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Timolol with latanoprost ocular

Presentation

Eye drops containing timolol maleate and latanoprost preservative containing and preservative free.

Drugs List

  • FIXAPOST 5mg+50microgram/ml eye drops preservative-free 0.2ml unit dose
  • MEDOX 5mg+50microgram/ml eye drops
  • timolol 5mg/ml and latanoprost 50microgram/ml eye drops
  • timolol 5mg/ml and latanoprost 50microgram/ml eye drops preservative-free 0.2ml unit dose
  • XALACOM eye drops
  • Therapeutic Indications

    Uses

    Elevated IOP in ocular hypertension when beta blocker alone insufficient
    Elevated IOP in open-angle glaucoma when beta blocker alone is insufficient

    Dosage

    Adults

    Instil 1 drop into the affected eye(s) once daily.

    If a dose is missed continue with the next dose as planned. The dose should not exceed 1 drop in the affected eye(s) daily.

    Contraindications

    Children under 18 years
    Sinus node dysfunction
    Asthma
    Breastfeeding
    Cardiogenic shock
    History of asthma
    Non-paced second degree atrioventricular block
    Non-paced third degree atrioventricular block
    Pregnancy
    Severe chronic obstructive pulmonary disease
    Sinoatrial exit block
    Sinus bradycardia
    Uncontrolled cardiac failure

    Precautions and Warnings

    Atopy
    History of allergies including anaphylaxis
    Predisposition to iritis
    Predisposition to uveitis
    Risk factors for cystoid macular oedema
    Wearing of contact lenses
    Aphakia
    Cardiac failure
    Cardiovascular disorder
    Chronic obstructive pulmonary disease
    Corneal disorder
    Diabetes mellitus
    First degree atrioventricular block
    Herpetic keratitis
    History of herpes simplex keratitis
    Hyperthyroidism
    Hypotension
    Inflammatory glaucoma
    Ischaemic heart disease
    Myasthenia gravis
    Narrow angle glaucoma
    Neovascular glaucoma
    Pigmentary glaucoma
    Prinzmetal's angina
    Pseudophakia with open angle glaucoma
    Pseudophakia with torn posterior lens capsule
    Raynaud's syndrome
    Severe peripheral circulatory disorder
    Severe Raynaud's syndrome
    Spontaneous hypoglycaemia

    Advise diabetic patients that hypoglycaemic symptoms may be reduced/altered
    Anaesthetist should be made aware patient is taking this medication
    Control cardiac failure before starting treatment
    May mask symptoms of hyperthyroidism
    May unmask the symptoms of myasthenia gravis
    Advise patient blurred vision may affect ability to drive/operate machinery
    Contains benzalkonium chloride
    Contains polyoxyethylene hydrogenated castor oil; may cause skin reactions
    In combined therapy, administer eye products at least five minutes apart
    To reduce systemic absorption compress lacrimal sac during administration
    Monitor for changes to iris pigmentation regularly
    Monitor intra-ocular pressure
    Monitor patient with history of severe cardiac disease for signs of failure
    Monitor patients with cardiac disorders
    Advise patient of possible change in eye colour
    Advise patient that some eye changes may be permanent
    Beta blockers may reduce the response to adrenaline in anaphylaxis
    Increased risk of choroidal detachment with use post filtration procedures
    Systemic absorption & adverse effects of systemic beta blockers may occur
    Advise patient to avoid touching the eye/other surfaces with container tip
    Before initiating treatment inform patient of possibility of eyelash growth
    Before initiating treatment inform patient of risk of eyelid skin darkening
    Before starting treatment inform patient of risk of increased iris pigment
    Remove contact lenses before use and re-insert 15 minutes after use

    Preserved formulations contain benzalkonium chloride, which may cause eye irritation and may discolour soft contact lenses.

    Preservative-free formulation contains macrogolglycerol hydroxystearate (castor oil polyoxyl hydrogenated) which may cause skin irritation.

    Pregnancy and Lactation

    Pregnancy

    The combination of timolol with latanoprost is contraindicated in pregnancy.

    Timolol
    Systemic use of beta blockers shows a risk of intrauterine growth retardation (IUGR) and use near delivery has seen symptoms of beta blockade (e.g. bradycardia, hypotension, respiratory distress and hypoglycaemia) in the neonate, hence close monitoring is needed during the first days of life.

    Latanoprost
    There is limited information available but neither human nor animal experiences suggest any significant risk to the embryo-foetus.

    Lactation

    The combination of timolol with latanoprost is contraindicated in breastfeeding.

    The manufacturer notes a decision should be made whether to cease breastfeeding or stop taking the medication.

    Timolol
    Timolol is excreted into breast milk but at therapeutic doses for eye drops it is unlikely that sufficient amounts will produce symptoms of beta blockade in the infant. 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.

    Latanoprost
    Latanoprost and its metabolites may pass into breast milk but plasma concentrations are probably very low.

    Side Effects

    Abdominal pain
    Aggravation of angina
    Aggravation of existing asthma
    Allergic reaction
    Alopecia
    Anaphylactic reaction
    Angioedema
    Arrhythmias
    Arthralgia
    Asthenia
    Asthma
    Atrioventricular block
    Blepharitis
    Blurred vision (transient)
    Bradycardia
    Bronchospasm
    Brown pigmentation of iris
    Burning and stinging of the eyes
    Cardiac arrest
    Cardiac failure
    Cerebral ischaemia
    Cerebrovascular accident
    Chest pain
    Choroidal detachment (following filtration surgery)
    Cold extremities
    Congestive cardiac failure
    Conjunctival hyperaemia
    Conjunctivitis
    Corneal disorders
    Corneal erosion
    Corneal oedema
    Cough
    Darkening of the palpebral skin
    Darkening, thickening and lengthening of eye lashes
    Darkening, thickening and lengthening of vellus hair
    Decreased corneal sensitivity
    Depression
    Diarrhoea
    Diplopia
    Distichiasis
    Dizziness
    Dry eyes
    Dry mouth
    Dysgeusia
    Dyspepsia
    Dyspnoea
    Erythema
    Exacerbation of myasthenia gravis
    Exacerbation of pre-existing asthma
    Exacerbation of psoriasis
    Eyelid oedema
    Eyelid reaction
    Fatigue
    Headache
    Hypoglycaemia
    Hypotension
    Increased iris pigmentation
    Increased lacrimation
    Insomnia
    Iris cyst
    Iritis
    Joint pain
    Keratitis
    Macular oedema
    Memory loss
    Misdirected eyelash growth
    Muscle pain
    Myalgia
    Nasopharyngitis
    Nausea
    Nightmares
    Ocular grittiness
    Ocular hyperaemia
    Ocular irritation
    Ocular itching
    Ocular pain
    Oedema
    Palpitations
    Paraesthesia
    Periorbital oedema
    Photophobia
    Pruritus
    Pseudopemphigoid of ocular conjunctiva
    Psoriasiform rash
    Ptosis
    Punctate epithelial erosions of eye (transient)
    Pyrexia
    Rash
    Raynaud's phenomenon
    Reduced libido
    Refractive changes
    Sensation of foreign body in eye
    Syncope
    Tearing
    Tinnitus
    Urticaria
    Uveitis
    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: February 2109

    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: Fixapost 50micrograms/ml + 5mg/ml eye drops, solution in single-dose container. Laboratoires THEA. Revised May 2018.

    Summary of Product Characteristics: Medox 50micrograms/ml + 5mg/ml eye drops, solution. Medicom Healthcare Ltd. Revised October 2018.

    Summary of Product Characteristics: Xalacom eye drops, solution. Pfizer Ltd. Revised September 2018.

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