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 |

1 vial P £22.00 DT = £22.00

Capsule

▶ Chloramphenicol (Non-proprietary)

Chloramphenicol 250 mg Chloramphenicol 250mg capsules |

60 capsule P £377.00 DT = £377.00

Daptomycin 21-Feb-2019

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

anaerobes.

l INDICATIONS AND DOSE

Complicated skin and soft-tissue infections caused by

Gram-positive bacteria

▶ BY INTRAVENOUS INFUSION

▶ 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

Gram-positive bacteria

▶ BY SLOW INTRAVENOUS INJECTION, OR BY INTRAVENOUS

INFUSION

▶ 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

INFUSION

▶ Adult: 6 mg/kg once daily, duration of treatment in

accordance with official recommendations

l CAUTIONS Obesity (limited information on safety and

efficacy)

l INTERACTIONS → Appendix 1: daptomycin

l SIDE-EFFECTS

▶ Common or very common Anaemia . anxiety . asthenia . constipation . diarrhoea . dizziness .fever. flatulence . gastrointestinal discomfort. headache . hypertension . hypotension . increased risk of infection . insomnia . nausea . pain . skin reactions . vomiting

▶ Uncommon Appetite decreased . arrhythmias . arthralgia . electrolyte imbalance . eosinophilia . flushing . glossitis . hyperglycaemia . muscle weakness . myalgia . myopathy . paraesthesia .renal impairment.taste altered . thrombocytosis .tremor. vertigo

▶ Rare or very rare Jaundice

▶ Frequency not known Acute generalised exanthematous

pustulosis (AGEP). antibiotic associated colitis . chills . cough . infusion related reaction . peripheral neuropathy . respiratory disorders . syncope

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

creatine elevated markedly.

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.

l RENAL IMPAIRMENT

▶ In children Manufacturer advises the dosage regimen has

not been established—use with caution and monitor renal

function regularly.

▶ 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

.

l MONITORING REQUIREMENTS

▶ 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

nephrotoxic drugs.

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

and dilution.

l NATIONAL FUNDING/ACCESS DECISIONS

Scottish Medicines Consortium (SMC) decisions

SMC No. 248/06

▶ 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

Infection

5

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.

SMC No. 449/08

▶ 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

Staphylococcus aureus bacteraemia associated with rightsided endocarditis or with complicated skin and soft-tissue

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)

Fidaxomicin 08-Feb-2019

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

infections.

l INDICATIONS AND DOSE

Clostridium difficile infection

▶ BY MOUTH

▶ 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

l SIDE-EFFECTS

▶ Common or very common Constipation . nausea . vomiting

▶ Uncommon Abdominal distension . appetite decreased . dizziness . dry mouth . flatulence . headache . skin

reactions .taste altered

▶ Frequency not known Angioedema . dyspnoea . hypersensitivity

l ALLERGY AND CROSS-SENSITIVITY Use with caution in

macrolide hypersensitivity.

l PREGNANCY Manufacturer advises avoid—no information

available.

l BREAST FEEDING Manufacturer advises avoid—no

information available.

l HEPATIC IMPAIRMENT Manufacturer advises caution in

moderate to severe impairment—limited information

available.

l RENAL IMPAIRMENT Manufacturer advises caution in

severe impairment—no information available.

l NATIONAL FUNDING/ACCESS DECISIONS

Scottish Medicines Consortium (SMC) decisions

SMC No. 791/12

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.

