Mycobutin

DRUG DESCRIPTION

MYCOBUTIN Capsules contain the antimycobacterial agent rifabutin, which is a semisynthetic ansamycin antibiotic derived from rifamycin S. MYCOBUTIN (rifabutin) Capsules for oral administration contain 150 mg of rifabutin, USP, per capsule, along with the inactive ingredients microcrystalline cellulose, magnesium stearate, red iron oxide, silica gel, sodium lauryl sulfate, titanium dioxide, and edible white ink.

The chemical name for rifabutin is 1',4-didehydro-1-deoxy-1,4-dihydro-5'-(2-methylpropyl)-1-oxorifamycin XIV (Chemical Abstracts Service, 9th Collective Index) or (9S, 12E, 14S, 15R, 16S, 17R, 18R, 19R, 20S, 21S, 22E, 24Z)-6,16,18,20-tetrahydroxy-1'-isobutyl-14-methoxy-7,9,15,17,19,21,25-heptamethyl-spiro [9,4-(epoxypentadeca[1,11,13]trienimino)-2H-furo[2',3':7,8]naphth[1,2-d]imidazole-2,4'-piperidine]-5,10,26-(3H,9H)-trione-16-acetate. Rifabutin has a molecular formula of C46H62N4O11, a molecular weight of 847.02 and the following structure:

Mycobutin rifabutin Structural Formula Illustration

Rifabutin is a red-violet powder soluble in chloroform and methanol, sparingly soluble in ethanol, and very slightly soluble in water (0.19 mg/mL). Its log P value (the base 10 logarithm of the partition coefficient between n-octanol and water) is 3.2 (n-octanol/water).

What are the possible side effects of rifabutin (Mycobutin)?

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...

Read All Potential Side Effects and See Pictures of Mycobutin

What are the precautions when taking rifabutin (Mycobutin)?

Before taking rifabutin, tell your doctor or pharmacist if you are allergic to it; or to other rifamycins (such as rifampin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, a certain blood disorder (porphyria).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Rifabutin may cause live bacterial vaccines (such as typhoid vaccine) not to work as well. Therefore, do not have any immunizations/vaccinations...

Read All Potential Precautions of Mycobutin


Mycobutin Consumer (continued)

SIDE EFFECTS: Diarrhea, stomach upset, changes in taste, or nausea/vomiting may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

This medication may cause urine, sweat, saliva, or tears to turn brown-orange. This effect is harmless and will disappear when the medication is stopped. However, dentures and contact lenses may be permanently stained.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these rare but serious side effects occur: easy bleeding/bruising, signs of a new infection (such as fever, persistent sore throat/cough), muscle weakness/pain, joint pain/swelling, eye pain/redness, vision problems, chest pain/pressure, persistent nausea/vomiting, unusual weakness/tiredness, dark urine, yellowing eyes/skin.

This medication may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

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

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking rifabutin, tell your doctor or pharmacist if you are allergic to it; or to other rifamycins (such as rifampin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, a certain blood disorder (porphyria).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Rifabutin may cause live bacterial vaccines (such as typhoid vaccine) not to work as well. Therefore, do not have any immunizations/vaccinations while using this medication without the consent of your doctor.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Discuss the risks and benefits with your doctor before breast-feeding. If you have HIV disease, do not breast-feed because breast milk can transmit HIV.


Mycobutin Patient Information Including Side Effects

Brand Names: Mycobutin

Generic Name: rifabutin (Pronunciation: RIF a BUE tin)

  • What is rifabutin (Mycobutin)?
  • What are the possible side effects of rifabutin (Mycobutin)?
  • What is the most important information I should know about rifabutin (Mycobutin)?
  • What should I discuss with my healthcare provider before taking rifabutin (Mycobutin)?
  • How should I take rifabutin (Mycobutin)?
  • What happens if I miss a dose (Mycobutin)?
  • What happens if I overdose (Mycobutin)?
  • What should I avoid while taking rifabutin (Mycobutin)?
  • What other drugs will affect rifabutin (Mycobutin)?
  • Where can I get more information?

What is rifabutin (Mycobutin)?

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 are the possible side effects of rifabutin (Mycobutin)?

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.

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

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.

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.

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