eye drops and are classified according to the subsequent convention: very common (≥ 1/10), common (≥ 1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), very rare (<1/10,000) and frequency unknown/cannot be estimated from the available data.

Corneal diseases: In patients with angle-closure glaucoma, the immediate treatment objective is to re-open the angle by constriction of the pupil with a miotic agent, betaxolol has no effect on the pupil, therefore, Betoptic should be used with a miotic to reduce elevated intraocular pressure in angle-closure glaucoma.

The major metabolic pathways yield two carboxylic acid forms plus unchanged betaxolol in the urine (approx. 16% of the administered dose). Betaxolol is characterised by its good oral absorption, low first pass loss and a relatively long half-life of approx 16-22 hours. Betaxolol is highly lipophilic which results in good permeation of the cornea, allowing high intraocular levels of the drug. The elimination of betaxolol is primarily by the renal rather than faecal route.

Frequency unknown: Psoriasiform rash or exacerbation of psoriasis.

An increase in Anti Nuclear Antibodies (ANA) has been seen; its clinical relevance is unclear.

Metabolism and nutrition disorders: Frequency unknown: Hypoglycaemia. Psychiatric disorders:.

Adults (including the elderly).

Novartis Pharmaceuticals UK Limited Frimley Business Park FrimleyCamberley Surrey GU16 7SR United Kingdom PL 00101/0991.

Uncommon: asthma, dyspnoea, rhinitis, Rare: cough, rhinorrhea Gastrointestinal disorders Uncommon: nausea Rare: dysgeusia.

Betoptic 0.5% eye drops, solution has no or negligible influence on the ability to drive and use machines.

If blurred vision occurs after instillation, the patient must wait until the vision clears before driving or using machinery. Temporary blurred vision or other visual disturbances may affect the ability to drive or use machines.

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Hyperthyroidism: Beta-blockers may also mask the signs of hyperthyroidism.

For ocular use only.

Consideration should be given to the gradual withdrawal of beta-adrenergic blocking agents prior to general anaesthesia because of the reduced ability of the heart to respond to beta-adrenergically mediated sympathetic reflex stimuli. The anaesthesiologist should be informed when the patient is receiving betaxolol. of adrenaline. Surgical anaesthesia: Beta-blocking ophthalmological preparations may block systemic beta-agonist effects e.g.

Betoptic is indicated for the reduction of elevated intraocular pressure in patients with ocular hypertension and chronic open angle glaucoma.

Betoptic