Dosage guidance:
Dosing: Dose based on actual body weight is acceptable for patients with tuberculosis who are not obese (Ref); ideal weight metrics for M. avium complex disease have not been determined.
Mycobacterium avium complex disease (off-label use):
Pulmonary disease (nodular/bronchiectatic disease): Oral: 25 mg/kg 3 times weekly as part of an appropriate combination regimen; continue treatment until patient is culture negative on therapy for ≥1 year (Ref).
Pulmonary disease (severe nodular/bronchiectatic or cavitary disease): Oral: 15 mg/kg once daily as part of an appropriate combination regimen; continue treatment until patient is culture negative on therapy for ≥1 year (Ref).
Disseminated disease in patients with HIV, treatment and chronic maintenance therapy: Oral: 15 mg/kg once daily as part of an appropriate combination regimen; may discontinue when patient has completed ≥12 months of therapy, has no signs/symptoms of M. avium complex disease, and has sustained (≥6 months) CD4 count >100 cells/mm3 in response to antiretroviral therapy (Ref).
Tuberculosis, drug susceptible:
Note: Always administer in combination with other antitubercular drugs (Ref).
Once-daily therapy: Note: The preferred frequency of administration is once daily; however, 5-days-per-week administration by directly observed therapy (DOT) is an acceptable alternative (Ref).
40 to 55 kg: Oral: 800 mg (14.5 to 20 mg/kg) once daily.
56 to 75 kg: Oral: 1.2 g (16 to 21.4 mg/kg) once daily.
76 to 90 kg: Oral: 1.6 g (17.8 to 21.1 mg/kg) once daily.
Three-times-weekly DOT (Ref):
40 to 55 kg: Oral: 1.2 g (21.8 to 30 mg/kg) 3 times weekly.
56 to 75 kg: Oral: 2 g (26.7 to 35.7 mg/kg) 3 times weekly.
76 to 90 kg: Oral: 2.4 g (26.7 to 31.6 mg/kg) 3 times weekly.
Twice-weekly DOT (Ref):
40 to 55 kg: Oral: 2 g (36.4 to 50 mg/kg) twice weekly.
56 to 75 kg: Oral: 2.8 g (37.3 to 50 mg/kg) twice weekly.
76 to 90 kg: Oral: 4 g (44.4 to 52.6 mg/kg) twice weekly.
Regimens: Treatment regimens for pulmonary tuberculosis consist of an initial 2-month phase of a 4-drug regimen that includes ethambutol, followed by a continuation phase consisting of a 2-drug regimen (does not include ethambutol) of an additional 4 to 7 months; ethambutol frequency and dosing differs depending on treatment regimen selected; consult current drug-susceptible TB guidelines (Ref).
The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.
Note: Therapeutic drug monitoring should be utilized, when possible, in patients with severe kidney impairment or on renal replacement therapies to avoid drug accumulation and adverse effects, such as optic neuropathy (Ref).
Altered kidney function (expert opinion derived from ATS/CDC/IDSA [Nahid 2016]; AST/CDC/ERS/IDSA [Nahid 2019]; HHS [OI adult] 2025; WHO 2014b):
CrCl ≥30 mL/minute: No dosage adjustment necessary.
CrCl <30 mL/minute: If usual recommended dose is administered once daily, then do not adjust the dose, but only administer 3 times weekly (eg, if usual dose is 15 mg/kg once daily, then administer 15 mg/kg 3 times weekly; if usual dose is 25 mg/kg once daily, then administer 25 mg/kg 3 times weekly). Since there are no clinical or pharmacokinetic data to support a renal dosage adjustment recommendation for dosing strategies other than once daily dosing (eg, the directly observed therapy [DOT] twice-weekly or 3-times–weekly dosing described in patients with normal kidney function) use of these dosing strategies are not recommended.
Hemodialysis, intermittent (thrice weekly): Dialyzable (extent not well characterized) (Ref): Dose as CrCl <30 mL/minute; administer after hemodialysis on dialysis days (Ref). Use with caution and close monitoring, as hemodialysis patients may develop optic adverse effects, even with properly adjusted doses (Ref).
Peritoneal dialysis: Likely dialyzable, but not considered a major route of removal (Ref): Dose as for CrCl <30 mL/minute (Ref). Use with caution and close monitoring (Ref).
CRRT: Drug clearance is dependent on the effluent flow rate, filter type, and method of renal replacement. Recommendations are based on high-flux dialyzers and effluent flow rates of 20 to 25 mL/kg/hour (or ~1,500 to 3,000 mL/hour) unless otherwise noted. Appropriate dosing requires consideration of adequate drug concentrations (eg, site of infection). Close monitoring of response and adverse effects (eg, optic neuropathy) due to drug accumulation is important.
