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580 Bacterial infection BNF 78

Infection

5

For healthcare workers who are immunocompromised,

follow standard advice for testing and treatment (see

Immunocompromised above).

Chemoprophylaxis for latent tuberculosis

Chemoprophylaxis involves use of either isoniazid p. 587

(with pyridoxine hydrochloride p. 1080) alone for six months

(recommended if interactions with rifamycins are a concern)

or rifampicin p. 582 and isoniazid (with pyridoxine

hydrochloride) for three months (recommended when

hepatotoxicity is a concern).

Choice of regimen is dependent on clinical factors,

including age, risk of hepatotoxicity and possible drug

interactions. Testing for HIV, hepatitis B and hepatitis C

should be offered before starting antituberculosis treatment

as this may affect choice of therapy.

Patients with severe liver disease should be treated under

the care of a specialist team; careful monitoring of liver

function is necessary in patients with non-severe liver

disease, abnormal liver function, or who misuse alcohol or

drugs.

See advice on immunisation against tuberculosis in BCG

vaccine p. 1297.

Treatment failure

Major causes of treatment failure are incorrect prescribing by

the physician and inadequate compliance by the patient.

Monthly tablet counts and urine examination (rifampicin

imparts an orange-red coloration) may be useful indicators

of compliance with treatment. Avoid both excessive and

inadequate dosage. Treatment should be supervised by a

specialist physician.

Treatment interruptions

A break in antituberculosis treatment of at least two weeks

(during the initial phase) or missing more than 20 % of

prescribed doses is classified as treatment interruption. Reestablishing treatment appropriately following interruptions

is key to ensuring treatment success without relapse, drug

resistance or further adverse events. If an adverse reaction

recurs upon re-introducing a particular drug, do not give

that drug in future regimens and consider extending the

total regimen accordingly.

Treatment interruptions due to drug-induced hepatotoxicity

Following treatment interruption due to drug-induced

hepatotoxicty, all potential causes of hepatotoxicity should

be investigated. Once hepatic function has recovered,

antituberculosis therapy should be sequentially reintroduced at previous full doses over a period of no more

than ten days, initially with ethambutol hydrochloride p. 586

and either isoniazid (with pyridoxine hydrochloride) or

rifampicin.

In patients with severe or highly infectious tuberculosis

who need to interrupt the standard regimen, consider

continuing treatment with at least two drugs with low risk of

hepatotoxicity, such as ethambutol hydrochloride and

streptomycin p. 520 (with or without a quinolone, such as

levofloxacin p. 559 or moxifloxacin p. 560), with ongoing

monitoring by a liver specialist.

Treatment interruptions due to cutaneous reactions

If a patient with severe or highly infectious tuberculosis has

a cutaneous reaction, consider continuing treatment with a

combination of at least two drugs with low risk for causing

cutaneous reactions, such as ethambutol hydrochloride and

streptomycin, with monitoring by a dermatologist.

Antituberculosis drugs

Isoniazid is cheap and highly effective. Like rifampicin it

should always be included in any antituberculosis regimen

unless there is a specific contra-indication.

Rifampicin, a rifamycin, is a key component of any

antituberculosis regimen. Like isoniazid it should always be

included unless there is a specific contra-indication.

During the first two months (‘initial phase’) of rifampicin

administration transient disturbance of liver function with

elevated serum transaminases is common but generally does

not require interruption of treatment. Occasionally more

serious liver toxicity requires a change of treatment

particularly in those with pre-existing liver disease.

On intermittent treatment six toxicity syndromes have

been recognised—influenza-like, abdominal, and respiratory

symptoms, shock, renal failure, and thrombocytopenic

purpura—and can occur in 20–30% of patients.

Rifabutin p. 575, another rifamycin, is indicated for

prophylaxis against M. avium complex infections in patients

with a low CD4 count; it is also licensed for the treatment of

non-tuberculous mycobacterial disease and pulmonary

tuberculosis.

Pyrazinamide p. 588 is a bactericidal drug only active

against intracellular dividing forms of Mycobacterium

tuberculosis; it exerts its main effect only in the first two or

three months. It is particularly useful in tuberculous

meningitis because of good meningeal penetration. It is not

active against M. bovis.

Ethambutol hydrochloride is included in a treatment

regimen if isoniazid resistance is suspected; it can be

omitted if the risk of resistance is low.

