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Mycobutin Generic Name & Formulations
Legal Class
Rx
General Description
Rifabutin 150mg; hard-gel caps.
Pharmacological Class
Rifamycin.
How Supplied
Caps—100
Manufacturer
Generic Availability
YES
Mycobutin Indications
Indications
Prevention of disseminated Mycobacterium avium complex (MAC) disease in advanced HIV infection.
Mycobutin Dosage and Administration
Adult
≥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).
Children
<18yrs: not established.
Mycobutin Contraindications
Contraindications
Concomitant delavirdine, voriconazole.
Mycobutin Boxed Warnings
Not Applicable
Mycobutin Warnings/Precautions
Warnings/Precautions
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. Monitor for severe cutaneous adverse reactions (eg, SJS, TEN, DRESS, AGEP). Do hematologic tests periodically. May stain body secretions and contact lenses. Moderate to severe hepatic impairment. Elderly. Pregnancy. Nursing mothers: not recommended.
Mycobutin Pharmacokinetics
See Literature
Mycobutin Interactions
Interactions
See Contraindications. Concomitant bictegravir, doravirine, rilpivirine: not recommended. Antagonizes dapsone, sulfamethoxazole-trimethoprim, zidovudine, oral contraceptives (use additional or alternative contraception methods) or drugs that are metabolized by CYP3A enzymes (eg, itraconazole, clarithromycin, indinavir, saquinavir/ritonavir, posaconazole). Potentiated by CYP3A inhibitors (eg, amprenavir, fluconazole, clarithromycin, indinavir, lopinavir/ritonavir, nelfinavir, posaconazole, saquinavir/ritonavir, tipranavir/ritonavir).
Mycobutin Adverse Reactions
Adverse Reactions
Discolored urine, GI upset, abdominal pain, dyspepsia, fever, myalgia, rash, taste perversion, neutropenia, thrombocytopenia, leukopenia; rare: myositis, uveitis.
Mycobutin Clinical Trials
See Literature
Mycobutin Note
Not Applicable
Mycobutin Patient Counseling
See Literature