Tablet

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

Fosfomycin 25-Apr-2019

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.

l INDICATIONS AND DOSE

Acute uncomplicated lower urinary-tract infections

▶ BY MOUTH USING GRANULES

▶ Adult: 3 g for 1 dose

Prophylaxis of urinary-tract infections in transurethral

surgical procedures

▶ BY MOUTH USING GRANULES

▶ 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

▶ BY INTRAVENOUS INFUSION

▶ 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

sensitive organisms

Complicated urinary-tract infections when first-line

treatment ineffective or inappropriate

▶ BY INTRAVENOUS INFUSION

▶ Adult: 12–16 g daily in 2–3 divided doses (max. per

dose 8 g)

Bacterial meningitis when first-line treatment ineffective

or inappropriate

▶ BY INTRAVENOUS INFUSION

▶ 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

sensitive organisms

l CAUTIONS

▶ With intravenous use Cardiac insufficiency . elderly (high

doses). hyperaldosteronism . hypernatraemia . hypertension . pulmonary oedema

l SIDE-EFFECTS

GENERAL SIDE-EFFECTS

▶ Common or very common Abdominal pain . diarrhoea . headache . nausea . vomiting

▶ Uncommon Skin reactions

▶ Frequency not known Antibiotic associated colitis

SPECIFIC SIDE-EFFECTS

▶ Common or very common

▶ With oral use Dizziness . vulvovaginal infection

▶ Uncommon

▶ With parenteral use Appetite decreased . dyspnoea . electrolyte imbalance . fatigue . oedema .taste altered . vertigo

▶ Rare or very rare

▶ With parenteral use Bone marrow disorders . eosinophilia . hepatic disorders . visual impairment

▶ Frequency not known

▶ With parenteral use Agranulocytosis . asthmatic attack . confusion . leucopenia . neutropenia .tachycardia . thrombocytopenia

570 Bacterial infection BNF 78

Infection

5

l PREGNANCY Manufacturer advises use only if potential

benefit outweighs risk.

l BREAST FEEDING Manufacturer advises use only if

potential benefit outweighs risk—present in milk.

l RENAL IMPAIRMENT

▶ With oral use Avoid oral treatment if eGFR less than

10 mL/minute/1.73 m2

.

▶ 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

.

l MONITORING REQUIREMENTS

▶ 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

expressed as fosfomycin base.

l NATIONAL FUNDING/ACCESS DECISIONS

Scottish Medicines Consortium (SMC) decisions

SMC No. 1033/15

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.

SMC No. 1163/16

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

▶ Fomicyt (Nordic Pharma Ltd)

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

Granules

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

Fusidic acid 16-Jun-2017

l DRUG ACTION Fusidic acid and its salts are narrowspectrum antibiotics used for staphylococcal infections.

l INDICATIONS 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

▶ Adult: 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

▶ 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

▶ Adult: 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

▶ 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

▶ 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

▶ 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

▶ With oral use

▶ Fusidic acid is incompletely absorbed and doses

recommended for suspension are proportionately

higher than those for sodium fusidate tablets.

l CAUTIONS

▶ With systemic use Impaired transport and metabolism of

bilirubin

▶ With topical use Avoid contact of cream or ointment with

eyes

CAUTIONS, FURTHER INFORMATION

▶ Avoiding resistance

▶ 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

in hospital.

l INTERACTIONS → Appendix 1: fusidic acid

l SIDE-EFFECTS

GENERAL SIDE-EFFECTS

▶ Uncommon Skin reactions

SPECIFIC SIDE-EFFECTS

▶ Common or very common

▶ With intravenous use Dizziness . drowsiness . hepatic

disorders . hyperbilirubinaemia .thrombophlebitis . vascular pain (reduced if given via central vein)

▶ With oral use Diarrhoea . dizziness . drowsiness . gastrointestinal discomfort. nausea . vomiting

▶ Uncommon

▶ With intravenous use Appetite decreased . asthenia . headache . malaise

▶ With oral use Appetite decreased . asthenia . headache . malaise .rash pustular

▶ Rare or very rare

▶ With topical use Angioedema . conjunctivitis

▶ Frequency not known

▶ With intravenous use Agranulocytosis . anaemia . leucopenia . neutropenia . pancytopenia .renal failure . rhabdomyolysis .thrombocytopenia

▶ With oral use Agranulocytosis . anaemia . hepatic disorders . hyperbilirubinaemia . leucopenia . neutropenia .

