Drugs List

Therapeutic Indications

Uses

Treatment of elevated intraocular pressure in chronic open-angle glaucoma
Treatment of elevated intraocular pressure in ocular hypertension

Contraindications

Asthma
Breastfeeding
Cardiogenic shock
History of asthma
History of obstructive pulmonary disease
Pregnancy
Second degree atrioventricular block
Severe chronic obstructive pulmonary disease
Sinoatrial exit block
Sinus bradycardia
Third degree atrioventricular block
Uncontrolled cardiac failure

Precautions and Warnings

Atopy
Children under 18 years
History of allergies including anaphylaxis
Soft contact lenses
Cardiac failure
Cardiovascular disorder
Chronic obstructive pulmonary disease
Corneal disorder
Diabetes mellitus
First degree atrioventricular block
Hyperthyroidism
Hypotension
Intermittent claudication
Non-paced sinus node dysfunction
Prinzmetal's angina
Raynaud's syndrome
Severe peripheral circulatory disorder
Spontaneous hypoglycaemia

Advise diabetic patients that hypoglycaemic symptoms may be reduced/altered
Control cardiac failure before starting treatment
Give concurrent miotic treatment if used to treat narrow angle glaucoma
May mask symptoms of hyperthyroidism
May unmask the symptoms of myasthenia gravis
Advise ability to drive/operate machinery may be affected by side effects
Advise patient blurred vision may affect ability to drive/operate machinery
Contains benzalkonium chloride. Not to be used with soft contact lenses
In combined therapy, administer eye products at least five minutes apart
To reduce systemic absorption compress lacrimal sac during administration
Assess intra-ocular pressure about 4 weeks after starting treatment
Monitor patient with history of severe cardiac disease for signs of failure
Monitor pulse rates in patients with potential for cardiac failure
Beta blockers may reduce the response to adrenaline in anaphylaxis
Contains phosphate: Risk of calcification in existing notable cornea damage
Systemic absorption & adverse effects of systemic beta blockers may occur
Consider gradual withdrawal of treatment prior to general anaesthesia
Do not withdraw this drug suddenly
Possibly withdraw treatment if dry eyes and/or skin rash occur
Not licensed for use in children under 18 years
Advise patient to avoid touching the eye/other surfaces with container tip
If soft contact lenses worn,insert them 15 minutes after using eye drops

Preserved formulations contain benzalkonium chloride.

The CSM (CHM) has advised that beta blockers, even those with apparent cardioselectivity, should not be used in patients with asthma or a history of obstructive airways disease, unless no alternative treatment is available. In such cases the risk of inducing bronchospasm should be appreciated and appropriate precautions taken.

Pregnancy and Lactation

Pregnancy

Levobunolol is contraindicated in pregnancy.

The manufacturer notes that as there is no adequate data for the use of levobunolol eye drops in pregnant women, this medication should not be used during pregnancy unless clearly necessary.

Studies involving the systemic use of beta blockers did not indicate malformative effects, but some pharmacological effects such as bradycardia have been observed in foetuses and neonates. Systemic use of some beta-blockers can cause intra-uterine growth retardation (IUGR) and reduced placental weight. In one case report, ophthalmic doses of a beta-blocker were seen to affect the foetal heart rate.

If, after careful consideration of the risks involved, levobunolol eye drops are used during pregnancy, it is advisable to consider lacrimal sac compression and removal of any excess on the skin with a tissue.

Any infant, exposed in utero to levobunolol eye drops should be monitored closely after birth for bradycardia and other symptoms.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Levobunolol is contraindicated in breastfeeding.

Levobunolol is excreted into breast milk. If treatment is required during lactation, consideration should be given to whether the mother should stop breast feeding.

If, after careful consideration of the risks involved, levobunolol eye drops are used during breastfeeding, it is advisable to consider lacrimal sac compression and removal of any excess on the skin with a tissue.

