▶ Child 12–17 years: 500 mg 4 times a day; increased if
necessary to 1 g 4 times a day, use increased dose in
▶ Adult: 0.5–1 g every 6 hours
▶ BY INTRAVENOUS INJECTION, OR BY INTRAVENOUS INFUSION
▶ Adult: 500 mg every 4–6 hours
▶ Adult: 500 mg every 4–6 hours
Endocarditis (in combination with another antibiotic if
necessary)| Listerial meningitis (in combination with
▶ In adults Ampicillin doses in BNF may differ from those in
GENERAL CAUTIONS Acute 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
▶ With intravenous use accumulation of electrolytes contained
in parenteral preparations can occur with high doses
l INTERACTIONS → Appendix 1: penicillins
l SIDE-EFFECTS Colitis haemorrhagic
l PREGNANCY Not known to be harmful.
l BREAST FEEDING Trace amounts in milk, but appropriate
▶ With intravenous use Accumulation of electrolytes
contained in parenteral preparations can occur in patients
Dose adjustments ▶ In adults Reduce dose if eGFR less than
▶ In children If estimated glomerular filtration rate less
than 10 mL/minute/1.73 m2 reduce dose or frequency;
l DIRECTIONS FOR ADMINISTRATION
▶ With oral use Administer at least 30 minutes before food.
▶ With intravenous use in adults For intravenous infusion
(Penbritin ®), give intermittently in Glucose 5% or Sodium
chloride 0.9%. Reconstituted solutions diluted and given
without delay; suggested volume 100 mL given over
30–60 minutes via drip tubing in Glucose 5% or Sodium
chloride 0.9%. Continuous infusion not usually
Medicines for Children leaflet: Ampicillin for bacterial infection
www.medicinesforchildren.org.uk/ampicillin-bacterial-infection
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 9, 23
▶ Ampicillin (Non-proprietary)
Ampicillin 25 mg per 1 ml Ampicillin 125mg/5ml oral suspension | 100 ml P £29.86 DT = £29.86
Ampicillin 50 mg per 1 ml Ampicillin 250mg/5ml oral suspension | 100 ml P £38.86 DT = £38.86
CAUTIONARY AND ADVISORY LABELS 9, 23
▶ Ampicillin (Non-proprietary)
Ampicillin 250 mg Ampicillin 250mg capsules | 28 capsule P £20.50 DT = £20.50
Ampicillin 500 mg Ampicillin 500mg capsules | 28 capsule P £40.30 DT = £40.30
Powder for solution for injection
▶ Ampicillin (Non-proprietary)
Ampicillin (as Ampicillin sodium) 500 mg Ampicillin 500mg
powder for solution for injection vials | 10 vial P £78.30 DT =
Mixed infections involving beta-lactamase-producing
▶ Child 1 month–9 years: 125/125 mg every 6 hours
▶ Child 10–17 years: 250/250 mg every 6 hours
▶ Adult: 250/250 mg every 6 hours
▶ BY INTRAMUSCULAR INJECTION, OR BY SLOW INTRAVENOUS
INJECTION, OR BY INTRAVENOUS INFUSION
▶ Adult: 250/250 mg every 6 hours
Severe mixed infections involving beta-lactamaseproducing staphylococci
▶ Child 1 month–9 years: 250/250 mg every 6 hours
▶ Adult: 500/500 mg every 6 hours
550 Bacterial infection BNF 78
▶ BY INTRAMUSCULAR INJECTION, OR BY SLOW INTRAVENOUS
INJECTION, OR BY INTRAVENOUS INFUSION
▶ Adult: 500/500 mg every 6 hours
Cholestatic jaundice and hepatitis may occur very rarely,
up to two months after treatment with flucloxacillin has
been stopped. Administration for more than 2 weeks and
increasing age are risk factors. Healthcare professionals
. flucloxacillin should not be used in patients with a
history of hepatic dysfunction associated with
. flucloxacillin should be used with caution in patients
. careful enquiry should be made about hypersensitivity
reactions to beta-lactam antibacterials.
GENERAL CAUTIONS Acute 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
▶ With intravenous use accumulation of electrolytes contained
in parenteral preparations can occur with high doses
l INTERACTIONS → Appendix 1: penicillins
l PREGNANCY Not known to be harmful.
l BREAST FEEDING Trace amount in milk, but appropriate to
l HEPATIC IMPAIRMENT Manufacturer advises use with
caution in hepatic dysfunction.
