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Ethambutol: Drug information

Ethambutol: Drug information
(For additional information see "Ethambutol: Patient drug information" and see "Ethambutol: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Myambutol
Brand Names: Canada
  • Etibi
Pharmacologic Category
  • Antitubercular Agent
Dosing: Adult
Mycobacterium avium complex disease

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 in combination with a macrolide (azithromycin or clarithromycin); 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 (ART). Note: Addition of a third or fourth drug should be considered for patients with advanced immunosuppression (CD4 count <50 cells/mm3), high mycobacterial loads (>2 log10 CFU/mL), or in the absence of effective ART (Ref).

Tuberculosis, drug-susceptible

Tuberculosis, drug-susceptible:

Note: Always administer in combination with other antitubercular drugs (Ref).

Dosing: Doses should be based on lean body weight for patients within a normal weight range for their height (optimal dosing for patients with obesity has not been established):

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).

56 to 75 kg: Oral: 1.2 g (16 to 21.4 mg/kg).

76 to 90 kg: Oral: 1.6 g (17.8 to 21.1 mg/kg).

Three-times-weekly DOT (Ref):

40 to 55 kg: Oral: 1.2 g (21.8 to 30 mg/kg).

56 to 75 kg: Oral: 2 g (26.7 to 35.7 mg/kg).

76 to 90 kg: Oral: 2.4 g (26.7 to 31.6 mg/kg).

Twice-weekly DOT (Ref):

40 to 55 kg: Oral: 2 g (36.4 to 50 mg/kg).

56 to 75 kg: Oral: 2.8 g (37.3 to 50 mg/kg).

76 to 90 kg: Oral: 4 g (44.4 to 52.6 mg/kg).

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).

Tuberculosis, drug resistant

Tuberculosis, drug resistant (alternative agent): Note: Expert consultation for optimal regimen and duration of treatment is advised (Ref).

Low dose (companion drug): Oral: 15 mg/kg once daily (Ref).

High dose (bacteriostatic drug): Oral: 25 mg/kg once daily (Ref).

Dosing: Kidney Impairment: Adult

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 2020]; 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).

Dosing: Hepatic Impairment: Adult

There are no dosage adjustments provided in the manufacturer's labeling; use with caution.

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Ethambutol: Pediatric drug information")

Mycobacterial infection, nontuberculous

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

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

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).

Dosing: Kidney Impairment: Pediatric

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.

Dosing: Hepatic Impairment: Pediatric

There are no dosage adjustments provided in the manufacturer's labeling; use with caution.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Frequency not defined.

Cardiovascular: Myocarditis, pericarditis

Central nervous system: Confusion, disorientation, dizziness, hallucination, headache, malaise, peripheral neuritis

Dermatologic: Dermatitis, erythema multiforme, exfoliative dermatitis, pruritus, skin rash

Endocrine & metabolic: Acute gout attack, hyperuricemia

Gastrointestinal: Abdominal pain, anorexia, gastric distress, nausea, vomiting

Hematologic & oncologic: Eosinophilia, leukopenia, lymphadenopathy, neutropenia, thrombocytopenia

Hepatic: Abnormal hepatic function tests, hepatitis, hepatotoxicity (possibly related to concurrent therapy)

Hypersensitivity: Anaphylaxis, anaphylactoid reaction, hypersensitivity reaction (syndrome includes cutaneous reactions, eosinophilia, and organ-specific inflammation)

Neuromuscular & skeletal: Arthralgia

Ophthalmic: Color blindness, decreased visual acuity, optic neuritis, scotoma, visual disturbance (usually reversible with discontinuation; irreversible blindness has been described)

Renal: Nephritis

Respiratory: Pneumonitis, pulmonary infiltrates (with or without eosinophilia)

Miscellaneous: Fever

Contraindications

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.

