ERYTHROMYCIN 500 mg Tablet, Delayed Release, 30-count
Other active recalls for Erythromycin (different manufacturers) — 2 · tap to view
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Macrolide class.
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🏭 Manufacturer & labeler
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🩺 Clinical
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 ↗- 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?
Patient education
Supplement & herbal interactions
Some supplements/herbs that may interact with Erythromycin — tap one for details:
Erythromycin may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.
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Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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🧪 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.
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UNII S4255P4G5M
Calcium silicate is a white powder made from calcium and silicon compounds. It acts as an anti-caking agent and flow aid, helping powder ingredients move smoothly during tablet or capsule manufacturing.
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UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
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UNII 9XZ8H6N6OH
A plant-based cellulose derivative used as a binder to hold tablet ingredients together, a thickener in liquids, and a coating agent to control how fast the medicine dissolves.
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UNII B1QE5P712K
Hypromellose 2208 is a plant-derived thickening agent that dissolves in water. It's used as a binder to help hold tablet ingredients together and as a coating on pills to control how quickly the medicine releases in your body.
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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.
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UNII 3OWL53L36A
A natural sugar alcohol derived from seaweed or synthesized in the lab. It's used as a filler to add bulk, a sweetener in sugar-free formulas, and a disintegrant to help tablets break apart in the stomach.
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UNII NX76LV5T8J
A synthetic plastic polymer made from methacrylic acid and ethyl acrylate. It's used as a coating or binder to control how and where the medicine dissolves in your digestive system.
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UNII TUF2IVW3M2
Poloxamer 407 is a synthetic polymer made from ethylene oxide and propylene oxide. In medicines, it acts as a thickener, emulsifier, and solubilizer to help mix ingredients and create the right texture.
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UNII 3WJQ0SDW1A
Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
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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.
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UNII 8MDF5V39QO
A white powder form of baking soda that acts as a buffer and pH regulator in medicines. It helps maintain the right acid-base balance and may aid tablet disintegration.
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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.
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UNII 368GB5141J
A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
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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.
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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.
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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.
16 inactive ingredients listed in the exact product block matched to this NDC.
Label-section wording can be broader than the structured product block and may mention additional formulation ingredients.
Where does this data come from?
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
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💲 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 system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $3.114 | $93.43 / 30 tablets |
| Medicaid paysCMS SDUD · 12 mo | $4.40 | $132.08 / 30 tablets |
| Medicare drug plans payPart D · Q2 2026 | $3.13 | $93.97 / 30 tablets |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Erythromycin 500 mgthis 13668-0588-30 | Torrent | 30 tablets | $3.114 | AB | Availability likely | — |
| Ery-Tab 500 mg 24338-0126-03 | Arbor | 30 tablets | $3.114 | AB | Availability likely | — |
| Erythromycin 500 mg 52536-0186-03 | Wilshire | 30 tablets | $3.114 | AB | Availability likely | — |
| Erythromycin 500 mg 69238-1473-01 | Amneal | 100 tablets | $6.373 | AB | FDA listed | +105% |
| Erythromycin 500 mg 51407-0854-30 | Golden | 30 tablets | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
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?
🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 13668-0588-01 | 100 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-588-01) | $3.11 / ea | $311.44 | 2021-07-26 | Active |
| 13668-0588-05 | 500 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-588-05) | — | — | 2021-07-26 | Active |
| 13668-0588-30 You're viewing this | 30 TABLET, DELAYED RELEASE in 1 BOTTLE (13668-588-30) | $3.11 / ea | $93.43 | 2021-09-21 | Active |
You're viewing the smallest of 3 pack sizes for this product.
This pack effectively ties for the lowest per-ea cost of the 2 priced pack sizes ($3.11 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 13668-0588-30?
What is the difference between NDC 13668-0588-30 and NDC 13668-0588-01?
What NDC number is used to bill for this package of ERYTHROMYCIN 500 mg Tablet, Delayed Release?
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
🎯 Indications and Usage ▾
INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin delayed-release tablets and other antibacterial drugs, erythromycin delayed-release tablets 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 delayed-release tablets are indicated in the treatment of infections caused by susceptible strains of the designated microorganisms in the diseases listed below: Upper respiratory tract infections of mild to moderate degree caused by Streptococcus pyogenes; Streptococcus pneumoniae; 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 pyogenes or Streptococcus pneumoniae .
Listeriosis caused by Listeria monocytogenes . 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).
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.
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 : Erythrocin TM Lactobionate-I.V. (erythromycin lactobionate for injection, USP) followed by erythromycin base orally, 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. Erythromycins are indicated for 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 . Primary syphilis caused by Treponema pallidum. Erythromycin (oral forms only) is an alternative choice of treatment for primary syphilis in patients allergic to the penicillins.
