ethambutol (Rx)

Brand and Other Names:Myambutol

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 100mg
  • 400mg

Tuberculosis

Prescribing information

  • Initial TB treatment: 15 mg/kg PO qDay
  • Prior TB treatment: 25 mg/kg PO qDay; after 60 days, decrease to 15 mg/kg PO qDay

Daily administration

  • Guidelines from American Thoracic Society (ATS), Centers for Disease Control and Prevention (CDC), and the Infectious Diseases Society of America (IDSA)
  • 40-55 kg: 800 mg PO
  • 56-75 kg: 1.2 g PO
  • >75 kg: 1.6 g PO

Twice weekly administration

  • Guidelines from American Thoracic Society (ATS), Centers for Disease Control and Prevention (CDC), and the Infectious Diseases Society of America (IDSA)
  • 40-55 kg: 2 g PO
  • 56-75 kg: 2.8 g PO
  • >75 kg: 4 g PO

3x per week administration

  • Guidelines from American Thoracic Society (ATS), Centers for Disease Control and Prevention (CDC), and the Infectious Diseases Society of America (IDSA)
  • 40-55 kg: 1.2 g PO
  • 56-75 kg: 2 g PO
  • >75 kg: 2.4 g PO

Dosing Considerations

During period when a patient is on a daily dose of 25 mg/kg, monthly eye examinations advised

In patients who have received previous antituberculous therapy, administer 25 mg/kg (11 mg/lb) of body weight, as single oral dose q24hr

Concurrently administer at least one other antituberculous drug to which organisms have been demonstrated to be susceptible by appropriate in vitro tests; suitable drugs usually consist of those not previously used in treatment of the patient

After 60 days of therapy administration, decrease dose to 15 mg/kg (7mg/lb) of body weight, and administer as a single oral dose q24hr

Disseminated MAC (Off-label)

Treatment: 15 mg/kg PO qD

Prophylaxis: use same dose with other antibiotics

Pulmonary M. Avium Complex (MAC) without HIV (Off-label)

25 mg/kg PO qD; after 60 d, decrease to 15 mg/kg PO qD

Other Indications & Uses

Tuberculosis: intended to be used concomitantly with other anti-TB drugs; usually isoniazid initially; subsequently, use second-line anti-TB drugs

Off-label: MAC infections

Dosage Forms & Strengths

tablet

  • 100mg
  • 400mg

Tuberculosis

Prescribing information

  • <13 years: Not recommended

ATS, CDC, and IDSA

  • Guidelines from American Thoracic Society (ATS), Centers for Disease Control and Prevention (CDC), and the Infectious Diseases Society of America (IDSA)
  • 15-20 mg/kg/day PO; not to exceed 1 g/day OR  
  • 50 mg/kg PO 2x/week; not to exceed 2.5 g/dose

AAP

  • Guidelines from the American Academy of Pediatrics (AAP)
  • 15-25 mg/kg/day PO; not to exceed 1 g/day OR  
  • 50 mg/kg PO 2x/week; not to exceed 2.5 g/dose

Dosing Considerations

During period when a patient is on a daily dose of 25 mg/kg, monthly eye examinations advised

In patients who have received previous antituberculous therapy, administer 25 mg/kg (11 mg/lb) of body weight, as single oral dose q24hr

Concurrently administer at least one other antituberculous drug to which organisms have been demonstrated to be susceptible by appropriate in vitro tests; suitable drugs usually consist of those not previously used in treatment of the patient

After 60 days of therapy administration, decrease dose to 15 mg/kg (7mg/lb) of body weight, and administer as a single oral dose q24hr

Disseminated MAC, Prophylaxis (Off-label)

As adult, 15 mg/kg PO qDay combined with other drugs; not to exceed 1 g/day

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Interactions

Interaction Checker

and ethambutol

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 

            Contraindicated (0)

              Serious - Use Alternative (1)

              • BCG vaccine live

                ethambutol decreases effects of BCG vaccine live by pharmacodynamic antagonism. Avoid or Use Alternate Drug.

              Monitor Closely (7)

              • allopurinol

                ethambutol decreases effects of allopurinol by Other (see comment). Use Caution/Monitor. Comment: Hyperuricemia reported with ethambutol and precipitation of gout reported; uric acid lowering agents may be require dosage adjustment.

