Drugs List

Therapeutic Indications

Uses

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

Contraindications

Asthma
Breastfeeding
Cardiac failure
Cardiogenic shock
Corneal disorder
History of asthma
History of obstructive pulmonary disease
Non-paced sinus node dysfunction
Pregnancy
Second degree atrioventricular block
Severe chronic obstructive pulmonary disease
Sinus bradycardia
Third degree atrioventricular block
Uncontrolled cardiac failure

Precautions and Warnings

Atopy
Children under 18 years
Wearing of contact lenses
Bradycardia
Cardiovascular disorder
Chronic obstructive pulmonary disease
Diabetes mellitus
First degree atrioventricular block
Hyperthyroidism
Hypotension
Ischaemic heart disease
Metabolic acidosis
Myasthenia gravis
Narrow angle glaucoma
Prinzmetal's angina
Psoriasis
Severe allergic rhinitis
Severe peripheral circulatory disorder
Uncontrolled phaeochromocytoma

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
Children under 18: Treatment to be initiated/supervised by a specialist
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
Examine cornea regularly
Monitor intra-ocular pressure
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
Consider slow discontinuation if dry eyes and skin rashes occur
Increased risk of choroidal detachment with use post filtration procedures
Seek doctor's advice if intercurrent ocular condition develops
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
Discontinue at the first signs of cardiac failure
Possibly withdraw treatment if dry eyes and/or skin rash occur
Not licensed for use in children under 18 years
Advise contact lens wearers of possibility of reduced lacrimation
Advise patient to avoid touching the eye/other surfaces with container tip
Remove contact lenses before use and re-insert 15 minutes after use

Pregnancy and Lactation

Pregnancy

Use timolol eye drops with caution in pregnancy.

Studies have not shown malformations with systemic beta-blockers but intra-uterine growth retardation and reduced placental weight has occurred. Pharmacological effects have been seen in the neonate when administered up to delivery such as bradycardia, hypotension, respiratory distress and hypoglycaemia. Monitor the babies first few days of life for bradycardia and other symptoms of beta-blocker exposure if this product is used up to delivery.

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

With systemic beta-blockers the baby may show a decreased heart rate, hypoglycaemia and respiratory problems, particularly in preterm neonates. However these are less likely to occur with topical use.

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

Use timolol eye drops with caution in breastfeeding.

Beta-blockers are excreted into breast milk, however it is not likely with this product that adequate quantities would be present in breastmilk to produce signs of beta-blockade in the infant. Hale states untoward effects on the infant have not been reported, and confirms the levels in the milk are probably too small to be clinically relevant. However if any sedation or weakness occurs medical advice should be sought.

If timolol eye gel is used during breastfeeding it is advisable to consider lacrimal sac compression and removal of any excess on the skin with a tissue.

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

Alopecia
Anaphylaxis
Angina pectoris
Angioedema
Arrhythmias
Arthralgia
Arthropathy
Asthenia
Blepharitis
Blurred vision (transient)
Bradycardia
Bronchospasm
Burning and stinging of the eyes
Cardiac arrest
Cerebral ischaemia
Cerebrovascular accident
Chest pain
Choroidal detachment (following filtration surgery)
Claudication
Cold extremities
Confusion
Congestive cardiac failure
Conjunctival hyperaemia
Conjunctivitis
Cough
Decreased corneal sensitivity
Decreased exercise tolerance
Depression
Diarrhoea
Difficulty in micturition
Diplopia
Dizziness
Dry mouth
Dryness and irritation of eyes
Dyspepsia
Dyspnoea
Exacerbation of psoriasis
Exfoliative dermatitis
Extremity pain
Fatigue
Gastralgia
Hallucinations
Headache
Heart block
Hyperglycaemia
Hypersensitivity reactions
Hypoglycaemia
Hypotension
Impaired concentration
Impotence
Increase in antinuclear antibodies (ANA)
Increased dreaming
Insomnia
Keratitis
Loss of libido
Memory loss
Myasthenia gravis-like syndrome
Nasal congestion
Nausea
Nightmares
Non-thrombocytopenic purpura
Ocular discharge
Ocular itching
Oedema
Palpitations
Paraesthesia
Peyronie's disease
Pruritus
Psoriasiform rash
Ptosis
Pulmonary oedema
Rales
Rash
Raynaud's phenomenon
Refractive changes
Respiratory failure
Second and third degree AV block
Sexual dysfunction
Sino-atrial block
Sweating
Syncope
Systemic lupus erythematosus
Tinnitus
Urticaria
Vasodilatation
Vertigo
Visual disturbances
Vomiting
Weakness
Worsening of arterial insufficiency

Presentation

Preservative free eye gel containing timolol

Drugs List

Therapeutic Indications

Uses

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

Dosage

Adults

Elderly

Children

Additional Dosage Information

Contraindications

Asthma
Breastfeeding
Cardiac failure
Cardiogenic shock
Corneal disorder
History of asthma
History of obstructive pulmonary disease
Non-paced sinus node dysfunction
Pregnancy
Second degree atrioventricular block
Severe chronic obstructive pulmonary disease
Sinus bradycardia
Third degree atrioventricular block
Uncontrolled cardiac failure

