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Drug Interactions between Rhinocort and Viekira XR

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

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Interactions between your drugs

Moderate

budesonide nasal ritonavir

Applies to: Rhinocort (budesonide nasal) and Viekira XR (dasabuvir / ombitasvir / paritaprevir / ritonavir)

MONITOR: Coadministration with inhibitors of CYP450 3A4 may increase the systemic bioavailability of budesonide, which undergoes extensive first-pass and systemic metabolism via intestinal and hepatic CYP450 3A4. In pharmacokinetic studies, 6- to 8-fold increases in budesonide systemic exposure (AUC) have been observed during coadministration of the potent CYP450 3A4 inhibitor ketoconazole with different oral formulations of budesonide. When ketoconazole was administered 12 hours after budesonide in one study, the AUC increase was approximately half that reported during simultaneous administration. In a prospective study of a cystic fibrosis center patient population, 11 of 25 patients receiving high-dose itraconazole (400 to 600 mg/day) and budesonide oral inhalation therapy (800 to 1600 mcg/day) were found to have adrenal insufficiency, including one who developed Cushing's syndrome, compared to none in a group of 12 patients treated with itraconazole alone. There was also no adrenal insufficiency in a group of 30 cystic fibrosis patients retrospectively included as controls, 24 of whom had been treated with high-dose inhaled budesonide for several years. Adrenal function improved, but did not normalize, in 10 of the 11 patients during a follow-up of two to ten months after discontinuation of itraconazole and institution of hydrocortisone replacement therapy. Limited pharmacokinetic data indicate that itraconazole (200 mg once daily) may increase the plasma levels of budesonide by about 4-fold following inhalation of a single 1000 mcg dose, which may be mainly due to increased bioavailability of the swallowed portion of the dose.

MANAGEMENT: The possibility of increased systemic adverse effects of budesonide should be considered during coadministration with CYP450 3A4 inhibitors. If concomitant use cannot be avoided, the dosing times between budesonide and the CYP450 3A4 inhibitor should be separated by as much as possible. In addition, the lowest effective dosage of budesonide should be prescribed, and further adjustments made as necessary according to therapeutic response and tolerance. Patients should be monitored for signs and symptoms of hypercorticism such as acne, striae, thinning of the skin, easy bruising, moon facies, dorsocervical "buffalo" hump, truncal obesity, increased appetite, acute weight gain, edema, hypertension, hirsutism, hyperhidrosis, proximal muscle wasting and weakness, glucose intolerance, exacerbation of preexisting diabetes, depression, and menstrual disorders. Other systemic glucocorticoid effects may include adrenal suppression, immunosuppression, posterior subcapsular cataracts, glaucoma, bone loss, and growth retardation in children and adolescents.

