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
▶ Chloramphenicol (Non-proprietary)
Chloramphenicol (as Chloramphenicol sodium succinate)
1 gram Chloramphenicol 1g powder for solution for injection vials |
▶ Chloramphenicol (Non-proprietary)
Chloramphenicol 250 mg Chloramphenicol 250mg capsules |
60 capsule P £377.00 DT = £377.00
l DRUG ACTION Daptomycin is a lipopeptide antibacterial
with a spectrum of activity similar to vancomycin but its
efficacy against enterococci has not been established. It
needs to be given with other antibacterials for mixed
infections involving Gram-negative bacteria and some
Complicated skin and soft-tissue infections caused by
▶ Child 12–23 months: 10 mg/kg once daily for up to
14 days, alternatively 12 mg/kg once daily, higher dose
only if associated with Staphylococcus aureus
bacteraemia—duration of treatment in accordance with
risk of complications in individual patients
▶ Child 2–6 years: 9 mg/kg once daily for up to 14 days,
alternatively 12 mg/kg once daily, higher dose only if
associated with Staphylococcus aureus bacteraemia—
duration of treatment in accordance with risk of
complications in individual patients
▶ Child 7–11 years: 7 mg/kg once daily for up to 14 days,
alternatively 9 mg/kg once daily, higher dose only if
associated with Staphylococcus aureus bacteraemia—
duration of treatment in accordance with risk of
complications in individual patients
▶ Child 12–17 years: 5 mg/kg once daily for up to 14 days,
alternatively 7 mg/kg once daily, higher dose only if
associated with Staphylococcus aureus bacteraemia—
duration of treatment in accordance with risk of
complications in individual patients
Complicated skin and soft-tissue infections caused by
▶ BY SLOW INTRAVENOUS INJECTION, OR BY INTRAVENOUS
▶ Adult: 4 mg/kg once daily for 7–14 days or longer if
necessary, alternatively 6 mg/kg once daily, higher
dose only if associated with Staphylococcus aureus
bacteraemia—duration of treatment may need to be
longer than 14 days in accordance with risk of
complications in individual patients
Right-sided infective endocarditis caused by
Staphylococcus aureus (administered on expert advice)
▶ BY SLOW INTRAVENOUS INJECTION, OR BY INTRAVENOUS
▶ Adult: 6 mg/kg once daily, duration of treatment in
accordance with official recommendations
l CAUTIONS Obesity (limited information on safety and
l INTERACTIONS → Appendix 1: daptomycin
▶ Frequency not known Acute generalised exanthematous
SIDE-EFFECTS, FURTHER INFORMATION If unexplained
muscle pain, tenderness, weakness, or cramps develop
during treatment, measure creatine kinase every 2 days;
discontinue if unexplained muscular symptoms and
l PREGNANCY Manufacturer advises use only if potential
benefit outweighs risk—no information available.
l BREAST FEEDING Present in milk in small amounts, but
absorption from gastrointestinal tract negligible.
l HEPATIC IMPAIRMENT Manufacturer advises caution in
severe impairment—no information available.
▶ In children Manufacturer advises the dosage regimen has
not been established—use with caution and monitor renal
▶ In adults Manufacturer advises use only when potential
benefit outweighs risk—higher risk of developing
myopathy; monitor renal function regularly.
Dose adjustments ▶ In adults Use normal dose every
48 hours if eGFR less than 30 mL/minute/1.73 m2
▶ Manufacturer advises monitor plasma creatine
phosphokinase (CPK) before treatment and then at least
weekly during treatment; monitor CPK more frequently in
patients at higher risk of developing myopathy, including
those with renal impairment, taking other drugs
associated with myopathy, or if CPK elevated more than
5 times upper limit of normal before treatment.
▶ Manufacturer advises monitor renal function regularly
during concomitant administration of potentially
l EFFECT ON LABORATORY TESTS Interference with assay for
prothrombin time and INR—take blood sample
immediately before daptomycin dose.
l DIRECTIONS FOR ADMINISTRATION
▶ In children For intravenous infusion, manufacturer advises
give intermittently in Sodium Chloride 0.9%; reconstitute
with Sodium Chloride 0.9% (350 mg in 7 mL, 500 mg in
10 mL); gently rotate vial without shaking; allow to stand
for at least 10 minutes then rotate gently to dissolve;
dilute requisite dose in 50 mL infusion fluid and give over
60 minutes for children aged 1–6 years and over
30 minutes for children aged 7–17 years.
