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RIMACTANE is a brand name for Rifampin (also known as Rifampicin). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 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…
Verbatim from this product's MHRA label. Tap a section to expand.
For the management of tuberculosis and certain opportunistic mycobacterial infections: Rifampicin 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).
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 Childr en Adul ts Child ren Adult s Child ren Adult s 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.
e. administration of the antituberculous agents under supervision) should be considered for all patients, irrespective of the treatment regimen they are receiving.
Use 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.
Use in Elderly:
No special dosage regime is necessary but concurrent hepatic insufficiency should be taken into account (see Pharmacokinetics).
) is chiefly encountered during intermittent therapy and may be a prelude to serious complications such as thrombocytopenia, purpura, haemolytic anaemia, dyspnoea and asthma-like attacks, shock and renal failure. In the event of its onset, therefore, one should consider the possibility of switching to daily medication.
Such a switch must always be made where the "flu syndrome" assumes a relatively severe form and if the aforementioned serious complications occur, the medication must be withdrawn at once and never reinstituted. 8 Undesirable effects) occurring with intermittent therapy (less than 2 to 3 times per week) patients should be closely monitored.
Patients should be cautioned against interrupting treatment. When changing over from intermittent to daily therapy, an incremental dosage must be employed, starting with approx. 75-150 mg on the first day. The desired therapeutic dose should be reached within 3-4 days.
During this time the patient's renal function should be closely monitored. Corticosteroids may prove useful in attenuating possible immunopathological reactions.
Resumption of therapy after its interruption:
Since severe reactions such as shock and renal failure may occur in rare cases upon resumption of therapy, incremental dosing under close surveillance is mandatory (see "intermittent therapy"). Owing to its enzyme-inducing effect, rifampicin must be employed with extreme caution in patients with porphyria, because activation of delta- aminolaevulinic acid synthetase may lead to an acute manifestation of the porphyria.
Rifampicin can enhance the metabolism of endogenous substrates including adrenal hormones, thyroid hormones and vitamin D. 5 Interaction with other medicinal products and other forms of interactions). Patients should abstain from alcohol while receiving treatment with Rifampicin.
In the treatment of tuberculosis rifampicin should be given under the supervision of a respiratory or other suitably qualified physician. Cautions should be taken in case of renal impairment if dose > 600 mg/day. All tuberculosis patients should have pretreatment measurement of liver function.
Adults treated for tuberculosis with rifampicin should have baseline measurements of hepatic enzymes, bilirubin, serum creatinine, a complete blood count, and a platelet count (or estimate). Baseline tests are unnecessary in children unless a complicating condition is known or clinically suspected.
Patients with impaired liver function should only be given rifampicin in cases of necessity, and then with caution and under close medical supervision. In these patients, lower doses of rifampicin are recommended and careful monitoring of liver function, especially serum alanine aminotransferase (ALT) and serum aspartate aminotransferase (AST) should initially be carried out prior to therapy, weekly for two weeks, then every two weeks for the next six weeks.
If signs of hepatocellular damage occur, rifampicin should be withdrawn. Rifampicin should be withdrawn if clinically significant changes in hepatic function occur. The need for other forms of antituberculous therapy and a different regimen should be considered.
Urgent advice should be obtained from a specialist in the management of tuberculosis. If rifampicin is reintroduced after liver function has returned to normal, liver function should be monitored daily. In patients with or likely to have liver function abnormalities including those with chronic liver disease, chronic alcoholism, elderly patients, malnourished patients, and possibly, children under two years of age, the benefit of combined treatment with rifampicin must be weighed against the possible risks.
This applies particularly to combination of isoniazid and/or pyrazinamide with rifampicin. In the presence of severely impaired liver function or jaundice the dosage may have to be reduced. If a patient has no evidence of pre-existing liver disease and normal pretreatment liver function, liver function tests need only be repeated if fever, vomiting, jaundice or other deterioration in the patient’s condition occurs.
1; • have jaundice; • are concurrently receiving saquinavir/ritonavir therapy (see section
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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For the chemoprophylaxis of meningococcal meningitis:
Note: Rifampicin should not be used to treat overt meningococcal meningitis. Use in Adults: 600mg twice daily (12 hourly) for 2 days.
