HomeNDC LookupIngredientsErythromycin Ethylsuccinate › 62559-0440-02
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Erythromycin Ethylsuccinate 200 mg/5mL Granule, For Suspension, 200 mL

by ANI Pharmaceuticals, Inc. · 200 mL in 1 BOTTLE (62559-440-02)
NDC 62559-0440-02
🏷️ FDA NDC (as labeled) 62559-440-02 billing pads the product segment with a zero
This package
Contains200 mL Cost per mL$1.53 NADAC Per package$306.10 / 200 ml Pack sizes2 compare ↓
Also priced by: Medicaid pays $1.27/unit · Part D plans $1.50/unit — full pricing hub ↓
Also comes in: 100 ml 62559-0440-01
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

🆔 Identity & classification

FDA NDC (as labeled) 62559-440-02
Product NDC 62559-440
11-digit billing NDC 62559044002
NCPDP billing unit ML — per mL (volume)
RxCUI 686400
UNII 1014KSJ86F
UPC 0362559440028
Application # ANDA062055
SPL Set ID 3de1e0b9-473b-44c0-a644-5fa14ad69a83
Established class (EPC) Macrolide Antimicrobial; Macrolide
Physiologic effect Decreased Sebaceous Gland Activity
Chemical class Macrolides
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2016-09-27
Route ORAL
Dosage form GRANULE, FOR SUSPENSION
Substance ERYTHROMYCIN ETHYLSUCCINATE
GPI-14 03100030301910
GPI class Erythromycin Ethylsuccinate
GCN Seq No 021205
GCN 40523
HICL code 004018
Ingredient (HICL) Erythromycin Ethylsuccinate
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W1
Therapeutic class — intermediate (HIC2) Antibiotics
HIC3 code W1D
Therapeutic class — specific (HIC3) Macrolide Antibiotics
AHFS code 08:12.12.04
AHFS class Erythromycin Antibiotics
FDB label name ERYTHROMYCIN 200 MG/5 ML SUSP
FDB brand name Erythromycin Ethylsuccinate
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 62559-440-02 — a 5-3-2 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 product segment → 62559-0440-02. 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 Macrolide class.

Pharmacologic class Macrolide, Macrolide Antimicrobial
Drug family (ATC) Antiinfectives for treatment of acne, Macrolides, Antibiotics
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.

🏭 Manufacturer & labeler

LabelerANI Pharmaceuticals, Inc.
Application holderANI PHARMACEUTICALS INC
FDA applicationANDA062055 (ANDA)
Labeler code62559
First marketedSep 2016
Product typeHuman Prescription Drug
Portfolio299 products on file
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.

🩺 Clinical

Label name ERYTHROMYCIN 200 MG/5 ML SUSP Ingredient Erythromycin Ethylsuccinate
📖 What it is MedlinePlus · NLM

Erythromycin is used to treat certain infection caused by bacteria including infections of the ears, lungs, sinuses, skin, throat, and reproductive organs. Erythromycin is in a class of medications called macrolide antibiotics. It works by stopping the growth of bacteria. Antibiotics such as erythromycin will not work for colds, flu, or other viral infections. Taking antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Erythromycin treats a pretty wide range of bacterial infections. That includes respiratory infections like bronchitis and pneumonia, skin infections, whooping cough, Legionnaires'...
  • What kinds of infections does erythromycin treat?
  • It depends on the form you have. If you're taking ERY-TAB delayed-release tablets, they work best on an empty stomach — ideally about 2 hours before a meal, though taking them with...
  • Can I take this on an empty stomach, or do I need food?
📖 Read our full Erythromycin guide →
7
Nutrient depletion considerations

Erythromycin Ethylsuccinate may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.

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.

