▶UncommonAppetite decreased.asthenia.headache.
malaise.skin reactions
▶Frequency not knownAgranulocytosis.anaemia.
leucopenia.neutropenia.pancytopenia.renal failure.
rhabdomyolysis.thrombocytopenia
SPECIFIC SIDE-EFFECTS
▶Common or very common
▶With intravenous useVascular pain (reduced if given via
central vein)
▶With oral useDiarrhoea.gastrointestinal discomfort.
nausea.vomiting
SIDE-EFFECTS, FURTHER INFORMATIONElevated liver
enzymes, hyperbilirubinaemia and jaundice can occur with
systemic use—these effects are usually reversible following
withdrawal of therapy.
lPREGNANCY
▶With systemic useNot known to be harmful; manufacturer
advises use only if potential benefit outweighs risk.
lBREAST FEEDING
▶With systemic usePresent in milk—manufacturer advises
caution.
lHEPATIC IMPAIRMENT
▶With systemic useManufacturer advises caution—monitor
liver function periodically during treatment.
lMONITORING REQUIREMENTS
▶With systemic useManufacturer advises monitor liver
function with high doses or on prolonged therapy;
monitoring also advised for patients with biliary tract
obstruction, those taking potentially hepatotoxic
medication, or those taking concurrent medication with a
similar excretion pathway.
lDIRECTIONS FOR ADMINISTRATIONManufacturer advises
for intravenous infusion, give intermittently in Sodium
chloride 0. 9 % or Glucose 5 %; reconstitute each vial with
10 mL buffer solution, then add contents of vial to 500 mL
infusionfluid to give a solution containing approximately
1 mg/mL. Give requisite dose via a central line over 2 hours
(give over at least 6 hours if administered via a large
peripheral vein).
lPRESCRIBING AND DISPENSING INFORMATIONFlavours of
oral liquid formulations may include banana and orange.
lPROFESSION SPECIFIC INFORMATION
Dental practitioners’formulary
May be prescribed as Sodium Fusidate ointment.lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Oral suspension
CAUTIONARY AND ADVISORY LABELS9, 21
▶Fucidin(LEO Pharma)
Fusidic acid 50 mg per 1 mlFucidin 250 mg/ 5 ml oral suspension|
50 mlP£ 6. 73 DT = £ 6. 73
Powder and solvent for solution for infusion
ELECTROLYTES:May contain Sodium
▶Fusidic acid (Non-proprietary)
Sodium fusidate 500 mgSodium fusidate 500 mg powder and
solvent for solution for infusion vials| 1 vialP£ 38. 00
Cream
EXCIPIENTS:May contain Butylated hydroxyanisole, cetostearyl alcohol
(including cetyl and stearyl alcohol)
▶Fusidic acid (Non-proprietary)
Fusidic acid 20 mg per 1 gramFusidic acid 2 % cream|
15 gramP£ 1. 92 DT = £ 1. 46 | 30 gramP£ 5. 00 DT = £ 2. 92
▶Fucidin(LEO Pharma)
Fusidic acid 20 mg per 1 gramFucidin 20 mg/g cream|
15 gramP£ 1. 92 DT = £ 1. 46 | 30 gramP£ 3. 59 DT = £ 2. 92
Ointment
EXCIPIENTS:May contain Cetostearyl alcohol (including cetyl and
stearyl alcohol), woolfat and related substances (including lanolin)
▶Fucidin(LEO Pharma)
Sodium fusidate 20 mg per 1 gramFucidin 20 mg/g ointment|
15 gramP£ 2. 68 DT = £ 2. 68 | 30 gramP£ 4. 55 DT = £ 4. 55Linezolid
lDRUG ACTIONLinezolid, an oxazolidinone antibacterial, is
active against Gram-positive bacteria including meticillin-
resistantStaphylococcus aureus(MRSA), and glycopeptide-
resistant enterococci. Resistance to linezolid can develop
with prolonged treatment or if the dose is less than that
recommended. Linezolid isnotactive against common
Gram-negative organisms; it must be given in combination
with other antibacterials for mixed infections that also
involve Gram-negative organisms.lINDICATIONS AND DOSE
Pneumonia (when other antibacterials e.g. a glycopetide,
such as vancomycin, cannot be used) (initiated under
specialist supervision)|Complicated skin and soft-tissue
infections caused by Gram-positive bacteria, when other
antibacterials cannot be used (initiated under specialist
supervision)
▶BY MOUTH, OR BY INTRAVENOUS INFUSION
▶Neonate up to 7 days: 10 mg/kg every 12 hours, increased
if necessary to 10 mg/kg every 8 hours, increased dose
can be used if poor response.▶Neonate 7 days to 28 days: 10 mg/kg every 8 hours.▶Child 1 month–11 years: 10 mg/kg every 8 hours (max. per
dose 600 mg)
▶Child 12–17 years: 600 mg every 12 hourslUNLICENSED USENot licensed for use in children.IMPORTANT SAFETY INFORMATION
CHM ADVICE (OPTIC NEUROPATHY)
Severe optic neuropathy may occur rarely, particularly if
linezolid is used for longer than 28 days. The CHM
recommends that:
.patients should be warned to report symptoms of
visual impairment (including blurred vision, visual
field defect, changes in visual acuity and colour vision)
immediately;
.patients experiencing new visual symptoms
(regardless of treatment duration) should be evaluated
promptly, and referred to an ophthalmologist if
necessary;
.visual function should be monitored regularly if
treatment is required for longer than 28 days.
BLOOD DISORDERS
Haematopoietic disorders (including thrombocytopenia,
anaemia, leucopenia, and pancytopenia) have been
reported in patients receiving linezolid. It is
recommended that full blood counts are monitored
weekly. Close monitoring is recommended in patients
who:
.receive treatment for more than 10 – 14 days;
.have pre-existing myelosuppression;
.are receiving drugs that may have adverse effects on
haemoglobin, blood counts, or platelet function;
.have severe renal impairment.
If significant myelosuppression occurs, treatment should
be stopped unless it is considered essential, in which
case intensive monitoring of blood counts and
appropriate management should be implemented.lCAUTIONSAcute confusional states.bipolar depression.
carcinoid tumour.phaeochromocytoma.schizophrenia.
thyrotoxicosis.uncontrolled hypertension
CAUTIONS, FURTHER INFORMATION
▶Close observationUnless close observation and blood
pressure monitoring possible, linezolid should be avoided
in uncontrolled hypertension, phaeochromocytoma,358 Bacterial infection BNFC 2018 – 2019
Infection5