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rifabutin

Generic Name: rifabutin (RIF a BUE tin)
Brand Name: Mycobutin

What is rifabutin?

Rifabutin is an antibiotic. It prevents bacteria from multiplying in your body.

Rifabutin is used to prevent mycobacterium avium complex (MAC) in people with HIV (human immunodeficiency virus) infection. Rifabutin is also used with other medications to treat tuberculosis in people with HIV.

Rifabutin is often given together with other antibiotics.

Rifabutin may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about rifabutin?

You should not take this medication if you are allergic to rifabutin, rifapentine (Priftin), or rifampin (Rifadin, Rifater, Rimactane, Rifamate).

Rifabutin should not be used without other antibiotics to prevent mycobacterium avium complex (MAC) infection in people with active tuberculosis. The tuberculosis may become resistant to treatment if rifabutin is used as a single medication. Be sure to take all your medications as prescribed by your doctor.

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Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Rifabutin will not treat a viral infection such as the common cold or flu.

Rifabutin can make birth control pills less effective. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking rifabutin.

Do not wear dentures or contact lenses while taking rifabutin. This medicine may discolor certain body fluids (including tears and saliva) with a red, orange, or brown color. While this is a harmless side effect, it may permanently stain dentures or contact lenses.

What should I discuss with my healthcare provider before taking rifabutin?

You should not take this medication if you are allergic to rifabutin, rifapentine (Priftin), or rifampin (Rifadin, Rifater, Rimactane, Rifamate).

Rifabutin should not be used without other antibiotics to prevent mycobacterium avium complex (MAC) infection in people with active tuberculosis. The tuberculosis may become resistant to treatment if rifabutin is used as a single medication. Be sure to take all your medications as prescribed by your doctor.

Before using rifabutin, tell your doctor if you are allergic to any drugs, or if you have kidney disease. You may need a dose adjustment or special tests to safely take rifabutin. Your doctor will tell you if any of your medication doses need to be changed.

FDA pregnancy category B. This medication is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.

Rifabutin can make birth control pills less effective. Ask your doctor about using a non-hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while taking rifabutin.

It is not known whether rifabutin passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Rifabutin may cause a red-orange discoloration of breast milk.

How should I take rifabutin?

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

You may take rifabutin with or without food. Take the medication with food if it causes stomach upset, nausea, or vomiting.

Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.

Store rifabutin at room temperature away from moisture and heat. Keep the bottle tightly closed.

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include headache, nausea, vomiting, or stomach pain.

What should I avoid while taking rifabutin?

Do not wear dentures or contact lenses while taking rifabutin. This medicine may discolor certain body fluids (including tears and saliva) with a red, orange, or brown color. While this is a harmless side effect, it may permanently stain dentures or contact lenses.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

Rifabutin side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • severe skin rash or itching;

  • pale skin, weakness, easy bruising or bleeding;

  • fever, chills, body aches, flu symptoms; or

  • eye pain or redness, vision loss.

Less serious side effects may include:

  • red, orange, or brown discoloration of your skin, tears, sweat, saliva, urine, or stools;

  • nausea, vomiting, diarrhea;

  • stomach pain;

  • belching, bloating, loss of appetite;

  • headache; or

  • mild skin rash or itching.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Rifabutin dosing information

Usual Adult Dose for Mycobacterium avium-intracellulare -- Prophylaxis:

300 mg orally once a day. If nausea of vomiting becomes a problem, rifabutin 150 mg orally every 12 hours is an alternative regimen.

Usual Adult Dose for Mycobacterium avium-intracellulare -- Treatment:

300 mg orally once a day. If nausea or vomiting becomes a problem, rifabutin 150 mg orally every 12 hours is an alternative regimen. Therapy often consists of clarithromycin and 2-4 other drugs such as ethambutol, rifampin, clofazimine, and/or other agents. The duration of treatment is generally 18 to 24 months. In immunocompromised patients therapy often consists of clarithromycin or azithromycin and 1 to 3 other drugs such as ethambutol, clofazimine, ciprofloxacin, ofloxacin, rifampin, rifabutin, or amikacin. As long as a clinical and microbiological response is documented, therapy should be continued for life.

Usual Adult Dose for Tuberculosis -- Prophylaxis:

300 mg orally once a day. If nausea of vomiting becomes a problem, rifabutin 150 mg orally every 12 hours is an alternative regimen.

Rifabutin is recommended by the USPHS/IDSA (U.S. Public Health Service/Infectious Diseases Society of America) Prevention of Opportunistic Infections Working Group as an alternative to rifampin for chemoprophylaxis when exposure to isoniazid-resistant tuberculosis is suspected.

