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Ethambutol Hydrochloride 400 mg Tablet, 30-count — NDC 70518-2966-00 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Ethambutol Hydrochloride 400 mg Tablet, 30-count — NDC 70518-2966-0 (Billing 70518-2966-00)

by REMEDYREPACK INC. · 30 TABLET in 1 BLISTER PACK

This is a package of 30 tablets of Ethambutol Hydrochloride 400 mg Tablet from REMEDYREPACK INC., marketed since Dec 2020 and currently FDA-listed. It is the main listing for this product, which comes in 2 package sizes.

NDC 70518-2966-00
🏷️ FDA NDC (as labeled) 70518-2966-0 billing pads the package segment with a zero
This package
Contains30-count Pack sizes2 compare ↓
Also priced by: Part D plans $0.4026/unit — full pricing hub ↓
Main listing for product 70518-2966 · Also comes in: 100 tablets 70518-2966-1
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Aug 13, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 70518-2966-0 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
70518 labeler · 2966 product · 0 package
Package marketed since
Dec 11, 2020
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC-A, from the NDC)
3 7051829660 9
FDA record last changed
Aug 13, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70518-2966-0
Product NDC 70518-2966
11-digit billing NDC 70518296600
RxCUI 995607
UNII QE4VW5FO07
Application # ANDA078939
SPL Set ID c12b3482-55f0-4324-bdcd-b129ca2dae73
Established class (EPC) Antimycobacterial
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2020-12-11
Route ORAL
Dosage form TABLET
Substance ETHAMBUTOL HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 009426
GCN 41801
HICL code 004085
Ingredient (HICL) Ethambutol Hcl
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W2
Therapeutic class — intermediate (HIC2) Antibacterials
HIC3 code W2E
Therapeutic class — specific (HIC3) Anti-Mycobacterium Agents
AHFS code 08:16.04.00
AHFS class Antituberculosis Agents
FDB label name ETHAMBUTOL HCL 400 MG TABLET
FDB brand name Ethambutol Hcl
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 009426
  • GCN: 41801
  • HICL (First Databank): 004085
  • AHFS class code: 08:16.04.00
  • RxCUI (RxNorm): 995607
Why two NDCs? The FDA registers this code as 70518-2966-0 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 70518-2966-00. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Antimycobacterial class.

Pharmacologic class Antimycobacterial
Drug family (ATC) Other drugs for treatment of tuberculosis
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name ETHAMBUTOL HCL 400 MG TABLET Ingredient Ethambutol Hcl
📖 What it is MedlinePlus · NLM

Ethambutol eliminates certain bacteria that cause tuberculosis (TB). It is used with other medicines to treat tuberculosis and to prevent you from giving the infection to others. This medication is sometimes prescribed for other uses; ask your doctor or pharmacist for more information.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats tuberculosis in the lungs. It is always taken with at least one other TB medicine, never alone. Using it with other drugs helps the treatment work and helps prevent resis...
  • Take it by mouth once a day. You can take it with or without food. Keep taking it as long as your doctor says, even if you feel better, because TB treatment takes time.
  • Some people get nausea, stomach upset, loss of appetite, headache or dizziness. The most important one to watch for is vision change, like blurry vision or trouble seeing colors. C...
  • Yes. Your vision should be checked before you start and periodically during treatment. If you are on a higher dose, checks are advised monthly. Tell your doctor about any eye sympt...
📖 Read our full Ethambutol guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
2
Nutrient depletion considerations

Ethambutol may be associated with lower levels of 2 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Ethambutol nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.4026 $12.08 / 30 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
70518-2966-00 You're viewing this Main listing 30 TABLET in 1 BLISTER PACK 2020-12-11 — Active
70518-2966-01 70518-2966-1 100 POUCH in 1 BOX / 1 TABLET in 1 POUCH 2023-02-15 — Discontinued by firm