▶ In adults For intravenous infusion, manufacturer advises
give intermittently in Sodium Chloride 0.9%; reconstitute
with Sodium Chloride 0.9% (350 mg in 7 mL, 500 mg in
10 mL); gently rotate vial without shaking; allow to stand
for at least 10 minutes then rotate gently to dissolve;
dilute requisite dose in 50 mL infusion fluid and give over
30 minutes. For intravenous injection, give over 2 minutes.
l HANDLING AND STORAGE Manufacturer advises store in a
refrigerator (2–8 °C)—consult product literature for
further information regarding storage after reconstitution
l NATIONAL FUNDING/ACCESS DECISIONS
Scottish Medicines Consortium (SMC) decisions
▶ In adults The Scottish Medicines Consortium has advised
(April 2006) that daptomycin (Cubicin ®) is accepted for
restricted use within NHS Scotland for treatment of
BNF 78 Bacterial infection 569
complicated skin and soft tissue infections in patients with
known or suspected methicillin resistant Staphylococcus
aureus infection and on the advice of local microbiologists
or specialists in infectious disease.
▶ In adults The Scottish Medicines Consortium has advised
(March 2008) that daptomycin (Cubicin ®) is accepted for
restricted use within NHS Scotland for the treatment of
infections in patients with known or suspected methicillin
resistant infection and on the advice of local
microbiologists or specialists in infectious disease.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
Powder for solution for infusion
▶ Daptomycin (Non-proprietary)
Daptomycin 350 mg Daptomycin 350mg powder for solution for
infusion vials | 1 vial P £60.00–£62.00 (Hospital only)
Daptomycin 500 mg Daptomycin 500mg powder for solution for
infusion vials | 1 vial P £88.00–£88.57 (Hospital only)
▶ Cubicin (Merck Sharp & Dohme Ltd)
Daptomycin 350 mg Cubicin 350mg powder for concentrate for
solution for infusion vials | 1 vial P £62.00
Daptomycin 500 mg Cubicin 500mg powder for concentrate for
solution for infusion vials | 1 vial P £88.57 (Hospital only)
l DRUG ACTION Fidaxomicin is a macrocyclic antibacterial
that is poorly absorbed from the gastro-intestinal tract,
and, therefore, it should not be used to treat systemic
Clostridium difficile infection
▶ Adult: 200 mg every 12 hours for 10 days, limited
clinical data is available on the use of fidaxomicin in
severe or life-threatening Clostridium difficile infection
l CAUTIONS Inflammatory bowel disease . severe or lifethreatening C. difficile infection
l INTERACTIONS → Appendix 1: fidaxomicin
▶ Common or very common Constipation . nausea . vomiting
▶ Frequency not known Angioedema . dyspnoea . hypersensitivity
l ALLERGY AND CROSS-SENSITIVITY Use with caution in
l PREGNANCY Manufacturer advises avoid—no information
l BREAST FEEDING Manufacturer advises avoid—no
l HEPATIC IMPAIRMENT Manufacturer advises caution in
moderate to severe impairment—limited information
l RENAL IMPAIRMENT Manufacturer advises caution in
severe impairment—no information available.
l NATIONAL FUNDING/ACCESS DECISIONS
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (July 2012)
that fidaxomicin (Dificlir ®) is accepted for restricted use
within NHS Scotland to treat the first recurrence of C.
difficile infection, on the advice of a microbiologist or
specialist in infectious diseases.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 9
▶ Dificlir (Astellas Pharma Ltd)
Fidaxomicin 200 mg Dificlir 200mg tablets | 20 tablet P £1,350.00 DT = £1,350.00
l DRUG ACTION Fosfomycin, a phosphonic acid
antibacterial, is active against a range of Gram-positive
and Gram-negative bacteria including Staphylococcus
aureus and Enterobacteriaceae.