              • aluminum hydroxide

                aluminum hydroxide increases levels of ethambutol by cation binding in GI tract. Use Caution/Monitor. Avoid administering aluminum hydroxide containing antacids for at least 4 hr following ethambutol dose.

              • aluminum hydroxide/magnesium carbonate

                aluminum hydroxide/magnesium carbonate increases levels of ethambutol by cation binding in GI tract. Use Caution/Monitor. Avoid administering aluminum hydroxide containing antacids for at least 4 hr following ethambutol dose.

              • aluminum hydroxide/magnesium trisilicate

                aluminum hydroxide/magnesium trisilicate increases levels of ethambutol by cation binding in GI tract. Use Caution/Monitor. Avoid administering aluminum hydroxide containing antacids for at least 4 hr following ethambutol dose.

              • febuxostat

                ethambutol decreases effects of febuxostat by Other (see comment). Use Caution/Monitor. Comment: Hyperuricemia reported with ethambutol and precipitation of gout reported; uric acid lowering agents may be require dosage adjustment.

              • probenecid

                ethambutol decreases effects of probenecid by Other (see comment). Use Caution/Monitor. Comment: Hyperuricemia reported with ethambutol and precipitation of gout reported; uric acid lowering agents may be require dosage adjustment.

              • sodium picosulfate/magnesium oxide/anhydrous citric acid

                ethambutol decreases effects of sodium picosulfate/magnesium oxide/anhydrous citric acid by altering metabolism. Use Caution/Monitor. Coadministration with antibiotics decreases efficacy by altering colonic bacterial flora needed to convert sodium picosulfate to active drug.

              Minor (0)

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                Adverse Effects

                Frequency Not Defined

                Acute gout or hyperuricemia

                Abdominal pain

                Anaphylaxis

                Anorexia

                Confusion, disorientation

                Fever

                Headache

                LFT abnormalities

                Malaise

                Nausea

                Optic neuritis; symptoms may include decreased acuity, color blindness or visual defects (usually revrsible with discontinuation, though irreversible blindness has been reported)

                Peripheral neuritis

                Pruritis

                Rash

                Vomiting

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                Warnings

                Contraindications

                Hypersensitivity

                Known optic neuritis (unless clinical judgment determines that it may be used)

                Patients unable to appreciate and report visual side effects or changes in vision (eg, young children, unconscious patients)

                Cautions

                May produce decreases in visual acuity which appear to be due to optic neuritis; effect may be related to dose and duration of treatment; effect is generally reversible when administration of drug is discontinued promptly; however, irreversible blindness has been reported

                Liver toxicities including fatalities reported; baseline and periodic assessment of hepatic function should be performed

                Not recommended for use in pediatric patients <13 years; safe conditions for use not established

                Patients with decreased renal function need dosage reduced as determined by serum levels of the drug; main path of excretion of this drug is by the kidneys

                Drug may have adverse effects on vision; physical examination should include ophthalmoscopy, finger perimetry and testing of color discrimination

                In patients with visual defects such as cataracts, recurrent inflammatory conditions of the eye, optic neuritis, and diabetic retinopathy, the evaluation of changes in visual acuity is more difficult, and care should be taken to be sure the variations in vision are not due to underlying disease conditions

                In such patients, consideration should be given to relationship between benefits expected and possible visual deterioration since evaluation of visual changes is difficult

                As with any potent drug, baseline and periodic assessment of organ system functions, including renal, hepatic, and hematopoietic, should be performed

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                Pregnancy & Lactation

                Pregnancy Category: B

                Lactation: enters breast milk; use with caution (AAP Committee states "compatible with nursing")

                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.

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                Pharmacology

                Mechanism of Action

                Interferes with metabolite production in Mycobacterium

                Absorption

                Bioavailability: ~80%

                Peak Plasma Time: 2-4 hr

                Distribution

                Widely throughout body; concentrated in kidneys, lungs, saliva, and red blood cells

                Relative diffusion from blood into CSF: Adequate with or without inflammation (exceeds usual MICs)

                CSF:blood level ratio: 0% (normal meninges); 25% (inflamed meninges)

                Protein binding: 20-30%

                Metabolism

                Hepatic (20%) to inactive metabolite

                Elimination

                Half-life elimination: 2.5-3.6 hr; 7-15 hr (end-stage renal disease)

                Excretion: ~50% urine; ~20% feces as unchanged drug

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                Administration

                Drug should not be used alone, in initial treatment or in retreatment.