▶ With intravenous use Accumulation of electrolytes
contained in parenteral preparations can occur in patients
Dose adjustments ▶ In adults Reduce dose if eGFR less than
▶ In children Reduce dose or frequency if estimated
glomerular filtration rate less than 10 mL/minute/1.73 m2
l EFFECT ON LABORATORY TESTS False-positive urinary
glucose (if tested for reducing substances).
l PRESCRIBING AND DISPENSING INFORMATION Dose
expressed as a combination of equal parts by mass of
flucloxacillin and ampicillin.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 9, 22
▶ Co-fluampicil (Non-proprietary)
Ampicillin (as Ampicillin trihydrate) 25 mg per 1 ml, Flucloxacillin
(as Flucloxacillin magnesium) 25 mg per 1 ml Co-fluampicil
125mg/125mg/5ml oral suspension | 100 ml P £23.93 DT =
Powder for solution for injection
ELECTROLYTES: May contain Sodium
▶ Co-fluampicil (Non-proprietary)
Ampicillin (as Ampicillin sodium) 250 mg, Flucloxacillin (as
Flucloxacillin sodium) 250 mg Co-fluampicil 250mg/250mg powder
for solution for injection vials | 10 vial P £13.33
CAUTIONARY AND ADVISORY LABELS 9, 22
▶ Co-fluampicil (Non-proprietary)
Ampicillin (as Ampicillin trihydrate) 250 mg, Flucloxacillin (as
Flucloxacillin sodium) 250 mg Co-fluampicil 250mg/250mg
capsules | 28 capsule P £2.27 DT = £1.95 | 100 capsule P £6.96
BROAD-SPECTRUM WITH BETALACTAMASE INHIBITOR
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
▶ Child 12–17 years: 250/125 mg every 8 hours; increased
to 500/125 mg every 8 hours, increased dose used for
▶ Adult: 250/125 mg every 8 hours; increased to
500/125 mg every 8 hours, increased dose used for
▶ BY INTRAVENOUS INJECTION, OR BY INTRAVENOUS INFUSION
▶ Child 1–2 months: 30 mg/kg every 12 hours, intravenous
infusion recommended in children less than 3 months
▶ Child 3 months–17 years: 30 mg/kg every 8 hours (max.
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
▶ Child 1–11 months: 0.25 mL/kilogram 3 times a day, dose
▶ Child 1–5 years: 0.25 mL/kilogram 3 times a day,
alternatively 5 mL 3 times a day, dose doubled in
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
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 2–23 months: 0.15 mL/kilogram twice daily,
▶ Child 2–6 years (body-weight 13–21 kg): 2.5 mL twice daily,
▶ Child 7–12 years (body-weight 22–40 kg): 5 mL twice daily,
▶ 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
▶ Adult: 10 mL twice daily; increased if necessary to
10 mL 3 times a day, increased frequency to be used in
BNF 78 Bacterial infection 551
Severe dental infection with spreading cellulitis | Dental
infection not responding to first-line antibacterial
▶ Child 12–17 years: 250/125 mg every 8 hours for 5 days
▶ Adult: 250/125 mg every 8 hours for 5 days
▶ BY INTRAVENOUS INJECTION, OR BY INTRAVENOUS INFUSION
▶ Adult: 1.2 g, to be administered up to 30 minutes
before the procedure, then 1.2 g every 8 hours for up to
2–3 further doses in high risk procedures
Acute exacerbation of bronchiectasis (doses for 125/31
▶ BY MOUTH USING ORAL SUSPENSION
▶ Child 1–11 months: 0.25 mL/kilogram 3 times a day for
▶ Child 1–5 years: 5 mL 3 times a day for 7–14 days,
alternatively 0.25 mL/kilogram 3 times a day for
Acute exacerbation of bronchiectasis (doses for 250/62
▶ BY MOUTH USING ORAL SUSPENSION
▶ Child 6–11 years: 5 mL 3 times a day for 7–14 days,
alternatively 0.15 mL/kilogram 3 times a day for
Acute exacerbation of bronchiectasis
▶ Child 12–17 years: 250/125 mg 3 times a day for
7–14 days, alternatively 500/125 mg 3 times a day for
▶ Adult: 500/125 mg 3 times a day for 7–14 days
▶ BY INTRAVENOUS INFUSION, OR BY INTRAVENOUS INJECTION
▶ Child 1–2 months: 30 mg/kg every 12 hours, intravenous
infusion is recommended in children less than
▶ Child 3 months–17 years: 30 mg/kg every 8 hours (max.
Acute exacerbation of chronic obstructive pulmonary
▶ Adult: 500/125 mg 3 times a day for 5 days
▶ BY INTRAVENOUS INJECTION, OR BY INTRAVENOUS INFUSION
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
▶ 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
▶ 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
▶ Adult: 500/125 mg 3 times a day for 5 days
Acute otitis media (doses for 125/31 suspension)
▶ BY MOUTH USING ORAL SUSPENSION
▶ Child 1–11 months: 0.25 mL/kilogram 3 times a day for
▶ Child 1–5 years: 5 mL 3 times a day for 5–7 days,
alternatively 0.25 mL/kilogram 3 times a day for
Acute otitis media (doses for 250/62 suspension)
▶ BY MOUTH USING ORAL SUSPENSION
▶ Child 6–11 years: 5 mL 3 times a day for 5–7 days,
alternatively 0.15 mL/kilogram 3 times a day for
▶ Child 12–17 years: 250/125 mg 3 times a day for
5–7 days, alternatively 500/125 mg 3 times a day for
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.
