HomeNDC LookupIngredientsErythromycin Ethylsuccinate › 75834-0295-01
Erythromycin Ethylsuccinate 200 mg/5mL Suspension, 100 mL — NDC 75834-0295-01 package photo

Erythromycin Ethylsuccinate 200 mg/5mL Suspension, 100 mL

by Nivagen Pharmaceuticals, Inc. · 100 mL in 1 BOTTLE (75834-295-01)
NDC 75834-0295-01
🏷️ FDA NDC (as labeled) 75834-295-01 billing pads the product segment with a zero
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) 75834-295-01
Product NDC 75834-295
11-digit billing NDC 75834029501
NCPDP billing unit ML — per mL (volume)
RxCUI 686400, 686418
UNII 1014KSJ86F
UPC 0375834295015, 0375834294018
Application # ANDA216212
SPL Set ID 46f74c4f-10fc-44cf-aec4-d113f49149bc
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 2023-02-01
Route ORAL
Dosage form SUSPENSION
Substance ERYTHROMYCIN ETHYLSUCCINATE
GPI-14 03100030301910
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 75834-295-01 — 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 → 75834-0295-01. 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

LabelerNivagen Pharmaceuticals, Inc.
Application holderCADILA PHARMACEUTICALS LTD
FDA applicationANDA216212 (ANDA)
Labeler code75834
First marketedFeb 2023
Product typeHuman Prescription Drug
Portfolio95 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
📗 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 Brown
FlavorBanana
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 T9D99G2B1R
    Caramel is a brown coloring substance made by heating sugar. It's added to medicines to give them color and sometimes a slight sweet taste without affecting how the drug works.
  • 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 1Q73Q2JULR
    Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
  • 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.
  • UNII TTV12P4NEE
    Xanthan gum is a thickening and stabilizing ingredient made from fermented corn or other sugars. It's added to medicines to improve texture, prevent separation of liquids and solids, and help the product stay consistent.

5 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 $0.915 $91.45 / 100 ml
Medicaid paysCMS SDUD · 12 mo $1.12 $112.20 / 100 ml
Medicare drug plans payPart D · Q2 2026 $1.50 $149.53 / 100 ml
NADAC price history (per mL) — tap or hover for the price & month
Dec 2023 Dec 2025 Apr 2026 Aug 2026 $1.510 $0.761
▼ Down 30% over the last 12 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
Erythromycin Ethylsuccinate 200 mg/5mL 52536-0134-13 Wilshire 100 ml $0.914 AB Availability likely
Erythromycin Ethylsuccinate 200 mg/5mL 60219-1503-01 Amneal 100 ml $0.914 AB Availability likely
Erythromycin Ethylsuccinate 200 mg/5mL 62559-0630-01 ANI 100 ml $0.914 AB Availability likely
Erythromycin Ethylsuccinate 200 mg/5mL 69238-1503-01 Amneal 100 ml $0.914 AB Availability likely
Erythromycin Ethylsuccinate 200 mg/5mLthis 75834-0295-01 Nivagen 100 ml $0.914 AB Availability likely
Erythromycin Ethylsuccinate 200 mg/5mL 52536-0136-13 Wilshire 200 ml $1.531 AB Availability likely +67%
Erythromycin Ethylsuccinate 200 mg/5mL 62559-0440-01 ANI 100 ml $1.977 AB Discontinued +116%
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