BNF 78 Bacterial infection 571

Infection

5

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

withdrawal of therapy.

l PREGNANCY

▶ With systemic use Not known to be harmful; manufacturer

advises use only if potential benefit outweighs risk.

l BREAST FEEDING

▶ With systemic use Present in milk—manufacturer advises

caution.

l HEPATIC IMPAIRMENT

▶ With systemic use Manufacturer advises caution.

l MONITORING REQUIREMENTS

▶ 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

similar excretion pathway.

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

include banana and orange.

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.

Tablet

CAUTIONARY AND ADVISORY LABELS 9

▶ Fucidin (LEO Pharma)

Sodium fusidate 250 mg Fucidin 250mg tablets | 10 tablet P £6.02 DT = £6.02 | 100 tablet P £54.99

Oral suspension

CAUTIONARY AND ADVISORY LABELS 9

▶ Fucidin (LEO Pharma)

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

Cream

EXCIPIENTS: May contain Butylated hydroxyanisole, cetostearyl alcohol

(including cetyl and stearyl alcohol)

▶ Fusidic acid (Non-proprietary)

Fusidic acid 20 mg per 1 gram Fusidic acid 2% cream | 15 gram P £2.05 DT = £1.83 | 30 gram P £5.00 DT = £3.66

▶ Fucidin (LEO Pharma)

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

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 gram Fucidin 20mg/g ointment | 15 gram P £2.68 DT = £2.68 | 30 gram P £4.55 DT = £4.55

Linezolid

l DRUG ACTION Linezolid, an oxazolidinone antibacterial, is

active against Gram-positive bacteria including meticillinresistant Staphylococcus aureus (MRSA), and glycopeptideresistant enterococci. Resistance to linezolid can develop

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.

l INDICATIONS 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

▶ Adult: 600 mg every 12 hours usually for 10–14 days

(maximum duration of treatment 28 days)

▶ BY INTRAVENOUS INFUSION

▶ Adult: 600 mg every 12 hours

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.

l CAUTIONS Acute confusional states . bipolar depression . carcinoid tumour. elderly (increased risk of blood

disorders). history of seizures . phaeochromocytoma . schizophrenia .thyrotoxicosis . uncontrolled hypertension

CAUTIONS, FURTHER INFORMATION

▶ 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

l SIDE-EFFECTS

▶ Common or very common Anaemia . constipation . diarrhoea . dizziness . gastrointestinal discomfort.

572 Bacterial infection BNF 78

Infection

5

headache . hypertension . increased risk of infection . insomnia . localised pain . nausea . skin reactions .taste

altered . vomiting

▶ Uncommon Arrhythmia . chills . dry mouth . eosinophilia . fatigue . gastritis . hyperhidrosis . hyponatraemia . leucopenia . neutropenia . oral disorders . pancreatitis . polyuria .renal failure . seizure . sensation abnormal . thirst.thrombocytopenia .thrombophlebitis .tinnitus . tongue discolouration .transient ischaemic attack . vision

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

milk in animal studies.

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

30–120 minutes.

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.

Infusion

EXCIPIENTS: May contain Glucose

ELECTROLYTES: May contain Sodium

▶ Linezolid (Non-proprietary)

Linezolid 2 mg per 1 ml Linezolid 600mg/300ml infusion bags | 10 bag P £445.00–£515.20 (Hospital only)

▶ Zyvox (Pfizer Ltd)

Linezolid 2 mg per 1 ml Zyvox 600mg/300ml infusion bags | 10 bag P £445.00

Oral suspension

CAUTIONARY AND ADVISORY LABELS 9, 10

EXCIPIENTS: May contain Aspartame

▶ Zyvox (Pfizer Ltd)