Streptomycin [unlicensed] is now rarely used in the UK

except for resistant organisms.

Drug-resistant tuberculosis

Drug-resistant tuberculosis should be treated by a specialist

physician with experience in such cases, and where

appropriate facilities for infection-control exist. Multidrugresistant tuberculosis (resistance to isoniazid and rifampicin,

with or without any other resistance) requires treatment with

at least six antituberculosis drugs to which the

mycobacterium is likely to be sensitive. Testing for

resistance to second-line drugs is recommended and

treatment should be modified according to susceptibility.

The risk of resistance is minimised by ensuring therapy is

administered in the correct dose and combination for the

prescribed duration.

Second-line drugs available for infections caused by

resistant organisms, or when first-line drugs cause

unacceptable side-effects, include aminosalicylic acid p. 584,

amikacin p. 518, capreomycin p. 585, cycloserine p. 585,

newer macrolides (e.g. azithromycin p. 536 and

clarithromycin p. 538), moxifloxacin and protionamide

(prothionamide; no longer on UK market). Bedaquiline

p. 585 and delamanid p. 586 are licensed for the treatment of

multiple-drug resistant pulmonary tuberculosis. Bedaquiline

has a long half-life.

Single drug-resistant tuberculosis

For single drug-resistance the following treatment regimens

are recommended:

Resistance to isoniazid:

. First two months (initial phase): rifampicin, pyrazinamide

and ethambutol hydrochloride

. Continue with (continuation phase): rifampicin and

ethambutol hydrochloride for seven months (up to ten

months for extensive disease)

Resistance to pyrazinamide:

. First two months (initial phase): rifampicin, ethambutol

hydrochloride and isoniazid (with pyridoxine

hydrochloride)

. Continue with (continuation phase): rifampicin and

isoniazid (with pyridoxine hydrochloride) for seven

months

BNF 78 Tuberculosis 581

Infection

5

Resistance to ethambutol hydrochloride:

. First two months (initial phase): rifampicin, pyrazinamide

and isoniazid (with pyridoxine hydrochloride)

. Continue with (continuation phase): rifampicin and

isoniazid (with pyridoxine hydrochloride) for four months

Resistance to rifampicin below:

. Offer treatment with at least six antituberculosis drugs to

which the mycobacterium is likely to be sensitive.

Management of tuberculosis in children

Children are given isoniazid p. 587, rifampicin, pyrazinamide

p. 588, and ethambutol hydrochloride p. 586 for the first two

months followed by isoniazid and rifampicin during the next

four months. However, care is needed in young children

receiving ethambutol hydrochloride because of the difficulty

in testing eyesight and in obtaining reports of visual

symptoms.

ANTIMYCOBACTERIALS › RIFAMYCINS

Rifampicin

l INDICATIONS AND DOSE

Brucellosis in combination with other antibacterials |

Legionnaires disease in combination with other

antibacterials | Serious staphylococcal infections in

combination with other antibacterials

▶ BY MOUTH, OR BY INTRAVENOUS INFUSION

▶ Child 1–11 months: 5–10 mg/kg twice daily

▶ Child 1–17 years: 10 mg/kg twice daily (max. per dose

600 mg)

▶ Adult: 0.6–1.2 g daily in 2–4 divided doses

Endocarditis in combination with other drugs

▶ BY MOUTH, OR BY INTRAVENOUS INFUSION

▶ Adult: 0.6–1.2 g daily in 2–4 divided doses

Tuberculosis, in combination with other drugs

(intermittent supervised 6-month treatment) (under

expert supervision)

▶ BY MOUTH

▶ Child: 15 mg/kg 3 times a week (max. per dose 900 mg)

for 6 months (initial and continuation phases)

▶ Adult: 600–900 mg 3 times a week for 6 months (initial

and continuation phases)

Tuberculosis, in combination with other drugs (standard

unsupervised 6-month treatment)

▶ BY MOUTH

▶ Child (body-weight up to 50 kg): 15 mg/kg once daily for

6 months (initial and continuation phases); maximum

450 mg per day

▶ Child (body-weight 50 kg and above): 15 mg/kg once daily

for 6 months (initial and continuation phases);

maximum 600 mg per day

▶ Adult (body-weight up to 50 kg): 450 mg once daily for

6 months (initial and continuation phases)