Warnings/Precautions

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.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral, as hydrochloride:

Myambutol: 400 mg [scored]

Generic: 100 mg, 400 mg

Generic Equivalent Available: US

Yes

Pricing: US

Tablets (Ethambutol HCl Oral)

100 mg (per each): $0.46 - $0.59

400 mg (per each): $0.72 - $1.79

Tablets (Myambutol Oral)

400 mg (per each): $0.98

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.

Dosage Forms: Canada

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]

Administration: Adult

Oral: Administer with or without food.

Administration: Pediatric

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).

Use: Labeled Indications

Tuberculosis: Treatment of pulmonary tuberculosis in combination with other antituberculosis agents.

Use: Off-Label: Adult

Mycobacterium avium complex disease

Medication Safety Issues
Sound-alike/look-alike issues:

Myambutol may be confused with Nembutal

Metabolism/Transport Effects

Substrate of OCT1, OCT2

Drug Interactions

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 Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Aluminum Hydroxide: May decrease the 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 clausii: Antibiotics may diminish the therapeutic effect of Bacillus clausii. Management: Bacillus clausii should be taken in between antibiotic doses during concomitant therapy. Risk D: Consider therapy modification

BCG (Intravesical): Antibiotics may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination

BCG Vaccine (Immunization): Antibiotics may diminish the therapeutic effect of BCG Vaccine (Immunization). Risk C: Monitor therapy

Cholera Vaccine: Antibiotics may diminish the therapeutic effect 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 combination

Fecal Microbiota (Live) (Oral): May diminish the therapeutic effect of Antibiotics. Risk X: Avoid combination

Fecal Microbiota (Live) (Rectal): Antibiotics may diminish the therapeutic effect of Fecal Microbiota (Live) (Rectal). Risk X: Avoid combination

Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies): Antibiotics may diminish the therapeutic effect of Immune Checkpoint Inhibitors (Anti-PD-1, -PD-L1, and -CTLA4 Therapies). Risk C: Monitor therapy

Lactobacillus and Estriol: Antibiotics may diminish the therapeutic effect of Lactobacillus and Estriol. Risk C: Monitor therapy

Sodium Picosulfate: Antibiotics may diminish the therapeutic effect 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 diminish the therapeutic effect 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

Reproductive Considerations

Evaluate pregnancy status prior to treatment of multidrug-resistant tuberculosis in females of reproductive potential. Females of reproductive potential should use effective contraception during treatment for multidrug-resistant tuberculosis (Esmail 2018).

Pregnancy Considerations

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. Tuberculosis (TB) disease (active TB) is also associated with adverse fetal outcomes including intrauterine growth restriction, low birth weight, preterm birth, and perinatal death (Esmail 2018; Miele 2020) as well as adverse maternal outcomes, including increased risks for anemia and cesarean delivery. Placental transmission may rarely occur with active maternal disease (Miele 2020).

Due to the risks of untreated TB, ethambutol is recommended as part of the initial treatment regimen of drug-susceptible active TB when the probability of maternal disease is moderate to high (ATS/CDC/IDSA [Nahid 2016]).

Ethambutol may also be used to treat multidrug-resistant TB. The treatment of multidrug-resistant TB in patients who are pregnant should be individualized; evidence to support a specific regimen is not available (ATS/CDC/ERS/IDSA [Nahid 2019]; WHO 2020).

Pregnancy-induced physiologic changes do not alter the pharmacokinetic properties of ethambutol in a clinically significant way; dose adjustment is not needed in patients who are pregnant (Abdelwahab 2020).

Breastfeeding Considerations

Ethambutol is present in breast milk.

The manufacturer suggests use during breastfeeding only if benefits to the mother outweigh the possible risk to the infant. Breastfeeding is not a contraindication during therapy for drug-susceptible tuberculosis in patients deemed noninfectious who are treated with first-line agents (ie, ethambutol). Exposure to ethambutol via breast milk should not be considered effective treatment for the breastfed infant (ATS/CDC/IDSA [Nahid 2016]). Breastfed infants should be monitored for jaundice (WHO 2002). Patients with multidrug-resistant tuberculosis and a sputum smear-positive test should avoid breastfeeding when possible (Esmail 2018).

