1. Name of the medicinal product
Rifadin 300mg Capsules
2. Qualitative and quantitative composition
Rifampicin Ph Eur 300 mg

For a full list of excipients, see section 6.1.
3. Pharmaceutical form
Capsule, hard.

The gelatine capsule is composed of two red halves.
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 to H. influenzae B disease when the household contains a child 4 years of age or younger, it is recommended that all members (including the child) receive rifampicin 20 mg/kg once daily (maximum daily dose 600 mg) for 4 days.

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