Use in Children:
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.
Rifampicin capsules may produce a reddish coloration of the urine, sweat, sputum and tears, and the patient should be forewarned of this. Soft contact lenses have been permanently stained. All patients with abnormalities should have follow up examinations, including laboratory testing, if necessary.
8). It is important to note that early manifestations of hypersensitivity, such as fever, lymphadenopathy or biological abnormalities (including eosinophilia, liver abnormalities) may be present even though rash is not evident. If such signs or symptoms are present, the patient should be advised to consult immediately their physician.
5 Interaction with other medicinal products and other forms of interaction Cytochrome P-450 enzyme interaction Rifampicin is a potent inducer of certain cytochrome P-450 enzymes. Co- administration of rifampicin with other drugs that are also metabolised through these cytochrome P-450 enzymes may accelerate the metabolism and reduce the activity of these other drugs.
Therefore, caution should be used when prescribing rifampicin with drugs metabolised by cytochrome P-450. To maintain optimum therapeutic blood levels, dosages of drugs metabolised by these enzymes may require adjustment when starting or stopping concomitantly administered rifampicin.
g. g. g. g. g. g. g. g. g. g. g. g. g. g. g. g. g. g. cimetidine) • clofibrate • systemic hormonal contraceptives • irinotecan • losartan • praziquantel • quinine • riluzole. Patients on oral contraceptives should be advised to use alternative, non- hormonal methods of birth control during Rifampicin therapy.
Diabetes may become more difficult to control. Treatment for corticoid- dependent asthma, patients may become more difficult or impossible Other interactions When rifampicin is given concomitantly with the combination saquinavir/ritonavir, the […]
Patients should be seen at least monthly during therapy and should be specifically questioned concerning symptoms associated with adverse reactions. As rifampicin is excreted principally by the biliary tract, caution should be exercised in treating patients with hepatic disorders.
In some patients hyperbilirubinaemia can occur in the early days of treatment. This results from competition between rifampicin and bilirubin for hepatic excretion. An isolated report showing a moderate rise in bilirubin and/or transaminase level is not in itself an indication for interrupting treatment; rather the decision should be made after repeating the tests, noting trends in the levels and considering them in conjunction with the patient’s clinical condition.
Patients receiving Rifampicin for the chemoprophylaxis of meningococcal meningitis should be kept under close surveillance. Special attention should be paid to signs of overt infection. Rifampicin should not be used to treat an overt meningococcal infection.
To prevent the emergence of resistant bacteria, Rifampicin must always be combined with other antibiotics/chemotherapeutic agents when used to treat infections. 8 Undesirable effects) is chiefly encountered during intermittent therapy and may be a prelude to serious complications such as thrombocytopenia, purpura, haemolytic anaemia, dyspnoea and asthma-like attacks, shock and renal failure.
In the event of its onset, therefore, one should consider the possibility of switching to daily medication. Such a switch must always be made where the "flu syndrome" assumes a relatively severe form and if the aforementioned serious complications occur, the medication must be withdrawn at once and never reinstituted.
8 Undesirable effects) occurring with intermittent therapy (less than 2 to 3 times per week) patients should be closely monitored. Patients should be cautioned against interrupting treatment. When changing over from intermittent to daily therapy, an incremental dosage must be employed, starting with approx.
75-150 mg on the first day. The desired therapeutic dose should be reached within 3-4 days. During this time the patient's renal function should be closely monitored. Corticosteroids may prove useful in attenuating possible immunopathological reactions.
Resumption of therapy after its interruption:
Since severe reactions such as shock and renal failure may occur in rare cases upon resumption of therapy, incremental dosing under close surveillance is mandatory (see "intermittent therapy"). Owing to its enzyme-inducing effect, rifampicin must be employed with extreme caution in patients with porphyria, because activation of delta- aminolaevulinic acid synthetase may lead to an acute manifestation of the porphyria.
Rifampicin can enhance the metabolism of endogenous substrates including adrenal hormones, thyroid hormones and vitamin D. To preclude all possibility of pregnancy during treatment with Rifampicin, non- hormonal means of contraception must be employed (see section