For HIV-infected patients, chemoprophylaxis is recommended for those with a positive tuberculin skin test (greater than or equal to 5 mm), prior positive skin test result without treatment, or contact with cases of active tuberculosis. In addition, tuberculin skin test negative, HIV-infected patients from high risk groups or geographic areas with a high prevalence of Mycobacterium tuberculosis may be candidates for chemoprophylaxis. Active tuberculosis should be ruled out prior to initiating preventive therapy.

There isn't general agreement on how to use rifabutin for preventive therapy. The decision to use non-isoniazid-containing regimens for chemoprophylaxis should require consultation with public health authorities.

Rifabutin is typically administered for 6 months to prevent the development of active tuberculosis in patients with no complicating factors. Patients with complicating factors such as HIV infection, diabetes, hematologic malignancy, or scars on chest X-ray should receive prophylaxis for 12 months.

Usual Adult Dose for Tuberculosis -- HIV Positive:

300 mg orally once a day. If nausea of vomiting becomes a problem, rifabutin 150 mg orally every 12 hours is an alternative regimen.

Due to the serious public and personal health risk associated with TB, the American Thoracic Society and the Centers for Disease Control strongly recommend giving anti-TB drugs in a directly observed therapy (DOT) program. If daily self-administered therapy is used, many experts strongly recommend use of combination preparations to decrease the chance of medication noncompliance.

The duration of therapy depends on the susceptibility of the organism. Pulmonary TB should be treated for a minimum of 6 months. In HIV-positive individuals, some experts believe that therapy should be continued for at least 9 months or 6 months beyond culture conversion. This practice is controversial. The current ATS/CDC recommendations are to treat TB in patients with HIV no differently than in those who are HIV-negative. However, before administering rifampin, providers must take into consideration the important drug-drug interactions that exist between rifampin and the non-nucleoside reverse transcriptase inhibitor and protease inhibitor agents used to treat HIV infection. Rifabutin is a safer agent to use in HIV-infected individuals taking certain antiretroviral agents.

In general, six-month regimens are effective if pyrazinamide (PZA) and isoniazid (INH) are included in the first two months of therapy. Recommended regimens are as follows.

Rate of INH resistance known to be less than 4%: Daily rifampin (RIF) or rifabutin (RFB) + INH + PZA for 2 months, followed by daily RIF or RFB + INH therapy for 4 months. If susceptibility test confirms INH resistance then follow regimen for INH resistant TB.

Rate of INH resistance is greater than or equal to 4% or unknown (and the patient will be compliant): Daily RIF or RFB + INH + PZA + either streptomycin (SM) or ethambutol (ETB) until susceptibility data is available. If no INH resistance, then continue with daily RIF or RFB + INH + PZA for a total of 2 months and finish with RIF or RFB + INH daily to complete 6 months of therapy. If confirmed INH resistance, then follow regimen for INH resistant TB.

Rate of INH resistance is greater than or equal to 4% or unknown (and the patient is noncompliant or unreliable): DOT with daily RIF or RFB + INH + PZA + either SM or ETB for 2 weeks then 2 to 3 times a week for 6 weeks. Therapy should then be continued with RIF or RFB + INH 2 to 3 times a week to complete 6 months of therapy. An alternative DOT regimen is RIF or RFB + INH + PZA + either SM or ETB 3 times a week for 6 months. Once susceptibility data is available and INH resistance is confirmed then follow regimen for INH resistant TB.

Confirmed INH resistant TB: DOT with daily RIF or RFB + ETB + PZA for 18 months or until sputum is culture negative for at least 12 months. If possible, the treatment of drug-resistant TB should be discussed with an expert in the treatment of such patients.

Usual Pediatric Dose for Mycobacterium avium-intracellulare -- Treatment:

5 mg/kg/day orally has been used in a limited number of cases. Used in combination with at least 2 other antimicrobials. Doses of rifabutin may be administered mixed with foods such as applesauce.

What other drugs will affect rifabutin?

The following drugs can interact with rifabutin. Tell your doctor if you are using any of these:

  • other antibiotics such as clarithromycin (Biaxin), erythromycin (E-Mycin, E.E.S., Ery-Tab), fluconazole (Diflucan), or itraconazole (Sporanox); or

  • HIV or AIDS medications such as amprenavir (Agenerase), delavirdine (Rescriptor), efavirenz (Sustiva), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir), or saquinavir (Invirase, Fortovase).

There are many other medicines that can interact with rifabutin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Where can I get more information?

  • Your pharmacist can provide more information about rifabutin.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 3.04. Revision Date: 2010-12-15, 5:01:39 PM.

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