1. Name of the medicinal product
Rifadin 100mg/5ml Oral Suspension
2. Qualitative and quantitative composition
Active substance (per 5ml dose)
Rifampicin 100 mg
Excipient with known effect (per 5ml dose)
Methyl-p-hydroxybenzoate (E218) 6.0 mg
Propyl-p-hydroxybenzoate (E216)1.5 mg
Tween 80 (Polysorbate 80)0.75 mg
Sucrose 2000 mg
Sodium metabisulphite (E223) 5.00 mg
For a full list of excipients, see section 6.1
3. Pharmaceutical form
Raspberry coloured and flavoured suspension.
4. Clinical particulars
4.1 Therapeutic indications
Indications for use
Tuberculosis: In combination with other active anti-tuberculosis drugs 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: In combination with at least one other active anti-leprosy drug in the management of multibacillary and paucibacillary leprosy to effect conversion of the infectious state to a non-infectious state.
Other Infections: 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.
Prophylaxis of meningococcal meningitis: For the treatment of asymptomatic carriers of N. meningitidis to eliminate meningococci from the nasopharynx.
Haemophilus influenzae: For the treatment of asymptomatic carriers of H.influenzae and as chemoprophylaxis of exposed children, 4 years of age or younger.
4.2 Posology and method of administration
Recommended Dosage
For oral administration
The daily dose of Rifadin, calculated from the patient's body weight, should preferably be taken at least 30 minutes before a meal or 2 hours after a meal to ensure rapid and complete absorption.
Tuberculosis:
Rifadin should be given with other effective anti-tuberculosis drugs to prevent the possible emergence of rifampicin-resistant strains of Mycobacteria.
Adults: The recommended single daily dose in tuberculosis is 8-12 mg/kg.
Usual Daily dose: Patients weighing less than 50 kg - 450 mg. Patients weighing 50 kg or more - 600 mg.
Children: In children, oral doses of 10-20 mg/kg body weight daily are recommended, although a total daily dose should not usually exceed 600 mg.
Leprosy:
600 mg doses of rifampicin should be given once per month. Alternatively, a daily regimen may be used. The recommended single 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.
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 600-1200 mg given in 2 to 4 divided doses, together with another appropriate antibiotic to prevent the emergence of resistant strains of the infecting organisms.
Prophylaxis of meningococcal meningitis
Adults: 600 mg twice daily for 2 days.
Children (1 - 12 years): 10 mg/kg twice daily for 2 days.
Children (3 months - 1 year): 5 mg/kg twice daily for 2 days.
Prophylaxis of Haemophilus influenzae
Adults and children: For members of households exposed