l UNLICENSED USE g Duration of treatment for acute
sinusitis differs from product literature and adheres to
national guidelines. hSee Sinusitis (acute) p. 1203 for
g Duration of treatment for acute otitis media differs
from product literature and adheres to national
guidelines. hSee Ear infections, antibacterial therapy
p. 511 for further information.
g Co-amoxiclav is used for the treatment of acute
exacerbation of bronchiectasis, hbut is not licensed for
this indication. See Respiratory system infections,
antibacterial therapy p. 515 for further information.
l CONTRA-INDICATIONS History of co-amoxiclav-associated
jaundice or hepatic dysfunction . history of penicillinassociated jaundice or hepatic dysfunction
GENERAL CAUTIONS Acute 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)
▶ With intravenous use accumulation of electrolytes contained
in parenteral preparations can occur with high doses
▶ Cholestatic jaundice Cholestatic 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.
l INTERACTIONS → Appendix 1: clavulanic acid . penicillins
▶ Common or very common Increased risk of infection
▶ Uncommon Dizziness . dyspepsia . headache
▶ With oral use Akathisia . black hairy tongue
l PREGNANCY Not known to be harmful.
l BREAST FEEDING Trace amount in milk, but appropriate to
l HEPATIC IMPAIRMENT Manufacturer advises caution.
552 Bacterial infection BNF 78
Monitoring Monitor liver function in liver disease.
l RENAL IMPAIRMENT Risk of crystalluria with high doses
(particularly during parenteral therapy).
▶ With intravenous use Accumulation of electrolytes
contained in parenteral preparations can occur in patients
Dose adjustments ▶ With oral use in adults Co-amoxiclav
250/125 tablets or 500/125 tablets: if eGFR
every 12 hours or one 500/125 strength tablet every
12 hours; if eGFR less than 10 mL/minute/1.73 m2
250/125 strength tablet every 24 hours or one 500/125
strength tablet every 24 hours.
Co-amoxiclav 400/57 suspension: avoid if eGFR less than
▶ With intravenous use in adults Co-amoxiclav injection
(expressed as co-amoxiclav): if eGFR
, 1.2 g initially, then 600 mg
every 12 hours; if eGFR less than 10 mL/minute/1.73 m2
1.2 g initially, then 600 mg every 24 hours.
▶ With oral use in children Co-amoxiclav 125/31 suspension,
250/62 suspension, 250/125 tablets, or 500/125 tablets: use
normal dose every 12 hours if estimated glomerular
filtration rate 10–30 mL/minute/1.73 m2
dose recommended for mild or moderate infections every
12 hours if estimated glomerular filtration rate less than
Co-amoxiclav 400/57 suspension: avoid if estimated
glomerular filtration rate less than 30 mL/minute/1.73 m2
▶ With intravenous use in children Co-amoxiclav injection: use
normal initial dose and then use half normal dose every
12 hours if estimated glomerular filtration rate
then use half normal dose every 24 hours if estimated
glomerular filtration rate less than 10 mL/minute/1.73 m2
l DIRECTIONS FOR ADMINISTRATION
▶ With intravenous use in children For intravenous infusion,
dilute reconstituted solution to a concentration of
10 mg/mL with Sodium Chloride 0.9%; give intermittently
over 30–40 minutes. For intravenous injection, administer
▶ With intravenous use in adults For intravenous infusion
(Augmentin ®), give intermittently in Sodium chloride
0.9%. Reconstitute 600 mg initially with 10 mL water for
injections, then dilute with 50 mL infusion fluid;
reconstitute 1.2 g initially with 20 mL water for injections,
then dilute with 100 mL infusion fluid; give over
30–40 minutes. For intravenous injection, administer over
3–4 minutes. Via drip tubing in Sodium chloride 0.9%.
l PRESCRIBING AND DISPENSING INFORMATION 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.
▶ With oral use Flavours of oral liquid formulations may
Medicines for Children leaflet: Co-amoxiclav for bacterial infections
www.medicinesforchildren.org.uk/co-amoxiclav-bacterialinfections-0
l PROFESSION SPECIFIC INFORMATION
Dental practitioners’ formulary
Co-amoxiclav 250/125 Tablets may be prescribed.
Co-amoxiclav 125/31 Suspension may be prescribed.