                Administer on a once every 24-hour basis only

                Absorption is not significantly altered by administration with food

                Therapy, in general, should be continued until bacteriological conversion has become permanent and maximal clinical improvement occurred

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                Images

                BRAND FORM. UNIT PRICE PILL IMAGE
                ethambutol oral
                -
                100 mg tablet
                ethambutol oral
                -
                400 mg tablet
                ethambutol oral
                -
                400 mg tablet
                ethambutol oral
                -
                100 mg tablet
                ethambutol oral
                -
                100 mg tablet
                ethambutol oral
                -
                400 mg tablet
                ethambutol oral
                -
                400 mg tablet
                Myambutol oral
                -
                400 mg tablet

                Copyright © 2010 First DataBank, Inc.

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                Patient Handout

                Patient Education
                ethambutol oral

                ETHAMBUTOL - ORAL

                (eth-AM-bue-tol)

                COMMON BRAND NAME(S): Myambutol

                USES: Ethambutol is used with other medications to treat tuberculosis (TB). Ethambutol is an antibiotic and works by stopping the growth of bacteria.This antibiotic treats only bacterial infections. It will not work for viral infections (such as common cold, flu). Using any antibiotic when it is not needed can cause it to not work for future infections.

                HOW TO USE: Take this medication by mouth with or without food as directed by your doctor, usually once daily. This medication may sometimes be taken twice weekly. Take this medication exactly as directed by your doctor. The dosage is based on your age, weight, medical condition, and response to treatment.If you also take antacids that contain aluminum, take this medication at least 4 hours before the antacid.For the best effect, take this antibiotic at evenly spaced times. To help you remember, take this medication at the same time(s) every day.Continue to take this medication (and other TB medications) until the full prescribed amount is finished, even if symptoms disappear. Stopping the medication too early or skipping doses may allow the bacteria to continue to grow, which may result in a return of the infection and cause the infection to be more difficult to treat (resistant).Tell your doctor if your condition lasts or gets worse.

                SIDE EFFECTS: Headache, loss of appetite, upset stomach, or nausea/vomiting may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.Remember that this medication has been prescribed because your doctor 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 right away if you have any serious side effects, including: vision changes (such as blurred/decreased vision, color blindness), symptoms of liver disease (such as nausea/vomiting that doesn't stop, unusual tiredness/weakness, severe stomach/abdominal pain, yellowing eyes/skin, dark urine), numbness/tingling of arms/legs, toe/joint pain, mental/mood disorders (such as confusion, hallucinations), signs of a new infection (such as sore throat that doesn't go away, fever), easy bleeding/bruising.A very serious allergic reaction to this drug is rare. However, get medical help right away 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 or at www.fda.gov/medwatch.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 ethambutol, tell your doctor or pharmacist if you are allergic to it; 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: eye problems (such as optic neuritis, cataracts, diabetic retinopathy), liver disease, kidney disease, alcohol use.Ethambutol may cause live bacterial vaccines (such as typhoid vaccine) to not work well. Tell your health care professional that you are using ethambutol before having any immunizations/vaccinations.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Alcohol may increase the risk of liver disease. Avoid alcoholic beverages while using this medication.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.This medication passes into breast milk but is unlikely to harm a nursing infant. Consult your doctor before breast-feeding. If you have HIV disease, do not breast-feed because breast milk can transmit HIV.

                DRUG INTERACTIONS: See also How to Use section.Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

                OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

                NOTES: Do not share this medication with others.Lab and/or medical tests (such as sputum test, eye/vision exams, kidney/liver function, complete blood count) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

                MISSED DOSE: It is important to take each dose of this medication as scheduled. If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

                STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

                Information last revised April 2023. Copyright(c) 2023 First Databank, Inc.

                IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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                Formulary

                FormularyPatient Discounts

                Adding plans allows you to compare formulary status to other drugs in the same class.

                To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

                Adding plans allows you to:

                • View the formulary and any restrictions for each plan.
                • Manage and view all your plans together – even plans in different states.
                • Compare formulary status to other drugs in the same class.
                • Access your plan list on any device – mobile or desktop.

                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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                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.