1. Name of the medicinal product
Rifadin for Infusion 600mg
2. Qualitative and quantitative composition
Rifampicin BP 600mg
3. Pharmaceutical form
Lyophilisate (for reconstitution prior to use) and accompanying ampoule of solvent.
4. Clinical particulars
4.1 Therapeutic indications
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.

Tuberculosis: 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.

Leprosy: 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.

Other infections: 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.
4.2 Posology and method of administration
Treatment with Rifadin for Infusion should include concomitant use of other appropriate antibacterials to prevent the emergence of resistant strains of the causative organism.

Tuberculosis:

Adults: A single daily administration of 600mg 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 600mg by mouth.

Children: The usual paediatric regimen is a single daily dose of up to 20mg/kg bodyweight; the total daily dose should not normally exceed 600mg.

Leprosy:

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.

Brucellosis, Legionnaires Disease or serious staphylococcal infections:

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.

Impaired liver function:

A daily dose of 8mg/kg should not be exceeded in patients with impaired liver function.

Use in the elderly:

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).
4.3 C