Drugs List

Therapeutic Indications

Uses

For use alone or in combination with systemic therapy in the treatment of primary and secondary skin infections caused by sensitive strains of Staphylococcus aureus, Streptococcus spp and Corynebacterium minutissimum.

Primary skin infections include:
Impetigo contagiosa
Superficial folliculitis
Sycosis barbae
Paronychia
Erythrasma

Secondary skin infections include:
Infected eczematoid dermatitis
Infected contact dermatitis
Infected cuts/abrasions

Dosage

Uncovered lesions
Apply gently 3 or 4 times per day.

Covered lesions
Less frequent applications may be more appropriate.

Administration

For topical administration

Precautions and Warnings

Prolonged or repeated administration may increase the risk of contact sensitisation and bacterial resistance.

Pregnancy and Lactation

Pregnancy

Use with caution.

Safety during human pregnancy has not been established, however animal studies and widespread usage for many years have not demonstrated teratogenic effects.
Systemic fusidic acid can penetrate the placental barrier.

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 14-17 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

Use with caution during breastfeeding.

Safety has not been established. When fusidic acid (as the sodium salt) has been given systemically, levels have been detected in breast milk. With topical use the possible amount of drug present is unlikely to affect the infant.

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

Rash
Hypersensitivity reactions
Conjunctivitis
Pruritus
Contact dermatitis
Irritation at application site
Urticaria
Angioedema
Eczema
Periorbital oedema

Presentation

Ointment containing 2% sodium fusidate

Drugs List

Therapeutic Indications

Uses

For use alone or in combination with systemic therapy in the treatment of primary and secondary skin infections caused by sensitive strains of Staphylococcus aureus, Streptococcus spp and Corynebacterium minutissimum.

Primary skin infections include:
Impetigo contagiosa
Superficial folliculitis
Sycosis barbae
Paronychia
Erythrasma

Secondary skin infections include:
Infected eczematoid dermatitis
Infected contact dermatitis
Infected cuts/abrasions

Dosage

Uncovered lesions
Apply gently 3 or 4 times per day.

Covered lesions
Less frequent applications may be more appropriate.

Administration

For topical administration

Precautions and Warnings

Prolonged or repeated administration may increase the risk of contact sensitisation and bacterial resistance.

Pregnancy and Lactation

Pregnancy

Use with caution.

Safety during human pregnancy has not been established, however animal studies and widespread usage for many years have not demonstrated teratogenic effects.
Systemic fusidic acid can penetrate the placental barrier.

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 14-17 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

Use with caution during breastfeeding.

Safety has not been established. When fusidic acid (as the sodium salt) has been given systemically, levels have been detected in breast milk. With topical use the possible amount of drug present is unlikely to affect the infant.

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

Rash
Hypersensitivity reactions
Conjunctivitis
Pruritus
Contact dermatitis
Irritation at application site
Urticaria
Angioedema
Eczema
Periorbital oedema

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 ).

Shelf Life and Storage

No special requirements for storage.

Reference Sources

British National Formulary, 62nd Edition (2011) Pharmaceutical Press, London.

Summary of Product Characteristics: Fucidin Ointment. Leo Laboratories Limited. Revised August 2010.