Label Changes for:

Ery-Ped (erythromycin ethylsuccinate) Liquids

January 2011

Changes have been made to the CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – January 2011

 

 

CONTRAINDICATIONS

  • Erythromycin is contraindicated in patients taking terfenadine, astemizole, cisapride, pimozide, ergotamine or dihydroergotamine. (See PRECAUTIONS - Drug Interactions)

WARNINGS

Drug Interactions
  • Serious adverse reactions have been reported in patients taking erythromycin concomitantly with CYP3A4 substrates. These include ...

PRECAUTIONS

Drug Interactions
  • 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).
  • Colchicine - Colchicine is a substrate for both CYP3A4 and the efflux transporter P-glycoprotein (P-gp). Erythromycin is considered a moderate inhibitor of CYP3A4. A significant increase in colchicine plasma concentration is anticipated when co-administered with moderate CYP3A4 inhibitors such as erythromycin. If co-administration of colchicine and erythromycin is necessary, the starting dose of colchicine may need to be reduced, and the maximum colchicine dose should be lowered. Patients should be monitored for clinical symptoms of colchicine toxicity (see WARNINGS)


ADVERSE REACTIONS

  • There have been reports of interstitial nephritis coincident with erythromycin use.
     
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