💊 What it looks like

Color White
FlavorCherry
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 3SY5LH9PMK
    Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
  • UNII RS7A450LGA
    A sodium salt derived from citric acid that helps regulate acidity and maintain pH balance in the medicine. It also works as a binding agent to hold tablet ingredients together.
  • UNII 92RU3N3Y1O
    Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
  • UNII A2I8C7HI9T
    Methylparaben is a preservative derived from benzoic acid that prevents growth of bacteria, fungi, and mold in medicines. It extends the product's shelf life and maintains safety during storage.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • UNII U725QWY32X
    Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
  • 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 C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.

8 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 DailyMedingredient 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.

💲 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 mLPer package
Retail pharmacies payNADAC · weekly $1.531 $306.10 / 200 ml
Medicaid paysCMS SDUD · 12 mo $1.27 $254.16 / 200 ml
Medicare drug plans payPart D · Q2 2026 $1.50 $299.06 / 200 ml
NADAC price history (per mL) — tap or hover for the price & month
Dec 2025 Feb 2026 May 2026 Aug 2026 $1.602 $1.478
▲ Up 4% over the last 9 months.
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.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Erythromycin Ethylsuccinate 200 mg/5mL 52536-0132-13 Wilshire 100 ml $0.914 AB Availability likely save 40%
Erythromycin Ethylsuccinate 200 mg/5mL 52536-0134-13 Wilshire 100 ml $0.914 AB Availability likely save 40%
Erythromycin Ethylsuccinate 200 mg/5mL 60219-1503-01 Amneal 100 ml $0.914 AB Availability likely save 40%
Erythromycin Ethylsuccinate 200 mg/5mL 62559-0630-01 ANI 100 ml $0.914 AB Availability likely save 40%
Erythromycin Ethylsuccinate 200 mg/5mL 69238-1503-01 Amneal 100 ml $0.914 AB Availability likely save 40%
Erythromycin Ethylsuccinate 200 mg/5mL 75834-0295-01 Nivagen 100 ml $0.914 AB Availability likely save 40%
Erythromycin Ethylsuccinate 200 mg/5mL 52536-0136-13 Wilshire 200 ml $1.531 AB Availability likely
Erythromycin Ethylsuccinate 200 mg/5mLthis 62559-0440-02 ANI 200 ml $1.531 AB Availability likely
Ery-Ped 200 mg/5mL 24338-0132-13 Azurity 100 ml AB FDA listed
E.e.s 200 mg/5mL 24338-0134-02 Azurity 100 ml AB FDA listed
E.e.s 200 mg/5mL 24338-0136-10 Azurity 200 ml AB FDA listed
Erythromycin ethylsuccinate 200 mg/5mL 71209-0102-21 Cadila 100 ml AB FDA listed
Erythromycin ethylsuccinate 200 mg/5mL 72162-2657-01 Bryant 100 ml AB FDA listed
E.e.s 200 mg/5mL 80005-0152-18 Carnegie 100 ml AB Discontinued
E.e.s 200 mg/5mL 80005-0153-34 Carnegie 200 ml AB Discontinued
Erythromycin ethylsuccinate 200 mg/5mL 85742-0029-28 Kanchan 100 ml 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