🏛️
2023
On the market since
Feb 2023
📍
2026
Currently FDA-listed
3 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 75834-0295-01, 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 – Q4 2025 · 4 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
11.1K
Units reimbursed last 4 qtrs
2.4M
Gross reimbursed last 4 qtrs
$2.71M
Avg / prescription
$244.54
Avg / unit
$1.1220
Latest quarter Q4 2025
2.6KRx
Medicaid pays / mL
$1.1220
gross reimbursed
vs
NADAC / mL
$0.9145
acquisition cost
=
Spread
+$0.2075
+23% 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
44% FFS 56% MCO
Fee-for-service · 4,881 Rx Managed care · 6,206 Rx
State Medicaid map
Alaska: no data reported AK Maine: 8,900 units · 638 per 100k residents ME Washington: 56,900 units · 728 per 100k residents WA Idaho: no data reported ID Montana: 12,100 units · 1,069 per 100k residents MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: 9,300 units · 157 per 100k residents WI Michigan: 18,100 units · 180 per 100k residents MI New York: 99,300 units · 507 per 100k residents NY Vermont: no data reported VT New Hampshire: 22,908 units · 1,634 per 100k residents NH Oregon: 5,600 units · 132 per 100k residents OR Nevada: 100,600 units · 3,150 per 100k residents NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 15,500 units · 483 per 100k residents IA Illinois: 11,000 units · 87.7 per 100k residents IL Indiana: 44,800 units · 653 per 100k residents IN Ohio: 79,406 units · 674 per 100k residents OH Pennsylvania: 251,400 units · 1,940 per 100k residents PA New Jersey: 66,300 units · 714 per 100k residents NJ Massachusetts: 104,600 units · 1,494 per 100k residents MA California: 264,126 units · 678 per 100k residents CA Utah: 4,100 units · 120 per 100k residents UT Colorado: 11,000 units · 187 per 100k residents CO Nebraska: no data reported NE Missouri: 48,200 units · 778 per 100k residents MO Kentucky: 68,534 units · 1,514 per 100k residents KY West Virginia: no data reported WV Virginia: 233,705 units · 2,681 per 100k residents VA Maryland: 89,300 units · 1,445 per 100k residents MD Connecticut: 17,500 units · 484 per 100k residents CT Rhode Island: 8,900 units · 813 per 100k residents RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: 18,200 units · 619 per 100k residents KS Arkansas: 43,700 units · 1,425 per 100k residents AR Tennessee: 50,100 units · 703 per 100k residents TN North Carolina: 77,000 units · 711 per 100k residents NC South Carolina: 33,400 units · 622 per 100k residents SC Delaware: 57,854 units · 5,611 per 100k residents DE Oklahoma: 40,400 units · 997 per 100k residents OK Louisiana: no data reported LA Mississippi: 56,300 units · 1,915 per 100k residents MS Alabama: 27,385 units · 536 per 100k residents AL Georgia: 31,100 units · 282 per 100k residents GA D.C.: 4,600 units · 677 per 100k residents DC Hawaii: no data reported HI Texas: 169,600 units · 556 per 100k residents TX Florida: 154,800 units · 685 per 100k residents FL
Units reimbursed · per 100k residents
87.75,611
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 Delaware 5,611 /100k
2 Nevada 3,150 /100k
3 Virginia 2,681 /100k
4 Pennsylvania 1,940 /100k
5 Mississippi 1,915 /100k
6 New Hampshire 1,634 /100k
7 Kentucky 1,514 /100k
8 Massachusetts 1,494 /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.

📊 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 Marketing startStatus
75834-0295-01 You're viewing this 100 mL in 1 BOTTLE (75834-295-01) 2023-02-01 Active

📄 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 for oral suspension and other antibacterial drugs, erythromycin ethylsuccinate for oral suspension 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 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 pneumoniae 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 penicillin-allergic patients. In 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 (treat…

⏱️ Dosage and Administration ~2 min read

DOSAGE AND ADMINISTRATION Erythromycin ethylsuccinate for oral suspension, USP 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 per kg per 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 per kg per day 15 to 25 mg per lb per day 10 to 15 lbs 200 mg 16 to 25 lbs 400 mg 26 to 50 lbs 800 mg 51 to 100 lbs 1,200 mg over 100 lbs 1,600 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 per kg per 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 per kg per 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 1.6 to 4 g daily in divided doses.

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 for oral suspension, 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 148 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 .) 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.

🔄 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. Hypotension, bradyarrhythmias, and lactic acidosis have been observed in patients receiving concurrent verapamil, belonging to the calcium channel blockers drug class.