Monitoring Parameters

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).

Reference Range

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).

Mechanism of Action

Inhibits arabinosyl transferase resulting in impaired mycobacterial cell wall synthesis

Pharmacokinetics (Adult Data Unless Noted)

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)

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

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).

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Myambutol;
  • (AR) Argentina: Etambutol | Etambutol northia | Etambutol richet;
  • (AT) Austria: Etibi | Myambutol;
  • (AU) Australia: Myambutol;
  • (BD) Bangladesh: Etb | Ethamben | Fiambutol | Mycobac | Servambutol | Sural;
  • (BE) Belgium: Myambutol;
  • (BG) Bulgaria: Etambutol;
  • (BR) Brazil: Furp etambutol;
  • (CH) Switzerland: Ethambutol labatec | Myambutol;
  • (CN) China: Ethambutol | Ethambutol hydrochloride | Sural;
  • (CO) Colombia: Ecox;
  • (CZ) Czech Republic: Sural;
  • (DE) Germany: Emb | Emb-fatol | Myambutol;
  • (DO) Dominican Republic: Luframbutol;
  • (EC) Ecuador: Etambutol | Ethambutol | Myambutol;
  • (EE) Estonia: Ethambutol | Oributol | Syntomen;
  • (EG) Egypt: Etibi;
  • (ET) Ethiopia: Ethambutol;
  • (FI) Finland: Etbutol | Ethambutol orion | Myambutol | Oributol | Stambutol;
  • (FR) France: Dexambutol | Ethambutol | Myambutol;
  • (GB) United Kingdom: Ethambutol | Ethambutol kent;
  • (GR) Greece: Myambutol;
  • (HK) Hong Kong: Emb-fatol | Ethambutec | Ethambutol | Lambutol | Myambutol;
  • (HR) Croatia: Etambutol | Sural;
  • (HU) Hungary: Sural;
  • (ID) Indonesia: Arsitam | Bacbutol | Butolex | Cetabutol | Corsabutol | Decabutol | Dexabutol | Ethambutol | Ethambutol Bernofarm | Etibi | Kalbutol | Myambutol | Ottobutol | Primbutol | Propar | Protibi | Santibi | Tibigon | Tibitol;
  • (IE) Ireland: Ethambutol;
  • (IL) Israel: Myambutol;
  • (IN) India: Albutol | Anacox-e | Biobutol | Butacox | Cavibutol | Colbutol | Combutol | Concox | Ebutol | Ecox | Ethambutol | Ethatol | Fairbutol | Koxi | Koxylar | Lifebutol | Lincambutol | Ly-butol | Marcobutol | Myambutol | Mycobact | Mycobutol | Mycostat | Ranbetol | Rptol | Sainbutol | Sunibutol | Synbutol | Themibutol | Tibitol | Tolbin | Ulticox | Ultiflox | Zytham;
  • (IT) Italy: Etapiam | Miambutol;
  • (JP) Japan: Ebutol | Esanbutol | Esanbutol hexal;
  • (KE) Kenya: Ecox | Etham;
  • (KR) Korea, Republic of: Esanbutol | Ethambutol | Korus ethambutol hcl | Myambutol | Tambutol | Tutol | Unibutol;
  • (LB) Lebanon: Myambutol;
  • (LT) Lithuania: Emb-fatol | Etambulol atb | Etambutol | Ethambutol | Ly butol | Myambutol | Mycobutol | Sural;
  • (LU) Luxembourg: Myambutol;
  • (LV) Latvia: Ethambutol | Ly butol | Mycobutol | Sural;
  • (MA) Morocco: Ethambutol Pharma;
  • (MX) Mexico: Brunibutol | Dovalem | Etambutol | Tambutec;
  • (MY) Malaysia: Ambutol | Ebutol | Ecox | Ethambutol | Ethol | Etinol;
  • (NG) Nigeria: Ethambutol | Surelife ethambutol;
  • (NL) Netherlands: Ethambutol Dihcl Fisher | Myambutol;
  • (NO) Norway: Emb-fatol;
  • (NZ) New Zealand: Apo-ethambutol | Emb fatol;
  • (PE) Peru: Etambutol | Tibutol;
  • (PH) Philippines: E Tol | Ethambin | Ethambutol hydrochloride | Hambutol | Odetol | Usa-ethambutol;