🏛️
2016
On the market since
Sep 2016
📍
2026
Currently FDA-listed
10 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 62559-0440-02, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
5K
Units reimbursed last 4 qtrs
1.3M
Gross reimbursed last 4 qtrs
$1.65M
Avg / prescription
$330.37
Avg / unit
$1.2708
Latest quarter Q1 2026
1.3KRx
Medicaid pays / mL
$1.2708
gross reimbursed
vs
NADAC / mL
$1.5305
acquisition cost
=
Spread
−$0.2597
-17% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care
50% FFS 50% MCO
Fee-for-service · 2,507 Rx Managed care · 2,478 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 17,000 units · 218 per 100k residents WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: 15,400 units · 261 per 100k residents WI Michigan: 28,400 units · 283 per 100k residents MI New York: 34,000 units · 174 per 100k residents NY Vermont: no data reported VT New Hampshire: 3,216 units · 229 per 100k residents NH Oregon: no data reported OR Nevada: 114,800 units · 3,594 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: 44,300 units · 353 per 100k residents IL Indiana: 83,400 units · 1,215 per 100k residents IN Ohio: no data reported OH Pennsylvania: 109,000 units · 841 per 100k residents PA New Jersey: 14,600 units · 157 per 100k residents NJ Massachusetts: 41,948 units · 599 per 100k residents MA California: 240,500 units · 617 per 100k residents CA Utah: no data reported UT Colorado: 15,400 units · 262 per 100k residents CO Nebraska: no data reported NE Missouri: 24,400 units · 394 per 100k residents MO Kentucky: 8,400 units · 186 per 100k residents KY West Virginia: no data reported WV Virginia: 122,300 units · 1,403 per 100k residents VA Maryland: 17,801 units · 288 per 100k residents MD Connecticut: 18,000 units · 498 per 100k residents CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 27,000 units · 379 per 100k residents TN North Carolina: 55,300 units · 510 per 100k residents NC South Carolina: 3,200 units · 59.6 per 100k residents SC Delaware: 11,000 units · 1,067 per 100k residents DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: 18,300 units · 622 per 100k residents MS Alabama: 4,000 units · 78.3 per 100k residents AL Georgia: 19,200 units · 174 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 119,880 units · 393 per 100k residents TX Florida: 85,200 units · 377 per 100k residents FL
Units reimbursed · per 100k residents
59.63,594
gray = no data reported
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Nevada 3,594 /100k
2 Virginia 1,403 /100k
3 Indiana 1,215 /100k
4 Delaware 1,067 /100k
5 Pennsylvania 841 /100k
6 Mississippi 622 /100k
7 California 617 /100k
8 Massachusetts 599 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
200 ml this page62559-0440-02 4,985 Rx · $1,646,896
100 ml62559-0440-01 No Medicaid data
Drug total (last 4 qtrs): 4,985 Rx · 1,295,945 units · $1,646,896 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Erythromycin Ethylsuccinate — the program that covers self-administered drugs. 3 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Erythromycin Ethylsuccinate. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$872.6K
Claims incl. refills
1.6K
Beneficiaries
696
Spend / beneficiary
$1,253.78
Spend / claim
$537.67
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Erythromycin Ethylsuccinate — the ingredient across all brands.

Top reported reactions

Drug Hypersensitivity72
Vomiting45
Nausea41
Diarrhoea36
Dyspnoea24
Rash24
Hypersensitivity22

Age at onset

Neonate1
Infant6
Child21
Adolescent2
Adult17
Elderly8

Reporter sex

611 reports
Male · 31%
Female · 69%
Unknown · 1%

Serious outcomes

Hospitalization148
Death36
Disabling33
Life-threatening25
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 53 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
62559-0440-01 100 mL in 1 BOTTLE (62559-440-01) $1.98 / mL $197.69 2016-09-27 Discontinued by firm
62559-0440-02 You're viewing this 200 mL in 1 BOTTLE (62559-440-02) $1.53 / mL $306.10 2016-09-27 Active

You're viewing the largest of 2 pack sizes for this product.

This pack has the lowest per-mL cost of the 2 priced pack sizes ($1.53 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 62559-0440-02?
NDC 62559-0440-02 contains 200 mL — 200 ml in 1 bottle.
What is the difference between NDC 62559-0440-02 and NDC 62559-0440-01?
Both are Erythromycin Ethylsuccinate 200 mg/5mL Granule, For Suspension — the drug itself is identical. NDC 62559-0440-02 is the 200 mL package, while NDC 62559-0440-01 is the 100 ml package. Per-mL NADAC also differs: $1.53 here vs $1.98 for the 100 ml pack.
What NDC number is used to bill for this package of Erythromycin Ethylsuccinate 200 mg/5mL Granule, For Suspension?
Bill NDC 62559-0440-02 — the 11-digit billing format is 62559044002. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ~2 min read

INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin ethylsuccinate and other antibacterial drugs, erythromycin ethylsuccinate should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

Erythromycin ethylsuccinate for oral suspension USP is indicated in the treatment of infections caused by susceptible strains of the designated organisms in the diseases listed below: Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes, Streptococcus pneumoniae, or Haemophilus influenzae (when used concomitantly with adequate doses of sulfonamides, since many strains of H. influenzae are not susceptible to the erythromycin concentrations ordinarily achieved). (See appropriate sulfonamide labeling for prescribing information.) Lower-respiratory tract infections of mild to moderate severity caused by Streptococcus pneumonia or Streptococcus pyogenes .