Linezolid 20 mg per 1 ml Zyvox 100mg/5ml granules for oral

suspension | 150 ml P £222.50 DT = £222.50

Tablet

CAUTIONARY AND ADVISORY LABELS 9, 10

▶ Linezolid (Non-proprietary)

Linezolid 600 mg Linezolid 600mg tablets | 10 tablet P £82.12–

£445.00 DT = £327.22

▶ Zyvox (Pfizer Ltd)

Linezolid 600 mg Zyvox 600mg tablets | 10 tablet P £445.00 DT

= £327.22

Tedizolid 07-Feb-2019

l DRUG ACTION Tedizolid is an oxazolidinone antibacterial,

which inhibits bacterial protein synthesis.

l INDICATIONS AND DOSE

Treatment of acute bacterial skin and skin structure

infections

▶ 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

clinically appropriate

l CAUTIONS Neutropenia—limited clinical experience . patients aged 75 years and over—limited clinical

experience

l INTERACTIONS → Appendix 1: tedizolid

l SIDE-EFFECTS

GENERAL SIDE-EFFECTS

▶ Common or very common Diarrhoea . dizziness .fatigue . headache . nausea . skin reactions . vomiting

▶ Uncommon Abscess . alopecia . antibiotic associated colitis . anxiety . arthralgia . bradycardia . chills . constipation . cough . dehydration . diabetic control impaired . drowsiness . dry mouth .fever. gastrointestinal discomfort . gastrointestinal disorders . haematochezia . hyperhidrosis . hyperkalaemia . increased risk of infection . irritability . limb discomfort. lymphadenopathy . muscle spasms . nasal

dryness . pain . peripheral oedema . pulmonary congestion . sensation abnormal . sleep disorders .taste altered . tremor. urine odour abnormal . vasodilation . vision

blurred . vitreous floater. vulvovaginal pruritus

SPECIFIC SIDE-EFFECTS

▶ Uncommon

▶ 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

milk in animal studies.

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.

l PATIENT AND CARER ADVICE

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

ophthalmologist if necessary.

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

SMC No. 1080/15

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

disease.

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

Infection

5

Tablet

▶ Sivextro (Merck Sharp & Dohme Ltd) A

Tedizolid phosphate 200 mg Sivextro 200mg tablets | 6 tablet P £862.00

Trimethoprim

l INDICATIONS AND DOSE

Urinary-tract infections | Respiratory-tract infections

▶ BY MOUTH

▶ Child 4–5 weeks: 4 mg/kg twice daily (max. per dose

200 mg)

▶ 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

▶ Adult: 200 mg twice daily

Prophylaxis of urinary-tract infection (considered for

recurrent infection, significant urinary-tract anomalies,

or significant kidney damage)

▶ BY MOUTH

▶ 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

night

▶ 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

dapsone)

▶ BY MOUTH

▶ Child: 5 mg/kg every 6–8 hours

▶ Adult: 5 mg/kg every 6–8 hours

Acne resistant to other antibacterials

▶ BY MOUTH

▶ Adult: 300 mg twice daily

Prostatitis

▶ BY MOUTH

▶ Adult: (consult product literature)

Shigellosis | Invasive salmonella infection

▶ BY MOUTH

▶ Adult: (consult product literature)

l UNLICENSED USE Not licensed for treatment of

pneumocystis pneumonia.

▶ In children Not licensed for use in children under 6 weeks.

