Drugs List

Therapeutic Indications

Uses

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

Contraindications

Children under 2 years
Breastfeeding
Hyperchloraemic acidosis
Renal impairment - creatinine clearance below 30 ml/minute

Precautions and Warnings

Children aged 2 to 18 years
Wearing of contact lenses
Cerebrovascular insufficiency
Corneal dystrophy
Depression
Diabetes mellitus
Hepatic impairment
History of uncontrolled cardiovascular disorder
Ischaemic heart disease
Postural hypotension
Pregnancy
Raynaud's syndrome
Renal impairment
Severe cardiovascular disorder
Thromboangiitis obliterans

Advise patient blurred vision may affect ability to drive/operate machinery
Contains benzalkonium chloride
In combined therapy, administer eye products at least five minutes apart
To reduce systemic absorption compress lacrimal sac during administration
Discontinue if severe hypersensitivity reactions 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

Pregnancy and Lactation

Pregnancy

Caution is advised in pregnancy.

There are no adequate data from the use of brinzolamide in pregnant women. Studies in animals have shown reproductive toxicity. The potential risk for humans is unknown.

In animal studies, no teratogenic effects were seen, however pre-implantation loss and postnatal growth reduction were seen in rabbits when brimonidine tartrate was present at plasma levels higher than those achieved during human treatment.

Well-controlled epidemiological studies with systemic use of beta-blockers did not indicate malformative effects, but some pharmacological effects such as bradycardia have been observed in foetuses or neonates. When systemic beta-blockers are used in pregnancy, potential effects such as decreased heart rate, hypoglycaemia and respiratory problems in the newborn are to be considered. concerns about Intra-uterine growth restriction have also been raised. Data on a limited number of exposed pregnancies indicate no adverse effects of timolol in eye drops on pregnancy or on the health of the foetus/newborn child but bradycardia and arrhythmia have been reported in one case in the foetus of a woman treated with timolol eye drops.

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

This medication is contraindicated in breastfeeding.

It is not known whether brinzolamide is excreted in human breast milk. Animal studies have shown excretion of brinzolamide in breast milk.

It is not known if brimonidine is excreted in human milk; it is known to be excreted in the milk of lactating rats.

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

Abnormal sensation in eye
Agitation
Alopecia
Amnesia
Angina pectoris
Apathy
Arrhythmias
Asthenopia
Back pain
Blepharitis
Blurred vision (transient)
Bradycardia
Bronchial hyperreactivity
Cardio-respiratory depression
Chest discomfort
Conjunctival blanching
Conjunctival oedema
Conjunctivitis
Contact dermatitis
Corneal deposits
Corneal disorders
Cough
Decreased erythrocyte count
Depression
Diplopia
Dizziness
Dry eyes
Dry mouth
Dryness and irritation of throat
Dysgeusia
Dyspepsia
Dyspnoea
Epistaxis
Erectile dysfunction
Eyelid erythema
Eyelid oedema
Gastro-intestinal disturbances
Headache
Hyperchloraemia
Hypersensitivity reactions
Hypertension
Hypoaesthesia
Hypotension
Increased lacrimation
Insomnia
Keratitis
Maculopapular rash
Madarosis
Meibomianitis
Memory disturbances
Miosis
Motor disturbances
Muscle spasm
Myalgia
Nasal congestion
Nasal dryness
Nasopharyngitis
Nausea
Nervousness
Nightmares
Ocular allergy
Ocular discharge
Ocular discomfort
Ocular hyperaemia
Ocular oedema
Oesophagitis
Oral hypoaesthesia
Oral paraesthesia
Pain
Palpitations
Paraesthesia
Pharyngitis
Pharyngolaryngeal pain
Photophobia
Photopsia
Postnasal drip
Pruritus
Pterygium
Rash
Reduced libido
Reduced visual acuity
Renal pain
Rhinorrhoea
Scleral disorders
Sinusitis
Skin tightness
Sneezing
Somnolence
Subconjunctival cyst
Syncope
Tachycardia
Tinnitus
Upper respiratory tract congestion
Urticaria
Uveitis
Variation in heart rate
Vertigo
Visual disturbances
Vomiting

Presentation

Eye drops containing brinzolamide with brimonidine tartrate

Drugs List

Therapeutic Indications

Uses

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

Dosage

Adults

Elderly

Children

Contraindications

Children under 2 years
Breastfeeding
Hyperchloraemic acidosis
Renal impairment - creatinine clearance below 30 ml/minute

