Ethambutol Hydrochloride 400 mg/1
Ethambutol Hydrochloride · TABLET · Lupin Pharmaceuticals, Inc.
Ethambutol Hydrochloride is a tablet containing ethambutol hydrochloride at 400 mg/1, taken oral. Manufactured by Lupin Pharmaceuticals, Inc..
Key Facts
- Brand Name
- Ethambutol Hydrochloride
- Generic Name
- Ethambutol Hydrochloride
- NDC Code (Product)
68180-281- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Strength
- 400 mg/1
- Dosage Form
- TABLET
- Route
- ORAL
- Marketing Status
- Application #
- ANDA078939
- Marketing Start
- 07/04/2009
Recall History
West-ward Pharmaceutical Corp.
Subpotent Drug: Out Of Specification results for assay at the stability time-point of 24 months.
Lupin Pharmaceuticals Inc.
Failed Impurities/Degradation Specifications: This product is being recalled due to an out of specification result for an impurity.
West-Ward Pharmaceutical Corp.
Subpotency: Out of Specification (OOS) result at the 36 month routine stability time point.
Teva Pharmaceuticals USA
CGMP Deviations: Ethambutol Hydrochloride Tablets, USP, 400 mg were manufactured using unapproved material: the incorrect gelatin excipient than specified in the product formulation.
West-Ward Pharmaceutical Corp.
Discoloration: Ethambutol HCl Tablets 400 mg is being recalled due to a Out of Specification result for description testing for a surface defect of ink.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Ethambutol Hydrochloride Tablets, USP are indicated for the treatment of pulmonary tuberculosis. It should not be used as the sole antituberculous drug, but should be used in conjunction with at least one other antituberculous drug. Selection of the companion drug should be based on clinical experience, considerations of comparative safety, and appropriate in vitro susceptibility studies. In patients who have not received previous antituberculous therapy, i.e., initial treatment, the most frequently used regimens have been the following: Ethambutol hydrochloride, USP plus isoniazid Ethambutol hydrochloride, USP plus isoniazid plus streptomycin In patients who have received previous antituberculous therapy, mycobacterial resistance to other drugs used in initial therapy is frequent. Consequently, in such retreatment patients, ethambutol hydrochloride should be combined with at least one of the second line drugs not previously administered to the patient and to which bacterial susceptibility has been indicated by appropriate in vitro studies. Antituberculous drugs used with ethambutol hydrochloride have included cycloserine, ethionamide, pyrazinamide, viomycin a…
Dosage & Administration
DOSAGE AND ADMINISTRATION Ethambutol hydrochloride should not be used alone, in initial treatment or in retreatment. Ethambutol hydrochloride should be administered on a once every 24-hour basis only. Absorption is not significantly altered by administration with food. Therapy, in general, should be continued until bacteriological conversion has become permanent and maximal clinical improvement has occurred. Ethambutol hydrochloride is not recommended for use in pediatric patients under 13 years of age since safe conditions for use have not been established. Initial Treatment In patients who have not received previous antituberculous therapy, administer ethambutol hydrochloride 15 mg/kg (7 mg/lb) of body weight, as a single oral dose once every 24 hours. In the more recent studies, isoniazid has been administered concurrently in a single, daily, oral dose. Retreatment In patients who have received previous antituberculous therapy, administer ethambutol hydrochloride 25 mg/kg (11 mg/lb) of body weight, as a single oral dose once every 24 hours. Concurrently administer at least one other antituberculous drug to which the organisms have been demonstrated to be susceptible by appropria…
Warnings
WARNINGS Ethambutol hydrochloride 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.
Contraindications
CONTRAINDICATIONS Ethambutol hydrochloride 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 judgment determines that it may be used. Ethambutol hydrochloride is contraindicated in patients who are unable to appreciate and report visual side effects or changes in vision (e.g., young children, unconscious patients).
Drug Interactions
Drug Interactions The results of a study of coadministration of ethambutol hydrochloride (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.
Adverse Reactions
ADVERSE REACTIONS Ethambutol hydrochloride may produce decreases in visual acuity, including irreversible blindness, which appear to be due to optic neuritis. Optic neuropathy including optic neuritis or retrobulbar neuritis occurring in association with ethambutol therapy may be characterized by one or more of the following events: decreased visual acuity, scotoma, color blindness, and/or visual defect. These events have also been reported in the absence of a diagnosis of optic or retrobulbar neuritis. Patients should be advised to report promptly to their physician any change in visual acuity. The change in visual acuity may be unilateral or bilateral and hence each eye must be tested separately and both eyes tested together. Testing of visual acuity should be performed before beginning ethambutol hydrochloride therapy and periodically during drug administration, except that it should be done monthly when a patient is on a dosage of more than 15 mg/kg/day. Snellen eye charts are recommended for testing of visual acuity. Studies have shown that there are definite fluctuations of one or two lines of the Snellen chart in the visual acuity of many tuberculous patients not receiving e…
Frequently Asked Questions
What is Ethambutol Hydrochloride used for?
Ethambutol Hydrochloride contains Ethambutol Hydrochloride. It is a tablet taken oral. Consult your doctor for specific uses.
Is Ethambutol Hydrochloride a controlled substance?
Ethambutol Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Ethambutol Hydrochloride?
The generic name for Ethambutol Hydrochloride is Ethambutol Hydrochloride. There are 4 other brand versions of Ethambutol Hydrochloride.
What is the NDC code for Ethambutol Hydrochloride 400 mg/1?
The NDC (National Drug Code) for Ethambutol Hydrochloride 400 mg/1 is 68180-281, listed by Lupin Pharmaceuticals, Inc..