▶ Adult (body-weight 50 kg and above): 600 mg once daily

for 6 months (initial and continuation phases)

Prevention of tuberculosis in susceptible close contacts or

those who have become tuberculin positive, in

combination with isoniazid

▶ BY MOUTH

▶ Child 1 month–11 years (body-weight up to 50 kg):

15 mg/kg daily for 3 months; maximum 450 mg per day

▶ Child 1 month–11 years (body-weight 50 kg and above):

15 mg/kg daily for 3 months; maximum 600 mg per day

▶ Child 12–17 years (body-weight up to 50 kg): 450 mg daily

for 3 months

▶ Child 12–17 years (body-weight 50 kg and above): 600 mg

daily for 3 months

▶ Adult (body-weight up to 50 kg): 450 mg daily for

3 months

▶ Adult (body-weight 50 kg and above): 600 mg daily for

3 months

Prevention of tuberculosis in susceptible close contacts or

those who have become tuberculin positive, who are

isoniazid-resistant

▶ BY MOUTH

▶ Child 1 month–11 years (body-weight up to 50 kg):

15 mg/kg daily for 6 months; maximum 450 mg per day

▶ Child 1 month–11 years (body-weight 50 kg and above):

15 mg/kg daily for 6 months; maximum 600 mg per day

▶ Child 12–17 years (body-weight up to 50 kg): 450 mg daily

for 6 months

▶ Child 12–17 years (body-weight 50 kg and above): 600 mg

daily for 6 months

Prevention of tuberculosis in susceptible close contacts or

those who have become tuberculin positive, who are

isoniazid-resistant and under 35 years

▶ BY MOUTH

▶ Adult 18–34 years (body-weight up to 50 kg): 450 mg daily

for 6 months

▶ Adult 18–34 years (body-weight 50 kg and above): 600 mg

daily for 6 months

Prevention of secondary case of Haemophilus influenzae

type b disease

▶ BY MOUTH

▶ Child 1–2 months: 10 mg/kg once daily for 4 days

▶ Child 3 months–11 years: 20 mg/kg once daily (max. per

dose 600 mg) for 4 days

▶ Child 12–17 years: 600 mg once daily for 4 days

▶ Adult: 600 mg once daily for 4 days

Prevention of secondary case of meningococcal meningitis

▶ BY MOUTH

▶ Child 1–11 months: 5 mg/kg every 12 hours for 2 days

▶ Child 1–11 years: 10 mg/kg every 12 hours (max. per dose

600 mg), for 2 days

▶ Child 12–17 years: 600 mg every 12 hours for 2 days

▶ Adult: 600 mg every 12 hours for 2 days

Multibacillary leprosy in combination with dapsone and

clofazimine (3-drug regimen)| Paucibacillary leprosy in

combination with dapsone (2-drug regimen)

▶ BY MOUTH

▶ Adult (body-weight up to 35 kg): 450 mg once a month,

supervised administration

▶ Adult (body-weight 35 kg and above): 600 mg once a

month, supervised administration

l CONTRA-INDICATIONS Acute porphyrias p. 1058 . jaundice

l CAUTIONS Discolours soft contact lenses

l INTERACTIONS → Appendix 1: rifampicin

l SIDE-EFFECTS

GENERAL SIDE-EFFECTS

▶ Common or very common Nausea .thrombocytopenia . vomiting

▶ Uncommon Diarrhoea . leucopenia

▶ Frequency not known Abdominal discomfort. acute kidney

injury . adrenal insufficiency . agranulocytosis . appetite

decreased . disseminated intravascular coagulation . dyspnoea . eosinophilia . flushing . haemolytic anaemia . hepatitis . hypersensitivity . influenza . intracranial

haemorrhage . menstrual disorder. muscle weakness . myopathy . oedema . pseudomembranous enterocolitis . severe cutaneous adverse reactions (SCARs). shock . skin

reactions . sputum discolouration . sweat discolouration . tear discolouration . urine discolouration . vasculitis . wheezing

SPECIFIC SIDE-EFFECTS

▶ With intravenous use Bone pain . gastrointestinal disorder. hyperbilirubinaemia . psychotic disorder

▶ With oral use Psychosis

582 Bacterial infection BNF 78

Infection

5

SIDE-EFFECTS, FURTHER INFORMATION Side-effects that

mainly occur with intermittent therapy include influenzalike symptoms (with chills, fever, dizziness, bone pain),

respiratory symptoms (including shortness of breath),

collapse and shock, haemolytic anaemia,

thrombocytopenic purpura, and acute renal failure.

