RIMACTANE Capsule 150mg Milligram

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

RIFAMPICIN

Available from:

Sandoz GmbH

Dosage:

150mg Milligram

Pharmaceutical form:

Capsule

Authorization date:

1997-07-05

Summary of Product characteristics

PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Rimactane Capsules 150mg.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains Rifampicin 150mg.
For list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsules, hard.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
In the treatment of tuberculosis and certain other mycobacterial infections.
_Non-mycobacterial infections:_
In these infections, e.g. _staphylococcal _infections, Rimactane should only be employed:
o
if the pathogens are resistant to the first-line antibiotics that normally prove effective,
o
if the pathogens are demonstrably sensitive to rifampicin,
o
if given in combination with other antibiotics/chemotherapeutic agents to which the pathogens are sensitive,
o
if a diagnosis of tuberculosis or leprosy has first been excluded.
_Prevention of meningococcal meningitis:_
Rimactane is also indicated for the chemoprophylaxis of _meningococcal meningitis._
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
_For the management of tuberculosis and certain opportunistic mycobacterial infections_:
Rimactane must always be given in association with other anti-tuberculosis drugs, to prevent emergence of resistant
strains.
_Use in Adults_: 450-600mg daily as a single dose (based on approximately 10mg per kg body weight). (Those patients
50kg (8 stone) and over should take 600mg rifampicin daily, whilst patients under 50kg should take 450mg).
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 06/02/2009_
_CRN 2053449_
_page number: 1_
The following chemotherapeutic agents are employed today as combined therapy for tuberculosis: rifampicin
(Rimactane) (RMP), isoniazid (INH), pyrazinamide (PZA), ethambutol (EMB), streptomycin (STM).
The