Drugs List

Therapeutic Indications

Uses

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

Contraindications

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

Precautions and Warnings

Atopy
Children under 18 years
History of allergies including anaphylaxis
Soft contact lenses
Cardiac disorder
Chronic corneal disorder
Chronic obstructive pulmonary disease
First degree atrioventricular block
Hepatic impairment
History of intra-ocular surgery
Hyperthyroidism
Hypoglycaemia
Hypotension
Myasthenia gravis
Narrow angle glaucoma
Peripheral vascular disease
Prinzmetal's angina
Uncontrolled diabetes mellitus

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 exacerbate myasthenia gravis
May mask symptoms of hyperthyroidism
Advise patient blurred vision may affect ability to drive/operate machinery
Contains benzalkonium chloride
Administer other ophthalmic products at least 10 minutes apart
To reduce systemic absorption compress lacrimal sac during administration
Monitor patients on prolonged therapy
Monitor patients with cardiovascular conditions
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
If soft contact lenses worn,insert them 15 minutes after using eye drops

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.

Therapy with oral carbonic anhydrase inhibitors has been associated with urolithiasis as a result of acid-base disturbances, especially in patients with a prior history of renal calculi. Patients with a prior history of renal calculi may be at increased risk of urolithiasis whilst using this medication.

Pregnancy and Lactation

Pregnancy

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

Use of dorzolamide hydrochloride with timolol maleate during pregnancy is contraindicated by the manufacturer.

At the time of writing there is limited published information 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.

Lactation

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

Use of dorzolamide hydrochloride with timolol maleate is contraindicated by the manufacturer. The manufacturer advises that breastfeeding is not recommended if treatment with this medication is required.

At the time of writing there is little published information 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
Alopecia
Anaphylaxis
Angioedema
Arrhythmias
Asthenia
Atrioventricular block
Bitter taste
Blepharitis
Blurred vision
Bradycardia
Bronchospasm
Burning sensation (local)
Cardiac arrest
Cardiac failure
Cerebral ischaemia
Cerebrovascular accident
Chest pain
Choroidal detachment (following filtration surgery)
Claudication
Cold extremities
Congestive cardiac failure
Conjunctivitis
Contact dermatitis
Corneal erosion
Corneal oedema
Cough
Decreased corneal sensitivity
Depression
Diarrhoea
Diplopia
Dizziness
Dry eyes
Dry mouth
Dyspepsia
Dyspnoea
Epistaxis
Exacerbation of psoriasis
Eye pain
Eyelid inflammation
Eyelid reaction
Fatigue
Hallucinations
Headache
Heart block
Hypersensitivity reactions
Hypoglycaemia
Hypotension
Impaired memory
Insomnia
Iridocyclitis
Keratitis
Lid margin crusting
Metabolic acidosis
Myasthenia gravis-like syndrome
Myopia (transient)
Nausea
Nightmares
Ocular hypotony
Ocular irritation
Ocular itching
Oedema
Palpitations
Paraesthesia
Peyronie's disease
Pruritus
Psoriasiform rash
Ptosis
Rash
Raynaud's phenomenon
Reddening of eyes
Reduced libido
Refractive changes
Respiratory failure
Rhinitis
Shortness of breath
Sinusitis
Stevens-Johnson syndrome
Stinging
Syncope
Systemic lupus erythematosus
Taste disturbances
Tearing
Throat irritation
Tinnitus
Toxic epidermal necrolysis
Urolithiasis
Urticaria
Visual disturbances
Vomiting

Presentation

Eye drops containing dorzolamide hydrochloride and timolol maleate (preservative containing).

Drugs List

Therapeutic Indications

Uses

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

Dosage

Adults

Children

Contraindications

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

Precautions and Warnings

Atopy
Children under 18 years
History of allergies including anaphylaxis
Soft contact lenses
Cardiac disorder
Chronic corneal disorder
Chronic obstructive pulmonary disease
First degree atrioventricular block
Hepatic impairment
History of intra-ocular surgery
Hyperthyroidism
Hypoglycaemia
Hypotension
Myasthenia gravis
Narrow angle glaucoma
Peripheral vascular disease
Prinzmetal's angina
Uncontrolled diabetes mellitus

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 exacerbate myasthenia gravis
May mask symptoms of hyperthyroidism
Advise patient blurred vision may affect ability to drive/operate machinery
Contains benzalkonium chloride
Administer other ophthalmic products at least 10 minutes apart
To reduce systemic absorption compress lacrimal sac during administration
Monitor patients on prolonged therapy
Monitor patients with cardiovascular conditions
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
If soft contact lenses worn,insert them 15 minutes after using eye drops

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.

Therapy with oral carbonic anhydrase inhibitors has been associated with urolithiasis as a result of acid-base disturbances, especially in patients with a prior history of renal calculi. Patients with a prior history of renal calculi may be at increased risk of urolithiasis whilst using this medication.

Pregnancy and Lactation

Pregnancy

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

Use of dorzolamide hydrochloride with timolol maleate during pregnancy is contraindicated by the manufacturer.

At the time of writing there is limited published information 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.

Lactation

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

Use of dorzolamide hydrochloride with timolol maleate is contraindicated by the manufacturer. The manufacturer advises that breastfeeding is not recommended if treatment with this medication is required.

At the time of writing there is little published information 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
Alopecia
Anaphylaxis
Angioedema
Arrhythmias
Asthenia
Atrioventricular block
Bitter taste
Blepharitis
Blurred vision
Bradycardia
Bronchospasm
Burning sensation (local)
Cardiac arrest
Cardiac failure
Cerebral ischaemia
Cerebrovascular accident
Chest pain
Choroidal detachment (following filtration surgery)
Claudication
Cold extremities
Congestive cardiac failure
Conjunctivitis
Contact dermatitis
Corneal erosion
Corneal oedema
Cough
Decreased corneal sensitivity
Depression
Diarrhoea
Diplopia
Dizziness
Dry eyes
Dry mouth
Dyspepsia
Dyspnoea
Epistaxis
Exacerbation of psoriasis
Eye pain
Eyelid inflammation
Eyelid reaction
Fatigue
Hallucinations
Headache
Heart block
Hypersensitivity reactions
Hypoglycaemia
Hypotension
Impaired memory
Insomnia
Iridocyclitis
Keratitis
Lid margin crusting
Metabolic acidosis
Myasthenia gravis-like syndrome
Myopia (transient)
Nausea
Nightmares
Ocular hypotony
Ocular irritation
Ocular itching
Oedema
Palpitations
Paraesthesia
Peyronie's disease
Pruritus
Psoriasiform rash
Ptosis
Rash
Raynaud's phenomenon
Reddening of eyes
Reduced libido
Refractive changes
Respiratory failure
Rhinitis
Shortness of breath
Sinusitis
Stevens-Johnson syndrome
Stinging
Syncope
Systemic lupus erythematosus
Taste disturbances
Tearing
Throat irritation
Tinnitus
Toxic epidermal necrolysis
Urolithiasis
Urticaria
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: 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 20mg/ml + 5mg/ml eye drops solution. Santen Oy. Revised June 2018.

Summary of Product Characteristics: Tidomat 20mg/ml + 5mg/ml eye drops solution. Kent Pharma (UK) Ltd. Revised February 2020.

NICE - Evidence Services
Available at: www.nice.org.uk
Last accessed: 09 September 2022.