Co-amoxiclav 250/62 Suspension may be prescribed.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug. Forms available
from special-order manufacturers include: infusion
CAUTIONARY AND ADVISORY LABELS 9
EXCIPIENTS: May contain Aspartame
▶ Co-amoxiclav (Non-proprietary)
Clavulanic acid (as Potassium clavulanate) 6.25 mg per 1 ml,
Co-amoxiclav 125mg/31mg/5ml oral suspension sugar free sugar-free
Clavulanic acid (as Potassium clavulanate) 12.5 mg per 1 ml,
Co-amoxiclav 250mg/62mg/5ml oral suspension sugar free sugar-free
| 70 ml P £2.05 sugar-free | 100 ml P £1.68 DT = £1.67
Clavulanic acid (as Potassium clavulanate) 11.4 mg per 1 ml,
▶ Augmentin (GlaxoSmithKline UK Ltd)
Clavulanic acid (as Potassium clavulanate) 6.25 mg per 1 ml,
Amoxicillin (as Amoxicillin trihydrate) 25 mg per 1 ml Augmentin
125/31 SF oral suspension sugar-free | 100 ml P £3.54 DT = £1.65
Clavulanic acid (as Potassium clavulanate) 12.5 mg per 1 ml,
Amoxicillin (as Amoxicillin trihydrate) 50 mg per 1 ml Augmentin
250/62 SF oral suspension sugar-free | 100 ml P £3.60 DT = £1.67
▶ Augmentin-Duo (GlaxoSmithKline UK Ltd)
Clavulanic acid (as Potassium clavulanate) 11.4 mg per 1 ml,
sugar-free | 70 ml P £5.79 DT = £5.79
CAUTIONARY AND ADVISORY LABELS 9
▶ Co-amoxiclav (Non-proprietary)
Clavulanic acid (as Potassium clavulanate) 125 mg, Amoxicillin
(as Amoxicillin trihydrate) 250 mg Co-amoxiclav 250mg/125mg
tablets | 21 tablet P £6.00 DT = £1.79
Clavulanic acid (as Potassium clavulanate) 125 mg, Amoxicillin
(as Amoxicillin trihydrate) 500 mg Co-amoxiclav 500mg/125mg
tablets | 21 tablet P £15.00 DT = £2.31
Clavulanic acid (as Potassium clavulanate) 125 mg, Amoxicillin
(as Amoxicillin trihydrate) 875 mg Co-amoxiclav 875mg/125mg
tablets | 14 tablet P £18.00 DT = £18.00
▶ Augmentin (GlaxoSmithKline UK Ltd)
Clavulanic acid (as Potassium clavulanate) 125 mg, Amoxicillin
(as Amoxicillin trihydrate) 250 mg Augmentin 375mg tablets | 21 tablet P £5.03 DT = £1.79
Clavulanic acid (as Potassium clavulanate) 125 mg, Amoxicillin
(as Amoxicillin trihydrate) 500 mg Augmentin 625mg tablets | 21 tablet P £9.60 DT = £2.31
Powder for solution for injection
ELECTROLYTES: May contain Potassium, sodium
▶ Co-amoxiclav (Non-proprietary)
Clavulanic acid (as Potassium clavulanate) 100 mg, Amoxicillin
(as Amoxicillin sodium) 500 mg Co-amoxiclav 500mg/100mg
powder for solution for injection vials | 10 vial P £10.60–£14.90 | 10 vial P £13.50 (Hospital only)
Clavulanic acid (as Potassium clavulanate) 200 mg, Amoxicillin
(as Amoxicillin sodium) 1000 mg Co-amoxiclav 1000mg/200mg
powder for solution for injection vials | 10 vial P £10.60–£29.70 | 10 vial P £27.50 (Hospital only)
▶ Augmentin Intravenous (GlaxoSmithKline UK Ltd)
Clavulanic acid (as Potassium clavulanate) 100 mg, Amoxicillin
(as Amoxicillin sodium) 500 mg Augmentin Intravenous 600mg
powder for solution for injection vials | 10 vial P £10.60
Clavulanic acid (as Potassium clavulanate) 200 mg, Amoxicillin
(as Amoxicillin sodium) 1000 mg Augmentin Intravenous 1.2g
powder for solution for injection vials | 10 vial P £10.60
BNF 78 Bacterial infection 553
Pivmecillinam hydrochloride 18-Sep-2018
▶ Child (body-weight 40 kg and above): Initially 400 mg for
1 dose, then 200 mg every 8 hours to a total of
▶ Adult (body-weight 40 kg and above): Initially 400 mg for
1 dose, then 200 mg every 8 hours to a total of
Chronic or recurrent bacteriuria
▶ Child (body-weight 40 kg and above): 400 mg every
▶ Adult (body-weight 40 kg and above): 400 mg every
▶ Child (body-weight up to 40 kg): 5–10 mg/kg every
6 hours, alternatively 20–40 mg/kg daily in 3 divided
▶ In children Not licensed for use in children under 3 months.
l CAUTIONS Avoid in Acute porphyrias p. 1058
l INTERACTIONS → Appendix 1: penicillins
▶ Common or very common Vulvovaginal fungal infection
l PREGNANCY Not known to be harmful, but manufacturer
l BREAST FEEDING Trace amount in milk, but appropriate to
l MONITORING REQUIREMENTS Liver and renal function
tests required in long-term use.
