ERY-TAB 500 mg/1

Erythromycin · TABLET, DELAYED RELEASE · Arbor Pharmaceuticals, Inc.

No Recall History

Plain English

ERY-TAB is a prescription tablet, delayed release containing erythromycin at 500 mg/1, taken oral. Manufactured by Arbor Pharmaceuticals, Inc..

Key Facts

Brand Name: ERY-TAB
Generic Name: Erythromycin
NDC Code (Product): 24338-126
Manufacturer: Arbor Pharmaceuticals, Inc.
Strength: 500 mg/1
Dosage Form: TABLET, DELAYED RELEASE
Route: ORAL
Marketing Status: HUMAN PRESCRIPTION DRUG
Application #: ANDA062298
Drug Class: Decreased Sebaceous Gland Activity [PE]; Macrolide Antimicrobial [EPC]
Marketing Start: 04/18/2011

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug hypersensitivity4,081 reports

nausea1,258 reports

vomiting1,101 reports

drug ineffective1,060 reports

diarrhoea1,056 reports

fatigue1,033 reports

dyspnoea1,031 reports

rash999 reports

off label use919 reports

headache870 reports

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 ERY-TAB ® and other antibacterial drugs, ERY-TAB ® 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. ERY-TAB ® 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 Strep…

Dosage & Administration

DOSAGE AND ADMINISTRATION In most patients, ERY-TAB ® (erythromycin delayed-release tablets) are well absorbed and may be dosed orally without regard to meals. However, optimal blood levels are obtained when ERY-TAB ® 250 mg, ERY-TAB ® 333 mg or ERY-TAB ® 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 administer…

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, 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 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 .) 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 ERY-TAB used for?

ERY-TAB contains Erythromycin. It is a tablet, delayed release taken oral. Consult your doctor for specific uses.

Is ERY-TAB a controlled substance?

ERY-TAB is not classified as a controlled substance by the DEA.

What is the generic name for ERY-TAB?

The generic name for ERY-TAB is Erythromycin. There are 12 other brand versions of Erythromycin.

What is the NDC code for ERY-TAB 500 mg/1?

The NDC (National Drug Code) for ERY-TAB 500 mg/1 is 24338-126, listed by Arbor Pharmaceuticals, Inc..

Product NDC

24338-126

Package NDC

24338-126-03

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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