RIMACTANE Capsule 300mg Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
28-04-2024
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Active ingredient:
RIFAMPICIN
Available from:
Sandoz GmbH
Dosage:
300mg 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 300mg
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains Rifampicin 300mg.
For excipients, see 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:
_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).
The following chemotherapeutic agents are employed today as combined therapy for tuberculosis: rifampicin
(Rimactane) (RMP), isoniazid (INH), pyrazinamide (PZA), ethambutol (EMB), streptomycin (STM).
- if the pathogens are resistant to the first-line antibiotics that normally prove effective,
- if the pathogens are demonstrably sensitive to rifampicin,
- if given in combination with other antibiotics/chemotherapeutic agents to which the pathogens are sensitive,
- if a diagnosis of tuberculosis or leprosy has first been excluded.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 18/11/2006_
_CRN 2020999_
_page number: 1_
The dosages recommended
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