Drugs List

Therapeutic Indications

Uses

Conjunctivitis - infective

Contraindications

Soft contact lenses

Precautions and Warnings

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
Advise patient to avoid touching the eye/other surfaces with container tip
Soft contact lenses should not be worn during treatment

Pregnancy and Lactation

Pregnancy

The manufacturer has noted that limited clinical data on exposed pregnancies is available. In animal studies and clinical experience with systemic and topical fusidic acid, no teratogenic effects have been seen. There is evidence that when given systemically, fusidic acid can cross the placenta. However, any risk to the foetus is considered unlikely using the very low doses of fusidic acid applied topically in this medication.

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

When given systemically some drug has been detected in breast milk, however the manufacturer reports that no effects on the infant are anticipated during eye drop administration, since the systemic exposure of the breastfeeding woman, and hence the infant, to fusidic acid is negligible.

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

Angioedema
Blurred vision (transient)
Dryness of eyes
Hypersensitivity reactions
Ocular burning
Ocular irritation
Ocular itching
Periorbital oedema
Pruritus
Rash
Smarting
Sore eyes
Stinging (transient)
Transient ocular discomfort
Urticaria
Watering eyes

Presentation

Viscous eye drops containing fusidic acid

Drugs List

Therapeutic Indications

Uses

Conjunctivitis - infective

Dosage

Adults

Elderly

Children

Contraindications

Soft contact lenses

Precautions and Warnings

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
Advise patient to avoid touching the eye/other surfaces with container tip
Soft contact lenses should not be worn during treatment

Pregnancy and Lactation

Pregnancy

The manufacturer has noted that limited clinical data on exposed pregnancies is available. In animal studies and clinical experience with systemic and topical fusidic acid, no teratogenic effects have been seen. There is evidence that when given systemically, fusidic acid can cross the placenta. However, any risk to the foetus is considered unlikely using the very low doses of fusidic acid applied topically in this medication.

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

When given systemically some drug has been detected in breast milk, however the manufacturer reports that no effects on the infant are anticipated during eye drop administration, since the systemic exposure of the breastfeeding woman, and hence the infant, to fusidic acid is negligible.

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

Angioedema
Blurred vision (transient)
Dryness of eyes
Hypersensitivity reactions
Ocular burning
Ocular irritation
Ocular itching
Periorbital oedema
Pruritus
Rash
Smarting
Sore eyes
Stinging (transient)
Transient ocular discomfort
Urticaria
Watering eyes

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.

Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press https://www.medicinescomplete.com [Accessed on 13.08.14].

Paediatric Formulary Committee. BNF for Children (online) London: BMJ Group, Pharmaceutical Press, and RCPCH Publications https://www.medicinescomplete.com [Accessed on 13.08.14].

Summary of Product Characteristics: Fusidic Acid 1% Viscous Eye Drops. Amdipharm UK Limited. Revised April 2014.