In treatment of primary syphilis, spinal fluid should be examined before treatment and as part of the follow-up after therapy. 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…
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION In most patients, erythromycin delayed-release tablets, are well absorbed and may be dosed orally without regard to meals. However, optimal blood levels are obtained when erythromycin delayed-release tablets, 250 mg, erythromycin delayed-release tablets, 333 mg and erythromycin delayed-release tablets, 500 mg tablets are given in the fasting state (at least 1/2 hour and preferably 2 hours before meals). Adults The usual dose is 250 mg four times daily in equally spaced doses.
The 333 mg tablet is recommended if dosage is desired every 8 hours. If twice-a-day dosage is desired, the recommended dose is 500 mg every 12 hours. Dosage may be increased up to 4 g per day according to the severity of the infection.
However, twice-a-day dosing is not recommended when doses larger than 1 g daily are administered. Children Age, weight, and severity of the infection are important factors in determining the proper dosage. The usual dosage is 30 to 50 mg/kg/day, in equally divided doses.
For more severe infections, this dose may be doubled but should not exceed 4 g per day. In the treatment of streptococcal infections of the upper respiratory tract (e.g., tonsillitis or pharyngitis), the therapeutic dosage of erythromycin should be administered for at least ten days. The American Heart Association suggests a dosage of 250 mg of erythromycin orally, twice a day in long-term prophylaxis of streptococcal upper respiratory tract infections for the prevention of recurring attacks of rheumatic fever in patients allergic to penicillin and sulfonamides.1 Conjunctivitis of the Newborn Caused by Chlamydia trachomatis Oral erythromycin suspension 50 mg/kg/day in 4 divided doses for at least 2 weeks.
3 Pneumonia of Infancy Caused by Chlamydia trachomatis Although the optimal duration of therapy has not been established, the recommended therapy is oral erythromycin suspension 50 mg/kg/day in 4 divided doses for at least 3 weeks. Urogenital Infections During Pregnancy Due to Chlamydia trachomatis Although the optimal dose and duration of therapy have not been established, the suggested treatment is 500 mg of erythromycin by mouth four times a day or two erythromycin 333 mg tablets orally every 8 hours on an empty stomach for at least 7 days.
For women who cannot tolerate this regimen, a decreased dose of one erythromycin 500 mg tablet orally every 12 hours, one 333 mg tablet orally every 8 hours or 250 mg by mouth four times a day should be used for at least 14 days. 3 For adults with uncomplicated urethral, endocervical, or rectal infections caused by Chlamydia trachomatis, when tetracycline is contraindicated or not tolerated 500 mg of erythromycin by mouth four times a day or two 333 mg tablets orally every 8 hours for at least 7 days. 3 For patients with nongonococcal urethritis caused by Ureaplasma urealyticum when tetracycline is contraindicated or not tolerated 500 mg of erythromycin by mouth four times a day or two 333 mg tablets orally every 8 hours for at least seven days.
3 Primary Syphilis 30 to 40 g given in divided doses over a period of 10 to 15 days. Acute Pelvic Inflammatory Disease Caused by N. Gonorrhoeae 500 mg Erythrocin Lactobionate-I.V.
(erythromycin lactobionate for injection, USP) every 6 hours for 3 days, followed by 500 mg of erythromycin base orally every 12 hours, or 333 mg of erythromycin base orally every 8 hours for 7 days. Intestinal Amebiasis Adults 500 mg every 12 hours, 333 mg every 8 hours or 250 mg every 6 hours for 10 to 14 days. Children 30 to 50 mg/kg/day in divided doses for 10 to 14 days.
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. Legionnaires' Disease Although optimal dosage has not been established, doses utilized in reported clinical data were 1 to 4 g daily in divided doses. Preoperative Prophylaxis for Elective Colorectal Surge…
⛔ Contraindications ▾
CONTRAINDICATIONS Erythromycin is contraindicated in patients with known hypersensitivity to this antibiotic. Erythromycin is contraindicated in patients taking terfenadine, astemizole, cisapride, pimozide, ergotamine, or dihydroergotamine. (See PRECAUTIONS – Drug Interactions. ) Do not use erythromycin concomitantly with HMG CoA reductase inhibitors (statins) that are extensively metabolized by CYP3A4 (lovastatin or simvastatin), due to the increased risk of myopathy, including rhabdomyolysis.
⚠️ Warnings ▾
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 delayed-release tablets, 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 ▾
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 .) 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 ▾
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 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, methyl-prednisolone, 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. Rare ca…
🔄 Drug / Laboratory Test Interactions ▾
Drug/Laboratory Test Interactions Erythromycin interferes with the fluorometric determination of urinary catecholamines.
🤰 Pregnancy ▾
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 ▾
Pediatric Use See INDICATIONS AND USAGE and DOSAGE AND ADMINISTRATION .
🧓 Geriatric Use ▾
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 delayed-release tablets (250 mg) contain 4.7 mg (0.2 mEq) of sodium per tablet. Erythromycin delayed-release tablets (333 mg) contain 6.2 mg (0.3 mEq) of sodium per tablet. Erythromycin delayed-release tablets (500 mg) contain 9.4 mg (0.4 mEq) of sodium per tablet.