▶ In adults Not licensed for treatment of acne resistant to

other antibacterials.

l CONTRA-INDICATIONS Blood dyscrasias

l CAUTIONS Elderly . Acute porphyrias p. 1058 . predisposition to folate deficiency

l INTERACTIONS → Appendix 1: trimethoprim

l SIDE-EFFECTS

▶ Common or very common Diarrhoea . electrolyte imbalance .fungal overgrowth . headache . nausea . skin reactions . vomiting

▶ Rare or very rare Agranulocytosis . angioedema . anxiety . appetite decreased . arthralgia . behaviour abnormal . bone

marrow disorders . confusion . constipation . cough . depression . dizziness . dyspnoea . eosinophilia . erythema

nodosum .fever. haemolysis . haemolytic anaemia . haemorrhage . hallucination . hepatic disorders . hypoglycaemia . lethargy . leucopenia . meningitis aseptic . movement disorders . myalgia . neutropenia . oral

disorders . pancreatitis . paraesthesia . peripheral neuritis . photosensitivity reaction . pseudomembranous

enterocolitis .renal impairment. seizure . severe

cutaneous adverse reactions (SCARs). sleep disorders . syncope . systemic lupus erythematosus (SLE). thrombocytopenia .tinnitus .tremor. uveitis . vasculitis . vertigo . wheezing

▶ 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

known to be harmful.

l RENAL IMPAIRMENT

Dose adjustments ▶ In adults Use half normal dose after

3 days if eGFR 15–30 mL/minute/1.73 m2

. Use half normal

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

. Use

half normal dose if estimated glomerular filtration rate less

than 15 mL/minute/1.73 m2

.

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).

l PATIENT AND CARER ADVICE

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

solution

Oral suspension

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

Tablet

CAUTIONARY AND ADVISORY LABELS 9

▶ Trimethoprim (Non-proprietary)

Trimethoprim 100 mg Trimethoprim 100mg tablets | 28 tablet P £9.99 DT = £0.83

Trimethoprim 200 mg Trimethoprim 200mg tablets | 6 tablet P £2.15 DT = £0.38 | 14 tablet P £9.99 DT = £0.89

Combinations available: Co-trimoxazole, p. 562

574 Bacterial infection BNF 78

Infection

5

ANTIMYCOBACTERIALS › RIFAMYCINS

Rifabutin

l INDICATIONS AND DOSE

Prophylaxis of Mycobacterium avium complex infections

in immunosuppressed patients with low CD4 count

▶ BY MOUTH

▶ Adult: 300 mg once daily, also consult product

literature

Treatment of non-tuberculous mycobacterial disease, in

combination with other drugs

▶ BY MOUTH

▶ Adult: 450–600 mg once daily for up to 6 months after

cultures negative

Treatment of pulmonary tuberculosis, in combination

with other drugs

▶ BY MOUTH

▶ Adult: 150–450 mg once daily for at least 6 months

l CAUTIONS Acute porphyrias p. 1058 . discolours soft

contact lenses

l INTERACTIONS → Appendix 1: rifabutin

l SIDE-EFFECTS Agranulocytosis . anaemia . arthralgia . bronchospasm . chest pain . corneal deposits . decreased

leucocytes . dyspnoea . eosinophilia . fever. haemolysis . hepatic disorders . influenza like illness . myalgia . nausea . neutropenia . pancytopenia . skin reactions . thrombocytopenia . urine discolouration . uveitis (more

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

available.

l BREAST FEEDING Manufacturer advises avoid—no

information available.

l HEPATIC IMPAIRMENT

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.

l RENAL IMPAIRMENT

Dose adjustments Use half normal dose if eGFR less than

30 mL/minute/1.73 m2

.

l MONITORING REQUIREMENTS

▶ 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

therapy.

▶ 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

patients.

l PRESCRIBING AND DISPENSING INFORMATION If treatment

interruption occurs, re-introduce with low dosage and

increase gradually.

l PATIENT AND CARER ADVICE

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

solution

Capsule

CAUTIONARY AND ADVISORY LABELS 8, 14

▶ Mycobutin (Pfizer Ltd)

Rifabutin 150 mg Mycobutin 150mg capsules | 30 capsule P £90.38

Rifaximin 07-Feb-2019

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.

