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Sodium fusidate parenteral

Updated 2 Feb 2023 | Fusidic acid

Presentation

Infusion of sodium fusidate

Drugs List

  • sodium fusidate 500mg powder and solvent for solution for infusion
  • Therapeutic Indications

    Uses

    Treatment of staphylococcal infections

    Dosage

    Adults

    Patients weighing more than 50 kg
    500 mg three times daily.

    Patients weighing less than 50 kg
    6 to 7 mg/kg bodyweight three times daily.

    Elderly

    (See Dosage; Adults)

    Children

    Patients weighing more than 50 kg
    500 mg three times daily.

    Patients weighing less than 50 kg
    6 to 7 mg/kg bodyweight three times daily.

    Additional Dosage Information

    See product information for details on reconstitution.

    If additional antibacterial therapy is to be employed, it is recommended that for parenteral administration, separate infusion fluid are to be used.

    Administration

    To be administered intravenously into a wide bore vein with a good blood flow.

    The diluted fluid should be infused via a central venous line over 2 hours. If a superficial vein is employed a more prolonged period of at least 6 hours is advisable.

    Contraindications

    None known

    Precautions and Warnings

    Biliary obstruction
    Biliary tract disorder
    Breastfeeding
    Hepatic impairment
    Jaundice
    Pregnancy

    Contains more than 1 mmol (23 mg) sodium per dose
    Consult national/regional policy on the use of anti-infectives
    Monitor hepatic function in patients with hepatic impairment
    Monitor hepatic function on long term therapy
    Advise patients to report muscle pain/tenderness/weakness
    Discontinue therapy if jaundice develops and persists

    Sodium fusidate must not be co-administered with statins.
    In patients where the use of systemic sodium fusidate is considered essential, statin treatment should be discontinued throughout the duration of sodium fusidate treatment.
    Statin therapy may be reintroduced 7 days after the last dose of sodium fusidate.
    In exceptional circumstances, where prolonged systemic sodium fusidate is needed e.g. for the treatment of severe infections, the need for co-administration of statin and sodium fusidate should only be considered on a case by case basis and under close medical supervision.

    Use other antibiotics which have similar biliary excretion pathway with caution.

    As with all antibiotics, extended or recurrent use may increase the risk of developing antibiotic resistance.

    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
    Anaphylactic reaction
    Anorexia
    Asthenia
    Cardiac arrhythmias
    Cholestasis
    Creatine kinase increased
    Darkening of urine
    Dizziness
    Drowsiness
    Fatigue
    Granulocytopenia
    Haematological disorders
    Headache
    Hyperbilirubinaemia
    Increase in alkaline phosphatase
    Increase of liver transaminases
    Increases in hepatic enzymes
    Jaundice
    Leukopenia
    Malaise
    Muscle pain
    Muscle weakness
    Myoglobinuria
    Neutropenia
    Pancytopenia
    Pruritus
    Rash
    Renal failure
    Rhabdomyolysis
    Thrombocytopenia
    Thrombophlebitis
    Urticaria
    Venous insufficiency

    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: April 2015.

    Reference Sources

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

    Summary of Product Characteristics: Sodium fusidate 500mg for intravenous infusion. Essential Pharma Ltd. Revised February 2015.

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