Discontinue if serious side-effects develop.

l ALLERGY AND CROSS-SENSITIVITY Contra-indicated in

patients with rifamycin hypersensitivity.

l CONCEPTION AND CONTRACEPTION

Important Effectiveness of hormonal contraceptives is

reduced and alternative family planning advice should be

offered.

l PREGNANCY Manufacturers advise very high doses

teratogenic in animal studies in first trimester; risk of

neonatal bleeding may be increased in third trimester.

l BREAST FEEDING Amount too small to be harmful.

l HEPATIC IMPAIRMENT Manufacturer advises caution—

monitor liver function weekly for two weeks, then every

two weeks for the next six weeks.

Dose adjustments Manufacturer advises maximum 8 mg/kg

per day.

l RENAL IMPAIRMENT

▶ In children Use with caution if doses above 10 mg/kg daily.

▶ In adults Use with caution if dose above 600 mg daily.

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,

liver function should be monitored on prolonged therapy.

▶ Blood counts should be monitored in patients on

prolonged therapy.

▶ In adults 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 DIRECTIONS FOR ADMINISTRATION

▶ With intravenous use in adults For intravenous infusion

(Rifadin ®), give intermittently in Glucose 5% or Sodium

chloride 0.9%; reconstitute with solvent provided then

dilute with 500 mL infusion fluid; give over 2–3 hours.

▶ With intravenous use in children Displacement value may be

significant, consult local reconstitution guidelines;

reconstitute with solvent provided. May be further diluted

with Glucose 5% or Sodium chloride 0.9% to a final

concentration of 1.2 mg/mL. Infuse over 2–3 hours.

l PRESCRIBING AND DISPENSING INFORMATION If treatment

interruption occurs, re-introduce with low dosage and

increase gradually.

Flavours of syrup may include raspberry.

▶ With oral use in children In general, doses should be rounded

up to facilitate administration of suitable volumes of liquid

or an appropriate strength of tablet. Doses may also need

to be recalculated to allow for weight gain in younger

children.

l PATIENT AND CARER ADVICE

Soft contact lenses Patients or their carers should be advised

that rifampicin 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.

Medicines for Children leaflet: Rifampicin for meningococcal

prophylaxis www.medicinesforchildren.org.uk/rifampicinmeningococcal-prophylaxis

Medicines for Children leaflet: Rifampicin for the treatment of

tuberculosis www.medicinesforchildren.org.uk/rifampicintreatment-tuberculosis

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 8, 14, 23

EXCIPIENTS: May contain Sucrose

▶ Rifadin (Sanofi)

Rifampicin 20 mg per 1 ml Rifadin 100mg/5ml syrup | 120 ml P £4.27 DT = £4.27

Capsule

CAUTIONARY AND ADVISORY LABELS 8, 14, 23

▶ Rifampicin (Non-proprietary)

Rifampicin 150 mg Rifampicin 150mg capsules | 100 capsule P £50.49 DT = £50.49

Rifampicin 300 mg Rifampicin 300mg capsules | 100 capsule P £123.89 DT = £123.89

▶ Rifadin (Sanofi)

Rifampicin 150 mg Rifadin 150mg capsules | 100 capsule P £18.32 DT = £50.49

Rifampicin 300 mg Rifadin 300mg capsules | 100 capsule P £36.63 DT = £123.89

▶ Rimactane (Sandoz Ltd)

Rifampicin 300 mg Rimactane 300mg capsules | 60 capsule P £21.98

Powder and solvent for solution for infusion

ELECTROLYTES: May contain Sodium

▶ Rifadin (Sanofi)

Rifampicin 600 mg Rifadin 600mg powder and solvent for solution

for infusion vials | 1 vial P £9.20

Rifampicin with ethambutol, isoniazid

and pyrazinamide

The properties listed below are those particular to the

combination only. For the properties of the components

please consider, rifampicin p. 582, ethambutol hydrochloride

p. 586, isoniazid p. 587, pyrazinamide p. 588.

l INDICATIONS AND DOSE

Initial treatment of tuberculosis

▶ BY MOUTH

▶ Adult (body-weight 30–39 kg): 2 tablets daily for

2 months (initial phase)