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 ▾
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 ▾
CLINICAL PHARMACOLOGY Orally administered erythromycin base and its salts are readily absorbed in the microbiologically active form. Interindividual variations in the absorption of erythromycin are, however, observed, and some patients do not achieve optimal serum levels. Erythromycin is largely bound to plasma proteins.
After absorption, erythromycin diffuses readily into most body fluids. In the absence of meningeal inflammation, low concentrations are normally achieved in the spinal fluid but the passage of the drug across the blood-brain barrier increases in meningitis. Erythromycin crosses the placental barrier, but fetal plasma levels are low.
The drug is excreted in human milk. Erythromycin is not removed by peritoneal dialysis or hemodialysis. In the presence of normal hepatic function, erythromycin is concentrated in the liver and is excreted in the bile; the effect of hepatic dysfunction on biliary excretion of erythromycin is not known.
After oral administration, less than 5% of the administered dose can be recovered in the active form in the urine. Erythromycin delayed-release tablets are coated with a polymer whose dissolution is pH dependent. This coating allows for minimal release of erythromycin in acidic environments, e.g., stomach.
The tablets are designed for optimal drug release and absorption in the small intestine. In multiple-dose, steady-state studies, erythromycin delayed-release tablets have demonstrated adequate drug delivery in both fasting and non-fasting conditions. Bioavailability data are available.
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 bacteria both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section. 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% of the following bacteria exhibit in vitro minimum inhibitory concentration (MIC) less than or equal to the susceptible breakpoint for erythromycin. However, the efficacy of erythromycin in treating clinical infections due to these bacteria has not been established in adequate and well controlled clinical trials. 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 ▾
HOW SUPPLIED Erythromycin delayed-release tablets, USP 250 mg are supplied as white to off white, oval shaped, enteric-coated tablets, debossed with ‘A25’ on one side and plain on the other side and supplied as: NDC Number Size 13668-586-30 HDPE bottles of 30 Tablets 13668-586-01 HDPE bottles of 100 Tablets 13668-586-05 HDPE bottles of 500 Tablets Erythromycin delayed-release tablets, USP 333 mg are supplied as white to off white, oval shaped, enteric-coated tablets, debossed with ‘A33’ on one side and plain on the other side and supplied as: NDC Number Size 13668-587-30 HDPE bottles of 30 Tablets 13668-587-01 HDPE bottles of 100 Tablets 13668-587-05 HDPE bottles of 500 Tablets Erythromycin delayed-release tablets, USP 500 mg are supplied as white to off white, oval shaped, enteric-coated tablets, debossed with ‘A50’ on one side and plain on the other side and supplied as: NDC Number Size 13668-588-30 HDPE bottles of 30 Tablets 13668-588-01 HDPE bottles of 100 Tablets 13668-588-05 HDPE bottles of 500 Tablets Recommended Storage Store at 20° to 25°C (68° to 77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [See USP Controlled Room Temperature]
🧪 Inactive Ingredients ▾
Inactive Ingredients Calcium silicate, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate, mannitol, methacrylic acid and ethyl acrylate copolymer, poloxamer 407, polyethylene glycol, pregelatinized maize starch, sodium bicarbonate, sodium citrate, sodium lauryl sulphate, talc and titanium dioxide.
📋 Description ▾
DESCRIPTION Erythromycin delayed-release tablets are an antibacterial product containing erythromycin base in a specially enteric-coated tablet. The coating protects the antibiotic from the inactivating effects of gastric acidity and permits efficient absorption of the antibiotic in the small intestine. Erythromycin delayed-release tablets for oral administration are available in three dosage strengths, each white to off white oval tablet containing 250 mg, 333 mg and 500 mg of erythromycin as the free base.
Erythromycin delayed-release tablets comply with USP Dissolution Test 1 . 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.
Erythromycin is a white to off-white powder, slightly soluble in water, freely soluble in alcohol and soluble in methanol. Erythromycin is known chemically as (3R*, 4S*, 5S*, 6R*, 7R*, 9R*, 11R*, 12R*,13S*, 14R*)-4-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-ribo-hexopyranosyl)oxy]-14-ethyl-7,12,13-trihydroxy-3,5,7,9,11,13-hexamethyl-6-[[3,4,6-trideoxy-3- dimethylamino)-β-D-xylo-hexopyranosyl]oxy] oxacyclotetradecane-2,10-dione. The molecular formula is C 37 H 67 NO 13 , and the molecular weight is 733.93.
The structural formula is: chemical-structure Inactive Ingredients Calcium silicate, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl cellulose, hypromellose, magnesium stearate, mannitol, methacrylic acid and ethyl acrylate copolymer, poloxamer 407, polyethylene glycol, pregelatinized maize starch, sodium bicarbonate, sodium citrate, sodium lauryl sulphate, talc and titanium dioxide.
💬 Information for Patients ▾
Information for Patients Patients should be counseled that antibacterial drugs including erythromycin delayed-release tablets should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When erythromycin delayed-release tablets are 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 delayed-release tablets 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.