Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2019 Publisher: Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Austria
Rifampicin is a major drug in the management of tuberculosis (all forms) and certain opportunistic mycobacterial infections. It is effective in cases resistant to other anti-tuberculosis agents and shows no cross-resistance outside the rifampycin group of drugs. In the treatment of tuberculosis Rifampicin must always be combined with other anti-tuberculosis agents. It is effective in combination with isoniazid, streptomycin, pyrazinamide, ethambutol and the majority of second line drugs.
Prophylaxis of meningococcal meningitis in close contact adult and paediatric patients.
Rifampicin must always be given in association with other anti-tuberculosis drugs, to prevent emergence of resistant strains.
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).
The dosages recommended by the Centres for Disease Control and Prevention are as follows:
| Daily | Twice a week | 3 times a week | |||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug | mg/kg | max. mg | mg/kg | max. mg | mg/kg | max. mg | |||
| Children | Adults | Children | Adults | Children | Adults | ||||
| RMP | 10-20 | 10 | 600 | 10-20 | 10 | 600 | 10-20 | 10 | 600 |
| INH | 10-15 | 5 | 300 | 20-40 | 15 | 900 | 20-40 | 15 | 900 |
| PZA | 30-40 | 15-30 | 2,000 | 50-70 | 50-70 | 4,000 | 50-70 | 50-70 | 3,000 |
| EMB | 15-25 | 5-25 | 2,500 | 50 | 50 | 2,500 | 25-30 | 25-30 | 2,500 |
| STM | 20-30 | 15 | 1,000 | 25-30 | 25-30 | 1,500 | 25-30 | 25-30 | 1,000 |
For the treatment of sputum-positive pulmonary tuberculosis, preference is given to the following regimens: (For dosage information please refer to the text above for Rifampicin and to the table for other components of the treatment).
Continuous therapy:
Daily for a total of 9 months:
Initial phase for 2 months: RMP + INH + PZA + EMB or STM.
Continuation phase for 7 months: RMP + INH.
A total duration of 9 months is recommended for tuberculosis with HIV infection and for tuberculous meningitis, disseminated tuberculosis, or spinal involvement with neurological complications.
Daily for a total of 6 months:
Initial phase for 2 months: RMP + INH + PZA + EMB or STM.
Continuation phase for 4 months: RMP + INH.
Partially intermittent therapy:
Total duration 6 months:
Initial phase for 2 months: RMP + INH + PZA + EMB or STM daily.
Continuation phase for 4 months: RMP + INH twice or 3 times a week.
Fully intermittent therapy:
Total duration 6 months: RMP + INH + PZA + EMB or STM 3 times a week.
DOTS strategy (directly observed treatment, short-course, i.e. administration of the antituberculous agents under supervision) should be considered for all patients, irrespective of the treatment regimen they are receiving.
Oral doses of 10-20 mg/kg body weight daily are recommended, although a total daily dose should not usually exceed 600 mg.
No special dosage regime is necessary but concurrent hepatic insufficiency should be taken into account (see Pharmacokinetics).
Note: Rifampicin should not be used to treat overt meningococcal meningitis.
Use in Adults: 600mg twice daily (12 hourly) for 2 days.
Children over 1 month: 10 mg per kg every 12 hours for 2 days.
Children under 1 month: 5 mg per kg every 12 hours for 2 days.
The maximum dose is 600 mg.
Use in the Elderly: There is no evidence to suggest that dose adjustments are necessary.
This prophylactic administration should be started as soon as possible. It is recommended that Rifampicin is only given for 2 days in this indication since resistance to this class of antibacterial agent may develop.
Nausea, vomiting, abdominal pain, pruritus, headache and increasing lethargy will probably occur within a short time after acute ingestion; unconsciousness may occur when there is severe hepatic disease. Transient increases in liver enzymes and/or bilirubin may occur. Brownish-red or orange colouration of the skin, urine, sweat, saliva, tears and faeces will occur, and its intensity is proportional to the amount ingested. Facial or periorbital oedema has also been reported in paediatric patients. Hypotension, sinus tachycardia, ventricular arrhythmias, seizures and cardiac arrest were reported in some fatal cases.
The minimum acute lethal or toxic dose is not well established. However, nonfatal acute overdoses in adults have been reported with doses ranging from 9 to 12 g rifampicin. Fatal acute overdoses in adults have been reported with doses ranging from 14-60 g. Alcohol or a history of alcohol abuse was involved in some of the fatal and nonfatal reports.
Nonfatal overdoses in paediatric patients ages 1 to 4 years old of 100 mg/kg for one to two doses have been reported.
Intensive supportive measures should be instituted and individual symptoms treated as they arise. Since nausea and vomiting are likely to be present, gastric lavage is probably preferable to induction of emesis. Following evacuation of the gastric contents, the instillation of activated charcoal slurry into the stomach may help absorb any remaining drug from the gastrointestinal tract. Antiemetic medication may be required to control severe nausea and vomiting. Active diuresis (with measured intake and output) will help promote excretion of the drug. Haemodialysis may be of value in some patients.
Four years.
Protect from moisture and heat (store below 30°C).
Medicines should be kept out of reach of children.
The capsules are opaque, two-piece, hard gelatine capsule size 1, reddish-brown in colour, marked with the monogram NG on each half and the code 300, and come in securitainers of 100 and PVC/PE/PVdC blister packs of 60.
No special requirements.
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