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Drugs List
Therapeutic Indications
Dosage
Administration
Contraindications
Precautions and Warnings
Pregnancy and Lactation
Side Effects
Monograph

Dosage

Adults
Elderly
Children
Neonates
Patients with Renal Impairment
Patients with Hepatic Impairment
Additional Dosage Information

Tuberculosis

A single daily dose of 600mg given by intravenous infusion over 2 to 3 hours gives serum concentrations of rifampicin similar to 600mg given orally.
In meningeal or pericardial tuberculosis, a corticosteroid should be started at the same time as antituberculosis therapy.

Leprosy

10mg/kg daily.

Patients weighing less than 50kg usually receive 450mg rifampicin.
Patients weighing 50kg or more usually receive 600mg rifampicin

Alternatively, 600mg doses may be given once per month.

Brucellosis; Legionaires' disease; Serious staphylococcal infection

600mg to 1200mg daily, given in two to four divided doses, together with another antibacterial agent.

Endocarditis (unlicensed)

600mg to 1.2g daily, given in two to four divided doses.

Precautions and Warnings

Rifampicin should be used under the supervision of a physician experienced in the treatment of the infection concerned.

Not recommended for patients with jaundice unless the expected benefits of therapy outweigh the possible risks.

Patients should be seen at least monthly during therapy and questioned regarding symptoms associated with adverse reactions.

All patients treated for tuberculosis should have baseline measurements of hepatic enzymes, bilirubin, serum creatinine, a complete blood count and a platelet count (or estimate). If there is no pre-existing liver disease and pre-treatment liver test are normal, repeat tests are required only if there is fever, vomiting, jaundice or deterioration in the patient's general condition.

For patients with hepatic impairment, use only when strictly needed, and then with caution and under close medical supervision. Lower doses are recommended. See Dosage - Hepatic Impairment .
In these patients, monitor liver function, especially SGPT and SGOT, before treatment, weekly for 2 weeks, then every 2 weeks for the next 6 weeks.
Discontinue treatment if signs of hepatocellular damage occur or if clinically significant changes in hepatic function occur. Consider the need for an alternative antituberculosis regime.
If rifampicin is reintroduced after liver function has returned to normal, monitor liver function daily.

In treatment regimens in which rifampicin is used concurrently with isoniazid, caution is recommended in the following:
Elderly patients
Children under 2 years of age
Malnourished patients
Patients with impaired liver function

Patients and their carers should be told how to recognise signs of liver disorder and advised to discontinue treatment and seek medical attention if symptoms such as persistent nausea, vomiting, malaise or jaundice develop.

Hyperbilirubinaemia may occur in the early days of treatment.
A moderate rise in bilirubin and/or transaminases is not necessarily an indication to discontinue treatment. Monitor the trends in the levels and consider these in conjunction with the patient's clinical condition.

Monitor patient receiving intermittent therapy (less than 2 to 3 times per week) for immunological reaction.

If treatment interrupted reintroduce with low dosage and increase gradually. If serious side-effects develop (e.g. renal failure, thrombocytopenia or haemolytic anaemia) rifampicin should be stopped and never restarted.

Specialist advice should be sought about tuberculosis treatment in immunocompromised patients. Dosage regimens should be chosen carefully and potentially hazardous interactions should be avoided.

Treatment may produce a reddish discolouration of the urine, sputum, and tears, and soft contact lenses may be discoloured.

Advise patients that the effect of hormonal contraceptives may be reduced and that non-hormonal methods of contraception should be used during treatment.

Renal impairment - glomerular filtration rate below 10ml/min. See Dosage - Renal Impairment.

Pregnancy - see Pregnancy section.

Breastfeeding - see Lactation section.

Porphyria - see Precautions and Warnings - Porphyria.

Rifampicin may interfere with some laboratory tests. See Effects on Laboratory Tests .

May cause vitamin K dependent coagulopathy and severe bleeding. Consider vitamin k supplementation, risk of vitamin K dependent coagulopathy.

Use in Porphyria

Rifampicin has been associated with acute attacks of porphyria - use with caution if safer alternative not available.

Pregnancy and Lactation

Pregnancy

Schaefer advises that the indications for treatment of active tuberculosis in pregnant women are no different from those for non-pregnant women. Untreated tuberculosis represents a greater hazard to the mother and her foetus than the treatment of the disease. Treatment considerations should depend on the progression of the disease and drug resistance, with some schedules recommending delaying treatment in pregnant women until a positive chest radiograph is established, unless they are a high risk patient (e.g. due to HIV, diabetes, recent converters or close contact to a person with the active disease)

Animal studies have reported spina bifida in mice and rats and cleft palates in mice when administered rifampicin. Teratogenicity has been reported in rats. Rifampicin crosses the human placenta to the foetus. No controlled studies link the use of rifampicin to congenital defects in humans. One report described a 4.4% incidence of malformations, which is similar to the expected frequency of defects in the healthy population, but higher than the rate noted for other tuberculosis patients.

Several reviews have concluded that rifampicin was not a proven teratogen and recommended the use of rifampicin with isoniazid and ethambutol if necessary. Schaefer concludes that rifampicin (within a multidrug regimen) is a drug of choice for the treatment of tuberculosis during pregnancy. When administered during the last few weeks of pregnancy, post-natal haemorrhage in the mother and neonate may occur and therapy with vitamin K1 may be required.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14-17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password at ( https://www.toxbase.org/ ) or if this is unavailable at the backup site ( https://www.TOXBASEbackup.org/ ).