l INDICATIONS AND DOSE

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

▶ BY MOUTH

▶ Adult: 200 mg every 8 hours for 3 days

Reduction in recurrence of hepatic encephalopathy

▶ BY MOUTH

▶ Adult: 550 mg twice daily

l CONTRA-INDICATIONS Intestinal obstruction

l INTERACTIONS → Appendix 1: rifaximin

l SIDE-EFFECTS

▶ Common or very common Arthralgia . ascites . constipation . depression . dizziness . dyspnoea . gastrointestinal

discomfort. gastrointestinal disorders . headaches . muscle

complaints . nausea . oedema . skin reactions . vomiting

▶ Uncommon Anaemia . anxiety . appetite decreased . asthenia . balance impaired . concentration impaired . confusion . cough . diplopia . drowsiness . dry lips . dry

mouth . dry throat. ear pain . fall . haematuria . hot flush . hyperhidrosis . hyperkalaemia . increased risk of infection . lymphocytosis . memory loss . muscle weakness . nasal

complaints . neutropenia . oropharyngeal pain . pain . palpitations . polymenorrhoea .respiratory disorders . seizure . sensation abnormal . sleep disorders . sunburn . taste altered . urinary disorders . urine abnormalities . vertigo

▶ 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

animal studies.

l BREAST FEEDING Unlikely to be present in milk in

significant amounts, but manufacturer advises avoid.

l HEPATIC IMPAIRMENT

▶ 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

Infection

5

l NATIONAL FUNDING/ACCESS DECISIONS

NICE 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

adults.

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

Tablet

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

DT = £15.15

2.1 Anthrax

Anthrax

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,

chloramphenicol p. 568, clarithromycin p. 538, clindamycin

p. 535, imipenem with cilastatin p. 522, rifampicin p. 582

Comments

Search This Blog

Archive

Show more

Popular posts from this blog

TRIPASS XR تري باس

CELEPHI 200 MG, Gélule

ZENOXIA 15 MG, Comprimé

VOXCIB 200 MG, Gélule

Kana Brax Laberax

فومي كايند

بعض الادويه نجد رموز عليها مثل IR ، MR, XR, CR, SR , DS ماذا تعني هذه الرموز

NIFLURIL 700 MG, Suppositoire adulte

Antifongiques مضادات الفطريات

Popular posts from this blog

علاقة البيبي بالفراولة بالالفا فيتو بروتين

التغيرات الخمس التي تحدث للجسم عند المشي

إحصائيات سنة 2020 | تعداد سكَان دول إفريقيا تنازليا :

ما هو الليمونير للأسنان ؟

ACUPAN 20 MG, Solution injectable

CELEPHI 200 MG, Gélule

الام الظهر

VOXCIB 200 MG, Gélule

ميبستان

Popular posts from this blog

TRIPASS XR تري باس

CELEPHI 200 MG, Gélule

Popular posts from this blog

TRIPASS XR تري باس

CELEPHI 200 MG, Gélule

ZENOXIA 15 MG, Comprimé

VOXCIB 200 MG, Gélule

Kana Brax Laberax

فومي كايند

بعض الادويه نجد رموز عليها مثل IR ، MR, XR, CR, SR , DS ماذا تعني هذه الرموز

NIFLURIL 700 MG, Suppositoire adulte

Antifongiques مضادات الفطريات

Popular posts from this blog

Kana Brax Laberax

TRIPASS XR تري باس

PARANTAL 100 MG, Suppositoire بارانتال 100 مجم تحاميل

الكبد الدهني Fatty Liver

الم اسفل الظهر (الحاد) الذي يظهر بشكل مفاجئ bal-agrisi

SEDALGIC 37.5 MG / 325 MG, Comprimé pelliculé [P] سيدالجيك 37.5 مجم / 325 مجم ، قرص مغلف [P]

نمـو الدمـاغ والتطـور العقـلي لـدى الطفـل

CELEPHI 200 MG, Gélule

أخطر أنواع المخدرات فى العالم و الشرق الاوسط

Archive

Show more