Note: Has not been studied in patients undergoing CRRT; some drug removal is expected but relatively large Vd will likely prevent substantial removal (Ref).
Dose as for CrCl <30 mL/minute; utilize therapeutic monitoring when possible to guide further dose adjustments (Ref).
PIRRT (eg, sustained, low-efficiency diafiltration): Note: Drug clearance is dependent on the effluent flow rate, filter type, and method of renal replacement. Appropriate dosing requires consideration of adequate drug concentrations (eg, site of infection). Close monitoring of response and adverse effects (eg, optic neuropathy) due to drug accumulation is important.
Note: Limited data available in patients undergoing PIRRT; some drug removal is expected, but relatively large Vd will likely prevent substantial removal (Ref). Recommendations assume daily PIRRT sessions.
Dose as for CrCl <30 mL/minute; on PIRRT days, administer after the PIRRT session (Ref). Utilize therapeutic monitoring, when possible, to guide further dose adjustments (Ref).
There are no dosage adjustments provided in the manufacturer's labeling; use with caution.
The recommendations for dosing in patients with obesity are based upon the best available evidence and clinical expertise. Senior Editorial Team: Jeffrey F. Barletta, PharmD, FCCM; Manjunath P. Pai, PharmD, FCP; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC.
Class 1, 2, and 3 obesity (BMI ≥30 kg/m2):
Consider the use of adjusted body weight for initial weight-based dosing and therapeutic drug monitoring to ensure optimal exposure (Ref).
Rationale for recommendations: Optimal dosing for patients with obesity has not been established; using lean body weight in patients with obesity may lead to underdosing, while use of actual body weight may lead to overdosing (Ref).
Refer to adult dosing.
(For additional information see "Ethambutol: Pediatric drug information")
Mycobacterial infection, nontuberculous: Limited data available:
Mycobacterium avium complex (MAC) infection in patients who are HIV-exposed/-infected:
Treatment: Note: Treatment should continue for at least 12 months and should be followed by secondary prophylaxis.
Infants and Children: Oral: 15 to 25 mg/kg/dose once daily as part of an appropriate combination regimen; maximum dose: 2,500 mg/dose (Ref).
Adolescents: Oral: 15 mg/kg/dose once daily as part of an appropriate combination regimen (Ref).
Secondary prophylaxis (chronic maintenance therapy):
Infants and Children: Oral: 15 to 25 mg/kg/dose once daily as part of an appropriate combination regimen; maximum dose: 2,500 mg/dose. May be discontinued if patient has completed ≥6 months of antiretroviral therapy and ≥12 months of MAC therapy, has no signs and symptoms of MAC, and achieves age-specific CD4 count goals for ≥6 months (age 2 to <6 years: >200 cells/mm3; ≥6 years: >100 cells/mm3) (Ref).
Adolescents: Oral: 15 mg/kg/dose once daily as part of an appropriate combination regimen. May be discontinued if patient has completed ≥12 months of MAC therapy, has no signs and symptoms of MAC, and has CD4 count >100 cells/mm3 in response to antiretroviral therapy for >6 months (Ref).
Pulmonary infection in patients with cystic fibrosis: Infants, Children, and Adolescents: Oral: 15 mg/kg/dose once daily as part of an appropriate combination regimen for ≥12 months after culture conversion (Ref).
Pulmonary infection in patients without cystic fibrosis: Infants, Children, and Adolescents: Oral: 20 mg/kg/dose once daily as part of an appropriate combination regimen for ≥12 months after culture conversion (Ref).
Tuberculosis disease [active tuberculosis]; drug susceptible (excluding meningitis): Note: Treatment regimens for active tuberculosis typically consist of an initial 2-month intensive phase of a 4-drug regimen (including ethambutol, although a full 2 months of ethambutol may not be necessary), followed by a 2-drug regimen continuation phase (not including ethambutol); see guidelines for details and duration (Ref). Always use in combination with other antitubercular drugs. Any regimens using less than once-daily dosing should be administered as directly observed therapy (DOT).
Once-daily therapy: Note: The preferred frequency of administration is once daily; however, 5-days-per-week administration by DOT at the same daily dose is an acceptable alternative.
Infants, Children, and Adolescents, weighing <40 kg: Oral: 20 mg/kg/dose once daily; suggested range: 15 to 25 mg/kg/dose.
