NDC 70518-2966 Ethambutol Hydrochloride

Ethambutol Hydrochloride

NDC Product Code 70518-2966

NDC CODE: 70518-2966

Proprietary Name: Ethambutol Hydrochloride What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Non-Proprietary Name: Ethambutol Hydrochloride What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

Product Characteristics

Color(s):
WHITE (C48325 - WHITE TO OFF-WHITE)
Shape: ROUND (C48348)
Size(s):
12 MM
Imprint(s):
L;U;C32
Score: 2

NDC Code Structure

  • 70518 - Remedyrepack Inc.

NDC 70518-2966-0

Package Description: 30 TABLET in 1 BLISTER PACK

NDC Product Information

Ethambutol Hydrochloride with NDC 70518-2966 is a a human prescription drug product labeled by Remedyrepack Inc.. The generic name of Ethambutol Hydrochloride is ethambutol hydrochloride. The product's dosage form is tablet and is administered via oral form.

Labeler Name: Remedyrepack Inc.

Dosage Form: Tablet - A solid dosage form containing medicinal substances with or without suitable diluents.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Ethambutol Hydrochloride Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • ETHAMBUTOL HYDROCHLORIDE 400 mg/1

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)
  • HYPROMELLOSES (UNII: 3NXW29V3WO)
  • MAGNESIUM STEARATE (UNII: 70097M6I30)
  • POLYETHYLENE GLYCOL 4000 (UNII: 4R4HFI6D95)
  • POVIDONE (UNII: FZ989GH94E)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
  • STARCH, CORN (UNII: O8232NY3SJ)
  • TALC (UNII: 7SEV7J4R1U)
  • TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Antimycobacterial - [EPC] (Established Pharmacologic Class)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Remedyrepack Inc.
Labeler Code: 70518
FDA Application Number: ANDA078939 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 12-11-2020 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Ethambutol Hydrochloride Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

100 mg and 400 mgRx Only

Repackaged and Distributed By:Remedy Repack, Inc.625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Description

Ethambutol hydrochloride is an oral chemotherapeutic agent which is specifically effective against actively growing microorganisms of the genus


Mycobacterium, including


M. tuberculosis. Ethambutol hydrochloride is a white, crystalline powder, It is freely soluble in water; soluble in alcohol and in methanol. The structural formula is:


C


10H


24N


2O


2•2HCl M.W. 277.23


(+)-2,2’ (Ethylenediimino)-di-1-butanol dihydrochlorideEach tablet, for oral administration, contains 100 mg or 400 mg Ethambutol Hydrochloride. In addition, each tablet contains the following inactive ingredients: colloidal silicon dioxide, corn starch, magnesium stearate, povidone and talc. Film coating contains: ethyl cellulose, hypromellose, macrogol, propylene glycol, talc and titanium dioxide.

Clinical Pharmacology

Ethambutol hydrochloride, following a single oral dose of 25 mg/kg of body weight, attains a peak of 2 to 5 mcg/mL in serum 2 to 4 hours after administration. When the drug is administered daily for longer periods of time at this dose, serum levels are similar. The serum level of ethambutol falls to undetectable levels by 24 hours after the last dose except in some patients with abnormal renal function. The intercellular concentrations of erythrocytes reach peak values approximately twice those of plasma and maintain this ratio throughout the 24 hours.During the 24-hour period following oral administration of ethambutol approximately 50 percent of the initial dose is excreted unchanged in the urine, while an additional 8 to 15 percent appears in the form of metabolites. The main path of metabolism appears to be an initial oxidation of the alcohol to an aldehydic intermediate, followed by conversion to a dicarboxylic acid. From 20 to 22 percent of the initial dose is excreted in the feces as unchanged drug. No drug accumulation has been observed with consecutive single daily doses of 25 mg/kg in patients with normal kidney function, although marked accumulation has been demonstrated in patients with renal insufficiency.Ethambutol diffuses into actively growing


mycobacterium cells such as tubercle bacilli. Ethambutol appears to inhibit the synthesis of one or more metabolites, thus causing impairment of cell metabolism, arrest of multiplication, and cell death. No cross resistance with other available antimycobacterial agents has been demonstrated.


Ethambutol has been shown to be effective against strains of


Mycobacterium tuberculosis but does not seem to be active against fungi, viruses, or other bacteria.