Pack size FAQ

What quantity is in this package?
This is a 30-count package — 30 tablet in 1 blister pack.
How does this package differ from NDC 70518-2966-01?
Both are Ethambutol Hydrochloride 400 mg Tablet — the drug itself is identical. This page's package is the 30-count one, while NDC 70518-2966-01 is the 100 tablets package.
What NDC number is used to bill for this package of Ethambutol Hydrochloride 400 mg Tablet?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Ethambutol Hydrochloride 400 mg 42806-0102-01 Epic 100 tablets $0.458 AB Availability likely —
Ethambutol Hydrochloride 400 mg 68084-0280-01 American 100 tablets $0.458 AB Availability likely —
Ethambutol Hydrochloride 400 mg 68180-0281-01 Lupin 100 tablets $0.458 AB Availability likely —
Ethambutol Hydrochloride 400 mg 54879-0002-01 STI 100 tablets $0.536 AB Discontinued —
Ethambutol Hydrochloride 400 mg 10135-0797-01 Marlex 100 tablets — AB FDA listed —
Ethambutol Hydrochloride 400 mgthis 70518-2966-00 REMEDYREPACK 30 tablets — AB FDA listed —
Ethambutol Hydrochloride 400 mg 85742-0006-04 Kanchan 100 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2020
On the market since
Dec 2020
📍
2026
Currently FDA-listed
6 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

What it looks like

Color white
ShapeRound
ImprintL;U;C32
Size12 mm
ScoringScored — splits in 2
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 7Z8S9VYZ4B
    Ethylcellulose is a plant-derived thickener and film-former made by chemically modifying cellulose. It's used as a binder to hold tablet ingredients together, a coating to control how quickly medicine is released, or a thickener in liquid formulations.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII 4R4HFI6D95
    Polyethylene glycol 4000 is a synthetic polymer derived from petroleum. It serves as a binder, filler, and lubricant in solid dosage forms, and helps control how quickly the medicine dissolves.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • UNII 7SEV7J4R1U
    A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

10 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerREMEDYREPACK INC.
Application holderLUPIN LTD
FDA applicationANDA078939 (ANDA)
Labeler code70518
First marketedDec 2020
Product typeHuman Prescription Drug
Portfolio1,527 products on file

More NDCs from REMEDYREPACK INC. labeler code 70518

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description ⚠️ Precautions 🍼 Nursing Mothers 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 174 words ▾

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 isoniazid Ethambutol 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.

⏱️ Dosage and Administration ~2 min read ▾

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 Table 15 mg/kg (7 mg/lb) Schedule Weight Range Daily Dose Pounds Kilograms ----------------- 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) Schedule Under 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

⛔ Contraindications 60 words ▾

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 74 words ▾

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.

🤒 Adverse Reactions ~3 min read ▾

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.

Initial Snellen Reading Reading Indicating Significant Decrease Significant Number of Lines Decrease Number of Points 20/13 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 a… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 78 words ▾

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 196 words ▾

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.

🧒 Pediatric Use 26 words ▾

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 81 words ▾

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.

🧬 Clinical Pharmacology ~2 min read ▾

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.

📦 How Supplied / Storage and Handling 110 words ▾

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: 70518-2966-00 NDC: 70518-2966-01 NDC: 70518-2966-02 PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 100 in 1 BOX PACKAGING: 1 in 1 POUCH Store 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

📋 Description 107 words ▾

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 10 H 24 N 2 O 2 •2HCl M.W.

277.23 (+)-2,2’ (Ethylenediimino)-di-1-butanol dihydrochloride Each 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.

Ethambutplhcl

⚠️ Precautions ~3 min read ▾

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 e… [Excerpted — this section continues on DailyMed.]

🍼 Nursing Mothers 32 words ▾

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.

📄 Package Label / Principal Display Panel 74 words ▾

DRUG: Ethambutol Hydrochloride GENERIC: Ethambutol Hydrochloride DOSAGE: TABLET ADMINSTRATION: ORAL NDC: 70518-2966-0 NDC: 70518-2966-1 NDC: 70518-2966-2 COLOR: white SHAPE: ROUND SCORE: Two even pieces SIZE: 12 mm IMPRINT: L;U;C32 PACKAGING: 30 in 1 BLISTER PACK PACKAGING: 100 in 1 BOX PACKAGING: 1 in 1 POUCH ACTIVE INGREDIENT(S): ETHAMBUTOL HYDROCHLORIDE 400mg in 1 INACTIVE INGREDIENT(S): ETHYLCELLULOSES HYPROMELLOSES MAGNESIUM STEARATE POLYETHYLENE GLYCOL 4000 POVIDONE PROPYLENE GLYCOL SILICON DIOXIDE STARCH, CORN TALC TITANIUM DIOXIDE MM1 MM2 MM3

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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← 70518-2964-00 · REMEDYREPACK 70518-2970-00 · REMEDYREPACK →
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