▶ Adult (body-weight 40–54 kg): 3 tablets daily for

2 months (initial phase)

▶ Adult (body-weight 55–69 kg): 4 tablets daily for

2 months (initial phase)

▶ Adult (body-weight 70 kg and above): 5 tablets daily for

2 months (initial phase)

DOSE EQUIVALENCE AND CONVERSION

▶ Tablet quantities refer to the number of Voractiv ®

Tablets which should be taken. Each Voractiv ® Tablet

contains ethambutol hydrochloride 275 mg, isoniazid

75 mg, pyrazinamide 400 mg and rifampicin 150 mg.

l CAUTIONS

Peripheral neuropathy The risk of peripheral neuropathy

may be increased by high doses of isoniazid; pyridoxine

should, therefore, be considered for those receiving

Voractiv ® 5 tablets daily.

l INTERACTIONS → Appendix 1: ethambutol . isoniazid . pyrazinamide .rifampicin

BNF 78 Tuberculosis 583

Infection

5

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug.

Tablet

CAUTIONARY AND ADVISORY LABELS 8, 14, 22

▶ Voractiv (Genus Pharmaceuticals Ltd)

Isoniazid 75 mg, Rifampicin 150 mg, Ethambutol hydrochloride

275 mg, Pyrazinamide 400 mg Voractiv tablets | 60 tablet P £39.50

Rifampicin with isoniazid

The properties listed below are those particular to the

combination only. For the properties of the components

please consider, rifampicin p. 582, isoniazid p. 587.

l INDICATIONS AND DOSE

Treatment of tuberculosis (continuation phase)

▶ BY MOUTH

▶ Adult (body-weight up to 50 kg): 450/300 mg daily for

4 months (continuation phase after 2-month initial

phase), use Rifinah ® 150/100 Tablets, preferably taken

before breakfast.

▶ Adult (body-weight 50 kg and above): 600/300 mg daily

for 4 months (continuation phase after 2-month initial

phase), use Rifinah ® 300/150 Tablets, preferably taken

before breakfast.

DOSE EQUIVALENCE AND CONVERSION

▶ Rifinah ® Tablets contain rifampicin and isoniazid; the

proportions are expressed in the form x/y where x and y

are the strengths in milligrams of rifampicin and

isoniazid respectively.

▶ Each Rifinah ® 150/100 Tablet contains rifampicin

150 mg and isoniazid 100 mg.

▶ Each Rifinah ® 300/150 Tablet contains rifampicin

300 mg and isoniazid 150 mg.

l INTERACTIONS → Appendix 1: isoniazid .rifampicin

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug.

Tablet

CAUTIONARY AND ADVISORY LABELS 8, 14, 23

▶ Rifinah (Sanofi)

Isoniazid 100 mg, Rifampicin 150 mg Rifinah 150mg/100mg

tablets | 84 tablet P £19.09 DT = £19.09

Isoniazid 150 mg, Rifampicin 300 mg Rifinah 300mg/150mg

tablets | 56 tablet P £25.22 DT = £25.22

Rifampicin with isoniazid and

pyrazinamide

The properties listed below are those particular to the

combination only. For the properties of the components

please consider, rifampicin p. 582, isoniazid p. 587,

pyrazinamide p. 588.

l INDICATIONS AND DOSE

Initial unsupervised treatment of tuberculosis (in

combination with ethambutol)

▶ BY MOUTH

▶ Adult (body-weight up to 40 kg): 3 tablets daily for

2 months (initial phase), use Rifater ® Tablets,

preferably taken before breakfast.

▶ Adult (body-weight 40–49 kg): 4 tablets daily for

2 months (initial phase), use Rifater ® Tablets,

preferably taken before breakfast.

▶ Adult (body-weight 50–64 kg): 5 tablets daily for

2 months (initial phase), use Rifater ® Tablets,

preferably taken before breakfast.

▶ Adult (body-weight 65 kg and above): 6 tablets daily for

2 months (initial phase), use Rifater ® Tablets,

preferably taken before breakfast.

DOSE EQUIVALENCE AND CONVERSION

▶ Tablet quantities refer to the number of Rifater ®

Tablets which should be taken. Each Rifater ® Tablet

contains isoniazid 50 mg, pyrazinamide 300 mg and

rifampicin 120 mg.

l INTERACTIONS → Appendix 1: isoniazid . pyrazinamide . rifampicin

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug.

