Powder for solution for injection
ELECTROLYTES:May contain Sodium
▶Co-fluampicil (Non-proprietary)
Ampicillin (as Ampicillin sodium) 250 mg, Flucloxacillin (as
Flucloxacillin sodium) 250 mgCo-fluampicil 250 mg/ 250 mg powder
for solution for injection vials| 10 vialP£ 13. 33
Capsule
CAUTIONARY AND ADVISORY LABELS9, 22
▶Co-fluampicil (Non-proprietary)
Ampicillin (as Ampicillin trihydrate) 250 mg, Flucloxacillin (as
Flucloxacillin sodium) 250 mgCo-fluampicil 250 mg/ 250 mg
capsules| 28 capsuleP£ 2. 27 DT = £ 1. 97 | 100 capsuleP
£ 8. 11
ANTIBACTERIALS›PENICILLINS,
BROAD-SPECTRUM WITH BETA-
LACTAMASE INHIBITOR
eiiiiF 336
Co-amoxiclav
lINDICATIONS AND DOSE
Infections due to beta-lactamase-producing strains
(where amoxicillin alone not appropriate), including
respiratory tract infections, bone and joint infections,
genito-urinary and abdominal infections, cellulitis and
animal bites
▶BY MOUTH USING TABLETS
▶Child 12–17 years: 250 / 125 mg every 8 hours; increased
to 500 / 125 mg every 8 hours, increased dose used for
severe infection
▶BY INTRAVENOUS INJECTION, OR BY INTRAVENOUS INFUSION
▶Neonate: 30 mg/kg every 12 hours.
▶Child 1–2 months: 30 mg/kg every 12 hours
▶Child 3 months–17 years: 30 mg/kg every 8 hours (max.
per dose 1. 2 g every 8 hours)
Infections due to beta-lactamase-producing strains
(where amoxicillin alone not appropriate) including
respiratory-tract infections, bone and joint infections,
genito-urinary and abdominal infections, cellulitis,
animal bites (doses for 125 / 31 suspension)
▶BY MOUTH USING ORAL SUSPENSION
▶Neonate: 0. 25 mL/kilogram 3 times a day.
▶Child 1–11 months: 0. 25 mL/kilogram 3 times a day, dose
doubled in severe infection
▶Child 1–5 years: 0. 25 mL/kilogram 3 times a day,
alternatively 5 mL 3 times a day, dose doubled in
severe infection
Infections due to beta-lactamase-producing strains
(where amoxicillin alone not appropriate) including
respiratory-tract infections, bone and joint infections,
genito-urinary and abdominal infections, cellulitis,
animal bites (doses for 250 / 62 suspension)
▶BY MOUTH USING ORAL SUSPENSION
▶Child 6–11 years: 0. 15 mL/kilogram 3 times a day,
alternatively 5 mL 3 times a day, dose doubled in
severe infection
Infections due to beta-lactamase-producing strains
(where amoxicillin alone not appropriate) including
respiratory-tract infections, bone and joint infections,
genito-urinary and abdominal infections, cellulitis,
animal bites (doses for 400 / 57 suspension)
▶BY MOUTH USING ORAL SUSPENSION
▶Child 2 months–1 year: 0. 15 mL/kilogram twice daily,
doubled in severe infection
▶Child 2–6 years (body-weight 13–21 kg): 2. 5 mL twice daily,
doubled in severe infection
▶Child 7–12 years (body-weight 22–40 kg): 5 mL twice daily,
doubled in severe infection
▶Child 12–17 years (body-weight 41 kg and above): 10 mL
twice daily; increased if necessary to 10 mL 3 times a
day, increased frequency to be used in severe infection
Severe dental infection with spreading cellulitis|Dental
infection not responding to first-line antibacterial
▶BY MOUTH USING TABLETS
▶Child 12–17 years: 250 / 125 mg every 8 hours for 5 days
Acute sinusitis (doses for 125 / 31 suspension)
▶BY MOUTH USING ORAL SUSPENSION
▶Child 1–11 months: 0. 25 mL/kilogram 3 times a day for
5 days
▶Child 1–5 years: 5 mL 3 times a day for 5 days,
alternatively 0. 25 mL/kilogram 3 times a day for 5 days
Acute sinusitis (doses for 250 / 62 suspension)
▶BY MOUTH USING ORAL SUSPENSION
▶Child 6–11 years: 5 mL 3 times a day for 5 days,
alternatively 0. 15 mL/kilogram 3 times a day for 5 days
Acute sinusitis
▶BY MOUTH
▶Child 12–17 years: 250 / 125 mg 3 times a day for 5 days,
alternatively 500 / 125 mg 3 times a day for 5 days
DOSE EQUIVALENCE AND CONVERSION
▶Doses are expressed as co-amoxiclav.
▶A mixture of amoxicillin (as the trihydrate or as the
sodium salt) and clavulanic acid (as potassium
clavulanate); the proportions are expressed in the form
x/y where x and y are the strengths in milligrams of
amoxicillin and clavulanic acid respectively.
lUNLICENSED USEgDoses and duration of treatment
for acute sinusitis in BNF Publications differ from product
literature and adhere to national guidelines.hSee
Sinusitis (acute) p. 697 for further information.
lCONTRA-INDICATIONSHistory of co-amoxiclav-associated
jaundice or hepatic dysfunction.history of penicillin-
associated jaundice or hepatic dysfunction
lCAUTIONS
GENERAL CAUTIONSAcute lymphocytic leukaemia
(increased risk of erythematous rashes).chronic
lymphocytic leukaemia (increased risk of erythematous
rashes).cytomegalovirus infection (increased risk of
erythematous rashes).glandular fever (erythematous
rashes common).maintain adequate hydration with high
doses (particularly during parental therapy)
SPECIFIC CAUTIONS
▶With intravenous useaccumulation of electrolytes contained
in parenteral preparations can occur with high doses
CAUTIONS, FURTHER INFORMATION
▶Cholestatic jaundiceCholestatic jaundice can occur either
during or shortly after the use of co-amoxiclav. An
epidemiological study has shown that the risk of acute
liver toxicity was about 6 times greater with co-amoxiclav
than with amoxicillin. Cholestatic jaundice is more
common in patients above the age of 65 years and in men;
these reactions have only rarely been reported in children.
Jaundice is usually self-limiting and very rarely fatal. The
duration of treatment should be appropriate to the
indication and should not usually exceed 14 days.
lINTERACTIONS→Appendix 1 : clavulanic acid.penicillins
lSIDE-EFFECTS
GENERAL SIDE-EFFECTS
▶Common or very commonIncreased risk of infection
▶UncommonDizziness.dyspepsia.headache
▶Frequency not knownAcute generalised exanthematous
pustulosis (AGEP).colitis haemorrhagic.crystalluria.
hypersensitivity vasculitis.meningitis aseptic
SPECIFIC SIDE-EFFECTS
▶Frequency not known
▶With oral useAkathisia.black hairy tongue
BNFC 2018 – 2019 Bacterial infection 343
Infection
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