Registered Kenya · PPB

MYCOBUTIN

RIFABUTIN

10295 150MG INN generic

What it does

Rifabutin is an antibiotic used to treat certain bacterial infections, particularly those caused by mycobacteria.

Commonly used for: tuberculosis (TB), mycobacterial infections

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
10295
Registration date
-
Expiry date
-
Status
Registered
Active ingredient
RIFABUTIN
Dosage form
150MG
Strength
-
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Pfizer
Applicant / LTR
-
Country of origin
FOREIGN
Manufacturer location
Friedrichstraße 110, 10117 Berlin, Germany

Source: Pharmacy and Poisons Board · fetched 2026-01-28 21:30:38 · updated 2026-07-20 11:04:47

Drug Interactions

28
Check interactions

Severe (10)

Antifungals,azoles - decreases exposure

Rifabutin is predicted to decrease the exposure to antifungals, azoles (isavuconazole). Avoid.

Severe Theoretical

Antimalarials - decreases exposure

Rifabutins lightly decreases the exposure to antimalarials (atovaquone). Avoid.

Severe Study

Atovaquone - decreases exposure

Rifabutins lightly decreases the exposure to antimalarials (atovaquone). Avoid.

Severe Study

Bictegravir - decreases exposure

Rifabutins lightly decreases the exposure to bictegravir. Avoid.

Severe Study

Cabazitaxel - decreases exposure

Rifabutinispredictedtodecreasetheexposuretotaxanes (cabazitaxel).Avoid.oTheoretical

Severe Theoretical

Isavuconazole - decreases exposure

Rifabutin is predicted to decrease the exposure to antifungals, azoles (isavuconazole). Avoid.

Severe Theoretical

Mobocertinib - decreases exposure

Rifabutinispredictedtodecreasetheexposureto mobocertinib.Avoid.rTheoretical

Severe Theoretical

Rifabutin - increases concentration

Ketoconazole is predicted to increase the concentration of rifamycins (rifabutin) and rifamycins (rifabutin) are predicted to decrease the concentration of ketoconazole. Avoid.

Severe Theoretical

Taxanes - decreases exposure

Rifabutinispredictedtodecreasetheexposuretotaxanes (cabazitaxel).Avoid.oTheoretical

Severe Theoretical

Voxilaprevir - decreases concentration

Rifabutinispredictedtodecreasetheconcentrationof voxilaprevir.Avoid.rTheoretical

Severe Theoretical

Moderate (10)

Clarithromycin - decreases concentration

Rifabutin decreases the concentration of macrolides (clarithromycin) and macrolides (clarithromycin) increase the concentration of rifabutin. Monitor and adjust dose.

Moderate Study

Macrolides - decreases concentration

Rifabutin decreases the concentration of macrolides (clarithromycin) and macrolides (clarithromycin) increase the concentration of rifabutin. Monitor and adjust dose.

Moderate Study

Pralsetinib - decreases exposure

Rifabutin is predicted to decrease the exposure to pralsetinib. Avoid or adjust dose-consult product literature.

Moderate Study

Rifabutin - increases risk of uveitis

Fluconazole increases the risk of uveitis when given with rifamycins (rifabutin). Adjust dose.

Moderate Study

Rifabutin - increases concentration

Miconazole is predicted to increase the concentration of rifamycins (rifabutin). Use with caution and adjust dose.

Moderate Theoretical

Rifabutin - increases exposure

Rifamycins (rifabutin) decrease the concentration of cobicistat and cobicistat increases the exposure to rifamycins (rifabutin). Avoid or adjust dose.

Moderate Study

Rifabutin - increases exposure

Ritonavir markedly increases the exposure to rifamycins (rifabutin). Avoid or adjust dose.

Moderate Study

Rifabutin - decreases exposure

Lumacaftor is predicted to decrease the exposure to rifamycins (rifabutin). Adjust dose.

Moderate Theoretical

Rifabutin - increases concentration

Erythromycin is predicted to increase the concentration of rifamycins (rifabutin) and rifamycins (rifabutin) are predicted to decrease the concentration of erythromycin. Monitor and adjust dose.

Moderate Theoretical

Rifabutin - decreases exposure

Efavirenz slightly decreases the exposure to rifamycins (rifabutin). Adjust dose.

Moderate Study

Unknown (8)

Antifungals,azoles - decreases concentration

Rifabutin decreases the concentration of antifungals, azoles (voriconazole) and antifungals, azoles (voriconazole) increase the concentration of rifabutin. Avoid or adjust voriconazole dose, p. 662.

Unknown Study

Cobicistat And Cobicistat Increases The Exposure To Rifabutin - decreases concentration

Rifabutin decreases the concentration of cobicistat and cobicistat increases the exposure to rifabutin. Avoid or adjust dose.

Unknown Study

Coumarins - decreases anticoagulant effect

Rifabutinmightdecreasetheanticoagulanteffectof coumarins.oTheoretical

Unknown Theoretical

Elexacaftor - decreases exposure

Rifabutinispredictedtodecreasetheexposuretoelexacaftor. Avoid.rTheoretical

Unknown Theoretical

Ledipasvir - decreases exposure

Rifabutinispredictedtodecreasetheexposuretoledipasvir. Avoid.rTheoretical

Unknown Theoretical

Letermovir - decreases concentration

Rifabutinispredictedtodecreasetheconcentrationof letermovir.oTheoretical

Unknown Theoretical

Rifabutin - increases concentration

Rifamycins (rifabutin) decrease the concentration of voriconazole and voriconazole increases the concentration of rifamycins (rifabutin). Avoid or adjust voriconazole dose, p. 662.

