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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).
) occurring with intermittent therapy (less than 2 to 3 times per week) patients should be closely monitored. Patients should be cautioned against interrupting treatment since these reactions may occur. Rifampicin has enzyme induction properties that can enhance the metabolism of endogenous substrates including adrenal hormones, thyroid hormones and vitamin D.
Isolated reports have associated porphyria exacerbation with rifampicin administration. Cases of thrombotic microangiopathy (TMA), manifested as thrombotic thrombocytopenic purpura (TTP) or haemolytic uremic syndrome (HUS), including fatal cases, have been reported with Rimactane capsules use.
If laboratory or clinical findings associated with TMA occur in a patient receiving Rimactane capsules, treatment should be discontinued and thorough evaluation for TMA performed, including platelet levels, renal function, serum lactate dehydrogenase (LDH) and a blood film for schistocytes (erythrocyte fragmentation).
ADAMTS13 activity and anti-ADAMTS13-antibody determination should be completed. If anti-ADAMTS13-antibody is elevated in conjunction with low ADAMTS13 activity, treatment with Rimactane capsules should not be resumed and patients should be treated accordingly (consider plasma exchange).
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.
Rifampicin infusion should be discontinued if an alternative etiology for the signs and symptoms cannot be established. After initial improvement of tuberculosis under therapy with Rimactane capsules, the symptoms may worsen again. In affected patients, clinical or radiological deterioration of existing tuberculous lesions or the development of new lesions have been detected.
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 pre-treatment measurements 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 also be withdrawn if clinically significant changes in hepatic function occur. The need for other forms of antituberculosis therapy and a different regimen should be considered.
Urgent advice should be obtained from a specialist in the management of tuberculosis. If rifampicin is re-introduced after liver function has returned to normal, liver function should be monitored daily. In patients with impaired liver function, elderly patients, malnourished patients, and possibly, children under two years of age, caution is particularly recommended when instituting therapeutic regimens in which isoniazid is to be used concurrently with rifampicin.
If the patient has no evidence of pre-existing liver disease and normal pre-treatment liver function, liver function tests need only be repeated if fever, vomiting, jaundice or other deterioration in the patient’s condition occur. Patients should be seen at least monthly during therapy and should be specifically questioned concerning symptoms associated with adverse reactions.
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.
Such reactions have been observed within the first few weeks or months of initiation of tuberculosis therapy. Cultures are usually negative, and such reactions do not usually indicate treatment failure. The cause of this paradoxical reaction is still unclear, but an exaggerated immune reaction is suspected as a possible cause.
In case a paradoxical reaction is suspected, symptomatic therapy to suppress the exaggerated immune reaction should be initiated if necessary. Furthermore, continuation of the planned tuberculosis combination therapy is recommended.
Patients should be advised to seek medical advice immediately if their symptoms worsen. The symptoms that occur are usually specific to the affected tissues. 8). Severe cutaneous adverse reactions (SCARs) including Steven-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), acute generalized exanthematous pustulosis (AGEP), which can be life-threatening or fatal, have been reported with a not known frequency in association with Rimactane capsules treatment.
At the time of prescription patients should be advised of the signs and symptoms and monitored closely for skin reactions. If signs and symptoms suggestive of these reactions appear, Rimactane capsules should be withdrawn immediately, and an alternative treatment considered (as appropriate).
Most of these reactions occurred within 2 days to 2 months after treatment initiation; the time to onset can vary depending on the conditions. Rifampicin infusion is for intravenous infusion only and must not be administered by intramuscular or subcutaneous route.
Avoid extravasation during injection; local irritation and inflammation due to extravascular infiltration of the infusion have been observed. If these occur, the infusion should be discontinued and restarted at another site. Rifampicin infusion may produce a discoloration(yellow, orange, red, brown) of the teeth, urine, sweat, sputum and tears, and the patient should be forewarned of this.
8). 5). Therefore, potential drug interactions should be considered whenever beginning or discontinuing rifampicin treatment. 8). Monitoring of occurrence of coagulopathy is recommended for patients at particular bleeding risk. Supplemental vitamin K administration should be considered when appropriate (vitamin K deficiency, hypoprothrombinemia).
8). ILD/pneumonitis is a potentially fatal disorder. Careful assessment of all patients with an acute onset and/or unexplained worsening of pulmonary symptoms (dyspnoea accompanied by dry cough) and fever should be performed to confirm the diagnosis of ILD/pneumonitis.
If ILD/pneumonitis is diagnosed, Rimactane Capsules should be permanently discontinued in case of severe manifestations (respiratory failure and acute respiratory distress syndrome) and appropriate treatment initiated as necessary.
All patients with abnormalities should have follow up examinations, including laboratory testing, if necessary. Excipients This medicine contains Lactose. Patients with rare hereditary problems of galactose intolerance, total […]
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.
Cases of drug-induced liver injury, including fatal cases (especially when used in combination with other anti-tuberculosis drugs), have been reported in patients treated with rifampicin with an onset of a few days to a few months following treatment initiation.
Signs and symptoms include elevated serum hepatic enzymes, cholestatic jaundice, hepatitis, hepatotoxicity, hepatocellular injury, and mixed liver injury. Most patients recovered on discontinuation of rifampicin treatment; nevertheless, progression to acute liver failure requiring liver transplantation can occur.
The mechanism of rifampicin-induced liver injury is not clearly elucidated, but data indicate either an immuno-allergic mechanism or direct toxicity of metabolic products. Patients should be instructed to contact their physician in case symptoms suggestive of liver injury occur.
In such patients rifampicin should be discontinued and liver function should be assessed. Rifampicin should not be re-introduced in patients with an episode of hepatic injury during treatment with rifampicin for which no other cause of liver injury has been determined.
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 since these reactions may occur. Rifampicin has enzyme induction properties that can enhance the metabolism of endogenous substrates including adrenal hormones, thyroid hormones and vitamin D.
Isolated reports have associated porphyria exacerbation with rifampicin administration. Cases of thrombotic microangiopathy (TMA), manifested as thrombotic thrombocytopenic purpura (TTP) or haemolytic uremic syndrome (HUS), including fatal cases, have been reported with Rimactane capsules use.
If laboratory or clinical findings associated with TMA occur in a patient receiving Rimactane capsules, treatment should be discontinued and thorough evaluation for TMA performed, including platelet levels, renal function, serum lactate dehydrogenase (LDH) and a blood film for schistocytes (erythrocyte fragmentation).
ADAMTS13 activity and anti-ADAMTS13-antibody determination should be completed. If anti-ADAMTS13-antibody is elevated in conjunction with low ADAMTS13 activity, treatment with Rimactane capsules should not be resumed and patients should be treated accordingly (consider plasma exchange).
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.
Rifampicin infusion should be discontinued if an alternative etiology for the signs and symptoms cannot be established. After initial improvement of tuberculosis under therapy with Rimactane capsules, the symptoms may worsen again. In affected patients, clinical or radiological deterioration of existing […]