Listeriosis caused by Listeria monocytogenes . Pertussis (whooping cough) caused by Bordetella pertussis . Erythromycin is effective in eliminating the organism from the nasopharynx of infected individuals rendering them noninfectious.

Some clinical studies suggest that erythromycin may be helpful in the prophylaxis of pertussis in exposed susceptible individuals. Respiratory tract infections due to Mycoplasma pneumoniae . Skin and skin structure infections of mild to moderate severity caused by Streptococcus pyogenes or Staphylococcus aureus (resistant staphylococci may emerge during treatment).

Diphtheria: Infections due to Corynebacterium diphtheriae , as an adjunct to antitoxin, to prevent establishment of carriers and to eradicate the organism in carriers. Erythrasma: In the treatment of infections due to Corynebacterium minutissimum . Intestinal amebiasis caused by Entamoeba histolytica (oral erythromycins only).

Extraenteric amebiasis requires treatment with other agents. Acute pelvic inflammatory disease caused by Neisseria gonorrhoeae : As an alternative drug in treatment of acute pelvic inflammatory disease caused by N. gonorrhoeae in female patients with a history of sensitivity to penicillin. Patients should have a serologic test for syphilis before receiving erythromycin as treatment of gonorrhea and a follow-up serologic test for syphilis after 3 months.

Syphilis caused by Treponema pallidum : Erythromycin is an alternate choice of treatment for primary syphilis in patients allergic to the penicillins. In treatment of primary syphilis, spinal fluid examinations should be done before treatment and as part of follow-up after therapy. Erythromycins are indicated for the treatment of the following infections caused by Chlamydia trachomatis : conjunctivitis of the newborn, pneumonia of infancy, and urogenital infections during pregnancy.

When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of uncomplicated urethral, endocervical, or rectal infections in adults due to Chlamydia trachomatis . When tetracyclines are contraindicated or not tolerated, erythromycin is indicated for the treatment of nongonococcal urethritis caused by Ureaplasma urealyticum . Legionnaires' Disease caused by Legionella pneumophila .

Although no controlled clinical efficacy studies have been conducted, in vitro and limited preliminary clinical data suggest that erythromycin may be effective in treating Legionnaires' Disease. Prophylaxis Prevention of Initial Attacks of Rheumatic Fever Penicillin is considered by the American Heart Association to be the drug of choice in the prevention of initial attacks of rheumatic fever (treatment of…

⏱️ Dosage and Administration ~2 min read

DOSAGE AND ADMINISTRATION Erythromycin ethylsuccinate suspension may be administered without regard to meals. Children Age, weight, and severity of the infection are important factors in determining the proper dosage. In mild to moderate infections the usual dosage of erythromycin ethylsuccinate for children is 30 to 50 mg/kg/day in equally divided doses every 6 hours.

For more severe infections this dosage may be doubled. If twice-a-day dosage is desired, one-half of the total daily dose may be given every 12 hours. Doses may also be given three times daily by administering one-third of the total daily dose every 8 hours.

The following dosage schedule is suggested for mild to moderate infections: Body Weight Total Daily Dose Under 10 lbs 30 to 50 mg/kg/day 15 to 25 mg/lb/day 10 to 15 lbs 200 mg 16 to 25 lbs 400 mg 26 to 50 lbs 800 mg 51 to 100 lbs 1200 mg over 100 lbs 1600 mg Adults 400 mg erythromycin ethylsuccinate every 6 hours is the usual dose. Dosage may be increased up to 4 g per day according to the severity of the infection. If twice-a-day dosage is desired, one-half of the total daily dose may be given every 12 hours.