Mycobacterium tuberculosis strains previously unexposed to ethambutol have been uniformly sensitive to concentrations of 8 or less mcg/ mL, depending on the nature of the culture media. When ethambutol has been used alone for treatment of tuberculosis, tubercle bacilli from these patients have developed resistance to ethambutol hydrochloride by


in-vitro susceptibility tests; the development of resistance has been unpredictable and appears to occur in a step-like manner. No cross resistance between ethambutol and other antituberculous drugs has been reported. Ethambutol has reduced the incidence of the emergence of mycobacterial resistance to isoniazid when both drugs have been used concurrently. An agar diffusion microbiologic assay, based upon inhibition of


Mycobacterium smegmatis (ATCC 607) may be used to determine concentrations of ethambutol in serum and urines.

Animal Pharmacology

Toxicological studies in dogs on high prolonged doses produced evidence of myocardial damage and failure, and depigmentation of the tapetum lucidum of the eyes, the significance of which is not known. Degenerative changes in the central nervous system, apparently not dose-related, have also been noted in dogs receiving ethambutol hydrochloride over a prolonged period. In the rhesus monkey, neurological signs appeared after treatment with high doses given daily over a period of several months. These were correlated with specific serum levels of ethambutol and with definite neuroanatomical changes in the central nervous system. Focal interstitial carditis was also noted in monkeys which received ethambutol hydrochloride in high doses for a prolonged period.

Indications And Usage

  • Ethambutol hydrochloride is 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 plus isoniazidEthambutol 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 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 have included cycloserine, ethionamide, pyrazinamide, viomycin and other drugs. Isoniazid, aminosalicylic acid, and streptomycin have also been used in multiple drug regimens. Alternating drug regimens have also been utilized.

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 judgement 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).

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


PRECAUTIONSand


ADVERSE REACTIONS).


Liver toxicities including fatalities have been reported (see


ADVERSE REACTIONS).


Baseline and periodic assessment of hepatic function should be performed.

Precautions

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 ethambutol, 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.

Drug Interactions

The results of a study of coadministration of ethambutol hydrochloride (50mg/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.

Pregnancy

Teratogenic Effects: Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. There are reports of ophthalmic abnormalities occurring in infants born to women on antituberculous therapy that included ethambutol hydrochloride. Ethambutol hydrochloride should be used during pregnancy only if the benefit justifies the potential risk to the fetus. Ethambutol hydrochloride 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, fetal mortality was slightly but not significantly (P>0.05) increased. Female 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 ethambutol hydrochloride 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 ethambutol hydrochloride during pregnancy gave birth to two fetuses with monophthalmia, one with a shortened right forearm accompanied by bilateral wrist-joint contracture and one with hare lip and cleft palate.

Nursing Mothers

Ethambutol hydrochloride is excreted into breast milk. The use of ethambutol hydrochloride should be considered only if the expected benefit to the mother outweighs the potential risk to the infant.

Pediatric Use

Ethambutol hydrochloride is not recommended for use in pediatric patients under thirteen years of age since safe conditions for use have not been established.

Geriatric Use

There are limited data on the use of ethambutol hydrochloride in the elderly. One study of 101 patients, 65 years and older, on multiple drug antituberculosis regimens included 94 patients on ethambutol hydrochloride. No differences in safety or 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.

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 of 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 per kilogram per 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 ethambutol.The following table may be useful in interpreting possible changes in visual acuity attributable to ethambutol.InitialSnellenReadingReading IndicatingSignificant DecreaseSignificantNumber of LinesDecreaseNumber of Points20/13