Precautions and Warnings

Atopy
Children under 18 years
Wearing of contact lenses
Bradycardia
Cardiovascular disorder
Chronic obstructive pulmonary disease
Diabetes mellitus
First degree atrioventricular block
Hyperthyroidism
Hypotension
Ischaemic heart disease
Metabolic acidosis
Myasthenia gravis
Narrow angle glaucoma
Prinzmetal's angina
Psoriasis
Severe allergic rhinitis
Severe peripheral circulatory disorder
Uncontrolled phaeochromocytoma

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
Children under 18: Treatment to be initiated/supervised by a specialist
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
Examine cornea regularly
Monitor intra-ocular pressure
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
Consider slow discontinuation if dry eyes and skin rashes occur
Increased risk of choroidal detachment with use post filtration procedures
Seek doctor's advice if intercurrent ocular condition develops
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
Discontinue at the first signs of cardiac failure
Possibly withdraw treatment if dry eyes and/or skin rash occur
Not licensed for use in children under 18 years
Advise contact lens wearers of possibility of reduced lacrimation
Advise patient to avoid touching the eye/other surfaces with container tip
Remove contact lenses before use and re-insert 15 minutes after use

Pregnancy and Lactation

Pregnancy

Use timolol eye drops with caution in pregnancy.

Studies have not shown malformations with systemic beta-blockers but intra-uterine growth retardation and reduced placental weight has occurred. Pharmacological effects have been seen in the neonate when administered up to delivery such as bradycardia, hypotension, respiratory distress and hypoglycaemia. Monitor the babies first few days of life for bradycardia and other symptoms of beta-blocker exposure if this product is used up to delivery.

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

With systemic beta-blockers the baby may show a decreased heart rate, hypoglycaemia and respiratory problems, particularly in preterm neonates. However these are less likely to occur with topical use.

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

Use timolol eye drops with caution in breastfeeding.

Beta-blockers are excreted into breast milk, however it is not likely with this product that adequate quantities would be present in breastmilk to produce signs of beta-blockade in the infant. Hale states untoward effects on the infant have not been reported, and confirms the levels in the milk are probably too small to be clinically relevant. However if any sedation or weakness occurs medical advice should be sought.

If timolol eye gel is used during breastfeeding it is advisable to consider lacrimal sac compression and removal of any excess on the skin with a tissue.

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

Counselling

Advise patient to wash their hands prior to use.

Avoid contamination of the dropper as this may cause infection of the eye.

Advise patient to take other eye drops 5 minutes apart and then wait another 15 minutes after the last other eye preparation before administering timolol eye gel.

Patient should use the single-dose eye gel container once only and discard immediately after administering the dose, the container has enough gel to treat both eyes.

Advise patient to put pressure on the tearduct in the corner of the eye (compression of the lacrimal sac) and for two minutes afterwards, which may help to reduce systemic absorption and increase the local effect.

Advise patients to inform their doctor about their treatment if they develop another ocular condition.

Athletes should be warned that this drug contains an active substance which may induce a positive analytical result in anti-doping controls.

These eye drops may cause slight blurring of vision when the medicine is in the eye, wait until this goes away before resuming normal activities.

Side Effects

Alopecia
Anaphylaxis
Angina pectoris
Angioedema
Arrhythmias
Arthralgia
Arthropathy
Asthenia
Blepharitis
Blurred vision (transient)
Bradycardia
Bronchospasm
Burning and stinging of the eyes
Cardiac arrest
Cerebral ischaemia
Cerebrovascular accident
Chest pain
Choroidal detachment (following filtration surgery)
Claudication
Cold extremities
Confusion
Congestive cardiac failure
Conjunctival hyperaemia
Conjunctivitis
Cough
Decreased corneal sensitivity
Decreased exercise tolerance
Depression
Diarrhoea
Difficulty in micturition
Diplopia
Dizziness
Dry mouth
Dryness and irritation of eyes
Dyspepsia
Dyspnoea
Exacerbation of psoriasis
Exfoliative dermatitis
Extremity pain
Fatigue
Gastralgia
Hallucinations
Headache
Heart block
Hyperglycaemia
Hypersensitivity reactions
Hypoglycaemia
Hypotension
Impaired concentration
Impotence
Increase in antinuclear antibodies (ANA)
Increased dreaming
Insomnia
Keratitis
Loss of libido
Memory loss
Myasthenia gravis-like syndrome
Nasal congestion
Nausea
Nightmares
Non-thrombocytopenic purpura
Ocular discharge
Ocular itching
Oedema
Palpitations
Paraesthesia
Peyronie's disease
Pruritus
Psoriasiform rash
Ptosis
Pulmonary oedema
Rales
Rash
Raynaud's phenomenon
Refractive changes
Respiratory failure
Second and third degree AV block
Sexual dysfunction
Sino-atrial block
Sweating
Syncope
Systemic lupus erythematosus
Tinnitus
Urticaria
Vasodilatation
Vertigo
Visual disturbances
Vomiting
Weakness
Worsening of arterial insufficiency

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: April 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.

Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.

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

Summary of Product Characteristics: Tiopex 0.1% eye gel, Spectrum Thea, April 2012.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 09 April 2014.

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
Timolol, Last revised: September 7, 2013.
Last accessed: April 9, 2014.