Ethambutol Hydrochloride

Danger

H360 (95.6%): May damage fertility or the unborn child [Danger Reproductive toxicity]

P203, P280, P318, P405, and P501 (click each P-code to see the statement)

Aggregated GHS information provided per 45 reports by companies from 6 notifications to the ECHA C&L Inventory.；Information may vary between notifications depending on impurities, additives, and other factors. The percentage value in parenthesis indicates the notified classification ratio from companies that provide hazard codes. Only hazard codes with percentage values above 10% are shown. For more detailed information, please visit ECHA C&L website.

IMAP assessments - 1-Butanol, 2,2'-(1,2-ethanediyldiimino)bis-, dihydrochloride, [S-(R*,R*)]-: Environment tier I assessment；IMAP assessments - 1-Butanol, 2,2'-(1,2-ethanediyldiimino)bis-, dihydrochloride, [S-(R*,R*)]-: Human health tier I assessment

Drug Induced Liver Injury Rank (DILIrank 2.0)

Ethambutol hydrochloride

vMost-DILI-concern

8

Warnings & precautions

DOI:10.1016/j.drudis.2016.02.015

◉ Summary of Use during Lactation；Limited information indicates that maternal doses of ethambutol up to 15 mg/kg daily produce low levels in milk and would not be expected to cause any adverse effects in breastfed infants, especially if the infant is older than 2 months. The amount of ethambutol in milk is insufficient to treat tuberculosis in the breastfed infant. The Centers for Disease Control and Prevention and other professional organizations state that breastfeeding should not be discouraged in women taking ethambutol.；◉ Effects in Breastfed Infants；In one uncontrolled study, 6-beta-hydroxycortisol levels were measured in 10 male infants whose mothers had tuberculosis and took ethambutol 1 gram daily plus isoniazid 300 mg daily and the infants of mothers (apparently without tuberculosis) who took no chronic drug therapy. The infants of mothers taking the antituberculars had consistently lower 6-beta-hydroxycortisol levels on 8 occasions at 15-day intervals from 90 to 195 days of age, but these differences were statistically significant on days 120 and 195 only. The authors attributed the lower levels to inhibition of hepatic metabolism of cortisol to 6-beta-hydroxycortisol by the antitubercular drugs in milk. However, ethambutol is not known to inhibit drug metabolism, so if the effect occurs it is more likely caused by isoniazid.；Ethambutol was used as part of a seven-drug regimen to treat a pregnant woman with multidrug-resistant tuberculosis during the second and third trimesters of pregnancy and postpartum. The infant was breastfed (extent and duration not stated). At age 4.6 years, the child was developing normally except for a mild speech delay.；Two mothers in Türkiye were diagnosed with tuberculosis at the 30th and 34th weeks of pregnancy. They immediately started isoniazid 300 mg, rifampin 600 mg, pyridoxine 50 mg daily for 6 months, plus pyrazinamide 25 mg/kg and ethambutol 25 mg/kg daily for 2 months. Both mothers breastfed their infants (extent not stated). Their infants were given isoniazid 5 mg/kg daily for 3 months prophylactically. Tuberculin skin tests were negative after 3 months and neither infant had tuberculosis at 1 year of age. No adverse effects of the drugs were mentioned.；◉ Effects on Lactation and Breastmilk；Relevant published information was not found as of the revision date.

ETHAMBUTOL HYDROCHLORIDE

Antimycobacterial [EPC]

Drugs used in the treatment of tuberculosis. They are divided into two main classes: first-line agents, those with the greatest efficacy and acceptable degrees of toxicity used successfully in the great majority of cases; and second-line drugs used in drug-resistant cases or those in which some other patient-related condition has compromised the effectiveness of primary therapy.