high-dose regimen in severe infection suspected or
known to be caused by less sensitive organismslCAUTIONS
▶With intravenous useCardiac insufficiency.
hyperaldosteronism.hypernatraemia.hypertension.
pulmonary oedema
lSIDE-EFFECTS
GENERAL SIDE-EFFECTS
▶Common or very commonAbdominal pain.antibiotic
associated colitis.diarrhoea.headache.nausea.vomiting
▶UncommonSkin reactions
SPECIFIC SIDE-EFFECTS
▶Common or very common
▶With oral useDizziness.vulvovaginal infection
▶Uncommon
▶With parenteral useAppetite decreased.dyspnoea.
electrolyte imbalance.fatigue.oedema.taste altered.
vertigo
▶Rare or very rare
▶With parenteral useBone marrow disorders.eosinophilia.
hepatic disorders.visual impairment
▶Frequency not known
▶With parenteral useAgranulocytosis.asthmatic attack.
confusion.leucopenia.neutropenia.pseudomembranous
enterocolitis.tachycardia.thrombocytopenia
lPREGNANCYManufacturer advises use only if potential
benefit outweighs risk.
lBREAST FEEDINGManufacturer advises use only if
potential benefit outweighs risk—present in milk.
lRENAL IMPAIRMENT
▶With oral useAvoidoraltreatment if estimated glomerular
filtration rate less than 10 mL/minute/ 1. 73 m^2.
▶With intravenous useAge under 12 years (body-weight under
40 kg)—no information available. Age 12 – 18 years (body-
weight over 40 kg)—use with caution if estimated
glomerularfiltration rate 40 – 80 mL/minute/ 1. 73 m
2
, and
consult product literature for dose if estimated glomerular
filtration rate less than 40 mL/minute/ 1. 73 m^2.lMONITORING REQUIREMENTS
▶With intravenous useMonitor electrolytes andfluid balance.
lDIRECTIONS FOR ADMINISTRATION
▶With intravenous useDisplacement value may be significant
when reconstituting injection, consult local guidelines.
Reconstitute each 2 -g vial with 50 mL Glucose 5 %or
Glucose 10 %orWater for Injections; do not exceed
infusion rate of 133 mg/minute.
▶With oral useManufacturer advises granules should be
taken on an empty stomach (about 2 – 3 hours before or
after a meal), preferably before bedtime and after
emptying the bladder. The granules should be dissolved
into a glass of water and taken immediately.
lPRESCRIBING AND DISPENSING INFORMATIONDoses
expressed as fosfomycin base.
lNATIONAL FUNDING/ACCESS DECISIONS
Scottish Medicines Consortium (SMC) Decisions
TheScottish Medicines Consortiumhas advised (February
2015 ) that fosfomycin (Fomicyt®) is accepted for restricted
use within NHS Scotland; initiation should be restricted to
microbiologists or infectious disease specialists.
TheScottish Medicines Consortiumhas advised
(September 2016 ) that fosfomycin trometamol (Monuril®)
is accepted for use within NHS Scotland for the treatment
of acute lower uncomplicated urinary tract infections,
caused by pathogens sensitive to fosfomycin in adult and
adolescent females and for prophylaxis in diagnostic and
surgical transurethral procedures.lMEDICINAL FORMS
There can be variation in the licensing of different medicines
containing the same drug.
Powder for solution for infusion
ELECTROLYTES:May contain Sodium
▶Fomicyt(Nordic Pharma Ltd)
Fosfomycin (as Fosfomycin sodium) 2 gramFomicyt 2 g powder for
solution for infusion vials| 10 vialP£ 150. 00
Fosfomycin (as Fosfomycin sodium) 4 gramFomicyt 4 g powder for
solution for infusion vials| 10 vialP£ 300. 00
Granules
CAUTIONARY AND ADVISORY LABELS9, 13, 23
EXCIPIENTS:May contain Sucrose
▶Fosfomycin (Non-proprietary)
Fosfomycin (as Fosfomycin trometamol) 3 gramFosfomycin 3 g
granules sachets| 1 sachetP£ 75. 45 DT = £ 4. 86
▶Monuril(Zambon S.p.A.)
Fosfomycin (as Fosfomycin trometamol) 3 gramMonuril 3 g
granules sachets| 1 sachetP£ 4. 86 DT = £ 4. 86Fusidic acid 16-Jun-2017
lDRUG ACTIONFusidic acid and its salts are narrow-
spectrum antibiotics used for staphylococcal infections.lINDICATIONS AND DOSE
Staphylococcal skin infection
▶BY MOUTH USING TABLETS
▶Child 12–17 years: 250 mg every 12 hours for 5 - 10 days,
dose expressed as sodium fusidate
▶TO THE SKIN
▶Child:Apply 3 – 4 times a day usually for 7 days
Penicillin-resistant staphylococcal infection including
osteomyelitis|Staphylococcal endocarditis in
combination with other antibacterials
▶BY MOUTH USING ORAL SUSPENSION
▶Neonate: 15 mg/kg 3 times a day.▶Child 1–11 months: 15 mg/kg 3 times a day
▶Child 1–4 years: 250 mg 3 times a day
▶Child 5–11 years: 500 mg 3 times a day
▶Child 12–17 years: 750 mg 3 times a day
▶BY MOUTH USING TABLETS
▶Child 12–17 years: 500 mg every 8 hours, increased to 1 g
every 8 hours, increased dose can be used for severe
infections, dose expressed as sodium fusidate
Staphylococcal infections due to susceptible organisms
▶BY INTRAVENOUS INFUSION
▶Child (body-weight up to 50 kg): 6 – 7 mg/kg 3 times a day,
dose expressed as sodium fusidate
▶Child (body-weight 50 kg and above): 500 mg 3 times a
day, dose expressed as sodium fusidate
DOSE EQUIVALENCE AND CONVERSION
▶Fusidic acid is incompletely absorbed and doses
recommended for suspension are proportionately
higher than those for sodium fusidate tablets.lCAUTIONS
▶With systemic useImpaired transport and metabolism of
bilirubin
▶With topical useAvoid contact of cream or ointment with
eyes
CAUTIONS, FURTHER INFORMATION
▶Avoiding resistanceTo avoid the development of resistance,
fusidic acid should not be used for longer than 10 days and
local microbiology advice should be sought before using it
in hospital.
lINTERACTIONS→Appendix 1 : fusidic acid
lSIDE-EFFECTS
GENERAL SIDE-EFFECTS
▶Common or very commonDizziness.drowsiness.hepatic
disorders.hyperbilirubinaemiaBNFC 2018 – 2019 Bacterial infection 357
Infection5