Concomitant administration of erythromycin and digoxin has been reported to result in elevated digoxin serum levels. 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 astemizole when taken concomitantly.…

🔄 Drug / Laboratory Test Interactions 12 words

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

🤰 Pregnancy 103 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 per kg per 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 per kg per day and to pregnant rabbits at 125 mg per kg per 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 184 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 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 for oral suspension, USP 200 mg/5 mL contains 117.5 mg (5.1 mEq) of sodium per individual dose. Erythromycin ethylsuccinate for oral suspension, USP 400 mg/5 mL contains 117.5 mg (5.1 mEq) of sodium per individual dose. Based on the 200 mg/5 mL strength, at the usual recommended doses, adult patients would receive a total of 940 mg/day (40.8 mEq) of sodium.

Based on the 400 mg/5 mL strength, at the usual recommended doses, adult patients would receive a total of 470 mg/day (20.4 mEq) of sodium. 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 under both fasting and nonfasting conditions. 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 50 S ribosomal subunits of susceptible organisms. It does not affect nucleic acid synthesis.

Antagonism has been demonstrated in vitro between erythromycin and clindamycin, lincomycin, and chloramphenicol. Resistance Many strains of Haemophilus influenzae are resistant to erythromycin alone but are susceptible to erythromycin and sulfonamides used concomitantly. Interactions with Other Antimicrobials Staphylococci resistant to erythromycin may emerge during a course of therapy.

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

Erythromycin exhibits in vitro minimal inhibitory concentrations (MIC's) of 0.5 mcg/mL or less against most (≥ 90%) strains of the following microorganisms; however, the safety and effectiveness of erythromycin in treating clinical infections due to these microorganisms have not been established in adequate and well-controlled clinical trials. Gram-positive Organisms: Viridans group streptococci Gram-negative Organisms: 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 ~1 min read

HOW SUPPLIED Erythromycin ethylsuccinate for oral suspension, USP 200 mg/ 5 mL is supplied in bottles of 100 mL ( NDC 75834-295-01) Erythromycin ethylsuccinate for oral suspension USP 400 mg/ 5 mL is supplied in bottles of 100 mL ( NDC 75834-294-01) Recommended Storage Store erythromycin ethylsuccinate for oral suspension, USP 200 mg/5 mL and erythromycin ethylsuccinate for oral suspension, USP 400 mg/5 mL, prior to mixing, below 86°F (30°C). After reconstitution, erythromycin ethylsuccinate for oral suspension, USP 200 mg/5 mL and erythromycin ethylsuccinate for oral suspension, USP 400 mg/5 mL must be stored at 20° to 25° C (68° to 77° F) [see USP Controlled Room Temperature] and use within 35 days; refrigeration is not required.

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 to 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 Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Trademarks are the properties of their respective owners.

Manufactured by: Cadila Pharmaceuticals Limited 1389, Trasad Road, Dholka-382225, District - Ahmedabad, Gujarat State, INDIA Manufactured For: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827 USA Toll free number: 1-877-977-0687 Revised: November, 2022

📋 Description 219 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 are practically insoluble in water, freely soluble in acetone, in anhydrous ethanol and in methanol.

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

The structural formula is: Erythromycin ethylsuccinate for oral suspension, USP 200 mg/5 mL when reconstituted with water, forms a suspension containing erythromycin ethylsuccinate equivalent to 200 mg erythromycin per 5 mL (teaspoonful) or 100 mg per 2.5 mL (dropperful) with an appealing banana flavor. Erythromycin ethylsuccinate for oral suspension, USP 400 mg/5 mL when reconstituted with water, forms a suspension containing erythromycin ethylsuccinate equivalent to 400 mg of erythromycin per 5 mL (teaspoonful) with an appealing banana flavor.

These products are intended primarily for pediatric use but can also be used in adults. Inactive Ingredients Erythromycin ethylsuccinate for oral suspension, USP 200 mg/5 mL, Erythromycin ethylsuccinate for oral suspension, USP 400 mg/5 mL: Banana flavour, caster sugar N° 1 400, neelinatural plain caramel powder, polysorbate 80, sodium citrate and xanthan gum. structure.jpg

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