|contraindications=* MYAMBUTOL is contraindicated in patients who are known to be hypersensitive to this drug. It is also contraindicated in patients with known optic neuritis unless clinical judgement determines that it may be used. MYAMBUTOL is contraindicated in patients who are unable to appreciate and report visual side effects or changes in vision (e.g., young children, unconscious patients).
<!--Warnings-->
<!--Warnings-->
|warnings=* Description
|warnings=* MYAMBUTOL may produce decreases in visual acuity which appear to be due to optic neuritis. This effect may be related to dose and duration of treatment. This effect is generally reversible when administration of the drug is discontinued promptly. However, irreversible blindness has been reported. (See PRECAUTIONS and ADVERSE REACTIONS).
liver toxicities including fatalities have been reported (see ADVERSE REACTIONS). Baseline and periodic assessment of hepatic function should be performed.
====Precautions====
====Precautions====
* Description
*MYAMBUTOL ethambutol hydrochloride is not recommended for use in pediatric patients under thirteen years of age since safe conditions for use have not been established.
Patients with decreased renal function need the dosage reduced as determined by serum levels of MYAMBUTOL, since the main path of excretion of this drug is by the kidneys.
Because this 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 the 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. (For recommended procedures, see next paragraphs under ADVERSE REACTIONS.)
As with any potent drug, baseline and periodic assessment of organ system functions, including renal, hepatic, and hematopoietic, should be performed.
<!--Adverse Reactions-->
<!--Adverse Reactions-->
Line 247:
Line 255:
<!--Drug Interactions-->
<!--Drug Interactions-->
|drugInteractions=* Drug
|drugInteractions=* The results of a study of coadministration of ethambutol (50 mg/kg) with an aluminum hydroxide containing antacid to 13 patients with tuberculosis showed a reduction of mean serum concentrations and urinary excretion of ethambutol of approximately 20% and 13%, respectively, suggesting that the oral absorption of ethambutol may be reduced by these antacid products. It is recommended to avoid concurrent administration of ethambutol with aluminum hydroxide containing antacids for at least 4 hours following ethambutol administration.
:* Description
|FDAPregCat=C
|useInPregnancyFDA=Teratogenic Effects: Pregnancy Category C.
<!--Use in Specific Populations-->
There are no adequate and well-controlled studies in pregnant women. There are reports of ophthalmic abnormalities occuring in infants born to women on antituberculous therapy that included ethambutol hydrochloride. MYAMBUTOL should be used during pregnancy only if the benefit justifies the potential risk to the fetus.
|useInPregnancyFDA=* '''Pregnancy Category'''
MYAMBUTOL has been shown to be teratogenic in pregnant mice and rabbits when given in high doses. When pregnant mice or rabbits were treated with high doses of ethambutol hydrochloride, fettal mortality was slightly but not significantly (P>0.05) increased. Femal rats treated with ethambutol hydrochloride displayed slight but insignificant (P>0.05) decreases in fertility and litter size.
In fetuses born of mice treated with high doses of MYAMBUTOL during pregnancy, a low incidence of cleft palate, exencephaly and abnormality of the vertebral column were observed. Minor abnormalities of the cervical vertebra were seen in the newborn of rats treated with high doses of ethambutol hydrochloride during pregnancy. Rabbits receiving high doses of MYAMBUTOL during pregnancy gave birth to two fetuses with monophthalmmia, one with a shortened right forearm accompanied by bulateral wrist-joint contracture and one with hare lip and cleft palate.
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
|useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInNursing=There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
|useInNursing=MYAMBUTOL is excreted into breast milk. The use of MYAMBUTOL should be considered only if the expected benefit to the mother outweighs the potential risk to the infant.
|useInPed=There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
|useInPed=MYAMBUTOL ethambutol hydrochloride is not recommended for use in pediatric patients under thirteen years of age since safe conditions have not been established.
|useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
|useInGeri=There are limited date on the use of ethambutol in the elderly. One study of 101 patients, 65 years and older, on multiple drug antituberculosis regimens included 94 patients on ethambutol. No differences in safety of tolerability were observed in these patients compared with that reported in adults in general.
Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
|useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
|useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
|useInRace=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
|useInRace=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
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Overview
Ethambutol is an anti- infective agent, antibacterial agent that is FDA approved for the treatment of pulmonary tuberculosis as an adjunct. Common adverse reactions include hyperuricemia, nausea, vomiting, mania.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Pulmonary tuberculosis; Adjunct
Dosing Information
Dosage
Condition2
Dosing Information
Dosage
Condition3
Dosing Information
Dosage
Condition4
Dosing Information
Dosage
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
Condition1
Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Ethambutol in adult patients.
