Rifabutin

Brands of Rifabutin  in Kenya:

Mycobutin®, Pfizer


Rifabutin in Kenya : Use in Tb, Price, Brand name, Cost
Rifabutin Chemical Structure

MODE OF ACTION OF RIFABUTIN:

Rifabutin acts via the inhibition of DNA-dependent RNA polymerase in gram-positive and some gram-negative bacteria, leading to a suppression of RNA synthesis and cell death.

INDICATIONS:

Rifabutin is indicated for:
– the prophylaxis of M. avium intracellulare complex (MAC) infections in patients with HIV disease with CD4 counts lower than 75 cells/mcl.
– the treatment of non-tuberculous mycobacterial disease (such as that caused by MAC and M. xenopi).
– pulmonary tuberculosis.

DOSAGE AND ADMINISTRATION:

Rifabutin can be administered as a single, daily, oral dose at any time independently of meals.
Posology
Adults
– prophylaxis of M. avium intracellulare complex (MAC) infections in patients with HIV disease with CD4 counts lower than 75 cells/mcl:
300 mg as a single agent.
– treatment of non-tuberculous mycobaterial disease:
450 – 600 mg in combination regimens for up to 6 months after negative cultures are obtained.
When Rifabutin is given in association with clarithromycin (or other macrolides) and/or fluconazole (or related compounds) the Rifabutin dosage may need to be reduced to 300 mg .
– treatment of pulmonary tuberculosis:
150 – 450 mg in combination regimens for at least 6 months.
In accordance with the commonly accepted criteria for the treatment of mycobacterial infections, Rifabutin should always be given in combination with other anti-mycobacterial drugs not belonging to the family of rifamycins.
Paediatric population
There are inadequate data to support the use of Rifabutin in children at the present time.
Elderly
No specific recommendations for dosage alterations in the elderly are suggested.

CONTRAINDICATIONS:

Rifabutin is contraindicated in patients who have had clinically significant hypersensitivity to rifabutin or to any other rifamycins.

DRUG INTERACTIONS:

Effect of Rifabutin on the Pharmacokinetics of Other Drugs
Rifabutin induces CYP3A enzymes and therefore may reduce the plasma concentrations of drugs metabolized by those enzymes. This effect may reduce the efficacy of standard doses of such drugs, which include itraconazole, clarithromycin, and saquinavir.
Effect of Other Drugs on Rifabutin Pharmacokinetics
Some drugs that inhibit CYP3A may significantly increase the plasma concentration of rifabutin. Therefore, carefully monitor for rifabutin associated adverse events in those patients also receiving CYP3A inhibitors, which include fluconazole and clarithromycin. In some cases, the dosage of rifabutin may need to be reduced when it is coadministered with CYP3A inhibitors.

ADVERSE DRUG REACTIONS:

Blood and lymphatic system disorders
White blood cell disorders (including agranulocytosis, lymphopenia, granulocytopenia, neutropenia, white blood cell count decreased, neutrophil count decreased), platelet count decreased.
Immune system disorders
Hypersensitivity, bronchospasm, rash, and eosinophilia.
Gastrointestinal disorders
Clostridium difficile colitis/ Clostridium difficile associated diarrhea.
Pyrexia, rash and other hypersensitivity reactions such as eosinophilia and bronchospasm might occur, as has been seen with other antibacterials.
A limited number of skin discoloration have been reported.
Rifamycin hypersensitivity reactions
Hypersensitivity to rifamycins have been reported including flu-like symptoms, bronchospasm, hypotension, urticaria, angioedema, conjunctivitis, thrombocytopenia or neutropenia.

Reporting of suspected adverse reactions:

The PPB Department of Pharmacovigilance was set up with a vision to develop, implement and continuously upgrade an appropriate system for detecting, reporting, and monitoring adverse drug reactions (ADRs) and other relevant problems with medicines in Kenya. The department strives to ensure the safety and efficacy of pharmaceutical products in Kenya.
Reporting suspected adverse reactions after authorization of the medicinal product are important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals/ Patients are encouraged to report any suspected adverse reactions via Pharmacovigilance Yellow Form, pv@pharmacyboardkenya.org or clicking below button:



Rifabutin in Kenya
Rifabutin in Kenya
Rifabutin in Kenya
Rifabutin in Kenya
Rifabutin in Kenya

Clinical | Pharmacokinetic data


Pregnancy Category: C
Routes of Administration: Oral
Bioavailability: 85%
Protein Binding: 85%
Metabolosim: Liver
Onset of Action: N/A
Elimination Half life: 28 to 62 hours (mean)
Excretion: Fecal and Kidney

Legal Status | Dosage forms & Strengths


Prescription Category:
Prescription only Medicine (POM) , ℞-only
Narcotic Drugs and Psychotropic Substances (Control ) Act Schedule:
This Drug is not Subject to DDA drugs Act
Dosage Forms | Strengths:
Capsules

Drug Indentifiers:

CAS Number
PubChem CID
DrugBank
ChemSpider
UNII
KEGG
ChEBI
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Drug Images

References/ Citation:




What was the patient being treated for
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