Acute uncomplicated lower urinary-tract infections
Prophylaxis of urinary-tract infections in transurethral
▶ Adult: 3 g, to be given 3 hours before surgery. Dose may
be repeated once, 24 hours after surgery
Osteomyelitis when first-line treatments are
inappropriate or ineffective | Hospital-acquired lower
respiratory-tract infections when first-line treatments
are inappropriate or ineffective
▶ Adult: 12–24 g daily in 2–3 divided doses (max. per
dose 8 g), use the high-dose regimen in severe
infection suspected or known to be caused by less
Complicated urinary-tract infections when first-line
treatment ineffective or inappropriate
▶ Adult: 12–16 g daily in 2–3 divided doses (max. per
Bacterial meningitis when first-line treatment ineffective
▶ Adult: 16–24 g daily in 3–4 divided doses (max. per
dose 8 g), use the high-dose regimen in severe
infection suspected or known to be caused by less
▶ With intravenous use Cardiac insufficiency . elderly (high
doses). hyperaldosteronism . hypernatraemia . hypertension . pulmonary oedema
▶ Common or very common Abdominal pain . diarrhoea . headache . nausea . vomiting
▶ Frequency not known Antibiotic associated colitis
▶ With oral use Dizziness . vulvovaginal infection
▶ With parenteral use Bone marrow disorders . eosinophilia . hepatic disorders . visual impairment
570 Bacterial infection BNF 78
l PREGNANCY Manufacturer advises use only if potential
l BREAST FEEDING Manufacturer advises use only if
potential benefit outweighs risk—present in milk.
▶ With oral use Avoid oral treatment if eGFR less than
▶ With intravenous use Use intravenous treatment with caution
if eGFR 40–80 mL/minute/1.73 m2 and consult product
literature for dose if eGFR less than 40 mL/minute/1.73 m2
▶ With intravenous use Monitor electrolytes and fluid balance.
l DIRECTIONS FOR ADMINISTRATION
▶ With intravenous use For intravenous infusion (Fomicyt ®),
give intermittently in Glucose 5% or 10% or Water for
Injections; reconstitute each 2-g vial with 50 mL infusion
fluid; give 2 g over 15 minutes.
▶ With oral use Manufacturer 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.
l PRESCRIBING AND DISPENSING INFORMATION Doses
l NATIONAL FUNDING/ACCESS DECISIONS
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (March
2015) that fosfomycin (Fomicyt ®) is accepted for restricted
use within NHS Scotland; initiation should be restricted to
microbiologists or infectious disease specialists.
The Scottish Medicines Consortium has 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.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
Powder for solution for infusion
ELECTROLYTES: May contain Sodium
Fosfomycin (as Fosfomycin sodium) 2 gram Fomicyt 2g powder for
solution for infusion vials | 10 vial P £150.00
Fosfomycin (as Fosfomycin sodium) 4 gram Fomicyt 4g powder for
solution for infusion vials | 10 vial P £300.00
CAUTIONARY AND ADVISORY LABELS 9, 13, 23
EXCIPIENTS: May contain Sucrose
▶ Fosfomycin (Non-proprietary)
Fosfomycin (as Fosfomycin trometamol) 3 gram Fosfomycin 3g
granules sachets | 1 sachet P £75.45 DT = £4.86
▶ Monuril (Profile Pharma Ltd)
Fosfomycin (as Fosfomycin trometamol) 3 gram Monuril 3g
granules sachets | 1 sachet P £4.86 DT = £4.86
▶ Child 12–17 years: 250 mg every 12 hours for 5-10 days,
dose expressed as sodium fusidate
▶ Adult: 250 mg every 12 hours for 5-10 days, dose
▶ Child: Apply 3–4 times a day usually for 7 days
▶ Adult: Apply 3–4 times a day
Penicillin-resistant staphylococcal infection including
osteomyelitis | Staphylococcal endocarditis in
combination with other antibacterials
▶ BY MOUTH USING ORAL SUSPENSION
▶ 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
▶ 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
▶ Adult: 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
▶ 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
▶ Adult (body-weight up to 50 kg): 6–7 mg/kg 3 times a
day, dose expressed as sodium fusidate
▶ Adult (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.
▶ With systemic use Impaired transport and metabolism of
▶ With topical use Avoid contact of cream or ointment with
▶ With topical use To 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
l INTERACTIONS → Appendix 1: fusidic acid
▶ With intravenous use Dizziness . drowsiness . hepatic
▶ With oral use Diarrhoea . dizziness . drowsiness . gastrointestinal discomfort. nausea . vomiting
▶ With intravenous use Appetite decreased . asthenia . headache . malaise
▶ With oral use Appetite decreased . asthenia . headache . malaise .rash pustular
▶ With topical use Angioedema . conjunctivitis
BNF 78 Bacterial infection 571
pancytopenia .renal failure .rhabdomyolysis . thrombocytopenia
SIDE-EFFECTS, FURTHER INFORMATION Elevated liver
enzymes, hyperbilirubinaemia and jaundice can occur with
systemic use—these effects are usually reversible following
▶ With systemic use Not known to be harmful; manufacturer
advises use only if potential benefit outweighs risk.
