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Timolol ocular

Updated 2 Feb 2023 | Beta-blockers (in glaucoma)

Presentation

Eye drops containing timolol maleate (preservative containing and preservative-free)

Drugs List

  • EYSANO 2.5mg/ml eye drops preservative-free
  • EYSANO 5mg/ml eye drops preservative-free
  • timolol 0.25% eye drops
  • timolol 0.5% eye drops
  • timolol 2.5mg/ml eye drops preservative-free
  • timolol 5mg/ml eye drops preservative-free
  • TIMOPTOL 0.25% eye drops
  • TIMOPTOL 0.5% eye drops
  • Therapeutic Indications

    Uses

    Open-angle glaucoma, including patients with aphakia
    Secondary glaucoma
    Treatment of elevated intraocular pressure in ocular hypertension

    Dosage

    Adults

    0.25% (2.5 mg/ml) and 0.5% (5 mg/ml) preservative-free eye drops
    Instil one drop of 0.25% (2.5 mg/ml) solution into the affected eye(s) once or twice a day.
    If clinical response is not adequate, instil one drop of 0.5% (5 mg/ml) solution into the affected eye(s) once or twice a day.

    Transfer from another topical beta-blocking agent
    Discontinue after a full day of treatment and start next day with timolol. Instil one drop of 0.25% (2.5 mg/ml) solution into the affected eye(s) once or twice a day.
    If clinical response is not adequate, instil one drop of 0.5% (5 mg/ml) solution into the affected eye(s) once or twice a day.

    Transfer from a single anti-glaucoma agent other than a topical beta-blocking agent
    Continue the agent and instil one drop of 0.25% (2.5 mg/ml) solution into the affected eye(s) once or twice a day. Discontinue the previous agent on the following day and continue with timolol.
    Depending on response, dosage can be increased to one drop of 0.5% (5 mg/ml) solution into the affected eye(s) once or twice a day.

    0.25% (2.5 mg/ml) and 0.5% (5 mg/ml) eye drops; 0.25% (2.5 mg/ml) and 0.5% (5 mg/ml) eye drops unit dose preservative-free
    Instil one drop of 0.25% (2.5 mg/ml) solution into the affected eye(s) twice a day.
    If clinical response is not adequate, instil one drop of 0.5% (5 mg/ml) solution into the affected eye(s) twice a day.

    Transfer from another topical beta-blocking agent
    Discontinue after a full day of treatment and start next day with timolol. Instil one drop of 0.25% (2.5 mg/ml) solution into the affected eye(s) twice a day.
    If clinical response is not adequate, instil one drop of 0.5% (5 mg/ml) solution into the affected eye(s) twice a day.

    Transfer from a single anti-glaucoma agent other than a topical beta-blocking agent
    Continue the agent and instil one drop of 0.25% (2.5 mg/ml) solution into the affected eye(s) twice a day. Discontinue the previous agent on the following day and continue with timolol.
    Depending on response, dosage can be increased to one drop of 0.5% (5 mg/ml) solution into the affected eye(s) twice daily.

    Children

    Not licensed in children under 18 years. Requires specialist management.

    Contraindications

    Asthma
    Cardiogenic shock
    History of asthma
    History of obstructive pulmonary disease
    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
    Breastfeeding
    Cardiac failure
    Cardiovascular disorder
    Diabetes mellitus
    Hypertension
    Hyperthyroidism
    Hypotension
    Ischaemic heart disease
    Metabolic acidosis
    Myasthenia gravis
    Narrow angle glaucoma
    Non-paced sinus node dysfunction
    Pregnancy
    Prinzmetal's angina
    Severe peripheral circulatory disorder
    Uncontrolled phaeochromocytoma

    Advise diabetic patients that hypoglycaemic symptoms may be reduced/altered
    Control cardiac failure before starting treatment
    May mask symptoms of hyperthyroidism
    May unmask the symptoms of myasthenia gravis
    Advise ability to drive/operate machinery may be affected by side effects
    Not licensed for use in children under 12 years
    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
    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
    Possibly withdraw treatment if dry eyes and/or skin rash occur
    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.

    Pregnancy and Lactation

    Pregnancy

    Use timolol eye drops with caution in pregnancy.

    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. The use of timolol eye drops during pregnancy has been reported to cause foetal bradycardia.

    If, after careful consideration of the risks involved, timolol 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 timolol 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

    Use timolol eye drops with caution in breastfeeding.

    Timolol is excreted into breast milk. Both oral and ophthalmic drops produce modest levels in milk. In one case report, a woman with elevated intraocular pressure applied ophthalmic 0.5% timolol drops to one eye twice daily, resulting in excretion of the drug in her breast milk. Most authorities consider that the levels seen were below the daily dose that would be below that expected to produce cardiac effects in the infant.

    If, after careful consideration of the risks involved, timolol 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 timolol via breast milk should be closely observed for hypotension, weakness, hypoglycaemia, sedation, depression, bradycardia and other signs or symptoms of beta blockade.

    One manufacturer notes that as timolol is detectable in human milk a decision should be taken by the breastfeeding mother to either stop taking timolol or stop nursing.

    Another manufacturer notes that the therapeutic dose of timolol in the eye drops is unlikely to be sufficient in breast milk to produce symptoms of beta-blockade in the infant.

    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
    Allergic reaction
    Alopecia
    Anaphylaxis
    Angina pectoris
    Angioedema
    Arrhythmias
    Arthralgia
    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
    Congestive cardiac failure
    Conjunctival hyperaemia
    Conjunctivitis
    Corneal erosion
    Cough
    Decreased corneal sensitivity
    Decreased exercise tolerance
    Depression
    Diarrhoea
    Difficulty in micturition
    Diplopia
    Dizziness
    Dry mouth
    Dryness and irritation of eyes
    Dysgeusia
    Dyspepsia
    Dyspnoea
    Exacerbation of psoriasis
    Exfoliative dermatitis
    Extremity pain
    Fatigue
    Headache
    Heart block
    Hyperglycaemia
    Hypoglycaemia
    Hypotension
    Impaired concentration
    Impotence
    Increased dreaming
    Insomnia
    Keratitis
    Loss of libido
    Memory loss
    Myalgia
    Myasthenia gravis-like syndrome
    Nausea
    Nightmares
    Non-thrombocytopenic purpura
    Ocular discharge
    Oedema
    Palpitations
    Paraesthesia
    Peyronie's disease
    Pruritus
    Psoriasiform rash
    Ptosis
    Pulmonary oedema
    Rales
    Rash
    Raynaud's phenomenon
    Reddening of eyes
    Refractive changes
    Respiratory failure
    Second and third degree AV block
    Sensation of foreign body in eye
    Sexual dysfunction
    Sino-atrial block
    Sweating
    Syncope
    Systemic lupus erythematosus
    Tearing
    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: May 2017

    Reference Sources

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

    Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.

    Summary of Product Characteristics: Eysano 2.5mg/ml Eye Drops, Solution. Aspire Pharma Ltd. Revised November 2016.

    Summary of Product Characteristics: Timoptol 0.25% and 0.5% w/v Eye Drops Solution. Santen Oy. Revised July 2015.

    Summary of Product Characteristics: Timoptol Unit Dose 0.25% and 0.5% w/v Eye Drops Solution. Santen Oy. Revised July 2015.

    NICE Evidence Services Available at: www.nice.org.uk Last accessed: 25 May 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
    Timolol Last revised: 10 March 2015
    Last accessed: 25 May 2017.

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