Erythromycin

Indications

INDICATIONS AND USAGE To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin tablets, USP and other antibacterial drugs, erythromycin tablets, USP 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 tablets, USP 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).

Dosage and administration (summary)

DOSAGE AND ADMINISTRATION In most patients, erythromycin tablets are well absorbed and may be dosed orally without regard to meals. However, optimal blood levels are obtained when erythromycin tablets are given in the fasting state (at least 1/2 hour and preferably 2 hours before meals). Adults The usual dosage of Erythromycin Tablets is one 250 mg tablet four times daily in equally spaced doses or one 500 mg tablet 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.

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.

Warnings and precautions

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.

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.

Storage and supply

HOW SUPPLIED Erythromycin Tablets, USP 250 mg are light pink, film coated, oval shaped tablet, debossed with "||||"on one side and plain on the other side and are supplied as follows: NDC 70710-1047-3 in bottles of 30 tablets with child-resistant closure. NDC 70710-1047-1 in bottles of 100 tablets with child-resistant closure.

Source: Erythromycin (Erythromycin) — US FDA prescribing information, 2024-03-20, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.