Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2023 Publisher: Aventis Pharma Limited, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK Trading as: Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK
Rifadin for Infusion is indicated for acutely ill patients who are unable to tolerate oral therapy, e.g. post-operative or comatose patients or patients in whom gastrointestinal absorption is impaired.
Rifadin, used in combination with other active anti-tuberculosis drugs, is indicated in the treatment of all forms of tuberculosis, including fresh, advanced, chronic and drug-resistant cases. Rifadin is also effective against most atypical strains of Mycobacteria.
Rifadin, used in combination with at least one other active anti-leprosy drug, is indicated in the management of multibacillary and paucibacillary leprosy to effect conversion of the infectious state to a non-infectious state.
Rifadin is indicated in the treatment of Brucellosis, Legionnaires Disease, and serious staphylococcal infections. To prevent emergence of resistant strains of the infecting organisms, Rifadin should be used in combination with another antibiotic appropriate for the infection.
Treatment with Rifadin for Infusion should include concomitant use of other appropriate anti-bacterials to prevent the emergence of resistant strains of the causative organism.
Adults: A single daily administration of 600 mg given by intravenous infusion over 2 to 3 hours has been found to be effective and well tolerated for adult patients. Serum concentrations following this dosage regimen are similar to those obtained after 600 mg by mouth.
Children: The usual paediatric regimen is a single daily dose of up to 20 mg/kg bodyweight; the total daily dose should not normally exceed 600 mg.
The recommended daily dose is 10 mg/kg.
Usual daily dose:
Patients weighing less than 50 kg – 450 mg
Patients weighing 50 kg or more – 600 mg.
Alternatively, 600 mg doses of rifampicin may be given once per month.
In the treatment of leprosy, rifampicin should always be used in conjunction with at least one other antileprosy drug.
Adults: The recommended daily dose is 600-1200mg given in 2 to 4 divided doses, together with another antibacterial agent with similar properties to prevent the emergence of resistant strains.
A daily dose of 8mg/kg should not be exceeded in patients with impaired liver function.
In elderly patients, the renal excretion of rifampicin is decreased proportionally with physiological decrease of renal function; due to compensatory increase of liver excretion, the serum terminal half-life is similar to that of younger patients. However, as increased blood levels have been noted in one study of rifampicin in elderly patients, caution should be exercised in using rifampicin in such patients, especially if there is evidence of liver function impairment.
When patients are able to accept oral medication, they should be transferred to Rifadin Capsules or Syrup (for further information on these products see their separate data sheets).
Nausea, vomiting, abdominal pain, pruritus, headache and increasing lethargy will probably occur within a short time after acute ingestion; unconsciousness may occur when there is severe hepatic disease. Transient increases in liver enzymes and/or bilirubin may occur. Brownish-red or orange colouration of the skin, urine, sweat, saliva, tears and faeces will occur, and its intensity is proportional to the amount ingested. Facial or periorbital oedema has also been reported in paediatric patients. Hypotension, sinus tachycardia, ventricular arrhythmias, seizures and cardiac arrest were reported in some fatal cases.
The minimum acute lethal or toxic dose is not well established. However, nonfatal acute overdoses in adults have been reported with doses ranging from 9 to 12 g rifampicin. Fatal acute overdoses in adults have been reported with doses ranging from 14-60 g. Alcohol or a history of alcohol abuse was involved in some of the fatal and nonfatal reports.
Nonfatal overdoses in paediatric patients ages 1 to 4 years old of 100 mg/kg for one to two doses have been reported.
Intensive supportive measures should be instituted and individual symptoms treated as they arise. Since nausea and vomiting are likely to be present, gastric lavage is probably preferable to induction of emesis. Following evacuation of the gastric contents, the instillation of activated charcoal slurry into the stomach may help absorb any remaining drug from the gastrointestinal tract. Antiemetic medication may be required to control severe nausea and vomiting. Active diuresis (with measured intake and output) will help promote excretion of the drug. Haemodialysis may be of value in some patients.
Unopened vial of lyophilisate: 36 months.
Unopened ampoule of solvent: 60 months.
Shelf life after dilution or reconstitution:
Water for Injections (10 ml WFI): Up to 30 hours.
Water for injections (10 ml WFI) and then diluted in glucose 5% solution for infusion: Up to 8 hours.
Water for injections (10 ml WFI) and then diluted in sodium chloride 0.9% solution for infusion: Up to 6 hours.
Store below 25°C.
20ml clear neutral glass vial sealed with butyl rubber stopper and aluminium/plastic “flip-off” cap (colour coded blue) containing 600mg Rifampicin and 10ml clear glass ampoule containing solvent.
Pack size: combination of 1 vial of lyophilisate and 1 ampoule of solvent.
Not applicable.
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