PCE Dispertab and Roflumilast Tablets

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.

Erythromycin may increase the blood levels and effects of roflumilast. You may be more likely to experience side effects of roflumilast such as diarrhea, nausea, abdominal pain, weight loss, headache, insomnia, depression, and anxiety. Let your doctor know if side effects become excessive or intolerable. It is important to tell your doctor about all other medications you use, including vitamins and herbs. Do not stop using any medications without first talking to your doctor.

MONITOR: Coadministration with erythromycin may increase the systemic exposure to roflumilast and its pharmacologically active N-oxide metabolite. The proposed mechanism is erythromycin inhibition of CYP450 3A4, the isoenzyme that partially metabolizes both roflumilast and the metabolite. In 16 healthy volunteers, administration of a single 500 mcg oral dose of roflumilast in combination with erythromycin (500 mg three times daily for 13 days) resulted in a 40% increase in mean roflumilast peak plasma concentration (Cmax) and a 70% increase in mean systemic exposure (AUC) compared to administration of roflumilast alone. The mean apparent clearance of roflumilast decreased from 8.2 L/hr to 4.8 L/hr in the presence of erythromycin. Additionally, erythromycin reduced the Cmax of roflumilast N-oxide by 34% and increased its AUC by 4% (not significant). Total phosphodiesterase 4 inhibitory activity (i.e., combined effect of both roflumilast and roflumilast N-oxide) increased by 9% in association with these changes. No clinically relevant adverse events were observed during the study.

MANAGEMENT: Caution is advised when roflumilast is used in combination with erythromycin. Treatment with roflumilast should be re-evaluated if an interaction is suspected and persistent intolerability occurs. Patients should be advised to contact their doctor if they experience increased frequency and/or severity of side effects such as diarrhea, nausea, abdominal pain, weight loss, headache, insomnia, depression, and anxiety.

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)

What is PCE Dispertab?

Roflumilast Tablets

Generic Name: roflumilast

Brand name: Daliresp

Synonyms: Roflumilast

What is Roflumilast Tablets?