▶ With systemic use Present in milk—manufacturer advises
▶ With systemic use Manufacturer advises caution.
▶ With systemic use Manufacturer 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
l DIRECTIONS FOR ADMINISTRATION
▶ With intravenous use Manufacturer 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 infusion fluid
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).
l PRESCRIBING AND DISPENSING INFORMATION
▶ With oral use Flavours of oral liquid formulations may
l PROFESSION SPECIFIC INFORMATION
Dental practitioners’ formulary
May be prescribed as Sodium Fusidate ointment.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
CAUTIONARY AND ADVISORY LABELS 9
Sodium fusidate 250 mg Fucidin 250mg tablets | 10 tablet P £6.02 DT = £6.02 | 100 tablet P £54.99
CAUTIONARY AND ADVISORY LABELS 9
Fusidic acid 50 mg per 1 ml Fucidin 250mg/5ml oral suspension | 50 ml P £6.73 DT = £6.73
Powder and solvent for solution for infusion
ELECTROLYTES: May contain Sodium
▶ Fusidic acid (Non-proprietary)
Sodium fusidate 500 mg Sodium fusidate 500mg powder and
solvent for solution for infusion vials | 1 vial P £20.50–£20.90
EXCIPIENTS: May contain Butylated hydroxyanisole, cetostearyl alcohol
(including cetyl and stearyl alcohol)
▶ Fusidic acid (Non-proprietary)
Fusidic acid 20 mg per 1 gram Fucidin 20mg/g cream |
15 gram P £1.92 DT = £1.83 | 30 gram P £3.59 DT = £3.66
EXCIPIENTS: May contain Cetostearyl alcohol (including cetyl and
stearyl alcohol), woolfat and related substances (including lanolin)
l DRUG ACTION Linezolid, an oxazolidinone antibacterial, is
with prolonged treatment or if the dose is less than that
recommended. Linezolid is not active against common
Gram-negative organisms; it must be given in combination
with other antibacterials for mixed infections that also
involve Gram-negative organisms.
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
▶ Adult: 600 mg every 12 hours usually for 10–14 days
(maximum duration of treatment 28 days)
▶ Adult: 600 mg every 12 hours
Severe optic neuropathy may occur rarely, particularly if
linezolid is used for longer than 28 days. The CHM
. patients should be warned to report symptoms of
visual impairment (including blurred vision, visual
field defect, changes in visual acuity and colour vision)
. patients experiencing new visual symptoms
(regardless of treatment duration) should be evaluated
promptly, and referred to an ophthalmologist if
. visual function should be monitored regularly if
treatment is required for longer than 28 days.
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
. 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.
▶ Close observation Unless close observation and blood
pressure monitoring possible, linezolid should be avoided
in uncontrolled hypertension, phaeochromocytoma,
carcinoid tumour, thyrotoxicosis, bipolar depression,
schizophrenia, or acute confusional states.
l INTERACTIONS → Appendix 1: linezolid
572 Bacterial infection BNF 78
disorders . vulvovaginal disorder
▶ Rare or very rare Antibiotic associated colitis . bone
marrow disorders .tooth discolouration
▶ Frequency not known Alopecia . angioedema . lactic
acidosis . nerve disorders . serotonin syndrome . severe
cutaneous adverse reactions (SCARs)
l PREGNANCY Manufacturer advises use only if potential
benefit outweighs risk—no information available.
l BREAST FEEDING Manufacturer advises avoid—present in
l HEPATIC IMPAIRMENT Manufacturer advises caution in
severe impairment (no information available).
l RENAL IMPAIRMENT Manufacturer advises metabolites
may accumulate if eGFR less than 30 mL/minute/1.73 m2
l MONITORING REQUIREMENTS Monitor full blood count
(including platelet count) weekly.
l DIRECTIONS FOR ADMINISTRATION
▶ With intravenous use Infusion to be administered over
l PRESCRIBING AND DISPENSING INFORMATION Flavours of
oral liquid formulations may include orange.