l EFFECT ON LABORATORY TESTS False positive urinary
glucose (if tested for reducing substances).
l DIRECTIONS FOR ADMINISTRATION Tablets should be
swallowed whole with plenty of fluid during meals while
l PATIENT AND CARER ADVICE Patient counselling is advised
on administration of pivmecillinam hydrochloride tablets
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 9, 21, 27
▶ Pivmecillinam hydrochloride (Non-proprietary)
Pivmecillinam hydrochloride 200 mg Pivmecillinam 200mg tablets
| 10 tablet P £5.40 DT = £5.40
Infections due to beta-lactamase-producing staphylococci
including otitis externa | Adjunct in pneumonia | Adjunct
in impetigo | Adjunct in cellulitis
▶ Child 1 month–1 year: 62.5–125 mg 4 times a day
▶ Child 2–9 years: 125–250 mg 4 times a day
▶ Child 10–17 years: 250–500 mg 4 times a day
▶ Adult: 250–500 mg 4 times a day
▶ Adult: 250–500 mg every 6 hours
▶ BY SLOW INTRAVENOUS INJECTION, OR BY INTRAVENOUS
▶ Adult: 0.25–2 g every 6 hours
Endocarditis (in combination with other antibacterial if
▶ BY SLOW INTRAVENOUS INJECTION, OR BY INTRAVENOUS
▶ Adult (body-weight up to 85 kg): 8 g daily in 4 divided
▶ Adult (body-weight 85 kg and above): 12 g daily in
▶ BY SLOW INTRAVENOUS INJECTION, OR BY INTRAVENOUS
▶ Adult: Up to 8 g daily in 3–4 divided doses
▶ INITIALLY BY SLOW INTRAVENOUS INJECTION, OR BY
▶ Adult: 1–2 g, to be administered up to 30 minutes
before the procedure, then (by mouth or by
intramuscular injection or by slow intravenous
injection or by intravenous infusion) 500 mg every
6 hours if required for up to 4 further doses in high risk
Staphylococcal lung infection in cystic fibrosis
▶ Child: 25 mg/kg 4 times a day (max. per dose 1 g),
alternatively 100 mg/kg daily in 3 divided doses;
Prevention of Staphylococcus aureus lung infection in
cystic fibrosis—primary prevention
▶ Child 1 month–3 years: 125 mg twice daily
Prevention of Staphylococcus aureus lung infection in
cystic fibrosis—secondary prevention
▶ Child: 50 mg/kg twice daily (max. per dose 1 g twice
▶ In adults Flucloxacillin doses in the BNF may differ from
Cholestatic jaundice and hepatitis may occur very rarely,
up to two months after treatment with flucloxacillin has
been stopped. Administration for more than 2 weeks and
increasing age are risk factors. Healthcare professionals
. flucloxacillin should not be used in patients with a
history of hepatic dysfunction associated with
554 Bacterial infection BNF 78
. flucloxacillin should be used with caution in patients
. careful enquiry should be made about hypersensitivity
reactions to beta-lactam antibacterials
▶ With intravenous use accumulation of electrolytes can occur
l INTERACTIONS → Appendix 1: penicillins
▶ Rare or very rare Arthralgia . fever
▶ With oral use Gastrointestinal disorder
▶ With oral use Eosinophilia . myalgia
l PREGNANCY Not known to be harmful.
l BREAST FEEDING Trace amounts in milk, but appropriate
l HEPATIC IMPAIRMENT Manufacturer advises caution;
including in those with risk factors for hepatic reactions.
▶ With intravenous use Accumulation of electrolytes can occur
in patients with renal failure.
Dose adjustments ▶ In adults Reduce dose if eGFR less than
▶ In children Use normal dose every 8 hours if estimated
glomerular filtration rate less than 10 mL/minute/1.73 m2
l EFFECT ON LABORATORY TESTS False-positive urinary
glucose (if tested for reducing substances).