Non–Guideline-Supported Use
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Ethambutol in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding FDA-Labeled Use of Ethambutol in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Condition1
Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Ethambutol in pediatric patients.
Non–Guideline-Supported Use
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Ethambutol in pediatric patients.
Contraindications
MYAMBUTOL is contraindicated in patients who are known to be hypersensitive to this drug. It is also contraindicated in patients with known optic neuritis unless clinical judgement determines that it may be used. MYAMBUTOL is contraindicated in patients who are unable to appreciate and report visual side effects or changes in vision (e.g., young children, unconscious patients).
Warnings
MYAMBUTOL may produce decreases in visual acuity which appear to be due to optic neuritis. This effect may be related to dose and duration of treatment. This effect is generally reversible when administration of the drug is discontinued promptly. However, irreversible blindness has been reported. (See PRECAUTIONS and ADVERSE REACTIONS).
liver toxicities including fatalities have been reported (see ADVERSE REACTIONS). Baseline and periodic assessment of hepatic function should be performed.
Precautions
MYAMBUTOL ethambutol hydrochloride is not recommended for use in pediatric patients under thirteen years of age since safe conditions for use have not been established.
Patients with decreased renal function need the dosage reduced as determined by serum levels of MYAMBUTOL, since the main path of excretion of this drug is by the kidneys.
Because this 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 the 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. (For recommended procedures, see next paragraphs under ADVERSE REACTIONS.)
As with any potent drug, baseline and periodic assessment of organ system functions, including renal, hepatic, and hematopoietic, should be performed.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Ethambutol in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Ethambutol in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Drug Interactions
The results of a study of coadministration of ethambutol (50 mg/kg) with an aluminum hydroxide containing antacid to 13 patients with tuberculosis showed a reduction of mean serum concentrations and urinary excretion of ethambutol of approximately 20% and 13%, respectively, suggesting that the oral absorption of ethambutol may be reduced by these antacid products. It is recommended to avoid concurrent administration of ethambutol with aluminum hydroxide containing antacids for at least 4 hours following ethambutol administration.
There are no adequate and well-controlled studies in pregnant women. There are reports of ophthalmic abnormalities occuring in infants born to women on antituberculous therapy that included ethambutol hydrochloride. MYAMBUTOL should be used during pregnancy only if the benefit justifies the potential risk to the fetus.
MYAMBUTOL has been shown to be teratogenic in pregnant mice and rabbits when given in high doses. When pregnant mice or rabbits were treated with high doses of ethambutol hydrochloride, fettal mortality was slightly but not significantly (P>0.05) increased. Femal rats treated with ethambutol hydrochloride displayed slight but insignificant (P>0.05) decreases in fertility and litter size.
In fetuses born of mice treated with high doses of MYAMBUTOL during pregnancy, a low incidence of cleft palate, exencephaly and abnormality of the vertebral column were observed. Minor abnormalities of the cervical vertebra were seen in the newborn of rats treated with high doses of ethambutol hydrochloride during pregnancy. Rabbits receiving high doses of MYAMBUTOL during pregnancy gave birth to two fetuses with monophthalmmia, one with a shortened right forearm accompanied by bulateral wrist-joint contracture and one with hare lip and cleft palate.
Pregnancy Category (AUS):
Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Ethambutol in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Ethambutol during labor and delivery.
Nursing Mothers
MYAMBUTOL is excreted into breast milk. The use of MYAMBUTOL should be considered only if the expected benefit to the mother outweighs the potential risk to the infant.
Pediatric Use
MYAMBUTOL ethambutol hydrochloride is not recommended for use in pediatric patients under thirteen years of age since safe conditions have not been established.
Geriatic Use
There are limited date on the use of ethambutol in the elderly. One study of 101 patients, 65 years and older, on multiple drug antituberculosis regimens included 94 patients on ethambutol. No differences in safety of tolerability were observed in these patients compared with that reported in adults in general.
Other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Gender
There is no FDA guidance on the use of Ethambutol with respect to specific gender populations.
Race
There is no FDA guidance on the use of Ethambutol with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Ethambutol in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Ethambutol in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Ethambutol in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Ethambutol in patients who are immunocompromised.
Administration and Monitoring
Administration
Oral
Intravenous
Monitoring
There is limited information regarding Monitoring of Ethambutol in the drug label.
Description
IV Compatibility
There is limited information regarding IV Compatibility of Ethambutol in the drug label.
Overdosage
Acute Overdose
Signs and Symptoms
Description
Management
Description
Chronic Overdose
There is limited information regarding Chronic Overdose of Ethambutol in the drug label.
Pharmacology
There is limited information regarding Ethambutol Pharmacology in the drug label.