  • (PK) Pakistan: Abbutol | Ambutol | Butal | Ethambutol | Etibi | Myambutol | Pire 1 | Schazobutol | Ubutol;
  • (PR) Puerto Rico: Ethambutol HCL | Ethambutol hydrochloride | Myambutol;
  • (PT) Portugal: Etambutol | Turresis;
  • (RO) Romania: Etambutol | Etambutol Atb;
  • (RU) Russian Federation: Combutol | Ebutol | Ecox | Emb-fatol | Ethambusin | Ethambutol | Ethambutol Akri | Ethambutol stada | Li butol | Ly butol | Mycobutol;
  • (SA) Saudi Arabia: Myambutol;
  • (SG) Singapore: Ebutol | Ethambutol | Myambutol;
  • (SI) Slovenia: Emb-fatol | Etambutol;
  • (SK) Slovakia: Sural;
  • (TH) Thailand: Ambutol | Asiabutal | AT B | Conbutol | Dexambutol | Etham | Ethambutol | Ethbutol | Etibi | Lambutol | Mobutol | Myambutol | Servambutol | Tibitab | Tibitol | Tobutol | Tubertham;
  • (TN) Tunisia: Ethambutol;
  • (TR) Turkey: Dimbutol | Ethambutol | Miambutol;
  • (TW) Taiwan: Ambutol | E butol | Ebutol | Epbutol | Ethambutol | Etibi | Feramtol | Matamfe | Myambutol | Myambutol I/P | Winbutol;
  • (UA) Ukraine: Bruambutol | Combutol | Ecox | Enbutol | Ethambutol;
  • (UG) Uganda: Etham;
  • (UY) Uruguay: Myambutol;
  • (ZA) South Africa: Dyna ethambutol | Ethambutol | Myambutol | Rolab-ethambutol;
  • (ZM) Zambia: Ecox;
  • (ZW) Zimbabwe: Ethambutol | Sandoz ethambutol | Thamtol
  1. Abdelwahab MT, Leisegang R, Dooley KE, et al. Population pharmacokinetics of isoniazid, pyrazinamide, and ethambutol in pregnant South African women with tuberculosis and HIV. Antimicrob Agents Chemother. 2020;64(3):e01978-19. doi:10.1128/AAC.01978-19 [PubMed 31844002]
  2. Addis A, Blowey D, Koren G. Tuberculosis During Pregnancy. Can Fam Physician. 1996;42:1461-1462. [PubMed 8792014]
  3. Alsultan A, Peloquin CA. Therapeutic drug monitoring in the treatment of tuberculosis: an update. Drugs. 2014;74(8):839-854. doi:10.1007/s40265-014-0222-8 [PubMed 24846578]
  4. American Thoracic Society. Targeted Tuberculin Testing and Treatment of Latent Tuberculosis Infection,. MMWR Recomm Rep. 2000;49(RR-6):1-51.
  5. Aronoff GR, Bennett WM, Berns JS, et al, Drug Prescribing in Renal Failure: Dosing Guidelines for Adults and Children. 5th ed. American College of Physicians; 2007.
  6. Bekker A, Schaaf HS, Draper HR, et al. Pharmacokinetics of rifampin, isoniazid, pyrazinamide, and ethambutol in infants dosed according to revised WHO-recommended treatment guidelines. Antimicrob Agents Chemother. 2016;60(4):2171-2179. doi:10.1128/AAC.02600-15 [PubMed 26810651]
  7. British Thoracic Society. Mycobacterium kansasii pulmonary infection: a prospective study of the results of nine months of treatment with rifampicin and ethambutol. Research Committee, British Thoracic Society. Thorax. 1994;49(5):442-445. [PubMed 8016763]
  8. Centers for Disease Control and Prevention, “Treatment of Tuberculosis. American Thoracic Society, CDC, and Infectious Diseases Society of America,” 2003,” MMWR Recomm Rep, 52(RR11):3-5. [PubMed 12836625]
  9. Chabala C, Turkova A, Hesseling AC, et al. Pharmacokinetics of first-line drugs in children with tuberculosis, using World Health Organization-recommended weight band doses and formulations. Clin Infect Dis. 2022;74(10):1767-1775. doi:10.1093/cid/ciab725 [PubMed 34420049]
