Drugs List

Therapeutic Indications

Uses

Treatment of staphylococcal infections

Treatment of all staphylococcal infections due to susceptible organisms such as; cutaneous infections, osteomyelitis, pneumonia, septicaemia, wound infections, endocarditis, superinfected cystic fibrosis.

Contraindications

Children under 12 years
Galactosaemia

Precautions and Warnings

Children aged 12 to 18 years
Biliary obstruction
Biliary tract disorder
Breastfeeding
Glucose-galactose malabsorption syndrome
Hepatic impairment
Jaundice
Lactose intolerance
Pregnancy

Consult national/regional policy on the use of anti-infectives
Contains lactose
Monitor hepatic function in patients on high oral doses
Monitor hepatic function in patients with hepatic impairment
Monitor hepatic function on long term therapy
Discontinue therapy if jaundice develops and persists
Discontinue and do not restart if severe cutaneous adverse reactions occur

Bacterial resistance has been reported to occur with the use of fusidic acid. As with all antibiotics, extended or recurrent use may increase the risk of developing resistance.

Serious cutaneous reactions such as drug reaction with eosinophilia and systemic symptoms syndrome (DRESS), toxic epidermal necrolysis and Steven-Johnson syndrome have occurred with systemic sodium fusidate treatment. Patients should monitor for signs and symptoms of serious cutaneous reactions, which usually occur in first week of therapy.

Permanently discontinue if systemic sodium fusidate serious cutaneous reactions occur.

Pregnancy and Lactation

Pregnancy

Sodium fusidate should be used with caution in pregnancy.

Sodium fusidate may only be used during pregnancy if the potential benefits outweigh the potential risks to the foetus.

At the time of writing there was inadequate evidence regarding use during human pregnancy. Animal studies plus many years of clinical experience suggest that there are no teratogenic effects. Fusidic acid is believed to cross the placental barrier when fusidic acid is administered systemically.

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

Sodium fusidate should be used with caution in breastfeeding.

Safety has not been established, although levels have been detected in breast milk when fusidic acid (as the sodium salt) has been administered systemically.

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

Acute renal failure
Agranulocytosis
Allergic reaction
Anaemia
Anaphylaxis
Bone marrow depression
Decreased erythrocyte count
Drug rash with eosinophilia and systemic symptoms (DRESS)
Gastro-intestinal disturbances
Granulocytopenia
Haematological disorders
Jaundice (reversible)
Nausea
Neutropenia
Pancytopenia
Rash
Reduced platelet count
Rhabdomyolysis
Stevens-Johnson syndrome
Thrombocytopenia
Toxic epidermal necrolysis
Vomiting

Presentation

Oral formulation of sodium fusidate.

Drugs List

Therapeutic Indications

Uses

Treatment of staphylococcal infections

Treatment of all staphylococcal infections due to susceptible organisms such as; cutaneous infections, osteomyelitis, pneumonia, septicaemia, wound infections, endocarditis, superinfected cystic fibrosis.

Dosage

Adults

Children

Contraindications

Children under 12 years
Galactosaemia

Precautions and Warnings

Children aged 12 to 18 years
Biliary obstruction
Biliary tract disorder
Breastfeeding
Glucose-galactose malabsorption syndrome
Hepatic impairment
Jaundice
Lactose intolerance
Pregnancy

Consult national/regional policy on the use of anti-infectives
Contains lactose
Monitor hepatic function in patients on high oral doses
Monitor hepatic function in patients with hepatic impairment
Monitor hepatic function on long term therapy
Discontinue therapy if jaundice develops and persists
Discontinue and do not restart if severe cutaneous adverse reactions occur

Bacterial resistance has been reported to occur with the use of fusidic acid. As with all antibiotics, extended or recurrent use may increase the risk of developing resistance.

Serious cutaneous reactions such as drug reaction with eosinophilia and systemic symptoms syndrome (DRESS), toxic epidermal necrolysis and Steven-Johnson syndrome have occurred with systemic sodium fusidate treatment. Patients should monitor for signs and symptoms of serious cutaneous reactions, which usually occur in first week of therapy.

Permanently discontinue if systemic sodium fusidate serious cutaneous reactions occur.

Pregnancy and Lactation

Pregnancy

Sodium fusidate should be used with caution in pregnancy.

Sodium fusidate may only be used during pregnancy if the potential benefits outweigh the potential risks to the foetus.

At the time of writing there was inadequate evidence regarding use during human pregnancy. Animal studies plus many years of clinical experience suggest that there are no teratogenic effects. Fusidic acid is believed to cross the placental barrier when fusidic acid is administered systemically.

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

Sodium fusidate should be used with caution in breastfeeding.

Safety has not been established, although levels have been detected in breast milk when fusidic acid (as the sodium salt) has been administered systemically.

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

Acute renal failure
Agranulocytosis
Allergic reaction
Anaemia
Anaphylaxis
Bone marrow depression
Decreased erythrocyte count
Drug rash with eosinophilia and systemic symptoms (DRESS)
Gastro-intestinal disturbances
Granulocytopenia
Haematological disorders
Jaundice (reversible)
Nausea
Neutropenia
Pancytopenia
Rash
Reduced platelet count
Rhabdomyolysis
Stevens-Johnson syndrome
Thrombocytopenia
Toxic epidermal necrolysis
Vomiting

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 2014

Reference Sources

Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.

Summary of Product Characteristics: Fucidin tablets. Leo Laboratories Ltd. Revised August 2018.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 05 September 2017