Tablet

CAUTIONARY AND ADVISORY LABELS 8, 14, 22

▶ Rifater (Sanofi)

Isoniazid 50 mg, Rifampicin 120 mg, Pyrazinamide

300 mg Rifater tablets | 100 tablet P £26.34

ANTIMYCOBACTERIALS › OTHER

Aminosalicylic acid 28-May-2018

l INDICATIONS AND DOSE

Multiple-drug resistant tuberculosis, in combination with

other drugs

▶ BY MOUTH

▶ Adult: 4 g every 8 hours for a usual treatment duration

of 24 months; maximum 12 g per day

Desensitisation regimen

▶ BY MOUTH

▶ Adult: (consult product literature)

l CAUTIONS Peptic ulcer

l INTERACTIONS → Appendix 1: aminosalicylic acid

l SIDE-EFFECTS

▶ Common or very common Diarrhoea . gastrointestinal

discomfort. nausea . skin reactions . vestibular syndrome . vomiting

▶ Uncommon Appetite decreased

▶ Rare or very rare Agranulocytosis . anaemia . crystalluria . dizziness . gastrointestinal disorders . gastrointestinal

haemorrhage . headache . hepatic disorders . hypoglycaemia . hypothyroidism . leucopenia . methaemoglobinaemia . peripheral neuropathy .taste

metallic .tendon pain .thrombocytopenia . visual

impairment. weight decreased

▶ Frequency not known Hypersensitivity

l PREGNANCY Manufacturer advises avoid unless

essential—toxicity in animal studies (highest risk during

first trimester).

l BREAST FEEDING Present in milk—manufacturer advises

avoid.

l HEPATIC IMPAIRMENT Manufacturer advises use with

caution.

l RENAL IMPAIRMENT Use with caution in mild to moderate

impairment. Avoid in severe impairment due to

accumulation of inactive metabolites.

l MONITORING REQUIREMENTS

▶ Monitor for hypersensitivity reaction during the first

3 months of treatment—for desensitisation dosing

regimen consult product literature.

▶ Monitor liver function—discontinue immediately if signs

or symptoms of hepatic toxicity (including rash, fever and

gastrointestinal disturbance).

l DIRECTIONS FOR ADMINISTRATION Disperse granules in

orange or tomato juice and take immediately (granules will

not dissolve, ensure all granules are swallowed). Granules

can be sprinkled on apple sauce or yoghurt for

administration.

584 Bacterial infection BNF 78

Infection

5

l PATIENT AND CARER ADVICE Patients should be advised

that the skeletons of the granules may be seen in the

stools. Counselling advised on administration.

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug.

Gastro-resistant granules

CAUTIONARY AND ADVISORY LABELS 9, 25

▶ Granupas (Lucane Pharma Ltd)

Aminosalicylic acid 1 gram per 1 gram Granupas gastro-resistant

granules 4g sachets sugar-free | 30 sachet P £331.00

Bedaquiline 05-Jun-2018

l INDICATIONS AND DOSE

Multiple-drug resistant pulmonary tuberculosis, in

combination with other drugs

▶ BY MOUTH

▶ Adult: Initially 400 mg once daily for 2 weeks, then

200 mg 3 times a week for 22 weeks, intervals of at least

48 hours between each dose, continue appropriate

combination therapy after bedaquiline

l CONTRA-INDICATIONS QTc interval more than

500 milliseconds (derived using Fridericia’s formula). ventricular arrhythmia

l CAUTIONS Hypothyroidism . QTc interval (derived using

Fridericia’s formula) 450–500 milliseconds—discontinue if

QTc interval more than 500 milliseconds .risk factors for

QT interval prolongation (e.g. electrolyte disturbances,

heart failure with reduced left ventricular ejection fraction,

history of symptomatic arrhythmias (avoid if ventricular

arrhythmia present), bradycardia, congenital long QT

syndrome)

l INTERACTIONS → Appendix 1: bedaquiline

l SIDE-EFFECTS

▶ Common or very common Arthralgia . diarrhoea . dizziness . headache . hepatic function abnormal . myalgia . nausea . QT interval prolongation . vomiting

SIDE-EFFECTS, FURTHER INFORMATION If syncope occurs,

obtain ECG.

l PREGNANCY Manufacturer advises avoid unless potential

benefit outweighs risk.

l BREAST FEEDING Manufacturer advises avoid—present in

milk in animal studies.

l HEPATIC IMPAIRMENT Manufacturer advises caution in

moderate impairment; avoid in severe impairment—no

information available.

l RENAL IMPAIRMENT Manufacturer advises caution if eGFR

less than 30 mL/minute/1.73 m2

.

l MONITORING REQUIREMENTS

▶ Determine serum potassium, calcium, and magnesium

before starting treatment (correct if abnormal)—

remeasure if QT prolongation occurs during treatment.