Doses may also be given three times daily by administering one-third of the total daily dose every 8 hours. For adult dosage calculation, use a ratio of 400 mg of erythromycin activity as the ethylsuccinate to 250 mg of erythromycin activity as the stearate, base or estolate. In the treatment of streptococcal infections, a therapeutic dosage of erythromycin ethylsuccinate should be administered for at least 10 days.

In continuous prophylaxis against recurrences of streptococcal infections in persons with a history of rheumatic heart disease, the usual dosage is 400 mg twice a day. For Treatment of Urethritis Due to C. trachomatis or U. urealyticum 800 mg three times a day for 7 days. For Treatment of Primary Syphilis Adults: 48 to 64 g given in divided doses over a period of 10 to 15 days.

For Intestinal Amebiasis Adults: 400 mg four times daily for 10 to 14 days. Children: 30 to 50 mg/kg/day in divided doses for 10 to 14 days. For Use in Pertussis Although optimal dosage and duration have not been established, doses of erythromycin utilized in reported clinical studies were 40 to 50 mg/kg/day, given in divided doses for 5 to 14 days.

For Treatment of Legionnaires' Disease Although optimal doses have not been established, doses utilized in reported clinical data were those recommended above (1.6 to 4 g daily in divided doses.) Directions for Mixing Erythromycin Ethylsuccinate for Oral Suspension 100 mL Add 70 mL water and shake vigorously. This makes 100 mL of suspension. 200 mL Add 140 mL water and shake vigorously.

This makes 200 mL of suspension.

Contraindications 59 words

CONTRAINDICATIONS Erythromycin is contraindicated in patients with known hypersensitivity to this antibiotic. Erythromycin is contraindicated in patients taking terfenadine, astemizole, pimozide, or cisapride. (See PRECAUTIONS - Drug Interactions .) Do not use erythromycin concomitantly with HMG CoA reductase inhibitors (statins) that are extensively metabolized by CYP 3A4 (lovastatin or simvastatin), due to the increased risk of myopathy, including rhabdomyolysis.

⚠️ Warnings ~2 min read

WARNINGS Hepatotoxicity There have been reports of hepatic dysfunction, including increased liver enzymes, and hepatocellular and/or cholestatic hepatitis, with or without jaundice, occurring in patients receiving oral erythromycin products. QT Prolongation Erythromycin has been associated with prolongation of the QT interval and infrequent cases of arrhythmia. Cases of torsades de pointes have been spontaneously reported during postmarketing surveillance in patients receiving erythromycin.

Fatalities have been reported. Erythromycin should be avoided in patients with known prolongation of the QT interval, patients with ongoing proarrhythmic conditions such as uncorrected hypokalemia or hypomagnesemia, clinically significant bradycardia, and in patients receiving Class IA (quinidine, procainamide) or Class III (dofetilide, amiodarone, sotalol) antiarrhythmic agents. Elderly patients may be more susceptible to drug-associated effects on the QT interval.

Syphilis in Pregnancy There have been reports suggesting that erythromycin does not reach the fetus in adequate concentration to prevent congenital syphilis. Infants born to women treated during pregnancy with oral erythromycin for early syphilis should be treated with an appropriate penicillin regimen. Clostridium difficile Associated Diarrhea Clostridium difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including erythromycin ethylsuccinate, and may range in severity from mild diarrhea to fatal colitis.

Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile . C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy.

CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.

Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated. Drug Interactions Serious adverse reactions have been reported in patients taking erythromycin concomitantly with CYP3A4 substrates. These include colchicine toxicity with colchicine; rhabdomyolysis with simvastatin, lovastatin, and atorvastatin; and hypotension with calcium channel blockers metabolized by CYP3A4 (e.g., verapamil, amlodipine, diltiazem) (see PRECAUTIONS - Drug Interactions ).