l PATIENT AND CARER ADVICE Patients should be advised to
read the patient information leaflet given with linezolid.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
EXCIPIENTS: May contain Glucose
ELECTROLYTES: May contain Sodium
Linezolid 2 mg per 1 ml Zyvox 600mg/300ml infusion bags | 10 bag P £445.00
CAUTIONARY AND ADVISORY LABELS 9, 10
EXCIPIENTS: May contain Aspartame
Linezolid 20 mg per 1 ml Zyvox 100mg/5ml granules for oral
suspension | 150 ml P £222.50 DT = £222.50
CAUTIONARY AND ADVISORY LABELS 9, 10
Linezolid 600 mg Linezolid 600mg tablets | 10 tablet P £82.12–
Linezolid 600 mg Zyvox 600mg tablets | 10 tablet P £445.00 DT
l DRUG ACTION Tedizolid is an oxazolidinone antibacterial,
which inhibits bacterial protein synthesis.
Treatment of acute bacterial skin and skin structure
▶ BY INTRAVENOUS INFUSION, OR BY MOUTH
▶ Adult: 200 mg once daily for 6 days, patients should be
switched from the intravenous to the oral route when
l INTERACTIONS → Appendix 1: tedizolid
blurred . vitreous floater. vulvovaginal pruritus
▶ With intravenous use Infusion related reaction
l CONCEPTION AND CONTRACEPTION Manufacturer
recommends effective contraception in women of
childbearing potential; an additional method of
contraception is advised in women taking hormonal
contraceptives—effectiveness may be reduced.
l PREGNANCY Manufacturer advises avoid—fetal
developmental toxicity in animal studies.
l BREAST FEEDING Manufacturer advises avoid—present in
l DIRECTIONS FOR ADMINISTRATION For intravenous infusion
(Sivextro ®) give intermittently in Sodium Chloride 0.9%;
reconstitute each 200 mg vial with 4 mL Water for
Injections, then dilute reconstituted solution in 250 mL
sodium chloride 0.9%; give over approx. 1 hour.
Optic neuropathy Although neuropathy (peripheral and
optic) has not been reported in patients treated with
tedizolid, manufacturer advises patients and carers are
warned to report symptoms of visual impairment
(including blurred vision, visual field defect, changes in
visual acuity and colour vision) immediately; patients
should be evaluated promptly, and referred to an
Missed doses Manufacturer advises that if a dose is more
than 16 hours late, the missed dose should not be taken
and the next dose should be taken at the normal time.
Driving and skilled tasks Patients and carers should be
counselled on the effects on driving and skilled tasks—
increased risk of dizziness and fatigue.
l NATIONAL FUNDING/ACCESS DECISIONS
Scottish Medicines Consortium (SMC) decisions
The Scottish Medicines Consortium has advised (August
2015) that tedizolid (Sivextro ®) is accepted for restricted
use within NHS Scotland as an alternative oxazolidinone
antibacterial for the treatment of acute bacterial skin and
skin structure infections caused by Gram-positive
Staphylococcus aureus (specifically methicillin-resistant
Staphylococcus aureus[MRSA] isolates), on the specific
advice of local microbiologists or specialists in infectious
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug.
Powder for solution for infusion
▶ Sivextro (Merck Sharp & Dohme Ltd) A
Tedizolid phosphate 200 mg Sivextro 200mg powder for
concentrate for solution for infusion vials | 6 vial P £862.00
BNF 78 Bacterial infection 573
▶ Sivextro (Merck Sharp & Dohme Ltd) A
Tedizolid phosphate 200 mg Sivextro 200mg tablets | 6 tablet P £862.00
Urinary-tract infections | Respiratory-tract infections
▶ Child 4–5 weeks: 4 mg/kg twice daily (max. per dose
▶ Child 6 weeks–5 months: 4 mg/kg twice daily (max. per
dose 200 mg), alternatively 25 mg twice daily
▶ Child 6 months–5 years: 4 mg/kg twice daily (max. per
dose 200 mg), alternatively 50 mg twice daily
▶ Child 6–11 years: 4 mg/kg twice daily (max. per dose
200 mg), alternatively 100 mg twice daily
▶ Child 12–17 years: 200 mg twice daily
Prophylaxis of urinary-tract infection (considered for
recurrent infection, significant urinary-tract anomalies,
▶ Child 4–5 weeks: 2 mg/kg once daily (max. per dose
100 mg), dose to be taken at night
▶ Child 6 weeks–5 months: 2 mg/kg once daily (max. per
dose 100 mg), dose to be taken at night, alternatively
12.5 mg once daily, dose to be taken at night
▶ Child 6 months–5 years: 2 mg/kg once daily (max. per
dose 100 mg), dose to be taken at night, alternatively
25 mg once daily, dose to be taken at night
▶ Child 6–11 years: 2 mg/kg once daily (max. per dose
100 mg), dose to be taken at night, alternatively 50 mg
once daily, dose to be taken at night
▶ Child 12–17 years: 100 mg once daily, dose to be taken at
▶ Adult: 100 mg once daily, dose to be taken at night
Treatment of mild to moderate Pneumocystis jirovecii
(Pneumocystis carinii) pneumonia in patients who
cannot tolerate co-trimoxazole (in combination with
▶ Child: 5 mg/kg every 6–8 hours
▶ Adult: 5 mg/kg every 6–8 hours
Acne resistant to other antibacterials
▶ Adult: (consult product literature)
Shigellosis | Invasive salmonella infection
▶ Adult: (consult product literature)
l UNLICENSED USE Not licensed for treatment of
▶ In children Not licensed for use in children under 6 weeks.