  10. Chew R, Jongbloed S, Jegatheesan D, et al. Ethambutol is cleared by a contemporary high-flux hemodialyzer, and drug monitoring ensures safety and therapeutic effect. Antimicrob Agents Chemother. 2017;61(6):e01988-16. doi:10.1128/AAC.01988-16 [PubMed 28396542]
  11. Daley CL, Iaccarino JM, Lange C, e al. Treatment of nontuberculous mycobacterial pulmonary disease: an official ATS/ERS/ESCMID/IDSA clinical practice guideline. Clin Infect Dis. 2020;71(4):905-913. doi:10.1093/cid/ciaa1125 [PubMed 32797222]
  12. Ducobu J, DuPont P, Laurent M, et al. Acute Isoniazid/Ethambutol/Rifampicin Overdosage. Lancet. 1982;1(8272):632. [PubMed 6121221]
  13. Esmail A, Sabur NF, Okpechi I, Dheda K. Management of drug-resistant tuberculosis in special sub-populations including those with HIV co-infection, pregnancy, diabetes, organ-specific dysfunction, and in the critically ill. J Thorac Dis. 2018;10(5):3102-3118. doi:10.21037/jtd.2018.05.11 [PubMed 29997980]
  14. Ethambutol hydrochloride [prescribing information]. Newtown, PA: STI Pharma LLC; July 2017.
  15. Ethambutol tablet [prescribing information]. Baltimore, MD: Lupin Pharmaceuticals Inc; February 2016.
  16. Etibi (ethambutol) [prescribing information]. Laval, Quebec, Canada: Bausch Health, Canada Inc; July 2019.
  17. Expert opinion. Senior Renal Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.
  18. Floto RA, Olivier KN, Saiman L, et al. US Cystic Fibrosis Foundation and European Cystic Fibrosis Society (CFF/ECFS) consensus recommendations for the management of non-tuberculous mycobacteria in individuals with cystic fibrosis. Thorax. 2016;71(suppl 1):i1-i22. doi:10.1136/thoraxjnl-2015-207360 [PubMed 26666259]
  19. Griffith DE, Brown-Elliott BA, Wallace RJ Jr. Thrice-weekly clarithromycin-containing regimen for treatment of Mycobacterium kansasii lung disease: results of a preliminary study. Clin Infect Dis. 2003;37(9):1178-1182. [PubMed 14557961]
  20. Havlir DV, Barnes PF. Tuberculosis in Patients With Human Immunodeficiency Virus Infection. N Engl J Med. 1999;340(5):367-373. [PubMed 9929528]
  21. Haworth CS, Banks J, Capstick T, et al. British Thoracic Society (BTS) guidelines for the management of non-tuberculous mycobacterial pulmonary disease (NTM-PD). Thorax. 2017;72(suppl 2):ii1-ii64. doi:10.1136/thoraxjnl-2017-210927 [PubMed 29054853]
  22. Jaganath D, Beaudry J, Salazar-Austin N. Tuberculosis in children. Infect Dis Clin North Am. 2022;36(1):49-71. doi:10.1016/j.idc.2021.11.008 [PubMed 35168714]
  23. Johnston JC, Campbell JR, Menzies D. Effect of intermittency on treatment outcomes in pulmonary tuberculosis: an updated systematic review and metaanalysis. Clin Infect Dis. 2017;64(9):1211-1220. doi:10.1093/cid/cix121 [PubMed 28203783]
  24. Loeffler AM, Gaensbauer J, Dasgupta-Tsinikas S, Wendorf K. Pediatrics. In: Drug-resistant Tuberculosis: A Survival Guide for Clinicians, Third edition/2022 Updates. Curry International Tuberculosis Center and California Department of Public Health; 2022: chap. 6.
  25. Malone RS, Fish DN, Spiegel DM, Childs JM, Peloquin CA. The effect of hemodialysis on isoniazid, rifampin, pyrazinamide, and ethambutol. Am J Respir Crit Care Med. 1999;159(5, pt 1):1580-1584. doi:10.1164/ajrccm.159.5.9810034 [PubMed 10228130]
