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Drug Interactions between Daliresp and erythromycin

This report displays the potential drug interactions for the following 2 drugs:

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Interactions between your drugs

Moderate

erythromycin roflumilast

Applies to: erythromycin and Daliresp (roflumilast)

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.

References

  1. Lahu G, Huennemeyer A, Herzog R, et al. (2009) "Effect of repeated dose of erythromycin on the pharmacokinetics of roflumilast and roflumilast N-oxide." Int J Clin Pharmacol Ther, 47, p. 236-45
  2. (2011) "Product Information. Daxas (roflumilast)." Nycomed Inc
  3. (2011) "Product Information. Daliresp (roflumilast)." Astra-Zeneca Pharmaceuticals

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Drug and food interactions

Moderate

erythromycin food

Applies to: erythromycin

ADJUST DOSING INTERVAL: Food may variably affect the bioavailability of different oral formulations and salt forms of erythromycin. The individual product package labeling should be consulted regarding the appropriate time of administration in relation to food ingestion. Grapefruit juice may increase the plasma concentrations of orally administered erythromycin. The proposed mechanism is inhibition of CYP450 3A4-mediated first-pass metabolism in the gut wall by certain compounds present in grapefruits. In an open-label, crossover study consisting of six healthy subjects, the coadministration with double-strength grapefruit juice increased the mean peak plasma concentration (Cmax) and area under the concentration-time curve (AUC) of a single dose of erythromycin (400 mg) by 52% and 49%, respectively, compared to water. The half-life was not affected. The clinical significance of this potential interaction is unknown.

MANAGEMENT: In general, optimal serum levels are achieved when erythromycin is taken in the fasting state, one-half to two hours before meals. However, some erythromycin products may be taken without regard to meals.

References

  1. Welling PG, Huang H, Hewitt PF, Lyons LL (1978) "Bioavailability of erythromycin stearate: influence of food and fluid volume." J Pharm Sci, 67, p. 764-6
  2. Welling PG, Elliott RL, Pitterle ME, et al. (1979) "Plasma levels following single and repeated doses of erythromycin estolate and erythromycin stearate." J Pharm Sci, 68, p. 150-5
  3. Welling PG (1977) "Influence of food and diet on gastrointestinal drug absorption: a review." J Pharmacokinet Biopharm, 5, p. 291-334
  4. Coyne TC, Shum S, Chun AH, Jeansonne L, Shirkey HC (1978) "Bioavailability of erythromycin ethylsuccinate in pediatric patients." J Clin Pharmacol, 18, p. 194-202
  5. Malmborg AS (1979) "Effect of food on absorption of erythromycin. A study of two derivatives, the stearate and the base." J Antimicrob Chemother, 5, p. 591-9
  6. Randinitis EJ, Sedman AJ, Welling PG, Kinkel AW (1989) "Effect of a high-fat meal on the bioavailability of a polymer-coated erythromycin particle tablet formulation." J Clin Pharmacol, 29, p. 79-84
  7. Kanazawa S, Ohkubo T, Sugawara K (2001) "The effects of grapefruit juice on the pharmacokinetics of erythromycin." Eur J Clin Pharmacol, 56, p. 799-803
View all 7 references

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Minor

roflumilast food

Applies to: Daliresp (roflumilast)

Food intake does not affect the total exposure to roflumilast and its pharmacologically active N-oxide metabolite, but delays the time to maximum concentration (Tmax) of roflumilast by one hour and reduces its peak plasma concentration (Cmax) by approximately 40%. The Tmax and Cmax of
roflumilast N-oxide are unaffected. Roflumilast may be taken with or without food.

References

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  2. (2011) "Product Information. Daxas (roflumilast)." Nycomed Inc
  3. (2011) "Product Information. Daliresp (roflumilast)." Astra-Zeneca Pharmaceuticals

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Minor

erythromycin food

Applies to: erythromycin

Ethanol, when combined with erythromycin, may delay absorption and therefore the clinical effects of the antibiotic. The mechanism appears to be due to slowed gastric emptying by ethanol. Data is available only for erythromycin ethylsuccinate. Patients should be advised to avoid ethanol while taking erythromycin salts.

References

  1. Morasso MI, Chavez J, Gai MN, Arancibia A (1990) "Influence of alcohol consumption on erythromycin ethylsuccinate kinetics." Int J Clin Pharmacol, 28, p. 426-9

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Therapeutic duplication warnings

No warnings were found for your selected drugs.

Therapeutic duplication warnings are only returned when drugs within the same group exceed the recommended therapeutic duplication maximum.

See also

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Drug Interaction Classification

These classifications are only a guideline. The relevance of a particular drug interaction to a specific individual is difficult to determine. Always consult your healthcare provider before starting or stopping any medication.
Major Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit.
Moderate Moderately clinically significant. Usually avoid combinations; use it only under special circumstances.
Minor Minimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan.
Unknown No interaction information available.

Further information

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