August 4, 2015
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Mycobutin

"Below is a list of the most popular prescription drugs dispensed in 2011 with links to drug monographs. The list may include the medication brand name and generic name.

Note: This information pertains to U.S. prescriptions only./"...

Mycobutin




Mycobutin Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 7/15/2015

Mycobutin (rifabutin) is an antibiotic used to prevent mycobacterium avium complex (MAC) in people with HIV (human immunodeficiency virus) infection. Mycobutin is also used with other medications to treat tuberculosis in people with HIV. Common side effects of Mycobutin include diarrhea, stomach upset or pain, changes in taste, nausea, vomiting, belching, bloating, loss of appetite, headache, skin rash, itching, or red, orange, or brown discoloration of your skin, tears, sweat, saliva, urine, or stools.

It is recommended that Mycobutin Capsules be administered at a dose of 300 mg once daily. Mycobutin may interact with other antibiotics, or HIV or AIDS medications. Many other medicines can interact with Mycobutin. Tell your doctor all prescription and over-the-counter medications and supplements you use. During pregnancy, Mycobutin should be used only when prescribed. It is unknown if this medication passes into breast milk. Consult your doctor before breastfeeding. If you have HIV disease, do not breastfeed because breast milk can transmit HIV.

Our Mycobutin (rifabutin) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Mycobutin in Detail - Patient Information: 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.

Read the entire detailed patient monograph for Mycobutin (Rifabutin)

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Mycobutin Overview - Patient Information: Side Effects

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.

Read the entire patient information overview for Mycobutin (Rifabutin)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Mycobutin FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Adverse Reactions From Clinical Trials

MYCOBUTIN 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 MYCOBUTIN, compared to 8% of patients receiving placebo in these trials. Primary reasons for discontinuation of MYCOBUTIN 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 MYCOBUTIN in studies 023 and 027.

Table: 3 Clinical Adverse Experiences Reported in ≥ 1% of Patients Treated With MYCOBUTIN

Adverse event MYCOBUTIN
(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 urine 30 6

Clinical Adverse Events Reported In < 1% Of Patients Who Received Mycobutin

Considering data from the 023 and 027 pivotal trials, and from other clinical studies, MYCOBUTIN appears to be a likely cause of the following adverse events which occurred in less than 1% of treated patients: flu-like syndrome, hepatitis, hemolysis, arthralgia, myositis, chest pressure or pain with dyspnea, skin discoloration, thrombocytopenia, pancytopenia and jaundice.

The following adverse events have occurred in more than one patient receiving MYCOBUTIN, but an etiologic role has not been established: seizure, paresthesia, aphasia, confusion, and nonspecific T wave changes on electrocardiogram.

When MYCOBUTIN was administered at doses from 1050 mg/day to 2400 mg/day, generalized arthralgia and uveitis were reported. These adverse experiences abated when MYCOBUTIN was discontinued.

Mild to severe, reversible uveitis has been reported less frequently when MYCOBUTIN is used at 300 mg as monotherapy in MAC prophylaxis versus MYCOBUTIN in combination with clarithromycin for MAC treatment (see also WARNINGS).

Uveitis has been infrequently reported when MYCOBUTIN is used at 300 mg/day as montherapy in MAC prophylaxis of HIV-infected persons, even with the concomitant use of fluconazole and/or macrolide antibacterials. However, if higher doses of MYCOBUTIN are administered in combination with these agents, the incidence of uveitis is higher. FDA proposes moving this paragraph from below with some revisions.

Patients who developed uveitis had mild to severe symptoms that resolved after treatment with corticosteroids and/or mydriatic eye drops; in some severe cases, however, resolution of symptoms occurred after several weeks.

When uveitis occurs, temporary discontinuance of MYCOBUTIN and ophthalmologic evaluation are recommended. In most mild cases, MYCOBUTIN may be restarted; however, if signs or symptoms recur, use of MYCOBUTIN should be discontinued (Morbidity and Mortality Weekly Report, September 9, 1994).

Corneal deposits have been reported during routine ophthalmologic surveillance of some HIV-positive pediatric patients receiving MYCOBUTIN as part of a multiple drug regimen for MAC prophylaxis. The deposits are tiny, almost transparent, asymptomatic peripheral and central corneal deposits, and do not impair vision.

The following table enumerates the changes in laboratory values that were considered as laboratory abnormalities in Studies 023 and 027.

Table 4 : Percentage of Patients With Laboratory Abnormalities

Laboratory abnormalities MYCOBUTIN
(n = 566) %
PLACEBO
(n = 580) %
Chemistry
  Increased alkaline phosphatase 1 < 1 3
  Increased SGOT 2 7 12
  Increased SGPT 2 9 11
Hematology
  Anemia 3 6 7
  Eosinophilia 1 1
  Leukopenia 4 17 16
  Neutropenia 5 25 20
  Thrombocytopenia 6 5 4
Includes grades 3 or 4 toxicities as specified:
1 All values > 450 U/L
2 All values > 150 U/L
3 All hemoglobin values < 8.0 g/dL
4 All WBC values < 1,500/mm 3
5
All ANC values < 750/mm 3
6
All platelet count values < 50,000/mm 3

The incidence of neutropenia in patients treated with MYCOBUTIN was significantly greater than in patients treated with placebo (p = 0.03). Although thrombocytopenia was not significantly more common among patients treated with MYCOBUTIN in these trials, MYCOBUTIN has been clearly linked to thrombocytopenia in rare cases. One patient in Study 023 developed thrombotic thrombocytopenic purpura, which was attributed to MYCOBUTIN.

Adverse Reactions From Post-Marketing Experience

Adverse reactions identified through post-marketing surveillance by system organ class (SOC) are listed below:

Blood and lymphatic system disorders: White blood cell disorders (including agranulocytosis, lymphopenia, granulocytopenia, neutropenia, white blood cell count decreased, neutrophil count decreased), platelet count decreased.

Immune system disorders: Hypersensitivity, bronchospasm, rash, and eosinophilia.

Gastrointestinal disorders: Clostridium difficile colitis/ Clostridium difficile associated diarrhea.

Pyrexia, rash and other hypersensitivity reactions such as eosinophilia and bronchospasm might occur, as has been seen with other antibacterials.

A limited number of skin discoloration have been reported.

Rifamycin hypersensitivity reactions: Hypersensitivity to rifamycins have been reported including flu-like symptoms, bronchospasm, hypotension, urticaria, angioedema, conjunctivitis, thrombocytopenia or neutropenia.

Read the entire FDA prescribing information for Mycobutin (Rifabutin)

Mycobutin - User Reviews

Mycobutin User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Mycobutin sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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