20/25


3


12


20/15


20/25


2


10


20/20


20/30


2


10


20/25


20/40


2


15


20/30


20/50


2


20


20/40


20/70


2


30


20/50


20/70


1


20


In general, changes in visual acuity less than those indicated under "Significant Number of Lines" and "Decrease Number of Points", may be due to chance variation, limitations of the testing method or physiologic variability. Conversely, changes in visual acuity equaling or exceeding those under "Significant Number of Lines" and "Decrease Number of Points" indicate the need for retesting and careful evaluation of the patient’s visual status. If careful evaluation confirms the magnitude of visual change and fails to reveal another cause, ethambutol should be discontinued and the patient reevaluated at frequent intervals. Progressive decreases in visual acuity during therapy must be considered to be due to ethambutol.If corrective glasses are used prior to treatment, these must be worn during visual acuity testing. During 1 to 2 years of therapy, a refractive error may develop which must be corrected in order to obtain accurate test results. Testing the visual acuity through a pinhole eliminates refractive error. Patients developing visual abnormality during ethambutol treatment may show subjective visual symptoms before, or simultaneously with, the demonstration of decreases in visual acuity, and all patients receiving ethambutol should be questioned periodically about blurred vision and other subjective eye symptoms.Recovery of visual acuity generally occurs over a period of weeks to months after the drug has been discontinued. Some patients have received ethambutol hydrochloride again after such recovery without recurrence of loss of visual acuity. Other adverse reactions reported include: hypersensitivity, anaphylactic/anaphylactoid reaction, dermatitis, erythema multiforme, pruritus, and joint pain; anorexia, nausea, vomiting, gastrointestinal upset, and abdominal pain; fever, malaise, headache, and dizziness; mental confusion, disorientation, and possible hallucinations; thrombocytopenia, leucopenia, and neutropenia. Numbness and tingling of the extremities due to peripheral neuritis have been reported. Elevated serum uric acid levels occur and precipitation of acute gout has been reported. Pulmonary infiltrates, with or without eosinophilia, also have been reported during ethambutol hydrochloride therapy. Liver toxicities, including fatalities, have been reported. (See


WARNINGS).


Since ethambutol hydrochloride is recommended for therapy in conjunction with one or more other antituberculous drugs, these changes may be related to the concurrent therapy. Hypersensitivity syndrome consisting of cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, and one or more of the following: hepatitis, pneumonitis, nephritis, myocarditis, pericarditis. Fever and lymphadenopathy may be present.

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 thirteen 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 appropriate


in-vitro tests. Suitable drugs usually consist of those not previously used in the treatment of the patient. After 60 days of ethambutol hydrochloride administration, decrease the dose to 15 mg/kg (7 mg/lb) of body weight, and administer as a single oral dose once every 24 hours.


During the period when a patient is on a daily dose of 25 mg/kg, monthly eye examinations are advised.See Table for easy selection of proper weight-dose tablet(s).Weight-Dose Table15 mg/kg (7 mg/lb) ScheduleWeight RangeDaily DosePoundsKilograms-----------------In mg


Under 85 lbs.


Under 37 kg


-----------------500


85 – 94.5


37 – 43


-----------------600


95 – 109.5 


43 – 50


-----------------700


110 – 124.5


50 – 57


-----------------800


125 – 139.5


57 – 64


-----------------900


140 – 154.5


64 – 71


-----------------1000


155 – 169.5 


71 – 79


-----------------1100


170 – 184.5


79 – 84


-----------------1200


185 – 199.5


84 – 90 


-----------------1300


200 – 214.5 


90 – 97


-----------------1400


215 and Over


Over 97


-----------------1500


25 mg/kg (11 mg/lb) ScheduleUnder 85 lbs.


Under 38 kg


-----------------900


85 – 92.5


38 – 42


-----------------1000


93 – 101.5


42 – 45.5


-----------------1100


102 – 109.5


45.5 – 50


-----------------1200


110 – 118.5


50 – 54


-----------------1300


119 – 128.5 


54 – 58


-----------------1400


129 – 136.5


58 – 62


-----------------1500


137 – 146.5


62 – 67


-----------------1600


147 – 155.5


67 – 71


-----------------1700


156 – 164.5


71 – 75


-----------------1800


165 – 173.5


75 – 79


-----------------1900


174 – 182.5


79 – 83


-----------------2000


183 – 191.5


83 – 87


-----------------2100


192 – 199.5


87 – 91


-----------------2200


200 – 209.5 


91 – 95 


-----------------2300


210 – 218.5


95 – 99


-----------------2400


219 and Over


Over 99


-----------------2500

How Supplied

Ethambutol Hydrochloride Tablets USP, 400 mg are available as white to off-white, round, biconvex, film-coated tablets debossed with ‘L’ and ‘U’ on either side of the breakline on one side and ‘C32’ on other side.They are supplied as follows:NDC: 70518-2966-00PACKAGING: 30 in 1 BLISTER PACKStore at 20°to 25°C (68°to 77°F) [See USP Controlled Room Temperature]. Protect from light and moisture.Dispense in a tight, light-resistant container defined in as the USP using a child-resistant closure.Repackaged and Distributed By:Remedy Repack, Inc.625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

* Please review the disclaimer below.