There have been post-marketing reports of colchicine toxicity with concomitant use of erythromycin and colchicine. This interaction is potentially life-threatening, and may occur while using both drugs at their recommended doses (see PRECAUTIONS - Drug Interactions ). Rhabdomyolysis with or without renal impairment has been reported in seriously ill patients receiving erythromycin concomitantly with lovastatin.

Therefore, patients receiving concomitant lovastatin and erythromycin should be carefully monitored for creatine kinase (CK) and serum transaminase levels. (See package insert for lovastatin.)

🤒 Adverse Reactions 165 words

ADVERSE REACTIONS The most frequent side effects of oral erythromycin preparations are gastrointestinal and are dose-related. They include nausea, vomiting, abdominal pain, diarrhea and anorexia. Symptoms of hepatitis, hepatic dysfunction and/or abnormal liver function test results may occur.

(See WARNINGS section.) Onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment. (See WARNINGS section.) Erythromycin has been associated with QT prolongation and ventricular arrhythmias, including ventricular tachycardia and torsades de pointes. (See WARNINGS .) Allergic reactions ranging from urticaria to anaphylaxis have occurred.

Skin reactions ranging from mild eruptions to erythema multiforme, Stevens-Johnson syndrome, and toxic epidermal necrolysis have been reported rarely. There have been reports of interstitial nephritis coincident with erythromycin use. There have been rare reports of pancreatitis and convulsions.

There have been isolated reports of reversible hearing loss occurring chiefly in patients with renal insufficiency and in patients receiving high doses of erythromycin. To report SUSPECTED ADVERSE REACTIONS, contact ANI Pharmaceuticals, Inc. at 1-855-204-1431 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

🔄 Drug Interactions ~2 min read

Drug Interactions Theophylline Erythromycin use in patients who are receiving high doses of theophylline may be associated with an increase in serum theophylline levels and potential theophylline toxicity. In case of theophylline toxicity and/or elevated serum theophylline levels, the dose of theophylline should be reduced while the patient is receiving concomitant erythromycin therapy. There have been published reports suggesting that when oral erythromycin is given concurrently with theophylline there is a decrease in erythromycin serum concentrations of approximately 35%.

The mechanism by which this interaction occurs is unknown. The decrease in erythromycin concentrations due to co-administration of theophylline could result in subtherapeutic concentrations of erythromycin. Verapamil Hypotension, bradyarrhythmias, and lactic acidosis have been observed in patients receiving concurrent verapamil, belonging to the calcium channel blockers drug class.

Digoxin Concomitant administration of erythromycin and digoxin has been reported to result in elevated digoxin serum levels. Anticoagulants There have been reports of increased anticoagulant effects when erythromycin and oral anticoagulants were used concomitantly. Increased anticoagulation effects due to interactions of erythromycin with various oral anticoagulants may be more pronounced in the elderly.

Erythromycin is a substrate and inhibitor of the 3A isoform subfamily of the cytochrome p450 enzyme system (CYP3A). Coadministration of erythromycin and a drug primarily metabolized by CYP3A may be associated with elevations in drug concentrations that could increase or prolong both the therapeutic and adverse effects of the concomitant drug. Dosage adjustments may be considered, and when possible, serum concentrations of drugs primarily metabolized by CYP3A should be monitored closely in patients concurrently receiving erythromycin.

The following are examples of some clinically significant CYP3A based drug interactions. Interactions with other drugs metabolized by the CYP3A isoform are also possible. The following CYP3A based drug interactions have been observed with erythromycin products in post-marketing experience: Ergotamine/dihydroergotamine Post-marketing reports indicate that co-administration of erythromycin with ergotamine or dihydroergotamine has been associated with acute ergot toxicity characterized by vasospasm and ischemia of the extremities and other tissues including the central nervous system.

Concomitant administration of erythromycin with ergotamine or dihydroergotamine is contraindicated (see CONTRAINDICATIONS ). Triazolobenzodiazepines (such as triazolam and alprazolam) and related benzodiazepines Erythromycin has been reported to decrease the clearance of triazolam and midazolam, and thus, may increase the pharmacologic effect of these benzodiazepines. HMG-CoA Reductase Inhibitors Erythromycin has been reported to increase concentrations of HMG-CoA reductase inhibitors (e.g., lovastatin and simvastatin).