Infants exposed to levobunolol via breast milk should be closely observed for lethargy, hypotension, bradycardia, apnoea and other signs or symptoms of beta blockade.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abdominal pain
Alopecia
Anterior uveitis
Arrhythmias
Ataxia (transient)
Atrioventricular block
Blepharitis
Blepharoconjunctivitis
Blurred vision
Bradycardia
Bronchospasm
Burning and stinging of the eyes
Cardiac arrest
Cardiac failure
Cerebral haematoma
Cerebrovascular accident
Choroidal detachment (following filtration surgery)
Cold extremities
Confusion
Congestive cardiac failure
Conjunctival irritation
Conjunctivitis
Contact dermatitis
Corneal reflex decreased
Cough
Decreased corneal sensitivity
Depression
Dermatitis
Diarrhoea
Diplopia
Dizziness
Dry eyes
Dry mouth
Dysgeusia
Dyspnoea
Erythema
Exacerbation of intermittent claudication
Exacerbation of myasthenia gravis
Eye pain
Eyelid oedema
Eyelid pruritus
Facial oedema
Fatigue
Hallucinations
Headache
Hypersensitivity reactions
Hypoglycaemia
Hypotension
Impaired autonomic response to hypoglycaemia
Impotence
Increased allergic sensitivity
Increased lacrimation
Increased seriousness of anaphylactic reactions
Induces asthma attacks
Insomnia
Iridocyclitis
Keratitis
Lethargy
Lichenoid keratosis
Loss of iris pigmentation
Memory loss
Myalgia
Nasal discomfort
Nausea
Nightmares
Ocular discharge
Ocular irritation
Ocular oedema
Ocular pruritus
Oedema
Palpitations
Paraesthesia
Photophobia
Pruritus
Psoriasis like symptoms
Ptosis
Quincke's oedema
Rash
Raynaud's phenomenon
Reduced libido
Respiratory failure
Sexual dysfunction
Skin exfoliation
Sleep disturbances
Somnolence
Syncope
Throat irritation
Ulcerative keratitis
Upper abdominal pain
Urticaria
Visual disturbances
Vomiting

Presentation

Eye drops containing levobunolol hydrochloride (preservative containing and preservative-free).

Drugs List

Therapeutic Indications

Uses

Treatment of elevated intraocular pressure in chronic open-angle glaucoma
Treatment of elevated intraocular pressure in ocular hypertension

Dosage

Adults

Children

Additional Dosage Information

Contraindications

Asthma
Breastfeeding
Cardiogenic shock
History of asthma
History of obstructive pulmonary disease
Pregnancy
Second degree atrioventricular block
Severe chronic obstructive pulmonary disease
Sinoatrial exit block
Sinus bradycardia
Third degree atrioventricular block
Uncontrolled cardiac failure

Precautions and Warnings

Atopy
Children under 18 years
History of allergies including anaphylaxis
Soft contact lenses
Cardiac failure
Cardiovascular disorder
Chronic obstructive pulmonary disease
Corneal disorder
Diabetes mellitus
First degree atrioventricular block
Hyperthyroidism
Hypotension
Intermittent claudication
Non-paced sinus node dysfunction
Prinzmetal's angina
Raynaud's syndrome
Severe peripheral circulatory disorder
Spontaneous hypoglycaemia

Advise diabetic patients that hypoglycaemic symptoms may be reduced/altered
Control cardiac failure before starting treatment
Give concurrent miotic treatment if used to treat narrow angle glaucoma
May mask symptoms of hyperthyroidism
May unmask the symptoms of myasthenia gravis
Advise ability to drive/operate machinery may be affected by side effects
Advise patient blurred vision may affect ability to drive/operate machinery
Contains benzalkonium chloride. Not to be used with soft contact lenses
In combined therapy, administer eye products at least five minutes apart
To reduce systemic absorption compress lacrimal sac during administration
Assess intra-ocular pressure about 4 weeks after starting treatment
Monitor patient with history of severe cardiac disease for signs of failure
Monitor pulse rates in patients with potential for cardiac failure
Beta blockers may reduce the response to adrenaline in anaphylaxis
Contains phosphate: Risk of calcification in existing notable cornea damage
Systemic absorption & adverse effects of systemic beta blockers may occur
Consider gradual withdrawal of treatment prior to general anaesthesia
Do not withdraw this drug suddenly
Possibly withdraw treatment if dry eyes and/or skin rash occur
Not licensed for use in children under 18 years
Advise patient to avoid touching the eye/other surfaces with container tip
If soft contact lenses worn,insert them 15 minutes after using eye drops

Preserved formulations contain benzalkonium chloride.