Children and Adolescents, weighing ≥40 kg: Note: Doses should be based on lean body weight for patients within a normal weight range for their height (optimal dosing in obesity has not been established).
40 to 55 kg: Oral: 800 mg once daily.
56 to 75 kg: Oral: 1,200 mg once daily.
76 to 90 kg: Oral: 1,600 mg once daily.
Three-times-weekly DOT:
Infants, Children, and Adolescents, weighing <40 kg: Oral: 50 mg/kg/dose 3 times weekly.
Children and Adolescents, weighing ≥40 kg: Note: Doses should be based on lean body weight for patients within a normal weight range for their height (optimal dosing in obesity has not been established).
40 to 55 kg: Oral: 1,200 mg 3 times weekly.
56 to 75 kg: Oral: 2,000 mg 3 times weekly.
76 to 90 kg: Oral: 2,400 mg 3 times weekly.
Twice-weekly DOT: Note: Regimen not generally recommended; associated with worse outcomes (treatment failure, relapse, and drug resistance) compared to daily dosing. Do not use in patients with HIV or those with smear-positive and/or cavitary disease; only for use in continuation phase (Ref).
Infants, Children, and Adolescents, weighing <40 kg: Oral: 50 mg/kg/dose twice weekly.
Children and Adolescents, weighing ≥40 kg: Note: Doses should be based on lean body weight for patients within a normal weight range for their height (optimal dosing in obesity has not been established).
40 to 55 kg: Oral: 2,000 mg twice weekly.
56 to 75 kg: Oral: 2,800 mg twice weekly.
76 to 90 kg: Oral: 4,000 mg twice weekly.
Tuberculosis disease [active tuberculosis]; drug resistant: Note: Duration should be individualized based on extent of disease, rapidity of culture conversion, clinical response, and toxicity; expert consultation for optimal regimen and duration of treatment is advised (Ref).
Infants, Children, and Adolescents: Oral: 20 to 25 mg/kg/dose once daily as part of an appropriate combination regimen (Ref).
Altered kidney function: Infants, Children, and Adolescents:
Note: Therapeutic drug monitoring should be utilized, when possible, in patients with severe kidney impairment or receiving renal replacement therapies to avoid drug accumulation and adverse effects, such as optic neuropathy (Ref). There are no clinical or pharmacokinetic data to support a renal dosage adjustment recommendation for dosing strategies other than once-daily dosing; dosing recommendations derived from adult guideline recommendations (Ref).
CrCl ≥30 mL/minute: No dosage adjustment necessary.
CrCl <30 mL/minute: Oral: 15 to 25 mg/kg/dose 3 times weekly.
There are no dosage adjustments provided in the manufacturer's labeling; use with caution.
The following adverse drug reactions are derived from product labeling unless otherwise specified. Adverse reactions may be reported as part of combination therapy.
Postmarketing:
Dermatologic: Dermatitis, erythema multiforme, lichenoid eruption (Grossman 1995), pruritus (Chung 2022), skin lesion (bullous) (Kollipara 2022), skin rash (Chung 2022), Stevens-Johnson syndrome (Chung 2022), toxic epidermal necrolysis (Pegram 1981)
Endocrine & metabolic: Acute gout attack, increased uric acid (Chung 2022)
Gastrointestinal: Abdominal pain (Chung 2022), anorexia (Chung 2022), gastric distress, nausea (Chung 2022), vomiting (Chung 2022)
Hematologic & oncologic: Agranulocytosis (Moon 2015), eosinophilia (Wong 1994), leukopenia (Chung 2022), neutropenia (Wong 1994), thrombocytopenia (Chung 2022)
Hepatic: Abnormal hepatic function tests (Chung 2022), hepatotoxicity
Hypersensitivity: Drug reaction with eosinophilia and systemic symptoms (Kapur 2019), hypersensitivity reaction (including anaphylaxis, nonimmune anaphylaxis) (Cernadas 2013)
Nervous system: Confusion, disorientation, dizziness (Chung 2022), headache (Chung 2022), malaise (Chung 2022), peripheral neuritis (numbness, tingling of extremities), psychotic symptoms (including hallucination) (Prasad 2008)
Neuromuscular & skeletal: Arthralgia (Chung 2022), subacute cutaneous lupus erythematosus (Huang 2022)
Ophthalmic: Optic neuropathy (including optic neuritis and retrobulbar neuritis) (Chan 2006; Kyncl 2023), visual disturbance (including color blindness, decreased visual acuity [unilateral or bilateral], irreversible blindness, scotoma) (Kyncl 2023)
Renal: Acute interstitial nephritis (García-Martín 1991), acute kidney injury (Kwon 2004)
Respiratory: Pneumonitis (including eosinophilic pneumonitis) (Saha 2013; Takami 1997), pulmonary infiltrates (with or without eosinophilia) (Wong 1995)
Miscellaneous: Fever (Chung 2022)
Hypersensitivity to ethambutol or any component of the formulation; optic neuritis (risk vs benefit decision); use in young children, unconscious patients, or any other patient who may be unable to discern and report visual changes.
