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  • Mycobutin
    / Pfizer


    Active Ingredient
    Rifabutin 150 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Hard Capsules

    30 X 150 mg

    partial basket chart 9265 13012

    Dosage

    Rifabutin is generally administered as a single, daily, oral dose at any time independently of meals.
    Adults: Rifabutin as a single agent: Prophylaxis of MAC infection in immune-depressed patients:  300 mg (2 capsules).
    Rifabutin in combination regimens: Non-tuberculous mycobacterial disease:  450-600 mg (3 to 4 capsules) for up to 6 months after negative cultures are obtained.
    MAC treatment: When Rifabutin is given in association with clarithromycin, the dosage of Rifabutin should be reduced to 300 mg after the first month of treatment.
    Pulmonary tuberculosis: 150 mg daily (1 capsule), for 6-9 months, or for at least 6 months after negative cultures are obtained.  This dosage should be increased to 300-450 mg/day in patients previously treated with anti-tuberculous drugs.
    Paediatric population: There are inadequate data to support the use of Rifabutin in children at the present time.
    ElderlyNo specific recommendations for dosage alterations in the elderly are suggested.


    Indications

    Chronic tuberculosis where there is firm evidence of acid fast bacteria resistent to Rifampicin or to two other alternative drugs.
    Treatment of infections caused by MAC or other atypical mycobacteria where there is evidence of resistant bacteria as above.
    Treatment of infections caused by MAC or other atypical mycobacteria in AIDS patients in all cases not subject to the above restrictions.
    Prevention of MAC infections in AIDS patients whose CD4 counts lower or eqval to 200mm³.


    Contra-Indications

    Hypersensitivity or history of hypersensitivity to the active substance, other rifamycins (e.g. rifampicin) or to any of the excipients. Due to insufficient clinical experience in pregnant and breast-feeding women and in children, Rifabutin should not be used in these patients.


    Special Precautions

    Before starting Rifabutin prophylaxis, patients should be assessed to ensure that they do not have active disease caused by pulmonary tuberculosis or other mycobacteria. Prophylaxis against MAC infection may need to be continued throughout the patient’s lifetime. Rifabutin may impart a red-orange colour to the urine and possibly to skin and body secretions. Contact lenses, especially soft, may be permanently stained. Mild hepatic impairment does not require a dose modification. Rifabutin should be used with caution in cases of severe liver insufficiency.  Mild to moderate renal impairment does not require any dosage adjustment. Severe renal impairment (creatinine clearance below 30 ml/min) requires a dosage reduction of 50%. It is recommended that white blood cell and platelet counts and liver enzymes be monitored periodically during treatment. When Rifabutin is used concomitantly with clarithromycin for MAC treatment, a decreased dose of Rifabutin is recommended due to the increase in plasma concentrations of Rifabutin. Because of the possibility of occurrence of uveitis, patients should  be carefully monitored when rifabutin is given in combination with clarithromycin (or other macrolides) and/or fluconazole (and related compounds).  If such an event occurs, the patient should be referred to an ophthalmologist and, if considered necessary, Rifabutin treatment should be suspended. Uveitis associated with Rifabutin must be distinguished from other ocular complications of HIV. Protease inhibitors act as substrates or inhibitors of CYP450 IIIA4 mediated metabolism.  Therefore, due to significant drug-drug interactions between protease inhibitors and rifabutin, their concomitant use should be based on the overall assessment of the patient and patient specific drug profile. Clostridium difficile associated diarrhoea (CDAD) has been reported with use of nearly all antibacterial agents, including rifabutin, and may range in severity from mild diarrhoea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhoea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents.
    See prescribing information for full details.


    Side Effects

    Leucopenia, anemia, pancytopenia, agranulocytosis lymphopenia granulo-cytopenia, neutropenia, thrombocytopenia, nausea, pyrexia.
    See prescribing information for full details.


    Drug interactions

    Rifabutin has been shown to induce the enzymes of the cytochrome P450 3A subfamily and therefore may affect the pharmacokinetic behaviour of drugs metabolized by the enzymes belonging to this subfamily.  Upward adjustment of the dosage of such drugs may be required when administered with Rifabutin Similarly, Rifabutin might reduce the activity of analgesics, anticoagulants, corticosteroids, cyclosporin, digitalis (although not digoxin), oral hypoglycaemics, narcotics, phenytoin and quinidine.
    See prescribing information for full details.


    Pregnancy and Lactation

    The drug should not be used in pregnant or nursing women.
    See prescribing information for full details.


    Overdose

    Gastric lavage and diuretic treatment should be carried out. Supportive care and symptomatic treatment should be administered.


    Important notes

    Storage: Store below 25°C.


    Manufacturer
    Pfizer Italy
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