The CSM (CHM) has advised that beta blockers, even those with apparent cardioselectivity, should not be used in patients with asthma or a history of obstructive airways disease, unless no alternative treatment is available. In such cases the risk of inducing bronchospasm should be appreciated and appropriate precautions taken.

Pregnancy and Lactation

Pregnancy

Levobunolol is contraindicated in pregnancy.

The manufacturer notes that as there is no adequate data for the use of levobunolol eye drops in pregnant women, this medication should not be used during pregnancy unless clearly necessary.

Studies involving the systemic use of beta blockers did not indicate malformative effects, but some pharmacological effects such as bradycardia have been observed in foetuses and neonates. Systemic use of some beta-blockers can cause intra-uterine growth retardation (IUGR) and reduced placental weight. In one case report, ophthalmic doses of a beta-blocker were seen to affect the foetal heart rate.

If, after careful consideration of the risks involved, levobunolol eye drops are used during pregnancy, it is advisable to consider lacrimal sac compression and removal of any excess on the skin with a tissue.

Any infant, exposed in utero to levobunolol eye drops should be monitored closely after birth for bradycardia and other symptoms.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Levobunolol is contraindicated in breastfeeding.

Levobunolol is excreted into breast milk. If treatment is required during lactation, consideration should be given to whether the mother should stop breast feeding.

If, after careful consideration of the risks involved, levobunolol eye drops are used during breastfeeding, it is advisable to consider lacrimal sac compression and removal of any excess on the skin with a tissue.

Infants exposed to levobunolol via breast milk should be closely observed for lethargy, hypotension, bradycardia, apnoea and other signs or symptoms of beta blockade.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abdominal pain
Alopecia
Anterior uveitis
Arrhythmias
Ataxia (transient)
Atrioventricular block
Blepharitis
Blepharoconjunctivitis
Blurred vision
Bradycardia
Bronchospasm
Burning and stinging of the eyes
Cardiac arrest
Cardiac failure
Cerebral haematoma
Cerebrovascular accident
Choroidal detachment (following filtration surgery)
Cold extremities
Confusion
Congestive cardiac failure
Conjunctival irritation
Conjunctivitis
Contact dermatitis
Corneal reflex decreased
Cough
Decreased corneal sensitivity
Depression
Dermatitis
Diarrhoea
Diplopia
Dizziness
Dry eyes
Dry mouth
Dysgeusia
Dyspnoea
Erythema
Exacerbation of intermittent claudication
Exacerbation of myasthenia gravis
Eye pain
Eyelid oedema
Eyelid pruritus
Facial oedema
Fatigue
Hallucinations
Headache
Hypersensitivity reactions
Hypoglycaemia
Hypotension
Impaired autonomic response to hypoglycaemia
Impotence
Increased allergic sensitivity
Increased lacrimation
Increased seriousness of anaphylactic reactions
Induces asthma attacks
Insomnia
Iridocyclitis
Keratitis
Lethargy
Lichenoid keratosis
Loss of iris pigmentation
Memory loss
Myalgia
Nasal discomfort
Nausea
Nightmares
Ocular discharge
Ocular irritation
Ocular oedema
Ocular pruritus
Oedema
Palpitations
Paraesthesia
Photophobia
Pruritus
Psoriasis like symptoms
Ptosis
Quincke's oedema
Rash
Raynaud's phenomenon
Reduced libido
Respiratory failure
Sexual dysfunction
Skin exfoliation
Sleep disturbances
Somnolence
Syncope
Throat irritation
Ulcerative keratitis
Upper abdominal pain
Urticaria
Visual disturbances
Vomiting

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: September 2014.

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.

Summary of Product Characteristics: Betagan eye drops 0.5%. Allegan Ltd. Revised September 2014.

Summary of Product Characteristics: Betagan Unit Dose. Allergan Ltd. Revised September 2014.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 22 August 2017

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Levobunolol Last revised: Sept 07, 2013
Last accessed: Sept 03, 2014