Concerns related to adverse effects:
• Hepatic toxicity: Has been reported, possibly due to concurrent therapy.
• Optic neuritis: May cause optic neuritis (unilateral or bilateral), resulting in decreased visual acuity or other vision changes. Discontinue promptly in patients with changes in vision, color blindness, or visual defects (effects normally reversible, but reversal may require up to a year). Irreversible blindness has been reported.
Disease-related concerns:
• Ocular disease: Evaluation of visual acuity changes may be more difficult in patients with cataracts, optic neuritis, diabetic retinopathy, and inflammatory conditions of the eye; consideration should be given to whether or not visual changes are related to disease progression or effects of therapy.
• Renal impairment: Use with caution in patients with renal impairment; dosage modification recommended.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Tablet, Oral, as hydrochloride:
Myambutol: 400 mg [DSC] [scored]
Generic: 100 mg, 400 mg
Yes
Tablets (Ethambutol HCl Oral)
100 mg (per each): $0.46 - $0.59
400 mg (per each): $0.72 - $1.79
Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Tablet, Oral, as hydrochloride:
Etibi: 100 mg, 400 mg [contains corn starch, fd&c blue #1 (brill blue) aluminum lake, quinoline (d&c yellow #10) aluminum lake]
Oral: Administer with or without food.
Oral: Administer with or without food; if GI upset occurs, administer with food. Tablet may be crushed for administration in patients who cannot swallow tablets; mix in a small amount of water or food (eg, grape jelly, sugar-free chocolate pudding) and administer immediately; may be administered via mouth or nasogastric tube (Ref).
Tuberculosis: Treatment of pulmonary tuberculosis in combination with other antituberculosis agents.
Mycobacterium avium complex disease
Myambutol may be confused with Nembutal
Substrate of OCT1, OCT2;
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.
Aluminum Hydroxide: May decrease serum concentration of Ethambutol. Management: Avoid concurrent administration of ethambutol and aluminum hydroxide. If coadministration cannot be avoided administer ethambutol first and then wait at least 4 hours before administering aluminum hydroxide-containing products. Risk D: Consider Therapy Modification
Bacillus Calmette Guerin (BCG) (Intravesical): Antibiotics may decrease therapeutic effects of Bacillus Calmette Guerin (BCG) (Intravesical). Risk X: Avoid
Bacillus Calmette Guerin (BCG) (Percutaneous): Antibiotics may decrease therapeutic effects of Bacillus Calmette Guerin (BCG) (Percutaneous). Risk C: Monitor
Bacillus clausii: Antibiotics may decrease therapeutic effects of Bacillus clausii. Management: Bacillus clausii should be taken in between antibiotic doses during concomitant therapy. Risk D: Consider Therapy Modification
Cholera Vaccine: Antibiotics may decrease therapeutic effects of Cholera Vaccine. Management: Avoid cholera vaccine in patients receiving systemic antibiotics, and within 14 days following the use of oral or parenteral antibiotics. Risk X: Avoid
Fecal Microbiota (Live) (Oral): Antibiotics may decrease therapeutic effects of Fecal Microbiota (Live) (Oral). Risk X: Avoid
Fecal Microbiota (Live) (Rectal): Antibiotics may decrease therapeutic effects of Fecal Microbiota (Live) (Rectal). Risk X: Avoid
Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Antibiotics may decrease therapeutic effects of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor
Lactobacillus and Estriol: Antibiotics may decrease therapeutic effects of Lactobacillus and Estriol. Risk C: Monitor
Mycophenolate: Antibiotics may decrease active metabolite exposure of Mycophenolate. Specifically, concentrations of mycophenolic acid (MPA) may be reduced. Risk C: Monitor
Sodium Picosulfate: Antibiotics may decrease therapeutic effects of Sodium Picosulfate. Management: Consider using an alternative product for bowel cleansing prior to a colonoscopy in patients who have recently used or are concurrently using an antibiotic. Risk D: Consider Therapy Modification
Typhoid Vaccine: Antibiotics may decrease therapeutic effects of Typhoid Vaccine. Only the live attenuated Ty21a strain is affected. Management: Avoid use of live attenuated typhoid vaccine (Ty21a) in patients being treated with systemic antibacterial agents. Postpone vaccination until 3 days after cessation of antibiotics and avoid starting antibiotics within 3 days of last vaccine dose. Risk D: Consider Therapy Modification
Ethambutol crosses the placenta (Shneerson 1979).
