Betaxolol

Registered South African indications:

• Ocular hypertension
• Chronic open angle glaucoma

Contraindications

• Hypersensitivity to the active ingredient or any of its excipients
• Sinus bradycardia
• Sick sinus syndrome
• Sino-atrial block
• Cardiogenic shock
• Overt cardiac failure
• Second or third degree heart block
• Reactive airway disease

Cautions

• Pregnancy
• Breastfeeding
• Cardiovascular disorders
• Severe peripheral circulatory disorders
• Asthma
• Chronic obstructive airway disease
• Hypoglycaemia
• Diabetes mellitus
• Hyperthyroidism
• Myaesthenia gravis
• Closed angle glaucoma
• Sicca syndrome
• History of atopy
• Corneal disease
• Concomitant use of soft contact lenses

Forms avail. in SA and covered in this monograph: opd

Ocular hypertension
Chronic open angle glaucoma

• Ophthalmic (opd): 1 drop into affected eye(s), 12hrly

Not established for use in children below 18 years

Pregnancy

• Caution
• Studies in animals with betaxolol hydrochloride, the agent was not shown to be teratogenic and there were no other adverse effects on reproduction at subtoxic dose levels
• Using nasolacrimal occlusion or closing the eyelids for 2 minutes, reduces systemic absorption. This may result in a decrease in systemic side effects
• There are no adequate data for the use of betaxolol in pregnant women. betaxolol should not be used during pregnancy unless clearly necessary
• 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 betaxolol is administered until delivery, the neonate should be carefully monitored during the first days of life

Breastfeeding

• Caution
• Beta-blockers are excreted in breast milk, having the potential to cause serious undesirable effects in the infant of the nursing mother. 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
• Using nasolacrimal occlusion or closing the eyelids for 2 minutes, reduces systemic absorption. This may result in a decrease in systemic side effects

Renal Impairment

• No dose adjustment recommended

Hepatic Impairment

• No dose adjustment recommended

Elderly

• No dose adjustment recommended

Porphyria Information

• Not porphyrinogenic (NP)

Drugs in Sport

• Prohibited - In certain sports

Prohibited - In  and out of competition:

Archery (WA)
Shooting (ISSF) (IPC)

Prohibited - In competition:

Automobile (FIA)
Billiards (all disciplines) (WCBS)
Darts (WDF)
Golf (IGF)
Skiing / Snowboarding (FIS) in ski jumping, freestyle aerials/halfpipe and snowboard halfpipe/big air
Underwater sports (CMAS) in constant-weight apnoea with or without fins, dynamic apnoea with and without fins, free immersion apnoea, Jump Blue apnoea, spearfishing, static apnoea, target shooting and variable weight apnoea

Central Nervous System Disorders

• Anxiety 
• Insomnia 
• Depression
• Headache
• Cerebrovascular accident 
• Cerebral ischemia
• Increases in signs and symptoms of myasthenia gravis 
• Paraesthesia
• Syncope
• Nightmares
• Memory loss 
• Hallucinations
• Psychoses
• Confusion
• Dizziness
• Ptosis

Cardiovascular Disorders

• Bradycardia 
• Tachycardia
• Hypotension
• Chest pain
• Palpitations 
• Oedema
• Congestive heart failure
• Atrioventricular block
• Cardiac arrest
• Slowed AV conduction
• Arrhythmia
• Raynaud's phenomenon 
• Increase of existing intermittent claudication

Respiratory Disorders

• Asthma
• Dyspnoea 
• Rhinitis
• Cough
• Rhinorrhea

Gastrointestinal Disorders

• Nausea and vomiting
• Dyspepsia
• Diarrhoea 
• Dry mouth 
• Abdominal pain 

Genitourinary Disorders

• Sexual dysfunction 
• Impotence

Endocrine and Metabolic Disorders

• Decreased libido
• Hypoglycaemia

Skin and Subcutaneous Tissue Disorders

• Dermatitis
• Rash
• Alopecia
• Psoriasiform rash or exacerbation of psoriasis
• Eyelid margin crusting
• Erythema of eyelid

Immune, Blood and Lymphatic System Disorders

• Systemic allergic reactions 

Sensory Disorders

• Ocular discomfort
• Blurred vision 
• Increased lacrimation
• Punctate keratitis 
• Conjunctivitis
• Blepharitis
• Visual impairment 
• Photophobia
• Eye pain
• Dry eye
• Asthenopia 
• Blepharospasm 
• Eye pruritus
• Eye discharge 
• Eye inflammation 
• Eye irritation
• Conjunctival disorder
• Conjunctival oedema
• Ocular hyperaemia
• Cataract
• Decreased corneal sensitivity 
• Choroidal detachment following filtration surgery
• Corneal erosion
• Dysgeusia
• Diplopia

• Calcium channel blockers
• Beta blockers
• Antiarrhythmics
• Digoxin
• Parasympathomimetics
• Guanethidine
• Adrenaline
• Adrenergic psychotropic agents

None routine

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.

Eye drops (ml) 2.5mg

• Betoptic S single dose (Novartis South Africa) originator
• Betoptic S 0.25% (Novartis South Africa) originator

Eye drops (ml) 5mg

• Betoptic (Novartis South Africa) originator
• Loxoptic (Actor)