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Dorzolamide hydrochloride with timolol maleate ocular preservative-free


Eye drops containing dorzolamide hydrochloride and timolol maleate preservative-free.

Drugs List

  • COSOPT 20mg+5mg/ml eye drops preservative-free 0.2ml unit dose
  • COSOPT IMULTI 20mg+5mg/ml eye drops preservative-free
  • dorzolamide 20mg/ml and timolol 5mg/ml eye drops preservative-free
  • dorzolamide 20mg/ml and timolol 5mg/ml eye drops preservative-free 0.2ml unit dose
  • EYLAMDO 20mg+5mg/ml eye drops preservative-free
  • VIZIDOR DUO 20mg+5mg/ml eye drops
  • Therapeutic Indications


    Elevated IOP in open-angle glaucoma when beta blocker alone is insufficient
    Elevated IOP in pseudoexfoliative glaucoma when beta blocker alone insuff;



    Instil 1 drop in the affected eye(s) twice daily.


    Children aged under 18 years (unlicensed):
    Instil 1 drop in the affected eye(s) twice daily.

    Patients with Renal Impairment

    This medication is contraindicated in patients with creatinine clearance below 30 ml/minute or with hyperchloraemic acidosis.
    Patients with a prior history of renal calculi may be at increased risk of urolithiasis whilst using this medication.


    Cardiogenic shock
    History of asthma
    Hyperchloraemic acidosis
    Non paced second/third degree AV block
    Non-paced sinus node dysfunction
    Renal impairment - creatinine clearance below 30 ml/minute
    Severe chronic obstructive pulmonary disease
    Sinoatrial exit block
    Sinus bradycardia
    Uncontrolled cardiac failure

    Precautions and Warnings

    Children under 18 years
    History of allergies including anaphylaxis
    Wearing of contact lenses
    Cardiac disorder
    Chronic obstructive pulmonary disease
    Corneal dystrophy
    Diabetes mellitus
    First degree atrioventricular block
    Hepatic impairment
    History of intra-ocular surgery
    Myasthenia gravis
    Narrow angle glaucoma
    Peripheral vascular disease
    Prinzmetal's angina
    Severe Raynaud's syndrome

    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
    Some formulations may contain traces of silver - risk of hypersensitivity
    Administer other ophthalmic products at least 10 minutes apart
    To reduce systemic absorption compress lacrimal sac during administration
    Monitoring of patients with compromised corneas required during use
    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
    Do not withdraw this drug suddenly
    Discontinue if hypersensitivity reactions occur
    Not licensed for use in children under 18 years
    Advise patient to avoid touching the eye/other surfaces with container tip

    The CSM 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


    Dorzolamide hydrochloride with timolol maleate eye drops preservative-free are contraindicated during pregnancy.

    The manufacturer recommends that dorzolamide with timolol eye drops preservative-free should not be used during pregnancy unless clearly necessary.

    At the time of writing there is limited published experience concerning the use of dorzolamide and timolol eye drops during pregnancy. In rabbits, dorzolamide produced teratogenic effect at maternotoxic doses.

    Studies have not revealed malformative effects as a result of using timolol, but have shown a risk for intra uterine growth retardation and decreased placental weight when beta-blockers are administered by the oral route. In addition, signs and symptoms of beta-blockage (e.g. bradycardia, hypotension, respiratory distress and hypoglycaemia) have been observed in the neonate when beta-blockers have been administered until delivery. Ophthalmic doses of timolol have also been seen to affect foetal heart rate in one case report. If the medication is administered until delivery, the neonate should be carefully monitored during the first days of life. Animal studies with timolol have shown reproductive toxicity at doses significantly higher than would be used in clinical practice. However Briggs concludes that the benefits of maternal therapy with beta-blockers may, in some cases, outweigh the risks to the foetus and therefore must be judged on a case by case basis. Schaefer concludes that eye drops may generally be used during pregnancy for the appropriate indications and if there are compelling treatment indications they should not be withheld but the dosage kept as low as possible.


    Dorzolamide hydrochloride with timolol maleate eye drops preservative-free are contraindicated during breastfeeding.

    The manufacturer recommends that dorzolamide with timolol eye drops preservative-free is not recommended during breastfeeding.

    At the time of writing there is little published experience concerning the use of dorzolamide and timolol eye drops during breastfeeding. It is not known whether dorzolamide is excreted in human milk. In lactating rats receiving dorzolamide, decreases in the body weight gain of offspring were observed. Timolol is excreted in breast milk, however ophthalmic use should pose little risk to a breastfed infant. Infants exposed to timolol via the breast milk should be closely observed for bradycardia and symptoms of beta-blockade. The long term effects of exposure have not been studied. Schaefer concludes that in general eye drops are compatible with breastfeeding as minimal amounts are absorbed systemically.

    Side Effects

    Abdominal pain
    Atrioventricular block
    Bitter taste
    Blurred vision
    Burning sensation (local)
    Cardiac arrest
    Cerebral ischaemia
    Cerebrovascular accident
    Chest pain
    Choroidal detachment (following filtration surgery)
    Cold extremities
    Congestive cardiac failure
    Contact dermatitis
    Corneal erosion
    Corneal oedema
    Decreased corneal sensitivity
    Dry eyes
    Dry mouth
    Epidermal necrolysis
    Exacerbation of psoriasis
    Eye pain
    Eyelid inflammation
    Eyelid reaction
    Heart block
    Hypersensitivity reactions
    Impaired memory
    Lid margin crusting
    Metabolic acidosis
    Myasthenia gravis-like syndrome
    Myopia (transient)
    Ocular hypotony
    Ocular irritation
    Ocular itching
    Peyronie's disease
    Psoriasiform rash
    Raynaud's phenomenon
    Reddening of eyes
    Reduced libido
    Refractive changes
    Respiratory failure
    Sensation of foreign body in eye
    Sexual disturbances
    Shortness of breath
    Stevens-Johnson syndrome
    Systemic lupus erythematosus
    Throat irritation
    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: January 2019

    Reference Sources

    Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

    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.

    Summary of Product Characteristics: Cosopt Preservative-Free 20mg/ml + 5mg/ml eye drops solution. Santen Oy. Revised December 2017.

    Summary of Product Characteristics: Cosopt iMulti 20mg/ml + 5mg/ml eye drops solution. Santen Oy. Revised May 2018.

    Summary of Product Characteristics: Eylamdo 20mg/ml eye drops solution. Aspire Pharma Ltd. Revised October 2017.

    Summary of Product Characteristics: Vizidor Duo 20 mg/ml + 5 mg/ml eye drops, solution. Bausch & Lomb UK Ltd. Revised January 2021.

    NICE Evidence Services
    Available at:
    Last accessed: 27 July 2021

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