In 1 case report, ethambutol placental concentrations were similar to those in the maternal plasma. Ethambutol was also present in the cord blood and amniotic fluid (Shneerson 1979).
Ophthalmic abnormalities have been reported in infants born to patients receiving ethambutol as a component of antituberculosis therapy.
Pregnancy-induced physiologic changes may alter the pharmacokinetic properties of ethambutol; additional data are needed (Abdelwahab 2020; Van Schalkwyk 2023).
Untreated tuberculosis (TB) disease (active TB) is associated with an increased risk of adverse pregnancy outcomes, including low birth weight infants, preterm birth, miscarriage, and perinatal death. Adverse maternal outcomes include an increased risk of anemia, preeclampsia, eclampsia, and sepsis. Placental TB transmission may also occur (congenital TB) (Hui 2022; Maugans 2023; Miele 2020).
Ethambutol is recommended as part of the initial treatment regimen of drug-susceptible TB disease when the probability of maternal disease is moderate to high (ATS/CDC/IDSA [Nahid 2016]). Treatment of multidrug resistant TB during pregnancy should be individualized. The selection of agents should be made as part of a shared decision-making process (ATS/CDC/ERS/IDSA [Nahid 2019]; ATS/CDC/ERS/IDSA [Saukkonen 2025]).
Ethambutol is recommended as part of a combination therapy for chronic maintenance therapy (secondary prophylaxis) of disseminated Mycobacterium avium complex disease in pregnant patients with HIV (HHS [OI adult 2025]).
Ethambutol is present in human milk (Snider 1984; Zuma 2022).
The manufacturer suggests use during breastfeeding only if benefits to the mother outweigh the possible risk to the infant; however, breastfeeding is encouraged for patients effectively treated for tuberculosis (TB) susceptible to first-line agents (such as ethambutol). Exposure to first-line agents via breast milk is not considered effective treatment for the breastfeeding infant (ATS/CDC/IDSA [Nahid 2016]; Loveday 2020).
Transmission of M. tuberculosis does not occur via breast milk; however, patients with TB disease (active TB) who are infectious should take precautions when in close contact with their infant to prevent airborne transmission (Loveday 2020; Maugans 2023).
Monitor infants exposed to ethambutol via breast milk for jaundice (WHO 2002).
TB mastitis is rare, and treatment is with medications used for pulmonary TB. Lactating patients with TB mastitis should discard milk from the affected breast until no longer infectious; breastfeeding can continue using the unaffected breast (Miele 2020; Thimmappa 2015).
Baseline and periodic (monthly) visual testing (Snellen test) and color discrimination tests (each eye individually, as well as both eyes tested together) in patients receiving >15 mg/kg/day; baseline and periodic renal, hepatic, and hematopoietic tests; ethambutol serum concentrations (when clinically indicated).
Ethambutol serum concentrations:
Note: Obtain samples at 2- and 6-hours post dose to detect delayed absorption or malabsorption; in patients on concomitant rifabutin or clarithromycin, 3- and 7-hour postdose samples may be preferred (Alsultan 2014).
If the usual recommended dose is 15 to 25 mg/kg once daily: target Cmax 2 to 6 mcg/mL (Alsultan 2014).
If the usual recommended dose is 50 mg/kg twice weekly: target Cmax 4 to 12 mcg/mL (Alsultan 2014).
Inhibits arabinosyl transferase resulting in impaired mycobacterial cell wall synthesis
Absorption: ~80%
Distribution: Widely throughout body; concentrated in kidneys, lungs, saliva, and red blood cells
CSF:blood level ratio: Normal meninges: 0%; Inflamed meninges: 25%
Protein binding: 20% to 30%
Metabolism: Hepatic (20%) to inactive metabolite
Half-life elimination: 2.5 to 3.6 hours; End-stage renal disease: 7 to 15 hours
Time to peak, serum: 2 to 4 hours
Excretion: Urine (~50% as unchanged drug, 8% to 15% as metabolites); feces (~20% as unchanged drug)
Pediatric: Clearance increases to 50% of full value by 2 months of age and reaches 99% of full value by 3 years of age (Tikiso 2022).
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