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Tafluprost with timolol ocular


Eye drops containing tafluprost with timolol (preservative-free)

Drugs List

  • tafluprost 15microgram/ml and timolol 5mg/ml eye drops preservative-free 0.3ml unit dose
  • TAPTIQOM 15microgram+5mg/ml eye drops 0.3ml unit dose
  • Therapeutic Indications


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



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

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


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

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


    Children under 18 years
    Cardiogenic shock
    History of asthma
    Second degree atrioventricular block
    Severe chronic obstructive pulmonary disease
    Sinoatrial exit block
    Sinus bradycardia
    Third degree atrioventricular block
    Uncontrolled cardiac failure

    Precautions and Warnings

    History of allergies including anaphylaxis
    Predisposition to iritis
    Predisposition to uveitis
    Risk factors for cystoid macular oedema
    Soft contact lenses
    Anterior chamber lens
    Cardiac failure
    Cardiovascular disorder
    Chronic obstructive pulmonary disease
    Congenital glaucoma
    Corneal disorder
    Diabetes mellitus
    First degree atrioventricular block
    Hepatic impairment
    Ischaemic heart disease
    Myasthenia gravis
    Narrow angle glaucoma
    Pigmentary glaucoma
    Prinzmetal's angina
    Pseudoexfoliative glaucoma
    Pseudophakia with torn posterior lens capsule
    Renal impairment
    Severe peripheral circulatory disorder

    Advise diabetic patients that hypoglycaemic symptoms may be reduced/altered
    Anaesthetist should be made aware patient is taking this medication
    May mask symptoms of hyperthyroidism
    May unmask the symptoms of myasthenia gravis
    Advise ability to drive/operate machinery may be affected by side effects
    In combined therapy, administer eye products at least five minutes apart
    To reduce systemic absorption compress lacrimal sac during administration
    Monitor intra-ocular pressure
    Monitor patient with history of severe cardiac disease for signs of failure
    Advise patient that some eye changes may be permanent
    Beta blockers may reduce the response to adrenaline in anaphylaxis
    May cause periorbital/eyelid skin darkening
    Seek doctor's advice if intercurrent ocular condition develops
    Systemic absorption & adverse effects of systemic beta blockers may occur
    Do not withdraw this drug suddenly
    Female: Ensure adequate contraception during treatment
    Advise patient not to exceed stated dose
    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

    Pregnancy and Lactation


    Use tafluprost with timolol with caution in pregnancy.

    The manufacturer notes that this medication should not be used in pregnancy unless clearly necessary (in cases where no other treatment option is available) and that it should not be used in women of childbearing potential unless adequate contraceptive measures are used.

    At the time of writing there is no published data concerning the use of tafluprost during human pregnancy. Studies in animals have shown reproductive toxicity. In embryo-foetal developmental studies tafluprost caused reductions in foetal body weights and increases in post-implantation losses as well as skeletal abnormalities in rats and rabbits even at very low doses. At increased doses in rats in a pre- and post-natal study the following were observed: increased mortality of newborns, decreased body weights, delayed pinna unfolding. At high doses in rats, reproduction toxicity studies with systemic administration, no effects on fertility or early embryonic development were noted.

    Prostaglandins increase uterine tone and can cause reduced perfusion to the foetus so although Schaefer normally concludes that eye drops may generally be used during pregnancy for the appropriate indications, caution with prostaglandin use is advised. If there are compelling treatment indications, as is the case with severe glaucoma, prostaglandin eye drops should not be withheld, but the dosage should be kept as low as possible (Schaefer 2007).

    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 ( ) or if this is unavailable at the backup site ( ).


    Use tafluprost with timolol with caution in breastfeeding.

    At the time of writing there is limited published information concerning the use of tafluprost during breastfeeding and it is unknown if it is excreted into human milk. As the half life of the active metabolite (tafluprost acid) is very short the oral bioavailability is expected to be very low. Studies in rats have shown excretion of tafluprost into breast milk after topical administration.

    Schaefer advises that Prostaglandins should only be used for compelling indications during breastfeeding, and if breastfeeding continues there should be careful observation of the baby.

    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.

    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

    Side Effects

    Abdominal pain
    Abnormal sensation in eye
    Anterior chamber flare
    Anterior chamber inflammation
    Atrioventricular block
    Blepharal pigmentation
    Blurred vision
    Cardiac arrest
    Cardiac failure
    Cells in anterior chamber of eye
    Cerebral ischaemia
    Cerebrovascular accident
    Chest pain
    Choroidal detachment (following filtration surgery)
    Cold extremities
    Congestive cardiac failure
    Conjunctival follicles
    Conjunctival hyperaemia
    Conjunctival oedema
    Conjunctival pigmentation
    Corneal erosion
    Decreased corneal sensitivity
    Dry eyes
    Dry mouth
    Exacerbation of pre-existing asthma
    Exacerbation of psoriasis
    Eyelash changes
    Eyelid erythema
    Eyelid oedema
    Eyelid sulcus
    Heart block
    Hypersensitivity reactions
    Hypertrichosis of eyelid
    Increased iris pigmentation
    Increased lacrimation
    Loss of libido
    Memory loss
    Myasthenia gravis-like syndrome
    Ocular allergy
    Ocular discharge
    Ocular discomfort
    Ocular hyperaemia
    Ocular pruritus
    Peyronie's disease
    Psoriasiform rash
    Raynaud's phenomenon
    Reduced visual acuity
    Refractive changes
    Respiratory failure
    Sensation of foreign body in eye
    Sexual dysfunction
    Superficial punctate keratitis
    Systemic lupus erythematosus
    Visual disturbances


    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 ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: July 2015.

    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.

    Joint Formulary Committee. British National Formulary(online) London: BMJ Group and Pharmaceutical Press. Accessed on 15 July 2015.

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

    Summary of Product Characteristics: Taptiqom 15 micrograms/ml + 5 mg/ml eye drops. Santen UK Limited. Revised December 2014.

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