Drugs List

Therapeutic Indications

Uses

Eye infection - topical treatment

Contraindications

Children under 1 year
Wearing of contact lenses
Breastfeeding
Pregnancy

Precautions and Warnings

Corneal damage
Dry eyes

Advise patient blurred vision may affect ability to drive/operate machinery
Contains benzalkonium chloride
To reduce systemic absorption compress lacrimal sac during administration
Monitor patients on prolonged therapy
Prolonged use may result in superinfection with non-susceptible organisms
Discontinue treatment if any infection worsens
Discontinue treatment if skin rash or other allergic reaction occurs
Length of treatment should not exceed 10 days
Advise patient not to use for 5 mins after applying any other ocular agent
Advise patient to avoid exposure to sunlight and UV rays during treatment
Advise patient to avoid touching the eye/other surfaces with container tip
Contact lenses should not be worn during treatment
Discolours soft contact lenses
Remove contact lenses before use and re-insert 15 minutes after use

Pregnancy and Lactation

Pregnancy

UK licensed product information recommends that ofloxacin eye drops should not be used during pregnancy. There is limited data on the use of quinolone antibiotic eye drops during pregnancy.

Quinolones have a high affinity for cartilage and bone tissue, this affinity is highest in immature cartilage. Ofloxacin is known to cross the placenta. Systemic quinolones have been shown to cause arthropathy in several animal species after administration in-utero and to immature animals. The use of systemic quinolones during human pregnancy has not been associated with an increase in the risk of major congenital malformations. A casual relationship with some of the birth defects noted in case studies cannot be excluded. In view of this and the known adverse effects in animals, fluoroquinolones should be avoided during pregnancy wherever possible, but if compellingly indicated, ciprofloxacin has a relatively large documented experience. Schaefer concludes that even first trimester exposure to systemic treatment is not an indication for termination of pregnancy but recommends offering detailed foetal ultrasonography.

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

UK licensed product information recommends that ofloxacin should not be used during breastfeeding and when use is judged essential, the manufacturers advise discontinuation of breast feeding whilst on therapy.

There is limited data on the use of quinolone antibiotic eye drops during breastfeeding. Ofloxacin is secreted in milk. Systemic ofloxacin has not been routinely used in children because of concern about arthropathy noted in the joints of young animals. Systemic quinolones should not routinely be used during breastfeeding where an antibiotic with a lower risk profile can be chosen. Most authorities consider that when treatment of a complicated infection necessitates use, a quinolone, preferably ciprofloxacin (for which there is the greatest experience), may be chosen.

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

Anaphylactic reaction
Anaphylactic shock
Angioedema
Blurred vision (transient)
Conjunctivitis
Dizziness
Dry eyes
Dyspnoea
Eyelid pruritus
Facial oedema
Hypersensitivity reactions
Increased lacrimation
Keratitis
Nausea
Ocular hyperaemia
Ocular irritation
Ocular oedema
Ocular pain
Ocular pruritus
Oropharyngeal swelling
Periorbital oedema
Photophobia
Photosensitivity
Sensation of foreign body in eye
Stevens-Johnson syndrome
Tongue swelling
Torsades de pointes
Toxic epidermal necrolysis
Transient ocular discomfort
Ventricular arrhythmias

Presentation

Ophthalmic solution containing ofloxacin

Drugs List

Therapeutic Indications

Uses

Eye infection - topical treatment

Dosage

Adults

Elderly

Children

Neonates

Contraindications

Children under 1 year
Wearing of contact lenses
Breastfeeding
Pregnancy

Precautions and Warnings

Corneal damage
Dry eyes

Advise patient blurred vision may affect ability to drive/operate machinery
Contains benzalkonium chloride
To reduce systemic absorption compress lacrimal sac during administration
Monitor patients on prolonged therapy
Prolonged use may result in superinfection with non-susceptible organisms
Discontinue treatment if any infection worsens
Discontinue treatment if skin rash or other allergic reaction occurs
Length of treatment should not exceed 10 days
Advise patient not to use for 5 mins after applying any other ocular agent
Advise patient to avoid exposure to sunlight and UV rays during treatment
Advise patient to avoid touching the eye/other surfaces with container tip
Contact lenses should not be worn during treatment
Discolours soft contact lenses
Remove contact lenses before use and re-insert 15 minutes after use

Pregnancy and Lactation

Pregnancy

UK licensed product information recommends that ofloxacin eye drops should not be used during pregnancy. There is limited data on the use of quinolone antibiotic eye drops during pregnancy.

Quinolones have a high affinity for cartilage and bone tissue, this affinity is highest in immature cartilage. Ofloxacin is known to cross the placenta. Systemic quinolones have been shown to cause arthropathy in several animal species after administration in-utero and to immature animals. The use of systemic quinolones during human pregnancy has not been associated with an increase in the risk of major congenital malformations. A casual relationship with some of the birth defects noted in case studies cannot be excluded. In view of this and the known adverse effects in animals, fluoroquinolones should be avoided during pregnancy wherever possible, but if compellingly indicated, ciprofloxacin has a relatively large documented experience. Schaefer concludes that even first trimester exposure to systemic treatment is not an indication for termination of pregnancy but recommends offering detailed foetal ultrasonography.

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

UK licensed product information recommends that ofloxacin should not be used during breastfeeding and when use is judged essential, the manufacturers advise discontinuation of breast feeding whilst on therapy.

There is limited data on the use of quinolone antibiotic eye drops during breastfeeding. Ofloxacin is secreted in milk. Systemic ofloxacin has not been routinely used in children because of concern about arthropathy noted in the joints of young animals. Systemic quinolones should not routinely be used during breastfeeding where an antibiotic with a lower risk profile can be chosen. Most authorities consider that when treatment of a complicated infection necessitates use, a quinolone, preferably ciprofloxacin (for which there is the greatest experience), may be chosen.

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

Anaphylactic reaction
Anaphylactic shock
Angioedema
Blurred vision (transient)
Conjunctivitis
Dizziness
Dry eyes
Dyspnoea
Eyelid pruritus
Facial oedema
Hypersensitivity reactions
Increased lacrimation
Keratitis
Nausea
Ocular hyperaemia
Ocular irritation
Ocular oedema
Ocular pain
Ocular pruritus
Oropharyngeal swelling
Periorbital oedema
Photophobia
Photosensitivity
Sensation of foreign body in eye
Stevens-Johnson syndrome
Tongue swelling
Torsades de pointes
Toxic epidermal necrolysis
Transient ocular discomfort
Ventricular arrhythmias

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: August 2013.

Reference Sources

British National Formulary, 65th Edition (March - September 2013) Pharmaceutical Press, London.

BNF for Children (2013-2014) Pharmaceutical Press, London.

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.

Paediatric Formulary Committee. BNF for Children (online) London: BMJ Group, Pharmaceutical Press, and RCPCH Publications [Accessed on 16.10.13].

Summary of Product Characteristics: Exocin 3mg/ml eye drops solution. Allergan Ltd. Revised September 2020.