  26. Miele K, Bamrah Morris S, Tepper NK. Tuberculosis in pregnancy. Obstet Gynecol. 2020;135(6):1444-1453. doi:10.1097/AOG.0000000000003890 [PubMed 32459437]
  27. Nahid P, Dorman SE, Alipanah N, et al. Official American Thoracic Society/Centers for Disease Control and Prevention/Infectious Diseases Society of America (ATS/CDC/IDSA) clinical practice guidelines: treatment of drug-susceptible tuberculosis. Clin Infect Dis. 2016;63(7):e147-e195. doi:10.1093/cid/ciw376 [PubMed 27516382]
  28. Nahid P, Mase SR, Migliori GB, et al. Treatment of drug-resistant tuberculosis. An official ATS/CDC/ERS/IDSA clinical practice guideline. Am J Respir Crit Care Med. 2019;200(10):e93-e142. doi:10.1164/rccm.201909-1874ST [PubMed 31729908]
  29. Peloquin CA, Durbin D, Childs J, Sterling TR, Weiner M. Stability of antituberculosis drugs mixed in food. Clin Infect Dis. 2007;45(4):521. doi:10.1086/520011 [PubMed 17638210]
  30. Prevention and Treatment of Tuberculosis Among Patients Infected With Human Immunodeficiency Virus: Principles of Therapy and Revised Recommendations. Centers for Disease Control and Prevention. MMWR Recomm Rep. 1998;47(RR-20):1-58. [PubMed 9809743]
  31. Scoville BA, De Lott LB, Trobe JD, Mueller BA. Ethambutol optic neuropathy in a hemodialysis patient receiving a guideline-recommended dose. J Neuroophthalmol. 2013;33(4):421-423. doi:10.1097/wno.0000000000000075 [PubMed 24196753]
  32. Shitrit D, Baum GL, Priess R, et al. Pulmonary Mycobacterium kansasii infection in Israel, 1999-2004: clinical features, drug susceptibility, and outcome. Chest. 2006;129(3):771-776. [PubMed 16537880]
  33. Shneerson JM, Francis RS. Ethambutol in pregnancy--foetal exposure. Tubercle. 1979;60(3):167-169. doi:10.1016/0041-3879(79)90018-7 [PubMed 516170]
  34. Si M, Li H, Chen Y, Peng H. Ethambutol and isoniazid induced severe neurotoxicity in a patient undergoing continuous ambulatory peritoneal dialysis. BMJ Case Rep. 2018;2018:bcr2017223187. doi:10.1136/bcr-2017-223187 [PubMed 29776936]
  35. Strunk AK, Ciesek S, Schmidt JJ, et al. Single- and multiple-dose pharmacokinetics of ethambutol and rifampicin in a tuberculosis patient with acute respiratory distress syndrome undergoing extended daily dialysis and ECMO treatment. Int J Infect Dis. 2016;42:1-3. doi:10.1016/j.ijid.2015.10.018 [PubMed 26518065]
  36. Tikiso T, McIlleron H, Abdelwahab MT, et al. Population pharmacokinetics of ethambutol in African children: a pooled analysis. J Antimicrob Chemother. 2022;77(7):1949-1959. doi:10.1093/jac/dkac127 [PubMed 35466379]
  37. Treatment of Latent Tuberculosis Infection (LTBI), Last Updated: April 8, 2004. http://www.cdc.gov/nchstp/tb/pubs/tbfactsheets/250110.htm. Accessed February 16, 2005.
  38. Turkova A, Wills GH, Wobudeya E, et al. Shorter treatment for nonsevere tuberculosis in African and Indian children. N Engl J Med. 2022;386(10):911-922. doi:10.1056/NEJMoa2104535 [PubMed 35263517]
  39. US Department of Health and Human Services (HHS) Panel on Opportunistic Infections in Children with and Exposed to HIV. Guidelines for the prevention and treatment of opportunistic infections in children with and exposed to HIV. Available at https://clinicalinfo.hiv.gov/en/guidelines/pediatric-opportunistic-infection. Updated September 2, 2022. Accessed April 18, 2023.