▶ Obtain ECG before starting treatment, and then at least

monthly during treatment or more frequently if

concomitant use with other drugs known to prolong the

QT interval.

▶ Monitor liver function before starting treatment and then

at least monthly during treatment—discontinue treatment

if severe abnormalities in liver function tests.

l PATIENT AND CARER ADVICE

Missed doses If a dose is missed during the first two weeks

of treatment, the missed dose should not be taken and the

next dose should be taken at the usual time; if a dose is

missed during weeks 3–24 of treatment, the missed dose

should be taken as soon as possible and then the usual

regimen resumed.

Driving and skilled tasks Dizziness may affect performance

of skilled tasks (e.g. driving)

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug.

Tablet

CAUTIONARY AND ADVISORY LABELS 4, 8, 21

▶ Sirturo (Janssen-Cilag Ltd) A

Bedaquiline (as Bedaquiline fumarate) 100 mg Sirturo 100mg

tablets | 188 tablet P £18,700.00

Capreomycin 26-Jun-2018

l INDICATIONS AND DOSE

Tuberculosis resistant to first-line drugs, in combination

with other drugs

▶ BY DEEP INTRAMUSCULAR INJECTION

▶ Adult: 1 g daily (max. per dose 20 mg/kg) for

2–4 months, then reduced to 1 g 2–3 times a week

l CAUTIONS Auditory impairment

l INTERACTIONS → Appendix 1: capreomycin

l SIDE-EFFECTS Eosinophilia .febrile disorders . hearing

impairment. leucocytosis . leucopenia . nephrotoxicity . pain . pseudo-Bartter syndrome . skin reactions . thrombocytopenia .tinnitus . vertigo

l PREGNANCY Manufacturer advises use only if potential

benefit outweighs risk—teratogenic in animal studies.

l BREAST FEEDING Manufacturer advises caution—no

information available.

l RENAL IMPAIRMENT Nephrotoxic; ototoxic.

Dose adjustments Reduce dose—consult product literature.

l MONITORING REQUIREMENTS Monitor renal, hepatic,

auditory, and vestibular function and electrolytes.

l MEDICINAL FORMS There can be variation in the licensing of

different medicines containing the same drug.

Powder for solution for injection

▶ Capreomycin (Non-proprietary)

Capreomycin (as Capreomycin sulfate) 1 gram Capreomycin 1g

powder for solution for injection vials | 1 vial P £31.47

Cycloserine

l INDICATIONS AND DOSE

Tuberculosis resistant to first-line drugs, in combination

with other drugs

▶ BY MOUTH

▶ Adult: Initially 250 mg every 12 hours for 2 weeks, then

increased if necessary up to 500 mg every 12 hours,

dose to be increased according to blood concentration

and response

PHARMACOKINETICS

▶ Cycloserine penetrates the CNS.

l CONTRA-INDICATIONS Alcohol dependence . depression . epilepsy . psychotic states . severe anxiety

l INTERACTIONS → Appendix 1: cycloserine

l SIDE-EFFECTS Behaviour abnormal . coma . confusion . congestive heart failure . drowsiness . dysarthria . headache . hyperirritability . megaloblastic anaemia . memory loss . neurological effects . paraesthesia . paresis . psychosis .rash .reflexes increased . seizures . suicidal

ideation .tremor. vertigo

SIDE-EFFECTS, FURTHER INFORMATION CNS toxicity

Discontinue or reduce dose if symptoms of CNS toxicity

occur.

Rashes or allergic dermatitis Discontinue or reduce

dose if rashes or allergic dermatitis develop.

l PREGNANCY Manufacturer advises use only if potential

benefit outweighs risk—crosses the placenta.

BNF 78 Tuberculosis 585

Infection

5

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