Formulary
Rifabutin: Indications, Dosing, Side Effects and Interactions
Rifabutin clinical drug profile including indications, dosing, side effects, cautions and interactions.
MedNext Academy | 3 min read
Rifabutin: Indications, Dosing, Side Effects and Interactions
Rifabutin clinical drug profile including indications, dosing, side effects, cautions and interactions.
Indications and dose
**Prophylaxis ofMycobacterium aviumcomplex infections in immunosuppressed patients with low CD4 count**
- **Adult** (By Mouth): Prophylaxis of Mycobacterium avium complex infections in immunosuppressed patients with low CD4 count 300 mg once daily, also consult product literature.
**Treatment of non-tuberculous mycobacterial disease, in combination with other drugs**
- **Adult** (By Mouth): 450-600 mg once daily for up to 6 months after cultures negative.
**Treatment of pulmonary tuberculosis, in combination with other drugs**
- **Adult** (By Mouth): 150-450 mg once daily for at least 6 months.
**Helicobacter pylorieradication [in combination with other drugs (seeHelicobacter pylori infection)]**
- **Adult** (By Mouth): Helicobacter pylori eradication [in combination with other drugs (see Helicobacter pylori infection )] 150 mg twice daily for 10 days for third-line eradication therapy.
**Prophylaxis of Mycobacterium avium complex infections in immunosuppressed patients with low CD4 count for rifabutin**
- **Child 1 month-11 years** (By mouth): 5 mg/kg once daily (max. per dose 300 mg), also consult product literature.
- **Child 12-17 years** (By mouth): 300 mg once daily, also consult product literature.
**Treatment of non-tuberculous mycobacterial disease, in combination with other drugs for rifabutin**
- **Child 1 month-11 years** (By mouth): 5 mg/kg once daily for up to 6 months after cultures negative.
- **Child 12-17 years** (By mouth): 450-600 mg once daily for up to 6 months after cultures negative.
**Treatment of pulmonary tuberculosis, in combination with other drugs for rifabutin**
- **Child 12-17 years** (By mouth): 150-450 mg once daily for at least 6 months.
Cautions
Acute porphyrias ; discolours soft contact lenses
Side effects
Frequency not known Agranulocytosis; anaemia; arthralgia; bronchospasm; chest pain; corneal deposits; decreased leucocytes; dyspnoea; eosinophilia; fever; haemolysis; hepatic disorders; influenza like illness; myalgia; nausea; neutropenia; pancytopenia; skin reactions; thrombocytopenia; urine discolouration; uveitis (more common following high doses or concomitant use with drugs that increase plasma concentration); vomiting
Interactions
**Severe interactions:**
- On the basis of the above metabolic considerations no significant interaction may be expected with ethambutol, theophylline, sulfonamides, pyrazinamide and zalcitabine (DDC).
- Table 1: Rifabutin Interaction Studies Coadministered Drugs Effect on Rifabutin Effect on Coadministered Drug Comments ANTIRETROVIRALS Amprenavir 2.9-fold AUC, 2.2-fold Cmax No significant...
- Atazanavir/ Ritonavir 48% in AUC, 149% Cmax of rifabutin.
- Darunavir/ Ritonavir No significant change in rifabutin kinetics.
- Dolutegravir ND No significant change in dolutegravir kinetics at steady state.
- Elvitegravir/ Cobicistat No significant change in rifabutin kinetics.
- Etravirine No significant change in rifabutin kinetics.
- Lopinavir/ ritonavir 5.7-fold AUC, 3.4 fold C max.
**Other interactions (50):**
- Rifabutin has been shown to induce the enzymes of the cytochrome P450 3A (CYP450 3A) subfamily and therefore may affect the pharmacokinetic behaviour of drugs metabolised by the enzymes belonging to...
- Similarly, rifabutin might reduce the activity of analgesics, anticoagulants, corticosteroids, cyclosporin, digitalis (although not digoxin), oral hypoglycaemics, narcotics, phenytoin and quinidine.
- Clinical studies have shown that rifabutin does not affect the pharmacokinetics of didanosine (DDI), and isoniazid (however, for the latter refer also to undesirable effects).
- As p-aminosalicylic acid has been shown to impede GI absorption of rifamycins it is recommended that when it and rifabutin are both to be administered they be given with an interval of 8 - 12 hours.
- The following table provides details of the possible effects of co-administration, on rifabutin and the co-administered drug, and risk-benefit statement.
- A 50% reduction in the rifabutin dose is recommended when combined with amprenavir.
Pregnancy
Manufacturer advises avoid-no information available.
Breast feeding
Manufacturer advises avoid-no information available.
Hepatic impairment
Manufacturer advises caution in severe impairment.
Renal impairment
Dose adjustments See Prescribing in renal impairment . Manufacturer advises use half normal dose if creatinine clearance less than 30 mL/minute.
Medicinal forms
Solution
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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