Precautions and Warnings

Children aged 2 to 18 years
Wearing of contact lenses
Cerebrovascular insufficiency
Corneal dystrophy
Depression
Diabetes mellitus
Hepatic impairment
History of uncontrolled cardiovascular disorder
Ischaemic heart disease
Postural hypotension
Pregnancy
Raynaud's syndrome
Renal impairment
Severe cardiovascular disorder
Thromboangiitis obliterans

Advise patient blurred vision may affect ability to drive/operate machinery
Contains benzalkonium chloride
In combined therapy, administer eye products at least five minutes apart
To reduce systemic absorption compress lacrimal sac during administration
Discontinue if severe hypersensitivity reactions 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

Pregnancy and Lactation

Pregnancy

Caution is advised in pregnancy.

There are no adequate data from the use of brinzolamide in pregnant women. Studies in animals have shown reproductive toxicity. The potential risk for humans is unknown.

In animal studies, no teratogenic effects were seen, however pre-implantation loss and postnatal growth reduction were seen in rabbits when brimonidine tartrate was present at plasma levels higher than those achieved during human treatment.

Well-controlled epidemiological studies with systemic use of beta-blockers did not indicate malformative effects, but some pharmacological effects such as bradycardia have been observed in foetuses or neonates. When systemic beta-blockers are used in pregnancy, potential effects such as decreased heart rate, hypoglycaemia and respiratory problems in the newborn are to be considered. concerns about Intra-uterine growth restriction have also been raised. Data on a limited number of exposed pregnancies indicate no adverse effects of timolol in eye drops on pregnancy or on the health of the foetus/newborn child but bradycardia and arrhythmia have been reported in one case in the foetus of a woman treated with timolol eye drops.

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

This medication is contraindicated in breastfeeding.

It is not known whether brinzolamide is excreted in human breast milk. Animal studies have shown excretion of brinzolamide in breast milk.

It is not known if brimonidine is excreted in human milk; it is known to be excreted in the milk of lactating rats.

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

Abnormal sensation in eye
Agitation
Alopecia
Amnesia
Angina pectoris
Apathy
Arrhythmias
Asthenopia
Back pain
Blepharitis
Blurred vision (transient)
Bradycardia
Bronchial hyperreactivity
Cardio-respiratory depression
Chest discomfort
Conjunctival blanching
Conjunctival oedema
Conjunctivitis
Contact dermatitis
Corneal deposits
Corneal disorders
Cough
Decreased erythrocyte count
Depression
Diplopia
Dizziness
Dry eyes
Dry mouth
Dryness and irritation of throat
Dysgeusia
Dyspepsia
Dyspnoea
Epistaxis
Erectile dysfunction
Eyelid erythema
Eyelid oedema
Gastro-intestinal disturbances
Headache
Hyperchloraemia
Hypersensitivity reactions
Hypertension
Hypoaesthesia
Hypotension
Increased lacrimation
Insomnia
Keratitis
Maculopapular rash
Madarosis
Meibomianitis
Memory disturbances
Miosis
Motor disturbances
Muscle spasm
Myalgia
Nasal congestion
Nasal dryness
Nasopharyngitis
Nausea
Nervousness
Nightmares
Ocular allergy
Ocular discharge
Ocular discomfort
Ocular hyperaemia
Ocular oedema
Oesophagitis
Oral hypoaesthesia
Oral paraesthesia
Pain
Palpitations
Paraesthesia
Pharyngitis
Pharyngolaryngeal pain
Photophobia
Photopsia
Postnasal drip
Pruritus
Pterygium
Rash
Reduced libido
Reduced visual acuity
Renal pain
Rhinorrhoea
Scleral disorders
Sinusitis
Skin tightness
Sneezing
Somnolence
Subconjunctival cyst
Syncope
Tachycardia
Tinnitus
Upper respiratory tract congestion
Urticaria
Uveitis
Variation in heart rate
Vertigo
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: September 2014

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.

Medications and Mothers' Milk, 14th Edition (2010) Hale, T. Hale Publishing, Amarillo, Texas.

Joint Formulary Committee. British National Formulary(online) London: BMJ Group and Pharmaceutical Press [Accessed on 23 September 2014].

Paediatric Formulary Committee. BNF for Children (online) London: BMJ Group, Pharmaceutical Press, and RCPCH Publications [Accessed on 23 September 2014].

Summary of Product Characteristics: Simbrinza 10mg/ml + 2mg/ml eye drops, suspension. Alcon Laboratories (U.K.) Ltd. Authorised July 2014.