Drugs List

Therapeutic Indications

Uses

Postoperative inflammation after cataract surgery

Contraindications

Children under 18 years
Wearing of contact lenses
Third trimester of pregnancy

Precautions and Warnings

Predisposition to haemorrhage
Asthma
Corneal disorder
Dry eyes
First trimester of pregnancy
Ocular infection
Second trimester of pregnancy

May impair healing or mask infection
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
Monitor for, and discontinue in, corneal epithelial breakdown
Not recommended for use longer than 2 weeks
Advise patient to avoid touching the eye/other surfaces with container tip
Discolours soft contact lenses
Not to be used with contact lenses
Remove contact lenses before use and re-insert 15 minutes after use

The CSM have warned, in relation to oral NSAIDs, that any degree of worsening of asthma may be related to the ingestion of NSAIDs.

Pregnancy and Lactation

Pregnancy

Bromfenac is contraindicated in the third trimester of pregnancy.

Use bromfenac with caution in the first and second trimesters of pregnancy.

NSAIDs (given systemically) are often discontinued in women failing to conceive although their role in inhibition of ovulation and in miscarriage is still being debated (Schaefer 2007). Studies have shown an increase in spontaneous abortion with the use of NSAIDs in early pregnancy (Briggs 2008). Discontinue if patient is attempting to become pregnant.

Bromfenac sodium is a prostaglandin synthetase inhibitor and may have the following effects during the 2nd and 3rd trimesters:
- Pulmonary and cardiac toxicity in the foetus (pulmonary hypertension with preterm closing of the ductus arteriosus). The risk exists from the beginning of the 6th month and increases if administration is close to full term.
- Functional renal injury in the foetus. From the 12th week: oligohydramnios (usually reversible after the end of treatment) or anuria (particularly with prolonged exposure). Following birth, renal failure may persist (especially with late and prolonged exposure).
- Inhibition of uterine contractions with delayed onset and prolongation of labour.
- Increased possibility of bleeding in mother and child.
- Increased risk of oedema formation for the mother.

No reports describing bromfenac use during human pregnancy have been found, to date.

In animal studies, doses of 900 times the recommended ophthalmic dose (given orally in rats) caused embryo foetal lethality, increased neonatal mortality and reduced postnatal growth. In rabbits, doses of 7500 times the recommended ophthalmic dose (given orally) caused increased post-implantation loss.

It is not known if bromfenac crosses the placenta, though if present in maternal circulation, its low molecular weight makes this possible. The manufacturer states that systemic exposure is negligible (amount not specified).

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

Bromfenac is considered safe for use in breastfeeding.

The manufacturer of bromfenac sodium eye drops indicates that bromfenac is excreted in rat breast milk (following oral administration of high doses). It is not known if it is excreted in human breast milk. No adverse effects on the infant are anticipated at therapeutic doses and bromfenac eyed drops may be used during breast feeding.

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
Allergic reaction
Anaphylactic reaction
Asthma
Blurred vision
Conjunctival hyperaemia
Corneal disorders
Corneal epithelium defect
Corneal epithelium disorder
Corneal erosion
Corneal infiltrates
Corneal oedema
Corneal or scleral malacia
Corneal perforation
Corneal scar
Corneal ulcer
Cough
Dry eyes
Epistaxis
Eye irritation
Eye pain
Eye pruritus
Eyelid bleeding
Eyelid oedema
Facial swelling
Haemorrhagic retinopathy
Ocular discharge
Ocular discomfort
Photophobia
Reddening of eyes
Reduced visual acuity
Retinal exudates
Runny nose
Tear film composition changes

Presentation

Eye drops containing bromfenac as sodium sesquihydrate (preservative containing)

Drugs List

Therapeutic Indications

Uses

Postoperative inflammation after cataract surgery

Dosage

Adults

Elderly

Contraindications

Children under 18 years
Wearing of contact lenses
Third trimester of pregnancy

Precautions and Warnings

Predisposition to haemorrhage
Asthma
Corneal disorder
Dry eyes
First trimester of pregnancy
Ocular infection
Second trimester of pregnancy

May impair healing or mask infection
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
Monitor for, and discontinue in, corneal epithelial breakdown
Not recommended for use longer than 2 weeks
Advise patient to avoid touching the eye/other surfaces with container tip
Discolours soft contact lenses
Not to be used with contact lenses
Remove contact lenses before use and re-insert 15 minutes after use

The CSM have warned, in relation to oral NSAIDs, that any degree of worsening of asthma may be related to the ingestion of NSAIDs.

Pregnancy and Lactation

Pregnancy

Bromfenac is contraindicated in the third trimester of pregnancy.

Use bromfenac with caution in the first and second trimesters of pregnancy.

NSAIDs (given systemically) are often discontinued in women failing to conceive although their role in inhibition of ovulation and in miscarriage is still being debated (Schaefer 2007). Studies have shown an increase in spontaneous abortion with the use of NSAIDs in early pregnancy (Briggs 2008). Discontinue if patient is attempting to become pregnant.

Bromfenac sodium is a prostaglandin synthetase inhibitor and may have the following effects during the 2nd and 3rd trimesters:
- Pulmonary and cardiac toxicity in the foetus (pulmonary hypertension with preterm closing of the ductus arteriosus). The risk exists from the beginning of the 6th month and increases if administration is close to full term.
- Functional renal injury in the foetus. From the 12th week: oligohydramnios (usually reversible after the end of treatment) or anuria (particularly with prolonged exposure). Following birth, renal failure may persist (especially with late and prolonged exposure).
- Inhibition of uterine contractions with delayed onset and prolongation of labour.
- Increased possibility of bleeding in mother and child.
- Increased risk of oedema formation for the mother.

No reports describing bromfenac use during human pregnancy have been found, to date.

In animal studies, doses of 900 times the recommended ophthalmic dose (given orally in rats) caused embryo foetal lethality, increased neonatal mortality and reduced postnatal growth. In rabbits, doses of 7500 times the recommended ophthalmic dose (given orally) caused increased post-implantation loss.

It is not known if bromfenac crosses the placenta, though if present in maternal circulation, its low molecular weight makes this possible. The manufacturer states that systemic exposure is negligible (amount not specified).

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

Bromfenac is considered safe for use in breastfeeding.

The manufacturer of bromfenac sodium eye drops indicates that bromfenac is excreted in rat breast milk (following oral administration of high doses). It is not known if it is excreted in human breast milk. No adverse effects on the infant are anticipated at therapeutic doses and bromfenac eyed drops may be used during breast feeding.

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
Allergic reaction
Anaphylactic reaction
Asthma
Blurred vision
Conjunctival hyperaemia
Corneal disorders
Corneal epithelium defect
Corneal epithelium disorder
Corneal erosion
Corneal infiltrates
Corneal oedema
Corneal or scleral malacia
Corneal perforation
Corneal scar
Corneal ulcer
Cough
Dry eyes
Epistaxis
Eye irritation
Eye pain
Eye pruritus
Eyelid bleeding
Eyelid oedema
Facial swelling
Haemorrhagic retinopathy
Ocular discharge
Ocular discomfort
Photophobia
Reddening of eyes
Reduced visual acuity
Retinal exudates
Runny nose
Tear film composition changes

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: July 2015

Reference Sources

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.

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Joint Formulary Committee. British National Formulary(online) London: BMJ Group and Pharmaceutical Press. Accessed on 06 July 2015.

Summary of Product Characteristics: Yellox 0.9 mg/ml Eye Drops, Solution. Bausch & Lomb UK Ltd. Revised October 2020.