l DIRECTIONS FOR ADMINISTRATION
▶ With intravenous use in adults For intravenous infusion
(Floxapen ®), give intermittently in Glucose 5% or Sodium
chloride 0.9%; suggested volume 100 mL given over
30–60 minutes. Via drip tubing in Glucose 5% or Sodium
chloride 0.9%; continuous infusion not usually
Medicines for Children leaflet: Flucloxacillin for bacterial infections
www.medicinesforchildren.org.uk/flucloxacillin-bacterialinfections
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug. Forms available
from special-order manufacturers include: infusion
CAUTIONARY AND ADVISORY LABELS 9, 23
▶ Flucloxacillin (Non-proprietary)
Flucloxacillin (as Flucloxacillin sodium) 25 mg per
1 ml Flucloxacillin 125mg/5ml oral solution | 100 ml P £20.99 DT
Flucloxacillin 125mg/5ml oral solution sugar free sugar-free | 100 ml P £26.70 DT = £21.05
Flucloxacillin (as Flucloxacillin sodium) 50 mg per
1 ml Flucloxacillin 250mg/5ml oral solution sugar free sugar-free |
Flucloxacillin 250mg/5ml oral solution | 100 ml P £35.09 DT =
CAUTIONARY AND ADVISORY LABELS 9, 23
▶ Flucloxacillin (Non-proprietary)
Flucloxacillin (as Flucloxacillin sodium) 250 mg Flucloxacillin
250mg capsules | 28 capsule P £1.42 DT = £1.42 | 100 capsule P £4.50–£17.80
Flucloxacillin (as Flucloxacillin sodium) 500 mg Flucloxacillin
500mg capsules | 28 capsule P £10.50 DT = £2.34 | 100 capsule P £8.36–£37.50
Powder for solution for injection
▶ Flucloxacillin (Non-proprietary)
Flucloxacillin (as Flucloxacillin sodium) 250 mg Flucloxacillin
250mg powder for solution for injection vials | 10 vial P £8.60 DT
= £8.60 (Hospital only) | 10 vial P £12.25 DT = £8.60
Flucloxacillin (as Flucloxacillin sodium) 500 mg Flucloxacillin
500mg powder for solution for injection vials | 10 vial P £24.50–
£35.00 DT = £17.20 | 10 vial P £17.20 DT = £17.20 (Hospital only)
Flucloxacillin (as Flucloxacillin sodium) 1 gram Flucloxacillin 1g
powder for solution for injection vials | 10 vial P £34.50 DT =
£34.50 (Hospital only) | 10 vial P £45.00–£49.00 DT = £34.50
Flucloxacillin (as Flucloxacillin sodium) 2 gram Flucloxacillin 2g
powder for solution for injection vials | 1 vial P £6.00 DT = £6.00
Combinations available: Co-fluampicil, p. 550
▶ BY INTRAMUSCULAR INJECTION, OR BY SLOW INTRAVENOUS
INJECTION, OR BY INTRAVENOUS INFUSION
▶ Adult: 2 g every 12 hours, alternatively 2 g every
8 hours, higher daily dose to be used in critically ill
▶ BY CONTINUOUS INTRAVENOUS INFUSION
▶ Adult: (consult product literature)
l CAUTIONS Accumulation of sodium from injection can
l INTERACTIONS → Appendix 1: penicillins
l SIDE-EFFECTS Arthralgia . fever. myalgia . nervous system
l PREGNANCY Not known to be harmful.
l BREAST FEEDING Trace amounts in milk.
l RENAL IMPAIRMENT Accumulation of sodium from
injection can occur in patients with renal failure.
Dose adjustments Manufacturer advises reduce usual dose
to 1 g every 12 hours if creatinine clearance
30–60 mL/minute; reduce usual dose to 1 g every 24 hours
if creatinine clearance 10–30 mL/minute; reduce usual
dose to 1 g every 48 hours or 500 mg every 24 hours if
creatinine clearance less than 10 mL/minute; no
information available to recommend dose adjustments
with higher daily dose for use in critically ill patients.
l EFFECT ON LABORATORY TESTS False-positive urinary
glucose (if tested for reducing substances).
l DIRECTIONS FOR ADMINISTRATION Manufacturer advises
for intramuscular injection, reconstitute 1 g with 2 mL water
for injections or Sodium chloride 0.9% (or 0.5 or 1%
lidocaine solution, if pain is experienced at injection site).
Manufacturer advises for slow intravenous injection,
reconstitute 1 g with 10 mL water for injections or Sodium
chloride 0.9%; give over 3–4 minutes. Manufacturer
advises for intermittent intravenous infusion, give in Glucose
5% or 10% or Sodium chloride 0.9% or Ringer’s solution or
Lactated Ringer’s solution. Reconstitute 1 g with 10 mL
water for injections or infusion fluid, then dilute in up to
150 mL infusion fluid; give over 30–40 minutes. For
continuous intravenous infusion, consult product literature.
BNF 78 Bacterial infection 555
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
Powder for solution for injection
ELECTROLYTES: May contain Sodium
▶ Negaban (Eumedica Pharmaceuticals)
Temocillin (as Temocillin sodium) 1 gram Negaban 1g powder for
solution for injection vials | 1 vial P £25.45
Colistimethate sodium 08-Feb-2019
(Colistin sulfomethate sodium)
l DRUG ACTION The polymyxin antibiotic, colistimethate
sodium (colistin sulfomethate sodium), is active against
Gram-negative organisms including Pseudomonas
aeruginosa, Acinetobacter baumanii, and Klebsiella
pneumoniae. It is not absorbed by mouth and thus needs to
be given by injection for a systemic effect.
