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PCE Dispertab and Seldane

Determining the interaction of PCE Dispertab and Seldane and the possibility of their joint administration.

Check result:
PCE Dispertab <> Seldane
Relevance: 03.12.2022 Reviewer: Shkutko P.M., M.D., in

In the database of official manuals used in the service creation an interaction registered by statistical results of studies was found, which can either lead to negative consequences for the patient health or strengthen a mutual positive effect. A doctor should be consulted to address the issue of joint drug administration.

Consumer:

Astemizole and terfenadine are no longer on the market in the US. Do not take astemizole or terfenadine with any other medication.

Professional:

CONTRAINDICATED: Coadministration with the ketolide, telithromycin, as well as certain macrolide antibiotics may significantly increase the plasma concentrations of astemizole and terfenadine. The mechanism is inhibition of CYP450 3A4, the isoenzyme responsible for the metabolic clearance of astemizole and terfenadine. High plasma levels of these agents have been associated with prolongation of the QT interval on the ECG; ventricular arrhythmias including ventricular tachycardia, ventricular fibrillation, and torsade de pointes; cardiac arrest; and sudden death. Macrolides that may significantly inhibit CYP450 3A4 include clarithromycin, erythromycin, and troleandomycin. Azithromycin and dirithromycin are generally believed to have little, if any, effect on CYP450 3A4. In a study of 9 healthy volunteers, erythromycin (500 mg every 8 hours for 7 days) increased the mean steady-state peak plasma concentration (Cmax) and area under the concentration-time curve (AUC) of the pharmacologically active metabolite of terfenadine (60 mg twice a day) by 107% and 170%, respectively, compared to administration of terfenadine alone. Three of the subjects also had accumulation of unmetabolized terfenadine. Electrocardiographic data revealed changes in the QT interval in a subset of subjects who demonstrated drug accumulation.

MANAGEMENT: Given the potential for serious and life-threatening adverse cardiac events associated with increased plasma levels of astemizole and terfenadine, the use of these agents with clarithromycin, erythromycin, troleandomycin, or telithromycin is considered contraindicated. Loratadine, cetirizine, or fexofenadine may be safer alternatives during therapy with telithromycin or macrolides. Depending on organism susceptibility, azithromycin and dirithromycin may be appropriate alternatives during therapy with astemizole or terfenadine.

References
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  • European Agency for the Evaluation of Medicinal Products. Committee for Proprietary Medicinal Products "European Public Assessment Report Ketek (telithromycin) (Rev. 2) Available from: URL: http:www.emea.eu.int/humandocs/Humans/EPAR/Ketek/Ketek.htm." ([2001]):
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PCE Dispertab

Generic Name: erythromycin

Brand name: EES. Granules, EES-400 Filmtab, EryPed 200, EryPed 400, Ery-Tab, Erythrocin Lactobionate, Erythrocin Stearate Filmtab, PCE Dispertab, E. E. S, EryPed, Erythrocin, Erythromycin Filmtabs, Erythromycin Lactobionate - IV

Synonyms: PCE Dispertab (Oral), PCE, PCE (Oral)

Seldane

Generic Name: terfenadine

Brand name: Seldane

Synonyms: n.a.

In the course of checking the drug compatibility and interactions, data from the following reference sources was used: Drugs.com, Rxlist.com, Webmd.com, Medscape.com.

Interaction with food and lifestyle
Disease interaction