Rifabutin 150 mg/1
Rifabutin · CAPSULE · REMEDYREPACK INC.
Rifabutin is an oral antibiotic used to treat or prevent infections caused by mycobacteria, particularly in patients with HIV/AIDS or those at risk for tuberculosis. It belongs to a class of drugs called rifamycins that work by stopping the growth of these bacteria.
Key Facts
- Brand Name
- Rifabutin
- Generic Name
- Rifabutin
- NDC Code (Product)
70518-4594- Manufacturer
- REMEDYREPACK INC.
- Strength
- 150 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA215041
- Drug Class
- Rifamycin Antimycobacterial [EPC]
- Marketing Start
- 03/24/2026
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Rifabutin capsules are indicated for the prevention of disseminated Mycobacterium avium complex (MAC) disease in patients with advanced HIV infection.
Dosage & Administration
DOSAGE AND ADMINISTRATION It is recommended that rifabutin capsules be administered at a dose of 300 mg once daily. For those patients with propensity to nausea, vomiting, or other gastrointestinal upset, administration of rifabutin at doses of 150 mg twice daily taken with food may be useful. Doses of rifabutin may be administered mixed with foods such as applesauce. For patients with severe renal impairment (creatinine clearance less than 30 mL/min), consider reducing the dose of rifabutin by 50%, if toxicity is suspected. No dosage adjustment is required for patients with mild to moderate renal impairment. Reduction of the dose of rifabutin may also be needed for patients receiving concomitant treatment with certain other drugs (see PRECAUTIONS-Drug Interactions ). Mild hepatic impairment does not require a dose modification. The pharmacokinetics of rifabutin in patients with moderate and severe hepatic impairment is not known.
Warnings
WARNINGS Tuberculosis Rifabutin capsules must not be administered for MAC prophylaxis to patients with active tuberculosis. Patients who develop complaints consistent with active tuberculosis while on prophylaxis with rifabutin should be evaluated immediately, so that those with active disease may be given an effective combination regimen of anti-tuberculosis medications. Administration of rifabutin as a single agent to patients with active tuberculosis is likely to lead to the development of tuberculosis that is resistant both to rifabutin and to rifampin. There is no evidence that rifabutin is an effective prophylaxis against M. tuberculosis . Patients requiring prophylaxis against both M. tuberculosis and Mycobacterium avium complex may be given isoniazid and rifabutin concurrently. Tuberculosis in HIV-positive patients is common and may present with atypical or extrapulmonary findings. Patients are likely to have a nonreactive purified protein derivative (PPD) despite active disease. In addition to chest X-ray and sputum culture, the following studies may be useful in the diagnosis of tuberculosis in the HIV-positive patient: blood culture, urine culture, or biopsy of a suspici…
Contraindications
CONTRAINDICATIONS Rifabutin capsules are contraindicated in patients who have had clinically significant hypersensitivity to rifabutin or to any other rifamycins. Rifabutin capsules are contraindicated in patients being treated with cabotegravir/rilpivirine prolonged-release injectable suspension ( see PRECAUTIONS-Drug Interactions, Table 2 ).
Drug Interactions
Drug Interactions Effect of Rifabutin on the Pharmacokinetics of Other Drugs: Rifabutin induces CYP3A enzymes and therefore may reduce the plasma concentrations of drugs metabolized by those enzymes. This effect may reduce the efficacy of standard doses of such drugs, which include itraconazole, clarithromycin, and saquinavir. Effect of Other Drugs on Rifabutin Pharmacokinetics: Some drugs that inhibit CYP3A may significantly increase the plasma concentration of rifabutin. Therefore, carefully monitor for rifabutin associated adverse events in those patients also receiving CYP3A inhibitors, which include fluconazole and clarithromycin. In some cases, the dosage of rifabutin may need to be reduced when it is coadministered with CYP3A inhibitors. Table 2 summarizes the results and magnitude of the pertinent drug interactions assessed with rifabutin. The clinical relevance of these interactions and subsequent dose modifications should be judged in light of the population studied, severity of the disease, patient's drug profile, and the likely impact on the risk/benefit ratio. Table 2 Rifabutin Interaction Studies Coadministered drug Dosing regimen of coadministered drug Dosing regimen…
Adverse Reactions
ADVERSE REACTIONS Adverse Reactions from Clinical Trials Rifabutin capsules were generally well tolerated in the controlled clinical trials. Discontinuation of therapy due to an adverse event was required in 16% of patients receiving rifabutin, compared to 8% of patients receiving placebo in these trials. Primary reasons for discontinuation of rifabutin were rash (4% of treated patients), gastrointestinal intolerance (3%), and neutropenia (2%). The following table enumerates adverse experiences that occurred at a frequency of 1% or greater, among the patients treated with rifabutin in studies 023 and 027. Table: 3 Clinical Adverse Experiences Reported in ≥1% of Patients Treated With Rifabutin Adverse event RIFABUTIN (n = 566) % Placebo (n = 580) % Body as a whole Abdominal pain 4 3 Asthenia 1 1 Chest pain 1 1 Fever 2 1 Headache 3 5 Pain 1 2 Blood and lymphatic system Leucopenia 10 7 Anemia 1 2 Digestive System Anorexia 2 2 Diarrhea 3 3 Dyspepsia 3 1 Eructation 3 1 Flatulence 2 1 Nausea 6 5 Nausea and vomiting 3 2 Vomiting 1 1 Musculoskeletal system Myalgia 2 1 Nervous system Insomnia 1 1 Skin and appendages Rash 11 8 Special senses Taste perversion 3 1 Urogenital system Discolored …
Frequently Asked Questions
What is Rifabutin used for?
Rifabutin is an oral antibiotic used to treat or prevent infections caused by mycobacteria, particularly in patients with HIV/AIDS or those at risk for tuberculosis. It belongs to a class of drugs called rifamycins that work by stopping the growth of these bacteria.
Is Rifabutin a controlled substance?
Rifabutin is not classified as a controlled substance by the DEA.
What is the generic name for Rifabutin?
The generic name for Rifabutin is Rifabutin. There are no other listed brand versions of Rifabutin.
What is the NDC code for Rifabutin 150 mg/1?
The NDC (National Drug Code) for Rifabutin 150 mg/1 is 70518-4594, listed by REMEDYREPACK INC..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)