Unknown Study

Voriconazole - decreases concentration

Rifabutin decreases the concentration of antifungals, azoles (voriconazole) and antifungals, azoles (voriconazole) increase the concentration of rifabutin. Avoid or adjust voriconazole dose, p. 662.

Unknown Study

Data from BNF 85 (British National Formulary). This is not a substitute for professional medical advice. Matched via: exact

Disclaimer: This information is sourced from Pharmacy and Poisons Board (Kenya). Always consult a qualified healthcare professional before using any medication.

About this medicine

Rifabutin is an antibiotic used to treat certain bacterial infections, particularly those caused by mycobacteria.

What it treats

  • tuberculosis (TB)
  • mycobacterial infections

How it works

Rifabutin works by stopping the growth of bacteria that cause infections.

Who it's for

It is generally used for people with specific bacterial infections, especially those with weakened immune systems.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: Rifabutin

BNF-referenced

Rifabutin is an antimycobacterial agent primarily used for the prophylaxis and treatment of infections caused by Mycobacterium avium complex in immunocompromised patients, and for the treatment of pulmonary tuberculosis in combination with other antitubercular drugs. It belongs to the rifamycin class and is known for its ability to penetrate macrophages and intracellular sites of infection.

Indications

  • Prophylaxis of Mycobacterium avium complex infections in immunosuppressed patients with low CD4 count
  • Treatment of non-tuberculous mycobacterial disease, in combination with other drugs
  • Treatment of pulmonary tuberculosis, in combination with other drugs
  • Helicobacter pylori eradication (unlicensed use)

Dosage

Children: Child 12–17 years: 450–600 mg once daily for up to 6 months after cultures negative. For children under 12 years, rifabutin is not licensed for use.

Adults: 300 mg once daily for prophylaxis of Mycobacterium avium complex infections. For treatment of pulmonary tuberculosis, the dosage ranges from 150-450 mg once daily for at least 6 months, depending on the treatment regimen.

Mechanism of action

Rifabutin exerts its antibacterial effect by inhibiting bacterial DNA-dependent RNA polymerase, which is essential for RNA synthesis in bacteria. This action ultimately disrupts protein synthesis, leading to bacterial cell death. It is particularly effective against mycobacteria, including those resistant to other antibiotics.

Pharmacodynamics

Rifabutin demonstrates concentration-dependent killing, meaning higher drug concentrations can lead to more effective bacterial eradication. The drug is effective against a variety of mycobacterial species, including those that cause tuberculosis and non-tuberculous mycobacterial infections.

Pharmacokinetics

Rifabutin is well absorbed from the gastrointestinal tract, with bioavailability ranging between 20% and 60%. It undergoes extensive hepatic metabolism primarily via the cytochrome P450 system, particularly CYP3A4. The elimination half-life is approximately 35 hours, allowing for once-daily dosing. It is excreted mainly in the urine and bile, and dosage adjustments may be necessary in patients with hepatic impairment.

Contra-indications

  • Hypersensitivity to rifabutin or any component of the formulation
  • Acute porphyrias
  • Intestinal obstruction

Adverse effects

  • Granulocytosis
  • Anaemia
  • Arthralgia
  • Bronchospasm
  • Chest pain
  • Corneal deposits
  • Decreased leucocytes
  • Dyspnoea
  • Eosinophilia
  • Fever
  • Haemolysis
  • Neutropenia
  • Pancytopenia
  • Skin reactions
  • Thrombocytopenia
  • Urine discoloration
  • Uveitis
  • Memory loss
  • Muscle weakness
  • Palpitations
  • Seizures
  • Taste alterations
  • Nasal disorders
  • Dry mouth
  • Throat pain
  • Hot flushes
  • Increased risk of infection

Interactions

  • Ketoconazole: Severe (increases concentration)
  • Antifungals, azoles: Severe (decreases exposure)
  • Isavuconazole: Severe (decreases exposure)
  • Antimalarials: Severe (decreases exposure)
  • Atovaquone: Severe (decreases exposure)
  • Bictegravir: Severe (decreases exposure)
  • Mobocertinib: Severe (decreases exposure)
  • Taxanes: Severe (decreases exposure)
  • Cabazitaxel: Severe (decreases exposure)
  • Voxilaprevir: Severe (decreases concentration)

Precautions

  • Use caution in patients with hepatic impairment
  • Monitor for signs of liver disorder
  • May discolor soft contact lenses
  • Gradually re-introduce after treatment interruption
  • Regular blood tests to monitor for blood dyscrasias

Pregnancy

Manufacturer advises caution; limited data on safety in pregnancy.

Breast-feeding

Manufacturer advises avoiding use; no information available on excretion in breast milk.

Storage

Store in a cool, dry place, away from direct sunlight. Keep out of reach of children.

Formulations

  • Capsules: 150 mg
BNF 85 (British National Formulary) p.655 BNF for Children 2019-2020 p.400 PubChem / pathway

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: Rifabutin

PubChem CID 135415564

Molecular formula: C46H62N4O11

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.

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