Drugplain

Erythromycin Ethylsuccinate 400 mg/5mL

Erythromycin · SUSPENSION · Amneal Pharmaceuticals NY LLC

No Recall History
Plain English

Erythromycin Ethylsuccinate is a suspension containing erythromycin at 400 mg/5mL, taken oral. Manufactured by Amneal Pharmaceuticals NY LLC.

Key Facts

Brand Name
Erythromycin Ethylsuccinate
Generic Name
Erythromycin
NDC Code (Product)
69238-1504
Manufacturer
Amneal Pharmaceuticals NY LLC
Strength
400 mg/5mL
Dosage Form
SUSPENSION
Route
ORAL
Marketing Status
Application #
ANDA211204
Marketing Start
11/04/2019

Recall History

No Recall History

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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.) Low…

Dosage & Administration

DOSAGE AND ADMINISTRATION Erythromycin ethylsuccinate for oral suspensions, 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 a…

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 e…

Contraindications

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.

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. …

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 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.

Frequently Asked Questions

What is Erythromycin Ethylsuccinate used for?

Erythromycin Ethylsuccinate contains Erythromycin. It is a suspension taken oral. Consult your doctor for specific uses.

Is Erythromycin Ethylsuccinate a controlled substance?

Erythromycin Ethylsuccinate is not classified as a controlled substance by the DEA.

What is the generic name for Erythromycin Ethylsuccinate?

The generic name for Erythromycin Ethylsuccinate is Erythromycin. There are 11 other brand versions of Erythromycin.

What is the NDC code for Erythromycin Ethylsuccinate 400 mg/5mL?

The NDC (National Drug Code) for Erythromycin Ethylsuccinate 400 mg/5mL is 69238-1504, listed by Amneal Pharmaceuticals NY LLC.

Product NDC

69238-1504

Package NDC

69238-1504-2

Other Erythromycin Ethylsuccinate Dosages

Other Erythromycin Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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