Classes
DEA Class; Rx
Common Brand Names; Mycobutin
- Antitubercular Agents
Description
Antimycobacterial agent; alternative to clarithromycin or azithromycin for MAC prophylaxis; alternative to rifampin for TB prophylaxis or treatment.
Indications
Contraindications
Hypersensitivity to rifamycins
Concomitant live bacterial vaccines
Adverse Effects
- Discoloration of urine (30%)
- Neutropenia (25%)
- Leukopenia (17%)
- Rash (11%)
- Incr AST/ALT (7-9%)
- Thrombocytopenia (5%)
- Abdominal pain (4%)
- Diarrhea (3%)
- Eructation (3%)
- Headache (3%)
- Nausea/vomiting (3%)
- Anorexia (2%)
- Flatulence (2%)
- Anemia
- Myalgia
Warnings
Monitor hematologic status
Eye pain, redness, loss of vision may indicate inflammatory ocular condition
Joint stiffness, swelling, tenderness or paresthesia may indicate arthralgias or myositis
May have brown-orange color of urine, feces, saliva, sputum, perspiration, tears, and skin
Severe Cutaneous Adverse Reactions
- Severe cutaneous adverse reactions (SCAR), such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) reported
- Closely monitor patients that develop a skin rash; discontinue therapy if lesions progress
- Specifically, for DRESS, a multi-system potential life-threatening SCAR, time to onset of first symptoms may be prolonged; DRESS is a clinical diagnosis, and its clinical presentation remains the basis for decision making; an early withdrawal of therapy is essential because of the syndrome’s mortality and visceral involvement (eg, liver, bone marrow or kidney)
Pregnancy and Lactation
Rifabutin crosses the placenta
No studies have examined if excreted in breast milk; however, women with HIV infection should not breastfeed
Maximum Dosage
300 mg/day PO is the FDA-approved maximum dosage; 450 mg/day PO has been used off-label.
300 mg/day PO is the FDA-approved maximum dosage; 450 mg/day PO has been used off-label.
Safety and efficacy have not been established; 5 mg/kg/day (Max: 300 mg/day) PO has been used off-label.
Safety and efficacy have not been established; 20 mg/kg/day (Max: 300 mg/day) PO has been used off-label.
Safety and efficacy have not been established; 20 mg/kg/day PO has been used off-label.
Safety and efficacy have not been established.
How supplied
Rifabutin
capsule
- 150mg
oral solution
- 10mg/mL
- 20mg/mL