▶ In adults Not licensed for treatment of acne resistant to
l CONTRA-INDICATIONS Blood dyscrasias
l CAUTIONS Elderly . Acute porphyrias p. 1058 . predisposition to folate deficiency
l INTERACTIONS → Appendix 1: trimethoprim
enterocolitis .renal impairment. seizure . severe
▶ Frequency not known Gastrointestinal disorder. megaloblastic anaemia . methaemoglobinaemia
l PREGNANCY Teratogenic risk in first trimester (folate
antagonist). Manufacturers advise avoid during pregnancy.
l BREAST FEEDING Present in milk—short-term use not
Dose adjustments ▶ In adults Use half normal dose after
3 days if eGFR 15–30 mL/minute/1.73 m2
dose if eGFR less than 15 mL/minute/1.73 m2
▶ In children Use half normal dose after 3 days if estimated
glomerular filtration rate 15–30 mL/minute/1.73 m2
half normal dose if estimated glomerular filtration rate less
Monitoring Monitor plasma-trimethoprim concentration if
eGFR less than 10 mL/minute/1.73 m2
l MONITORING REQUIREMENTS Manufacturer recommends
blood counts on long-term therapy (but evidence of
practical value unsatisfactory).
Blood disorders On long-term treatment, patients and their
carers should be told how to recognise signs of blood
disorders and advised to seek immediate medical attention
if symptoms such as fever, sore throat, rash, mouth ulcers,
purpura, bruising or bleeding develop.
Medicines for Children leaflet: Trimethoprim for bacterial infections
www.medicinesforchildren.org.uk/trimethoprim-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: oral suspension, oral
CAUTIONARY AND ADVISORY LABELS 9
▶ Trimethoprim (Non-proprietary)
Trimethoprim 10 mg per 1 ml Trimethoprim 50mg/5ml oral
suspension sugar free sugar-free | 100 ml P £5.70 DT = £5.70
▶ Monotrim (Chemidex Pharma Ltd)
Trimethoprim 10 mg per 1 ml Monotrim 50mg/5ml oral suspension
sugar-free | 100 ml P £1.77 DT = £5.70
CAUTIONARY AND ADVISORY LABELS 9
▶ Trimethoprim (Non-proprietary)
Trimethoprim 100 mg Trimethoprim 100mg tablets | 28 tablet P £9.99 DT = £0.83
Combinations available: Co-trimoxazole, p. 562
574 Bacterial infection BNF 78
ANTIMYCOBACTERIALS › RIFAMYCINS
Prophylaxis of Mycobacterium avium complex infections
in immunosuppressed patients with low CD4 count
▶ Adult: 300 mg once daily, also consult product
Treatment of non-tuberculous mycobacterial disease, in
▶ Adult: 450–600 mg once daily for up to 6 months after
Treatment of pulmonary tuberculosis, in combination
▶ Adult: 150–450 mg once daily for at least 6 months
l CAUTIONS Acute porphyrias p. 1058 . discolours soft
l INTERACTIONS → Appendix 1: rifabutin
common following high doses or concomitant use with
drugs that increase plasma concentration). vomiting
l ALLERGY AND CROSS-SENSITIVITY Contra-indicated in
patients with rifamycin hypersensitivity.
l CONCEPTION AND CONTRACEPTION
Important Rifabutin induces hepatic enzymes and the
effectiveness of hormonal contraceptives is reduced;
alternative family planning advice should be offered.
l PREGNANCY Manufacturer advises avoid—no information
l BREAST FEEDING Manufacturer advises avoid—no
Dose adjustments Reduce dose in severe impairment.
