Generic Name and Formulations:
Rifabutin 150mg; hard-gel caps.
Indications for MYCOBUTIN:
Prevention of disseminated Mycobacterium avium complex (MAC) disease in advanced HIV infection.
≥18yrs: 300mg once daily. If inclined to GI upset, may give 150mg twice daily with food. Severe renal impairment (CrCl <30mL/min), concomitant amprenavir, indinavir, or nelfinavir: reduce rifabutin dose by 50%. Concomitant ritonavir, fosamprenavir/ritonavir, lopinavir/ritonavir, saquinavir/ritonavir, tipranavir/ritonavir: reduce rifabutin dose by 75% (to max 150mg every other day or 3 times per week).
<18yrs: not established.
Active tuberculosis: do not administer. Evaluate and test for tuberculosis before and during therapy; treat with combination antituberculosis regimen if active disease occurs. Suspend therapy if uveitis is suspected. Do hematologic tests periodically. May stain body secretions and contact lenses. Moderate-to-severe hepatic impairment. Elderly. Pregnancy (Cat.B). Nursing mothers: not recommended.
Concomitant delavirdine, voriconazole: not recommended. Antagonizes dapsone, sulfamethoxazole-trimethoprim, zidovudine, oral contraceptives (change or use additional nonhormonal birth control methods) or drugs that are metabolized by CYP3A enzymes (eg, itraconazole, clarithromycin, saquinavir, posaconazole). Potentiated by CYP3A inhibitors (eg, fluconazole, clarithromycin, posaconazole).
Discolored urine, GI upset, abdominal pain, dyspepsia, fever, myalgia, rash, taste perversion, neutropenia, thrombocytopenia, leukopenia; rare: myositis, uveitis.