  40. US Department of Health and Human Services (HHS) Panel on Opportunistic Infections in Adults and Adolescents with HIV. Guidelines for the prevention and treatment of opportunistic infections in adults and adolescents with HIV: recommendations from the Centers for Disease Control and Prevention, the National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of America. https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/Adult_OI.pdf. Accessed April 30, 2020.
  41. US Department of Health and Human Services (HHS) Panel on Opportunistic Infections in Adults and Adolescents with HIV. Guidelines for the prevention and treatment of opportunistic infections in adults and adolescents with HIV: recommendations from the Centers for Disease Control and Prevention, the National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of America. https://clinicalinfo.hiv.gov/sites/default/files/guidelines/documents/Adult_OI.pdf. Accessed June 24, 2022.
  42. US Department of Health and Human Services (HHS) Panel on Opportunistic Infections in Adults and Adolescents with HIV. Guidelines for the prevention and treatment of opportunistic infections in adults and adolescents with HIV: recommendations from the Centers for Disease Control and Prevention, the National Institutes of Health, and the HIV Medicine Association of the Infectious Diseases Society of America. https://clinicalinfo.hiv.gov/en/guidelines/hiv-clinical-guidelines-adult-and-adolescent-opportunistic-infections/whats-new. Updated January 18, 2023. Accessed April 18, 2023.
  43. World Health Organization (WHO). Breastfeeding and maternal medication, recommendations for drugs in the eleventh WHO model list of essential drugs. http://www.who.int/maternal_child_adolescent/documents/55732/en/. Published 2002.
  44. World Health Organization (WHO). Guidance for national tuberculosis programmes on the management of tuberculosis in children. 2nd ed. 2014a.
  45. World Health Organization (WHO). Treatment of tuberculosis guidelines. 4th edition. 2010.
  46. World Health Organization (WHO). WHO consolidated guidelines on tuberculosis. Module 4: treatment - drug-resistant tuberculosis treatment. https://www.who.int/publications/i/item/9789240007048. Published 2020.
  47. World Health Organization (WHO). WHO consolidated guidelines on tuberculosis: module 5: management of tuberculosis in children and adolescents. https://www.who.int/publications/i/item/9789240046764. Published September 21, 2022a. Accessed April 18, 2023.
  48. World Health Organization (WHO). Companion Handbook to the WHO Guidelines for the Programmatic Management of Drug-Resistant Tuberculosis. World Health Organization; 2014b. [PubMed 25320836]
  49. World Health Organization (WHO). WHO operational handbook on tuberculosis: module 5: management of tuberculosis in children and adolescents. https://www.who.int/publications/i/item/9789240046832. Published March 17, 2022b. Accessed April 18, 2023.
  50. Yoshikawa TT. Tuberculosis in Aging Adults. J Am Geriatr Soc. 1992;40(2):178-187. [PubMed 1740604]
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