Ethambutol hydrochloride warnings and precautions: Difference between revisions
No edit summary |
|||
| Line 5: | Line 5: | ||
== | ==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. | 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. | ||
Liver toxicities including fatalities have been reported . Baseline and periodic assessment of hepatic function should be performed. | Liver toxicities including fatalities have been reported . 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. | 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. | ||
| Line 16: | Line 16: | ||
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. | 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. | 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. | ||
As with any potent drug, baseline and periodic assessment of organ system functions, including renal, hepatic, and hematopoietic, should be performed.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = MYAMBUTOL (ETHAMBUTOL HYDROCHLORIDE) TABLET, FILM COATED [STI PHARMA, LLC] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=b362b3cd-2c26-4af5-baa4-084217729fa5 | publisher = | date = | accessdate }}</ref> | As with any potent drug, baseline and periodic assessment of organ system functions, including renal, hepatic, and hematopoietic, should be performed.<ref name="dailymed.nlm.nih.gov">{{Cite web | last = | first = | title = MYAMBUTOL (ETHAMBUTOL HYDROCHLORIDE) TABLET, FILM COATED [STI PHARMA, LLC] | url = http://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=b362b3cd-2c26-4af5-baa4-084217729fa5 | publisher = | date = | accessdate }}</ref> | ||
Revision as of 14:47, 27 December 2013
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1] ; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]
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. Liver toxicities including fatalities have been reported . 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.
As with any potent drug, baseline and periodic assessment of organ system functions, including renal, hepatic, and hematopoietic, should be performed.[1]
References
- ↑ "MYAMBUTOL (ETHAMBUTOL HYDROCHLORIDE) TABLET, FILM COATED [STI PHARMA, LLC]". Text " accessdate " ignored (help)
Adapted from the FDA Package Insert.