Drugs List

Therapeutic Indications

Uses

Corneal ulcers Conjunctivitis - infective Blepharitis - infective

Contraindications

Ophthalmic Solution
Soft contact lenses

Eye Ointment
Children under 1 year Wearing of contact lenses

Precautions and Warnings

Pregnancy Breastfeeding
Discontinue treatment if skin rash or other allergic reaction occurs If blurred vision occurs, advise patient not to drive or operate machinery Prolonged use may result in superinfection with non-susceptible organisms Warn patient to report symptoms of allergic type hypersensitivity In combined therapy, administer eye products at least five minutes apart To reduce systemic absorption compress lacrimal sac during administration Advise patient to avoid touching the eye/other surfaces with container tip

Ophthalmic Solution Children under 1 year Contains benzalkonium chloride. Not to be used with soft contact lenses

Eye Ointment
Contact lenses should not be worn during treatment

Pregnancy and Lactation

Pregnancy

UK licensed product information recommends that ciprofloxacin ophthalmic preparations should be used with caution in pregnancy and only if clearly necessary. There is a lack of clinical data regarding the use of the ophthalmic preparations during pregnancy. Pharmacokinetic studies observing systemic absorption following administration of the eye drops showed plasma levels 450 -fold lower than after oral administration of a 250 mg dose. No studies on systemic absorption from the ointment are available.

Ciprofloxacin has been shown to cause arthropathy in several animal species after administration in-utero and to immature animals. Animal reproduction studies using oral and parenteral administration did not reveal any evidence of teratogenicity or impairment of fertility.

The use of systemic ciprofloxacin during human pregnancy has not been associated with an increase in the risk of major congenital malformations. A causal 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 ciprofloxacin 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 ciprofloxacin should be used with caution during breastfeeding.

Excretion of ciprofloxacin into human milk following ophthalmic administration has not been investigated. Pharmacokinetic studies observing systemic absorption following administration of the eye drops showed plasma levels 450 -fold lower than oral administration of a 250 mg dose. No studies on systemic absorption from the ointment are available The dose available to be presented to a nursing infant is expected to be low. One authority concludes that maternal use of an eye or ear drops containing ciprofloxacin presents a negligible risk to the nursing infant (LactMed).

Ciprofloxacin, when taken orally is secreted in milk. Ciprofloxacin has not been routinely used in children because of concern about arthropathy noted in the joints of young animals. Most authorities consider that ciprofloxacin is usually compatible with breastfeeding. Systemic quinolones should not routinely be used during breastfeeding where an antibiotic with a lower risk profile can be chosen. When essential, drug exposure to the infant may be minimised by avoiding feeding for 4 hours after each dose. There has been one case reported of pseudomembranous colitis in a 2 month old infant attributed to maternal use of oral ciprofloxacin during breastfeeding. Any infants exposed during feeding should be monitored.

To substantially diminish the amount of drug that reaches the breastmilk after using eye drops, place pressure over the tear duct by the corner of the eye for 1 minute or more, then remove the excess solution with an absorbent tissue.

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

Burning and stinging of the eyes Ocular discomfort Itching sensation (local) Sensation of foreign body in eye Lid margin crusting Taste disturbances Corneal staining Keratitis Eyelid oedema Photophobia Corneal microdeposits (reversible) Nausea Visual disturbances Blurred vision Hypersensitivity reactions Stinging (transient) Conjunctival hyperaemia Pruritus Eye pain Dermatitis Lacrimation Rash Toxic epidermal necrolysis Exfoliative dermatitis Stevens-Johnson syndrome Urticaria Keratopathy

Presentation

Eye drops containing ciprofloxacin (preservative containing).

Drugs List

Therapeutic Indications

Uses

Corneal ulcers Conjunctivitis - infective Blepharitis - infective

Dosage

Adults

Children

Contraindications

Ophthalmic Solution
Soft contact lenses

Eye Ointment
Children under 1 year Wearing of contact lenses

Precautions and Warnings

Pregnancy Breastfeeding
Discontinue treatment if skin rash or other allergic reaction occurs If blurred vision occurs, advise patient not to drive or operate machinery Prolonged use may result in superinfection with non-susceptible organisms Warn patient to report symptoms of allergic type hypersensitivity In combined therapy, administer eye products at least five minutes apart To reduce systemic absorption compress lacrimal sac during administration Advise patient to avoid touching the eye/other surfaces with container tip

Ophthalmic Solution Children under 1 year Contains benzalkonium chloride. Not to be used with soft contact lenses

Eye Ointment
Contact lenses should not be worn during treatment

Pregnancy and Lactation

Pregnancy

UK licensed product information recommends that ciprofloxacin ophthalmic preparations should be used with caution in pregnancy and only if clearly necessary. There is a lack of clinical data regarding the use of the ophthalmic preparations during pregnancy. Pharmacokinetic studies observing systemic absorption following administration of the eye drops showed plasma levels 450 -fold lower than after oral administration of a 250 mg dose. No studies on systemic absorption from the ointment are available.

Ciprofloxacin has been shown to cause arthropathy in several animal species after administration in-utero and to immature animals. Animal reproduction studies using oral and parenteral administration did not reveal any evidence of teratogenicity or impairment of fertility.

The use of systemic ciprofloxacin during human pregnancy has not been associated with an increase in the risk of major congenital malformations. A causal 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 ciprofloxacin 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 ciprofloxacin should be used with caution during breastfeeding.

Excretion of ciprofloxacin into human milk following ophthalmic administration has not been investigated. Pharmacokinetic studies observing systemic absorption following administration of the eye drops showed plasma levels 450 -fold lower than oral administration of a 250 mg dose. No studies on systemic absorption from the ointment are available The dose available to be presented to a nursing infant is expected to be low. One authority concludes that maternal use of an eye or ear drops containing ciprofloxacin presents a negligible risk to the nursing infant (LactMed).

Ciprofloxacin, when taken orally is secreted in milk. Ciprofloxacin has not been routinely used in children because of concern about arthropathy noted in the joints of young animals. Most authorities consider that ciprofloxacin is usually compatible with breastfeeding. Systemic quinolones should not routinely be used during breastfeeding where an antibiotic with a lower risk profile can be chosen. When essential, drug exposure to the infant may be minimised by avoiding feeding for 4 hours after each dose. There has been one case reported of pseudomembranous colitis in a 2 month old infant attributed to maternal use of oral ciprofloxacin during breastfeeding. Any infants exposed during feeding should be monitored.

To substantially diminish the amount of drug that reaches the breastmilk after using eye drops, place pressure over the tear duct by the corner of the eye for 1 minute or more, then remove the excess solution with an absorbent tissue.

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

Burning and stinging of the eyes Ocular discomfort Itching sensation (local) Sensation of foreign body in eye Lid margin crusting Taste disturbances Corneal staining Keratitis Eyelid oedema Photophobia Corneal microdeposits (reversible) Nausea Visual disturbances Blurred vision Hypersensitivity reactions Stinging (transient) Conjunctival hyperaemia Pruritus Eye pain Dermatitis Lacrimation Rash Toxic epidermal necrolysis Exfoliative dermatitis Stevens-Johnson syndrome Urticaria Keratopathy

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 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.

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.

Summary of Product Characteristics: Ciloxan 0.3% w/v eye drops, solution. Novartis Phamaceuticals UK Ltd. Revised May 2017.

UK Drugs in Lactation Advisory Service.
Available at: https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1
Last accessed: August 14, 2014

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Ciprofloxacin Last revised: September 7, 2013
Last accessed: August 14, 2014