Mycobutin

Generic Name: rifabutin (Oral route)

rif-a-BUE-tin

Commonly used brand name(s)

In the U.S.

  • Mycobutin

Available Dosage Forms:

  • Capsule

Therapeutic Class: Antitubercular

Chemical Class: Rifamycin

Uses For Mycobutin

Rifabutin is used to help prevent Mycobacterium avium complex (MAC) disease from causing disease throughout the body in patients with advanced human immunodeficiency virus (HIV) infection. MAC is an infection caused by two similar bacteria, Mycobacterium avium and Mycobacterium intracellulare. Mycobacterium avium is more common in patients with HIV infection. MAC also may occur in other patients whose immune system is not working properly. Symptoms of MAC in people with acquired immunodeficiency syndrome (AIDS) include fever, night sweats, chills, weight loss, and weakness. Rifabutin will not work for colds, flu, or most other infections.

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Rifabutin is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, rifabutin is used in certain patients with the following medical condition:

  • Treatment of tuberculosis in patients with human immunodeficiency virus (HIV) infection

Before Using Mycobutin

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Studies on this medicine have only been done in adult patients, and there is no specific information comparing use of rifabutin in children with use in other age groups. However, studies are being done to determine the best dose for children.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of rifabutin in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

Pregnancy Category Explanation
All Trimesters B Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Artemether
  • Lumefantrine
  • Lurasidone
  • Maraviroc
  • Ranolazine
  • Rilpivirine
  • Voriconazole

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Abiraterone Acetate
  • Amprenavir
  • Atazanavir
  • Axitinib
  • Bedaquiline
  • Boceprevir
  • Bortezomib
  • Bosutinib
  • Cabazitaxel
  • Cabozantinib
  • Clarithromycin
  • Clozapine
  • Cobicistat
  • Crizotinib
  • Cyclosporine
  • Dabrafenib
  • Darunavir
  • Dasatinib
  • Delavirdine
  • Doxorubicin
  • Doxorubicin Hydrochloride Liposome
  • Efavirenz
  • Elvitegravir
  • Enzalutamide
  • Erlotinib
  • Eslicarbazepine Acetate
  • Etravirine
  • Everolimus
  • Fentanyl
  • Fluconazole
  • Fosamprenavir
  • Hydrocodone
  • Ibrutinib
  • Ifosfamide
  • Indinavir
  • Irinotecan
  • Itraconazole
  • Ivacaftor
  • Ixabepilone
  • Ketoconazole
  • Lapatinib
  • Linagliptin
  • Lopinavir
  • Macitentan
  • Mifepristone
  • Mitotane
  • Nelfinavir
  • Nifedipine
  • Nilotinib
  • Pazopanib
  • Perampanel
  • Piperaquine
  • Pomalidomide
  • Ponatinib
  • Posaconazole
  • Primidone
  • Quetiapine
  • Regorafenib
  • Ritonavir
  • Romidepsin
  • Saquinavir
  • Simeprevir
  • Sofosbuvir
  • Sunitinib
  • Tacrolimus
  • Telaprevir
  • Temsirolimus
  • Tipranavir
  • Tolvaptan
  • Trabectedin
  • Vandetanib
  • Vemurafenib
  • Vilazodone
  • Vincristine Sulfate
  • Vincristine Sulfate Liposome
  • Vinflunine
  • Vortioxetine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Atovaquone
  • Azithromycin
  • Dapsone
  • Desogestrel
  • Didanosine
  • Dienogest
  • Drospirenone
  • Estradiol Cypionate
  • Estradiol Valerate
  • Ethinyl Estradiol
  • Ethynodiol Diacetate
  • Etonogestrel
  • Imatinib
  • Levonorgestrel
  • Medroxyprogesterone Acetate
  • Mestranol
  • Nevirapine
  • Norelgestromin
  • Norethindrone
  • Norgestimate
  • Norgestrel
  • Ospemifene
  • Sirolimus
  • Sulfamethoxazole
  • Trimetrexate
  • Warfarin
  • Zidovudine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Kidney disease, mild to severe

Proper Use of Mycobutin

Rifabutin may be taken on an empty stomach (either 1 hour before or 2 hours after a meal). However, if this medicine upsets your stomach, you may want to take it with food.

For patients unable to swallow capsules:

  • The contents of the capsules may be mixed with applesauce. Be sure to take all the food to get the full dose of medicine.

To help prevent MAC disease, it is very important that you keep taking this medicine for the full time of treatment. You may have to take it every day for many months. It is important that you do not miss any doses.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage forms (capsules):
    • For the prevention of Mycobacterium avium complex (MAC):
      • Adults and teenagers—300 milligrams (mg) once a day, or 150 mg two times a day.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If this medicine is taken on an irregular schedule, side effects may occur more often and may be more serious than usual. If you have any questions about this, check with your health care professional.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using Mycobutin

It is very important that your doctor check your progress at regular visits.

Rifabutin will cause your urine, stool, saliva, skin, sputum, sweat, and tears to turn reddish-orange to reddish-brown. This is to be expected while you are taking this medicine. This effect may cause soft contact lenses to become permanently discolored. Standard cleaning solutions may not take out all the discoloration. Therefore, it is best not to wear soft contact lenses while taking this medicine. Hard contact lenses are not discolored by rifabutin. If you have any questions about this, check with your doctor.

Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.

Mycobutin Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common
  • Diarrhea
  • fever
  • heartburn
  • indigestion
  • loss of appetite
  • nausea
  • skin itching and/or rash
Less common
  • Loss of strength or energy
  • muscle pain
Rare
  • Black, tarry, stools
  • bruising or purple spots on skin
  • change in taste
  • chills
  • cough
  • eye pain
  • joint pain
  • loss of vision
  • lower back or side pain
  • muscle inflammation or pain
  • pale skin
  • painful or difficult urination
  • shortness of breath
  • ulcers, sores, or white spots in mouth
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • yellow skin
  • sore throat
  • sour stomach
  • vomiting

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
  • Abdominal pain
  • bad, unusual, or unpleasant (after) taste in mouth
  • belching
  • bloated, full feeling
  • change in taste
  • chest pain
  • excess air or gas in stomach or intestines
  • headache
  • passing gas
  • rash
  • trouble in sleeping

This medicine commonly causes reddish-orange to reddish-brown discoloration of urine, stools, saliva, skin, sputum, sweat, and tears. This side effect usually does not need medical attention. However, tears that have been discolored by this medicine may also discolor soft contact lenses (see Precautions While Using This Medicine).

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

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