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rifabutin (Rx)Brand and Other Names:Mycobutin

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

capsule

  • 150mg

oral solution

  • 10mg/mL
  • 20mg/mL
more...

MAC Prophylaxis

Indicated for prefention of disseminated Mycobacterium avium complex (MAC) disease in paitents with advanced HIV infection

300 mg PO qDay

Patients with N/V diathesis: 150 mg PO BID with food

Active TB (off-label)

5 mg/kg PO qD or 2-3x/week + other antitubercular agents, no more than 300 mg/dose

MAC Treatment (Orphan)

Treatment of disseminated Mycobacterium avium complex disease

Orphan indication sponsor

  • Pfizer, Inc; 235 East 42nd Street; New York, NY 10017

Crohn Disease (Orphan)

Combination of clarithromycin, rifabutin, and clofazimine for treatment of pediatric Crohn disease

Orphan indication sponsor

  • RedHill Biopharma Ltd; 42 Givati St; Israel

Renal Impairment

CrCl<30mL/min dose should be reduced by 50%

Other Indications & Uses

MAC, TB

Off-label: resistant H. pylori (300 mg/d + amoxicillin 1000 mg BID + pantoprazole 40 mg BID x10 d); Treatment of active TB (concomitant with other anti-TB agents)

Dosage Forms & Strengths

capsule

  • 150mg

oral solution

  • 10mg/mL
  • 20mg/mL
more...

Mycobacterium Avium Complex (MAC)

Treatment: 5-10 mg/kg PO qD ; no more than 300 mg/d

Prophylaxis: 1st episode in HIV/recurrence: 5 mg/kg PO qD; no more than 300 mg/d

Active TB with HIV (Off-label)

10-20 mg/kg PO qD OR 2x/week + other antitubercular agents; no more than 300 mg/dose

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Interactions

Interaction Checker

rifabutin and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            Discoloration of urine (30%)

            Neutropenia (25%)

            Leukopenia (17%)

            Rash (11%)

            1-10%

            Incr AST/ALT (7-9%)

            Thrombocytopenia (5%)

            Abdominal pain (4%)

            Diarrhea (3%)

            Eructation (3%)

            Headache (3%)

            Nausea/vomiting (3%)

            Anorexia (2%)

            Flatulence (2%)

            Anemia

            Myalgia

            Postmarketing reports

            Blood and lymphatic system disorders: Agranulocytosis, lymphopenia, granulocytopenia, white blood cell ccount decreased, neutrophil count ddecreased), platelet count decreased

            Immune system disorders: Hypersensitivity, bronchospasm

            Gastrointestinal disorders: Clostridium difficile colitis/ Clostridium difficile associated diarrhea

            Pyrexia, rash and other hypersensitivity reactions such as eosinophilia, bronchospasm and shock might occur, as has been seen with other antibacterials; a limited number of skin discoloration have been reported

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            Warnings

            Contraindications

            Hypersensitivity to rifamycins

            Concomitant live bacterial vaccines

            Cautions

            Monitor hematologic status

            Eye pain, redness, loss of vision may indicate inflammatory ocular condition

            Joint stiffness, swelling, tenderness or paresthesia may indicate arthralgias or myositis

            May have brown-orange color of urine, feces, saliva, sputum, perspiration, tears, & skin

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            Pregnancy & Lactation

            Pregnancy Category: B

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

            more...
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            Pharmacology

            Lacatation: unknown

            Absorption: readily, 53%

            Distribution: body tissues including the lungs, liver, spleen, eyes, & kidneys

            Vd: 9.32 L/kg

            Protein Bound: 85%

            Bioavailability: absolute: HIV: 20%

            Half-Life, Elim45 hr (range: 16-69 hr)

            Peak Plasma Time: 2-4 hr

            Metabolism: hepatic CYP3A4 to active and inactive metabolites

            Excretion

            Urine: 10% as unchanged drug, 53% as metabolites

            Feces: 10% as unchanged drug, 30% as metabolites

            Mechanism of Action

            Inhibits DNA-dependent RNA polymerase

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            Images

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            Formulary

            FormularyPatient Discounts

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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