Monitoring In patients with pre-existing liver disease or
hepatic impairment monitor liver function regularly and
particularly frequently in the first 2 months; blood counts
should also be monitored in these patients.
Dose adjustments Use half normal dose if eGFR less than
▶ Renal function should be checked before treatment.
▶ Hepatic function should be checked before treatment. If
there is no evidence of liver disease (and pre-treatment
liver function is normal), further checks are only necessary
if the patient develops fever, malaise, vomiting, jaundice
or unexplained deterioration during treatment. However,
hepatic function should be monitored on prolonged
▶ Blood counts should be monitored on prolonged therapy.
▶ Those with alcohol dependence should have frequent
checks of hepatic function, particularly in the first
2 months. Blood counts should also be monitored in these
l PRESCRIBING AND DISPENSING INFORMATION If treatment
interruption occurs, re-introduce with low dosage and
Soft contact lenses Patients or their carers should be advised
that rifabutin discolours soft contact lenses.
Hepatic disorders Patients or their carers should be told how
to recognise signs of liver disorder, and advised to
discontinue treatment and seek immediate medical
attention if symptoms such as persistent nausea,
vomiting, malaise or jaundice develop.
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug. Forms available
from special-order manufacturers include: oral suspension, oral
CAUTIONARY AND ADVISORY LABELS 8, 14
Rifabutin 150 mg Mycobutin 150mg capsules | 30 capsule P £90.38
l DRUG ACTION Rifaximin is a rifamycin that is poorly
absorbed from the gastro-intestinal tract, and, therefore,
should not be used to treat systemic infections.
Travellers’ diarrhoea that is not associated with fever,
bloody diarrhoea, blood or leucocytes in the stool, or 8
or more unformed stools in the previous 24 hours
▶ Adult: 200 mg every 8 hours for 3 days
Reduction in recurrence of hepatic encephalopathy
l CONTRA-INDICATIONS Intestinal obstruction
l INTERACTIONS → Appendix 1: rifaximin
discomfort. gastrointestinal disorders . headaches . muscle
complaints . nausea . oedema . skin reactions . vomiting
▶ Rare or very rare Hypertension . hypotension
▶ Frequency not known Angioedema . syncope . thrombocytopenia . urine discolouration
l ALLERGY AND CROSS-SENSITIVITY Contra-indicated if
history of rifamycin hypersensitivity.
l PREGNANCY Manufacturer advises avoid—toxicity in
l BREAST FEEDING Unlikely to be present in milk in
significant amounts, but manufacturer advises avoid.
▶ When used for Hepatic encephalopathy Manufacturer advises
caution in severe impairment (risk of increased exposure).
l PRESCRIBING AND DISPENSING INFORMATION Not
recommended for diarrhoea associated with invasive
organisms such as Campylobacter and Shigella.
BNF 78 Bacterial infection 575
l NATIONAL FUNDING/ACCESS DECISIONS
▶ Rifaximin for preventing episodes of overt hepatic
encephalopathy (March 2015) NICE TA337
Rifaximin (Targaxan ®) is recommended, within its
marketing authorisation, as an option for reducing the
recurrence of episodes of overt hepatic encephalopathy in
www.nice.org.uk/guidance/ta337
l MEDICINAL FORMS There can be variation in the licensing of
different medicines containing the same drug. Forms available
from special-order manufacturers include: oral suspension
CAUTIONARY AND ADVISORY LABELS 9(Xifaxantan ® brand only), 14
▶ Targaxan (Norgine Pharmaceuticals Ltd)
Rifaximin 550 mg Targaxan 550mg tablets | 56 tablet P £259.23 DT = £259.23
▶ Xifaxanta (Norgine Pharmaceuticals Ltd)
Rifaximin 200 mg Xifaxanta 200mg tablets | 9 tablet P £15.15
Treatment and post-exposure prophylaxis
Inhalation or gastro-intestinal anthrax should be treated
initially with either ciprofloxacin p. 558 or, in patients over
12 years, doxycycline p. 564 [unlicensed indication]
combined with one or two other antibacterials (such as
amoxicillin p. 548, benzylpenicillin sodium p. 547,
No comments:
Post a Comment
اكتب تعليق حول الموضوع