Rare reports of rhabdomyolysis have been reported in patients taking these drugs concomitantly. Sildenafil (Viagra) Erythromycin has been reported to increase the systemic exposure (AUC) of sildenafil. Reduction of sildenafil dosage should be considered.

(See Viagra package insert.) There have been spontaneous or published reports of CYP3A based interactions of erythromycin with cyclosporine, carbamazepine, tacrolimus, alfentanil, disopyramide, rifabutin, quinidine, methylprednisolone, cilostazol, vinblastine, and bromocriptine. Concomitant administration of erythromycin with cisapride, pimozide, astemizole, or terfenadine is contraindicated. (See CONTRAINDICATIONS .) In addition, there have been reports of interactions of erythromycin with drugs not thought to be metabolized by CYP3A, including hexobarbital, phenytoin, and valproate.

Erythromycin has been reported to significantly alter the metabolism of the nonsedating antihistamines terfenadine and aste…

🔄 Drug / Laboratory Test Interactions 12 words

Drug/Laboratory Test Interactions Erythromycin interferes with the fluorometric determination of urinary catecholamines.

🤰 Pregnancy 91 words

Pregnancy Teratogenic Effects There is no evidence of teratogenicity or any other adverse effect on reproduction in female rats fed erythromycin base by oral gavage at 350 mg/kg/day (approximately twice the maximum recommended human dose on a body surface area) prior to and during mating, during gestation, and through weaning. No evidence of teratogenicity or embryotoxicity was observed when erythromycin base was given by oral gavage to pregnant rats and mice at 700 mg/kg/day and to pregnant rabbits at 125 mg/kg/day (approximately 1 to 3 times the maximum recommended human dose).

🧒 Pediatric Use 11 words

Pediatric Use See INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION sections.

🧓 Geriatric Use 110 words

Geriatric Use Elderly patients, particularly those with reduced renal or hepatic function, may be at increased risk for developing erythromycin-induced hearing loss. (See ADVERSE REACTIONS and DOSAGE AND ADMINISTRATION ). Elderly patients may be more susceptible to the development of torsades de pointes arrhythmias than younger patients.

(See WARNINGS ). Elderly patients may experience increased effects of oral anticoagulant therapy while undergoing treatment with erythromycin. (See PRECAUTIONS - Drug Interactions ).

Erythromycin ethylsuccinate granules contain 16.7 mg (0.7 mEq) of sodium per individual dose. The geriatric population may respond with a blunted natriuresis to salt loading. This may be clinically important with regard to such diseases as congestive heart failure.

🆘 Overdosage 37 words

OVERDOSAGE In case of overdosage, erythromycin should be discontinued. Overdosage should be handled with the prompt elimination of unabsorbed drug and all other appropriate measures should be instituted. Erythromycin is not removed by peritoneal dialysis or hemodialysis.

🧬 Clinical Pharmacology ~2 min read

CLINICAL PHARMACOLOGY Orally administered erythromycin ethylsuccinate suspension is readily and reliably absorbed. Comparable serum levels of erythromycin are achieved in the fasting and nonfasting states. Erythromycin diffuses readily into most body fluids.

Only low concentrations are normally achieved in the spinal fluid, but passage of the drug across the blood-brain barrier increases in meningitis. In the presence of normal hepatic function, erythromycin is concentrated in the liver and excreted in the bile; the effect of hepatic dysfunction on excretion of erythromycin by the liver into the bile is not known. Less than 5 percent of the orally administered dose of erythromycin is excreted in active form in the urine.

Erythromycin crosses the placental barrier, but fetal plasma levels are low. The drug is excreted in human milk. Microbiology Mechanism of Action Erythromycin acts by inhibition of protein synthesis by binding 50S ribosomal subunits of susceptible organisms.