Serious infections due to selected aerobic Gram-negative
bacteria in patients with limited treatment options
▶ Adult: 9 million units daily in 2–3 divided doses, an
initial loading dose of 9 million units should be used in
those who are critically ill, loading and maintenance
doses of up to 12 million units may be required in some
cases, however clinical experience is limited and safety
has not been established—consult product literature
Management of chronic pulmonary infections due to
Pseudomonas aeruginosa in patients with cystic fibrosis
▶ BY INHALATION OF NEBULISED SOLUTION
▶ Child 2–17 years: 1–2 million units 2–3 times a day, for
specific advice on administration using nebulisers—
consult product literature; maximum 6 million units
▶ Adult: 1–2 million units 2–3 times a day, for specific
advice on administration using nebulisers—consult
product literature; maximum 6 million units per day
▶ Adult: 1.66 million units twice daily
l CONTRA-INDICATIONS Myasthenia gravis
GENERAL CAUTIONS Children under 1 year of age (effects of
immature renal and metabolic function on conversion to
active colistin not known) (in children)
▶ When used by inhalation Severe haemoptysis—risk of further
l INTERACTIONS → Appendix 1: colistimethate
disorders . proteinuria . seizure . sputum purulent.thirst. weight change
SIDE-EFFECTS, FURTHER INFORMATION Neurotoxicity and
nephrotoxicity are dose-related.
▶ When used by inhalation Clinical use suggests probably safe.
▶ With intravenous use Manufacturer advises use only if
potential benefit outweighs risk.
l BREAST FEEDING Present in milk but poorly absorbed from
gut; manufacturers advise avoid (or use only if potential
▶ With intravenous use Manufacturer advises caution (no
▶ When used by inhalation Manufacturer advises caution.
Dose adjustments ▶ With intravenous use Manufacturer
advises reduce maintenance dose if creatinine clearance
less than 50 mL/minute—consult product literature.
Monitoring ▶ With intravenous use In renal impairment,
monitor plasma colistimethate sodium concentration
during parenteral treatment—consult product literature.
Recommended ‘peak’ plasma colistimethate sodium
concentration (approx. 1 hour after intravenous injection
or infusion) 5–15 mg/litre; pre-dose (‘trough’)
▶ With intravenous use Monitor renal function.
▶ When used by inhalation Measure lung function before and
after initial dose of colistimethate sodium and monitor for
bronchospasm; if bronchospasm occurs in a patient not
using a bronchodilator, repeat test using a bronchodilator
before the dose of colistimethate sodium.
l DIRECTIONS FOR ADMINISTRATION
▶ When used by inhalation Manufacturer advises if other
treatments are being administered, they should be taken
in the order recommended by the physician. For
nebulisation, consult product literature for information on
▶ With intravenous use in adults For intravenous infusion,
manufacturer advises following reconstitution, dilute
requisite dose, usually with 50 mL Sodium Chloride 0.9%;
give over 30–60 minutes. Patients fitted with a totally
implantable venous access device may tolerate an
injection. For slow intravenous injection into a totally
implantable venous access device, dilute to a
concentration of 200 000 units/mL with Sodium Chloride
0.9%; give over at least 5 minutes.
l PRESCRIBING AND DISPENSING INFORMATION
Colistimethate sodium is included in some preparations
▶ When used by inhalation Patient should be advised to rinse
mouth with water after each dose of dry powder
inhalation. Patients or carers should be given advice on
how to administer colistimethate sodium; first dose should
be given under medical supervision.
Driving and skilled tasks Manufacturer advises patients and
carers should be counselled on the effects on driving and
performance of skilled tasks—increased risk of dizziness,
confusion and visual disturbances.