References

  1. Jonsson G, Astrom A, Andersson P (1995) "Budesonide is metabolized by cytochrome P450 3A (CYP3A) enzymes in human liver." Drug Metab Dispos, 23, p. 137-42
  2. (2001) "Product Information. Entocort (budesonide)." AstraZeneca Pharma Inc
  3. Raaska K, Niemi M, Neuvonen M, Neuvonen PJ, Kivisto KT (2002) "Plasma concentrations of inhaled budesonide and its effects on plasma cortisol are increased by the cytochrome P4503A4 inhibitor itraconazole." Clin Pharmacol Ther, 72, p. 362-369
  4. Main KM, Skov M, Sillesen IB, et al. (2002) "Cushing's syndrome due to pharmacological interaction in a cystic fibrosis patient." Acta Paediatr, 91, p. 1008-11
  5. Skov M, Main KM, Sillesen IB, Muller J, Koch C, Lanng S (2002) "Iatrogenic adrenal insufficiency as a side-effect of combined treatment of itraconazole and budesonide." Eur Respir J, 20, p. 127-33
  6. De Wachter E, Vanbesien J, De Schutter I, Malfroot A, De Schepper J (2003) "Rapidly developing Cushing syndrome in a 4-year-old patient during combined treatment with itraconazole and inhaled budesonide." Eur J Pediatr
  7. Bolland MJ, Bagg W, Thomas MG, Lucas JA, Ticehurst R, Black PN (2004) "Cushing's syndrome due to interaction between inhaled corticosteroids and itraconazole." Ann Pharmacother, 38, p. 46-9
  8. Edsbacker S, Andersson T (2004) "Pharmacokinetics of budesonide (Entocort EC) capsules for Crohn's disease." Clin Pharmacokinet, 43, p. 803-21
  9. De Wachter E, Malfroot A, De Schutter I, Vanbesien J, De Schepper J (2003) "Inhaled budesonide induced Cushing's syndrome in cystic fibrosis patients, due to drug inhibition of cytochrome P450." J Calif Dent Assoc, 2, p. 72-5
  10. Cerner Multum, Inc. "UK Summary of Product Characteristics."
  11. Cerner Multum, Inc. "Australian Product Information."
  12. Molimard M, Girodet PO, Pollet C, et al. (2008) "Inhaled corticosteroids and adrenal insufficiency: prevalence and clinical presentation." Drug Saf, 31, p. 769-74
  13. Daveluy A, Raignoux C, Miremont-Salame G, et al. (2009) "Drug interactions between inhaled corticosteroids and enzymatic inhibitors." Eur J Clin Pharmacol
  14. Kedem E, Shahar E, Hassoun G, Pollack S (2010) "Iatrogenic Cushing's syndrome due to coadministration of ritonavir and inhaled budesonide in an asthmatic human immunodeficiency virus infected patient." J Asthma, 47, p. 830-1
  15. (2011) "Product Information. Victrelis (boceprevir)." Schering-Plough Corporation
  16. (2011) "Product Information. Incivek (telaprevir)." Vertex Pharmaceuticals
View all 16 references

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Drug and food interactions

Moderate

ritonavir food

Applies to: Viekira XR (dasabuvir / ombitasvir / paritaprevir / ritonavir)

ADJUST DOSING INTERVAL: Administration with food may modestly affect the bioavailability of ritonavir from the various available formulations. When the oral solution was given under nonfasting conditions, peak ritonavir concentrations decreased 23% and the extent of absorption decreased 7% relative to fasting conditions. Dilution of the oral solution (within one hour of dosing) with 240 mL of chocolate milk or a nutritional supplement (Advera or Ensure) did not significantly affect the extent and rate of ritonavir absorption. When a single 100 mg dose of the tablet was administered with a high-fat meal (907 kcal; 52% fat, 15% protein, 33% carbohydrates), approximately 20% decreases in mean peak concentration (Cmax) and systemic exposure (AUC) were observed relative to administration after fasting. Similar decreases in Cmax and AUC were reported when the tablet was administered with a moderate-fat meal. In contrast, the extent of absorption of ritonavir from the soft gelatin capsule formulation was 13% higher when administered with a meal (615 KCal; 14.5% fat, 9% protein, and 76% carbohydrate) relative to fasting.

MANAGEMENT: Ritonavir should be taken with meals to enhance gastrointestinal tolerability.

References

  1. (2001) "Product Information. Norvir (ritonavir)." Abbott Pharmaceutical

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Moderate

paritaprevir food

Applies to: Viekira XR (dasabuvir / ombitasvir / paritaprevir / ritonavir)

ADJUST DOSING INTERVAL: Food enhances the oral bioavailability of ombitasvir, paritaprevir, ritonavir, and dasabuvir. Relative to fasting conditions, administration of ombitasvir, paritaprevir, ritonavir, and dasabuvir with a moderate-fat meal (approximately 600 Kcal; 20% to 30% calories from fat) increased the mean systemic exposure (AUC) by 82%, 211%, 49%, and 30%, respectively. Relative to fasting conditions, administration of ombitasvir, paritaprevir, ritonavir, and dasabuvir with a high-fat meal (approximately 900 Kcal; with 60% calories from fat) increased the mean AUC by 76%, 180%, 44%, and 22%, respectively.

MANAGEMENT: Ombitasvir/paritaprevir/ritonavir plus dasabuvir should always be administered with a meal. The fat or calorie content does not matter.

References

  1. (2022) "Product Information. Viekira Pak (dasabuvir/ombitasvir/paritaprev/ritonav)." AbbVie US LLC

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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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