It does not affect nucleic acid synthesis. Resistance The major route of resistance is modification of the 23S rRNA in the 50S ribosomal subunit to insensitivity while efflux can also be significant. Interactions with Other Antimicrobials Antagonism exists in vitro between erythromycin and clindamycin, lincomycin, and chloramphenicol.

Antimicrobial Activity Erythromycin has been shown to be active against most isolates of the following microorganisms, both in vitro and in clinical infections (See INDICATIONS AND USAGE ). Aerobic bacteria Gram-positive bacteria: Corynebacterium diphtheriae Corynebacterium minutissimum Listeria monocytogenes Staphylococcus aureus (resistant organisms may emerge during treatment) Streptococcus pneumoniae Streptococcus pyogenes Gram-negative bacteria: Bordetella pertussis Haemophilus influenzae Legionella pneumophila Neisseria gonorrhoeae Other microorganisms Chlamydia trachomatis Entamoeba histolytica Mycoplasma pneumoniae Treponema pallidum Ureaplasma urealyticum The following in vitro data are available, but their clinical significance is unknown.

At least 90 percent of the following bacteria exhibit in vitro minimum inhibitory concentration (MIC) less than or equal to the susceptible breakpoint for erythromycin against isolates of similar genus or organism group. However, the efficacy of erythromycin in treating clinical infections caused by these bacteria has not been established in adequate and well controlled clinical trials. Aerobic bacteria Gram-positive bacteria: Viridans group streptococci Gram-negative bacteria: Moraxella catarrhalis Susceptibility Testing For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see: https://www.fda.gov/STIC.

📦 How Supplied / Storage and Handling 135 words

HOW SUPPLIED Erythromycin Ethylsuccinate for Oral Suspension USP is available as: 200mg/5mL: Each 5 mL teaspoon of reconstituted cherry-flavored suspension contains activity equivalent to 200 mg of erythromycin. Available in bottles of: 100 mL NDC 62559-440-01 200 mL NDC 62559-440-02 Recommended storage Store granules, prior to mixing, at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. After mixing, refrigerate and use within ten days.

REFERENCES 1. Committee on Rheumatic Fever, Endocarditis, and Kawasaki Disease of the Council on Cardiovascular Disease in the Young, the American Heart Association: Prevention of Rheumatic Fever. Circulation.

78(4):1082-1086, October 1988. 2. Honein, M.A., et al.: Infantile hypertrophic pyloric stenosis after pertussis prophylaxis with erythromycin: a case review and cohort study.

The Lancet 1999:354 (9196): 2101-5. Manufactured by: ANI Pharmaceuticals, Inc. Baudette, MN 56623 9857 Rev 02/25 ani-logo

📋 Description 141 words

DESCRIPTION Erythromycin is produced by a strain of Saccharopolyspora erythraea (formerly Streptomyces erythraeus ) and belongs to the macrolide group of antibiotics. It is basic and readily forms salts with acids. The base, the stearate salt, and the esters are poorly soluble in water.

Erythromycin ethylsuccinate is an ester of erythromycin suitable for oral administration. Erythromycin ethylsuccinate is known chemically as erythromycin 2'-(ethylsuccinate). The molecular formula is C 43 H 75 NO 16 and the molecular weight is 862.06.

The structural formula is: The granules are intended for reconstitution with water. Each 5 mL teaspoonful of reconstituted palatable cherry-flavored suspension contains erythromycin ethylsuccinate equivalent to 200 mg of erythromycin. Granules are intended primarily for pediatric use but can also be used in adults.

Inactive Ingredients: artificial cherry flavor, lactose anhydrous, methylparaben, polysorbate 80, povidone, simethicone, sodium citrate anhydrous, and sucrose. structure

💬 Information for Patients 176 words

Information for Patients Patients should be counseled that antibacterial drugs including erythromycin ethylsuccinate should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When erythromycin ethylsuccinate is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed.

Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by erythromycin ethylsuccinate or other antibacterial drugs in the future. Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic.

If this occurs, patients should contact their physician as soon as possible.

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