l NATIONAL FUNDING/ACCESS DECISIONS
▶ Colistimethate sodium and tobramycin dry powders for
inhalation for treating pseudomonas lung infection in cystic
fibrosis (March 2013) NICE TA276
Colistimethate sodium dry powder for inhalation is
recommended for chronic pulmonary infection caused by
Pseudomonas aeruginosa in patients with cystic fibrosis
who would benefit from continued treatment, but do not
tolerate the drug in its nebulised form. The manufacturer
must provide colistimethate sodium dry powder for
556 Bacterial infection BNF 78
inhalation at the discount agreed as part of the patient
access scheme to primary, secondary and tertiary care in
the NHS. Patients currently receiving colistimethate
sodium dry powder for inhalation can continue treatment
until they and their NHS clinician consider it appropriate
www.nice.org.uk/guidance/ta276
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
Powder for solution for injection
ELECTROLYTES: May contain Sodium
▶ Colistimethate sodium (Non-proprietary)
Colistimethate sodium 1000000 unit Colistimethate 1million unit
powder for solution for injection vials | 10 vial P £18.00 DT =
£18.00 | 10 vial P £30.00 DT = £18.00 (Hospital only)
Colistimethate sodium 1000000 unit Colomycin 1million unit
powder for solution for injection vials | 10 vial P £18.00 DT =
Colistimethate sodium 2000000 unit Colomycin 2million unit
powder for solution for injection vials | 10 vial P £32.40 DT =
▶ Promixin (Profile Pharma Ltd)
Colistimethate sodium 1000000 unit Promixin 1million unit
powder for solution for injection vials | 10 vial P £37.50 DT =
Colistimethate sodium 1662500 unit Colobreathe 1,662,500unit
inhalation powder capsules | 56 capsule P £968.80 DT = £968.80
▶ Promixin (Profile Pharma Ltd)
Colistimethate sodium 1000000 unit Promixin 1million unit
powder for nebuliser solution unit dose vials | 30 unit dose P £204.00 DT = £204.00
MHRA/CHM advice: Systemic and inhaled
fluoroquinolones (November 2018, and March 2019)
The MHRA and CHM have released important safety
information regarding the use of systemic and inhaled
fluoroquinolones. For restrictions and precautions, see
Important safety information for all quinolones: ciprofloxacin
p. 558, levofloxacin p. 559, moxifloxacin p. 560, and
In the UK, only fluoroquinolones are available; the
recommendations below therefore refer to the use of
Ciprofloxacin is active against both Gram-positive and
Gram-negative bacteria. It is particularly active against
Gram-negative bacteria, including Salmonella, Shigella,
Campylobacter, Neisseria, and Pseudomonas. Ciprofloxacin
has only moderate activity against Gram-positive bacteria
such as Streptococcus pneumoniae and Enterococcus faecalis;
it should not be used for pneumococcal pneumonia. It is
active against Chlamydia and some mycobacteria. Most
anaerobic organisms are not susceptible. Ciprofloxacin can
be used for respiratory tract infections (but not for
infections, gonorrhoea and septicaemia caused by sensitive
Ofloxacin is licensed for urinary-tract infections, lower
respiratory-tract infections, gonorrhoea, and nongonococcal urethritis and cervicitis.
Pneumococci than ciprofloxacin.
Many Staphylococci are resistant to quinolones and their use
should be avoided in MRSA infections.
ciprofloxacin. Moxifloxacin is not active against
Pseudomonas aeruginosa or meticillin-resistant
The CSM has warned that quinolones may induce
convulsions in patients with or without a history of
convulsions; taking NSAIDs at the same time may also
Tendon damage (including rupture) has been reported
rarely in patients receiving quinolones. Tendon rupture
may occur within 48 hours of starting treatment; cases
have also been reported several months after stopping a
quinolone. Healthcare professionals are reminded that:
. quinolones are contra-indicated in patients with a
history of tendon disorders related to quinolone use;
. patients over 60 years of age are more prone to tendon
. the risk of tendon damage is increased by the
concomitant use of corticosteroids;
. if tendinitis is suspected, the quinolone should be
MHRA/CHM ADVICE: SYSTEMIC AND INHALED
FLUOROQUINOLONES: SMALL INCREASED RISK OF AORTIC
ANEURYSM AND DISSECTION; ADVICE FOR PRESCRIBING IN HIGHRISK PATIENTS (NOVEMBER 2018)
The MHRA advises that benefit-risk should be assessed
and other therapeutic options considered before using
fluoroquinolones in patients at risk of aortic aneurysm
and dissection. Patients (particularly the elderly and
those at risk) and their carers should be informed about
rare events of aortic aneurysm and dissection, and
MHRA/CHM ADVICE: FLUOROQUINOLONE ANTIBIOTICS: NEW
RESTRICTIONS AND PRECAUTIONS FOR USE DUE TO VERY RARE
REPORTS OF DISABLING AND POTENTIALLY LONG-LASTING OR
IRREVERSIBLE SIDE EFFECTS (MARCH 2019)
Disabling, long-lasting or potentially irreversible adverse
reactions affecting musculoskeletal and nervous systems
have been reported very rarely with fluoroquinolone
antibiotics. Healthcare professionals are advised to
inform patients to stop treatment at the first signs of a
serious adverse reaction, such as tendinitis or tendon
rupture, muscle pain, muscle weakness, joint pain, joint
swelling, peripheral neuropathy, and CNS effects, and to
contact their doctor immediately. Fluoroquinolones
should not be prescribed for non-severe or self-limiting
infections, or non-bacterial conditions. Unless other
commonly recommended antibiotics are inappropriate,
fluoroquinolones should not be prescribed for some mild
to moderate infections, such as acute exacerbation of
chronic bronchitis and chronic obstructive pulmonary
disease, and ciprofloxacin or levofloxacin should not be
prescribed for uncomplicated cystitis. Fluoroquinolones
should be avoided in patients who have previously had
serious adverse reactions. Use of fluoroquinolones with
corticosteroids should also be avoided as it may
exacerbate fluoroquinolone-induced tendinitis and
tendon rupture. Fluoroquinolones should be prescribed
with caution in patients older than 60 years and in
Comments
Post a Comment
اكتب تعليق حول الموضوع