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Betoptic 0.25 Eye Drops Suspension (MD)

9.20.2017 | Logan Blare
Betoptic 0.25 Eye Drops Suspension (MD)

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

Hyperthyroidism : Beta-adrenergic blocking agents may mask the signs 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.

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

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. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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

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

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). The response of these patients should be closely observed.

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

Betoptic 0.25% eye drops suspension has no or negligible influence on the ability to drive and use machines.

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

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

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. bradycardia, hypotension, respiratory distress and hypoglycaemia) have been observed in the neonate when beta-blockers have been administered until delivery. Lactation. In addition, signs and symptoms of beta-blockade (e.g. If BETOPTIC SUSPESION is administered until delivery, the neonate should be carefully monitored during the first days of life.

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

MedDRA preferred term (v 13.0) Immune system disorders:

Children. If the intraocular pressure of the patient is not adequay controlled on this regimen, concomitant therapy with pilocarpine and other miotics and/or adrenaline (epinephrine) and/or carbonic anhydrase inhibitors can be instituted.

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

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

General disorders and administration site conditions Frequency unknown: asthenia.

Reporting of suspected adverse reactions.

Avoid contact with soft contact lenses. Contact lenses: Betaxolol Eye Drops contain benzalkonium chloride which may cause irritation and is known to discolour 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.

Respiratory, thoracic and mediastinal disorders.

The DROP-TAINER utilizes a tamper evident closure with a breakaway ring. BETOPTIC SUSPENSION is packaged as a 5 ml label fill in a 5 ml and a 10 ml label fill in a 10 ml natural low density polyethylene (LDPE), DROP-TAINER with a LDPE dispensing plug and a 15 mm white polypropylene closure.

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

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

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

Betaxolol has no significant effect on pulmonary function as measured by FEV1, Forced Vital Capacity (FVC), FEV1/FVC and no evidence of cardiovascular beta-adrenergicblockade during exercise was observed.

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

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.

No specific drug interaction studies have been performed with betaxolol.

Safety and effectiveness in children have not been established.

There are no further pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC. Benzalkonium chloride.

To reduce systemic absorption, see section 4.2. 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.

Frequency unknown: Psoriasiform rash or exacerbation of psoriasis.

Incidence of systemic ADRs after topical ophthalmic administration is lower than for systemic administration. 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. General: Like other topically applied ophthalmic agents, betaxolol is absorbed systemically. To reduce the systemic absorption, see section 4.2.

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

POM - Prescription Only Medicine.

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Very common: ocular discomfort.

Betaxolol 0.25% w/v (as hydrochloride).

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

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

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

Poly (styrene divinylbenzene) sulphonic acid Carbomer Boric acid Mannitol Disodium edetate N-Lauroylsarcosine.

Frequency unknown: Sexual dysfunction, impotence.

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

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

Listed adverse reactions include reactions seen within the class of ophthalmic beta-blockers. 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. This may cause similar undesirable effects as seen with systemic beta-blocking agents.

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

Reproductive system and breast disorders Rare: libido decreased.

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. Cardiac disorders: In patients with cardiovascular diseases (e.g. Treatment with BETOPTIC SUSPENSION should be discontinued at the first signs of cardiac failure. Patients with cardiovascular diseases should be watched for signs of deterioration of these diseases and of adverse reactions.

The onset of action of betaxolol 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.

BETOPTIC SUSPENSION provides IOP lowering activity equivalent to that demonstrated by BETOPTIC Ophthalmic Solution 0.5%. When instilled in the eye, betaxolol has the action of reducing elevated as well as normal intraocular pressure (IOP), whether or not accompanied by glaucoma. It is thought to produce this effect by reducing the rate of production of aqueous humour as demonstrated by tonography and aqueous fluorophotometry. Ophthalmic betaxolol has little or no effect on the constriction of the pupil and little effect on respiratory and cardiovascular function.

Reproductive system and breast disorders.

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

In this formulation, betaxolol molecules are ionically bound to the amberlite resin. Upon instillation the betaxolol molecules are displaced by ions in the tear film. This displacement process occurs over several minutes and enhances the ocular comfort observed for Betoptic Suspension. The polar nature of betaxolol can produce apparent ocular discomfort.

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

Skin and subcutaneous tissue disorders.

There was evidence of drug related postimplantation loss in rabbits and rats at dose levels above 12 mg/kg and 128 mg/kg (1500 and 16,000 times the maximum recommended human ocular dose), respectively. Reproduction studies have been conducted with orally administered betaxolol HCl in rats and rabbits.

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.

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

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.

Skin and subcutaneous tissue disorders.

of adrenaline. Surgical anaesthesia: Beta-blocking ophthalmological preparations may block systemic beta-agonist effects e.g. 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.

Store the bottle in the outer carton in order to protect from light.

If blurred vision occurs 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.

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.

Betaxolol, a cardioselective (beta1-adrenergic) receptor blocking agent, does not have significant membrane-stabilising (local anaesthetic) activity and is devoid of intrinsic sympathomimetic action. In patients with severe impairment of myocardial function, beta-adrenergic receptor antagonists may inhibit the sympathetic stimulatory effect necessary to maintain adequate cardiac function. Orally administered beta-adrenergic blocking agents may reduce cardiac output in healthy subjects and patients with heart disease.

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

In some patients, the intraocular pressure lowering responses to BETOPTIC SUSPENSION may require a few weeks to stabilise. The recommended dose is one drop in the affected eye(s) twice daily. Careful monitoring of glaucoma patients is advised.

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

Musculoskeletal and connective tissue disorders: Frequency unknown: Myalgia.

Special caution should be exercised in patients with a history of atophy or anaphylaxis. Betablockers can decrease the response to adrenaline used to treat anaphylactic reactions.

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.

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).

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

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

Rare: dermatitis, rash, alopecia.

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

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

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

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

Respiratory, thoracic, and mediastinal disorders.

Novartis Pharmaceuticals UK Limited Frimley Business Park Frimley Camberley Surrey GU16 7SR United Kingdom PL 00101/0990 22nd August 1997 01 May 2017 POM.

Summary of the safety profile.

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The volume of each drop dispensed is 24 μl.

Pharmacotherapeutic Group: Ophthalmologicals - Antiglaucoma Preparations & Miotics.

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

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

Common: vision blurred, lacrimation increased.

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

Adults (including Elderly). BETOPTIC SUSPENSION lowers the intraocular pressure and is indicated in patients with chronic open-angle glaucoma and ocular hypertension.

When BETOPTIC SUSPENSION is used to reduce elevated intraocular pressure in angle-closure glaucoma, it should be used with a miotic and not alone. Corneal diseases: 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.

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.

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 bronchospastic disease), Gastrointestinal disorders:

Studies in animals with Betaxolol HCl was not shown to be teratogenic and there were no other adverse effects on reproduction at subtoxic dose levels (see section 5.3).

ATC Code: S01E D02.