Lactation

The UK Drugs in Lactation Advisory Service considers that rifampicin is safe to use in breastfeeding women. The Centres for Disease Control and Prevention (USA) state that breastfeeding should not be discouraged in patients taking rifampicin. Low levels of rifampicin are excreted in breast milk but the concentration is not considered sufficient for treatment of tuberculosis in the breastfed infant.

Schaefer concludes that isoniazid (in combination with 0.5 to 1mg of vitamin B6 prophylaxis per day for the infant), rifampicin and pyrazinamide are the tuberculostatics of choice during breastfeeding.

Infant should be monitored for toxicity including hepatitis and vision changes. Observe for fatigue, weakness, malaise, anorexia, nausea and vomiting.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Presentation

Powder for solution for infusion (as lyophilisate) containing rifampicin 600mg/vial together with diluent.

Drugs List

RIFADIN 600mg powder for concentrate for solution for infusion

rifampicin 600mg powder for concentrate for solution for infusion

Therapeutic Indications

Uses

Parenteral rifampicin is indicted for acutely ill patients who are unable to tolerate oral treatment (e.g. post-operative or comatose patients or those in whom gastrointestinal absorption is impaired).

Tuberculosis
Treatment of all forms of tuberculosis including fresh, advanced, chronic and drug-resistant cases.
Rifampicin must be used in combination with other anti-tuberculosis drugs.
It is effective against most atypical strains of Mycobacteria.

Leprosy
Management of multibacillary and paucibacillary leprosy to effect conversion to a non-infectious state.
Rifampicin must be used in combination with at least one other anti-leprosy drug.

Other infections
Treatment of brucellosis, Legionnaires' disease and serious staphylococcal infections in combination with another antibiotic indicated for the infection.

Dosage

In all indications, treatment with rifampicin must include the concomitant use of other appropriate antibacterials to prevent the emergence of resistant strains of the causative organism.

If treatment interrupted reintroduce with low dosage and increase gradually

Adults

Tuberculosis
A single daily dose of 600mg given by intravenous infusion over 2 to 3 hours gives serum concentrations of rifampicin similar to 600mg given orally.
In meningeal or pericardial tuberculosis, a corticosteroid should be started at the same time as antituberculosis therapy.

Leprosy
10mg/kg daily.

Patients weighing less than 50kg usually receive 450mg rifampicin.
Patients weighing 50kg or more usually receive 600mg rifampicin

Alternatively, 600mg doses may be given once per month.

Brucellosis; Legionaires' disease; Serious staphylococcal infection
600mg to 1200mg daily, given in two to four divided doses, together with another antibacterial agent.

Endocarditis (unlicensed)
600mg to 1.2g daily, given in two to four divided doses.

Elderly

In the elderly, renal excretion of rifampicin is reduced in proportion to the physiological decrease in renal function, but there is a compensatory increase in hepatic excretion such that the half-life is similar to that in younger patients.

However, caution is advised particularly if there is evidence of hepatic impairment.

Children

Tuberculosis
A single daily dose of up to 20mg/kg.
Maximum dose: 600mg daily.
In meningeal or pericardial tuberculosis, a corticosteroid should be started at the same time as antituberculosis therapy.

Brucellosis; Legionaires' disease; Serious staphylococcal infection (unlicensed)
Children aged 1 to 18 years
10mg/kg (up to 600mg per dose) twice daily, together with another antibacterial agent.
Children aged 1 month to 1 year
5mg/kg to 10mg/kg twice daily, together with another antibacterial agent.

Neonates

Brucellosis; Legionaires' disease; Serious staphylococcal infection (unlicensed)
5mg/kg to 10mg/kg twice daily, together with another antibacterial agent.

Patients with Renal Impairment

The Renal Drug Handbook suggests the following:
Glomerular filtration rate 10ml/minute or greater: Dose as in normal renal function.
Glomerular filtration rate below 10ml/minute: 50% to 100% of normal dose.
Monitor rifampicin levels if necessary. In severe renal impairment, there is no increase in half-life at doses less than 600mg daily. Cautions should be taken in case of renal impairment if dose exceeds 600mg.

Patients with Hepatic Impairment

Do not exceed a daily dose of 8mg/kg.
Use only when strictly necessary and then under close medical supervision. Monitor liver function, especially serum glutamic transaminase (SGPT) and serum glutamic oxaloacetic transaminase (SGOT), before treatment, weekly for two weeks, then every two weeks for the next six weeks.

Discontinue treatment if signs of hepatocellular damage occur or if clinically significant changes in hepatic function occur. Consider the need for an alternative antituberculosis regime.

If rifampicin is reintroduced after liver function has returned to normal, monitor liver function daily.

Although rifampicin is not recommended for use in patients with jaundice the therapeutic benefit of rifampicin infusion should be weighed against the possible risks.

Additional Dosage Information

Patients should be transferred to oral medication whenever possible.

Tuberculosis is treated in two phases, an initial phase using four drugs and a continuation phase using two drugs in fully sensitive cases. Treatment requires specialist knowledge, particularly where the disease involves resistant organisms or non-respiratory organisms.

Administration

To be given by intravenous infusion after reconstitution and dilution.

Infuse over 2 -3 hours.

Compatibilities

Rifampicin is compatible for up to 6 hours with glucose 5% and sodium chloride 0.9%.

Incompatibilities

Rifampicin for infusion is not compatible with:
Sodium bicarbonate 5%
Sodium lactate 0.167M
Ringer acetate with glucose
Perfudex

Contraindications

None known