What Mycobutin is used for and how to use it
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Mycobutin - Consumer Medicine Information

Manufacture: Pfizer Inc.
Country: Canada
Condition: Mycobacterium avium-intracellulare, Treatment, Mycobacterium avium-intracellulare, Prophylaxis, Tuberculosis, Prophylaxis, Tuberculosis, HIV Positive
Class: Rifamycin derivatives
Form: Capsules
Ingredients: rifabutin, edible white ink, magnesium stearate, microcrystalline cellulose, red iron oxide, silica gel, sodium lauryl sulfate, titanium dioxide

MYCOBUTIN

(rifabutin capsules)

What is MYCOBUTIN Used For

  • Mycobutin is given to patients with advanced HIV infection.
  • It is used to prevent serious disease caused by germs a group of (bacteria) called Mycobacterium avium complex (MAC).
  • MAC may cause a lung disease like tuberculosis (TB).

How Does Mycobutin Work

  • Mycobutin is an antibiotic drug that treats infections caused by germs (bacteria) called mycobacteria.
  • Mycobacteria are germs (bacteria) that cannot be killed using other antibiotics.

What are the Ingredients in Mycobutin

Medicinal Ingredients

Rifabutin.

Non-medicinal Ingredients

Edible white ink, magnesium stearate, microcrystalline cellulose, red iron oxide, silica gel, sodium lauryl sulfate and titanium dioxide.

Mycobutin Comes in the Following Dosage Form

It comes as a 150 mg capsule (pill). The capsule is dark red with the name of the drug ‘PHARMACIA & UPJOHN/ MYCOBUTIN’ written in white letters.

Do not Use Mycobutin If

  • If you are allergic (hypersensitive) to this drug.
  • If you are allergic to any of the other ingredients in Mycobutin (Read also “What are the ingredients in Mycobutin” above.)
  • If you are allergic to any drug containing rifamycin.

To help avoid side effects and make sure you take the drug properly, talk to your healthcare professional before you take Mycobutin. Talk about any health conditions or problems you may have, including if you:

  • Have severe kidney or liver problems. (You may need a lower dose of the drug.)
  • Get mild to severe diarrhea. (This could be a serious infection called C. difficile.)
  • Get eye problems like
    • pain
    • blurred vision
    • floating dark spots in your vision
    • redness
    • sensitivity to light.
    These could be signs of a problem called uveitis (inflammation in the inside of the eye.)
  • Are pregnant or thinking of getting pregnant.
  • If you are breast feeding your baby or thinking of breast feeding your baby.
  • Have ever had an allergic reaction to any medicines.

Your health care professional will test to be sure you do not have active TB or another infection.

If you are taking MYCOBUTIN with other medicines that treat infection, you may also be asked to have regular eye exams.

Tell your healthcare professional about all the medicines you take, even the ones you get without a prescription (example vitamins).

The Following Drugs may Interact With Mycobutin

  • Drugs to treat diabetes
  • Painkillers like acetylsalicylic acid (ASA) and others
  • Narcotics, including methadone
  • Blood thinners (anticoagulants) like warfarin
  • Steroids (to treat inflammation or allergy) like prednisolone
  • Drugs to suppress the immune system like cyclosporine (ciclosporin) and tacrolimus
  • Drugs for heart conditions like quinidine or digitalis (digoxin is okay)
  • Drugs to treat skin infections or pneumonia like dapsone
  • Drugs to treat epilepsy or seizures like phenytoin (Dilantin)
  • Drugs to treat fungal infections like fluconazole, itraconazole, posaconazole, voriconazole, ketoconazole and miconazole
  • Drugs to treat viral infections like indinavir, saquinavir, ritonavir or amprenavir, fosamprenavir/ritonavir, lopinavir/ritonavir and tipranavir/ritonavir
  • The anti-HIV drug called delviradine
  • The antibiotic drug called clarithromycin
  • Birth control pills that have ethinyl estradiol and/or norethindrone. (These drugs may not be as effective if you are on MYCOBUTIN and your healthcare professional may recommend a different kind or an additional kind of birth control.)

How to Take Mycobutin

  • It is very important to take Mycobutin exactly as your healthcare professional has told you to. Never change the dose by yourself. Do not stop taking Mycobutin unless your healthcare professional tells you to because your infection could return.
  • Take this drug at the same time every day.
  • Swallow the Mycobutin capsules (pills) whole with a drink of water.

Usual Dose

  • Take two Mycobutin capsules (pills) by mouth once a day.
  • If you have nausea, feel sick to your stomach, or throw up you can take one capsule (pill) by mouth twice a day. In this case, take with food.

Overdose

If you think you have taken too much Mycobutin, contact your healthcare professional, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

If you forget to take a dose, take it as soon as you remember, unless it is time for your next dose. Do not take a double dose to make up for a missed dose.

What are the Possible Side Effects From Using Mycobutin

Some of the possible side effects are listed below. These are not all the possible side effects you may get when taking Mycobutin. If you have side effects not listed here, contact your healthcare professional.

The most common side effect of Mycobutin is a change in the colour of your urine from yellow to brown-orange. Colour changes like this may also affect bowel movements, spit, sweat, tears or skin. If you wear contact lenses, they may be permanently stained.

Other side effects include:

  • A drop in the number of white blood cells (these fight infections).
  • Skin rashes
  • Stomach problems like upset stomach, burping, passing gas, nausea (feeling sick to your stomach), vomiting (throwing up) and belly pain.
  • Ask your healthcare professional about how to tell if you have Mycobacterium avium complex (MAC) disease and/or TB.
  • Let your healthcare professional know if you get any of these side effects and symptoms.

If you notice symptoms such as severe diarrhea (bloody or watery) with or without fever, abdominal (belly) pain, or tenderness, you may have Clostridium difficile colitis (C. difficile – bowel inflammation). If this occurs, stop taking Mycobutin and contact your healthcare professional immediately.

Side Effects and What to Do About Them

Symptom / effectTalk to your healthcare professionalStop taking drug and get immediate medical help
Only if severeIn all cases
COMMON
DiarrheaThe diarrhea is watery, bloody, or lasts for a while. You may or may not have fever or belly pain.
UNCOMMON
Sudden wheeziness or problems breathing
Pain in your chest
Swelling of your eyelids, face or lips
Rash or itching (especially over your whole body)
RARE
Muscle aches
Uveitis: symptoms can be eye pain, blurred vision, floating dark spots, eye redness and sensitivity to light
Pain in a number of joints

If you have a symptom or side effect that is not listed here and that bothers you or becomes bad enough to interfere with your daily activities, talk with your healthcare professional.

Reporting Side Effects

You can help improve the safe use of health products for Canadians by reporting serious and unexpected side effects to Health Canada. Your report may help to identify new side effects and change the product safety information.

3 ways to report:

  • Online at MedEffect;
  • By calling 1-866-234-2345 (toll-free);
  • By completing a Consumer Side Effect Reporting Form and sending it by:
    • Fax to 1-866-678-6789 (toll-free), or
    • Mail to: Canada Vigilance Program
      Health Canada, Postal Locator 0701E
      Ottawa, ON
      K1A 0K9

Postage paid labels and the Consumer Side Effect Reporting Form are available at MedEffect.

NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice.

Storage

  • Store your bottle of capsules at room temperature (15º to 30ºC).
  • Keep the container tightly closed.
  • Keep this medication where children cannot reach it or see it.

If You Want More Information About Mycobutin

  • Talk to your healthcare professional.
  • Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website, the manufacturer’s website http://www.pfizer.ca or by calling 1-800-463-6001.