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Drug Interactions between isotretinoin and vamorolone

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

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Interactions between your drugs

Moderate

ISOtretinoin vamorolone

Applies to: isotretinoin and vamorolone

Consumer information for this interaction is not currently available.

MONITOR: Theoretical concerns exist that isotretinoin and corticosteroids may have additive effects on bone loss. Decreased bone mineral density (osteomalacia, osteopenia, osteoporosis) and bone fractures have been reported with either treatment alone during prolonged administration. Avascular necrosis has also been reported with corticosteroids, particularly when given in high dosages or for prolonged periods. However, no formal clinical trials have been conducted to evaluate whether there is an interactive effect on bone loss during coadministration.

MANAGEMENT: Caution is advised when isotretinoin is used in combination with corticosteroids, particularly in patients with a history of osteomalacia, osteoporosis, or other disorders of bone metabolism. Bone-related laboratory and radiological tests should be considered.

References

  1. Need AG, Philcox JC, Hartley TF, Nordin BE "Calcium metabolism and osteoporosis in cortiscosteroid-treated postmenopausal women." Aust N Z J Med 16 (1986): 341-6
  2. Mitchison HC, Bassendine MF, Malcolm AJ, et al. "A pilot, double-blind, controlled 1-year trial of prednisolone treatment in primary biliary cirrhosis: hepatic improvement but greater bone loss." Hepatology 10 (1989): 420-9
  3. McCluskey J, Gutteridge DH "Avascular necrosis of bone after high doses of dexamethasone during neurosurgery." Br Med J (Clin Res Ed) 284 (1982): 333-4
  4. Anderton JM, Helm R "Multiple joint osteonecrosis following short-term steroid therapy. Case report." J Bone Joint Surg Am 64 (1982): 139-41
  5. Taylor LJ "Multifocal avascular necrosis after short-term high-dose steroid therapy. A report of three cases." J Bone Joint Surg Br 66 (1984): 431-3
  6. Fast A, Alon M, Weiss S, Zer-Aviv FR "Avascular necrosis of bone following short-term dexamethasone therapy for brain edema. Case report." J Neurosurg 61 (1984): 983-5
  7. Black KA, Khangure MS, Owen ET "Dexamethasone and osteonecrosis." Aust N Z J Med 11 (1981): 521-5
  8. Sambrook PN, Hassall JE, York JR "Osteonecrosis after high dosage, short term corticosteroid therapy." J Rheumatol 11 (1984): 514-6
  9. Archer AG, Nelson MC, Abbondanzo SL, Bogumill GP "Case report 554: Osteonecrosis at multiple sites as noted." Skeletal Radiol 18 (1989): 380-4
  10. Williams IA, Mitchell AD, Rothman W, Tallett P, Williams K, Pitt P "Survey of the long term incidence of osteonecrosis of the hip and adverse medical events in rheumatoid arthritis after high dose intravenous methylprednisolone." Ann Rheum Dis 47 (1988): 930-3
  11. Bijlsma JW, Duursma SA, Bosch R, Raymakers JA, Huber-Bruning O "Acute changes in calcium and bone metabolism during methylprednisolone pulse therapy in rheumatoid arthritis." Br J Rheumatol 27 (1988): 215-9
  12. Mizuta H, Kubota K, Shiraishi M, Kai K, Nakamura E, Takagi K "Steroid-related bilateral osteonecrosis of the patella." Arthroscopy 9 (1993): 114-6
  13. "Product Information. Accutane (isotretinoin)." Roche Laboratories PROD (2001):
  14. Marystone JF, Barrettconnor EL, Morton DJ "Inhaled and oral corticosteroids: their effects on bone mineral density in older adults." Am J Public Health 85 (1995): 1693-5
  15. Packe GE, Douglas JG, McDonald AF, Robins SP, Reid DM "Bone density in asthmatic patients taking high dose inhaled beclomethasone diproprionate and intermittent systemic corticosteroids." Thorax 47 (1992): 414-7
  16. Cruess RL "Experience with steroid-induced avascular necrosis of the shoulder and etiologic considerations regarding osteonecrosis of the hip." Clin Orthop Jan-Feb(13 (1978): 86-93
  17. Saisu T, Sakamoto K, Yamada K, Kashiwabara H, Yokoyama T, Iida S, Harada Y, Ikenoue S, Sakamoto M, Moriya H "High incidence of osteonecrosis of femoral head in patients receiving more than 2 g of intravenous methylprednisolone after renal transplantation." Transplant Proc 28 (1996): 1559-60
  18. Ledford D, Apter A, Brenner AM, Rubin K, Prestwood K, Frieri M, Lukert B "Osteoporosis in the corticosteroid-treated patient with asthma." J Allergy Clin Immunol 102 (1998): 353-62
  19. Goldstein MF, Fallon JJ, Harning R "Chronic glucocorticoid therapy-induced osteoporosis in patients with obstructive lung disease." Chest 116 (1999): 1733-49
View all 19 references

Drug and food interactions

Moderate

vamorolone food

Applies to: vamorolone

Consumer information for this interaction is not currently available.

GENERALLY AVOID: Grapefruit juice may increase the plasma concentrations of vamorolone. The proposed mechanism is inhibition of CYP450 3A4-mediated metabolism in the gut wall by certain compounds present in grapefruit. The metabolism of vamorolone is mediated by the isoenzymes CYP450 3A4/5, and CYP450 2C8, and uridine diphosphate glucuronosyltransferases (UGT) 1A3, 2B7, and 2B17. In general, the effect of grapefruit juice is concentration-, dose-, and preparation-dependent, and can vary widely among brands. Certain preparations of grapefruit juice (e.g., high dose, double strength) have sometimes demonstrated potent inhibition of CYP450 3A4, while other preparations (e.g., low dose, single strength) have typically demonstrated moderate inhibition. Increased systemic exposure to vamorolone may increase the risk of corticosteroid adverse effects such as hypercorticism, hyperglycemia, adrenal suppression, immunosuppression, hypertension, salt and water retention, electrolyte abnormalities, behavioral and mood disturbances, posterior subcapsular cataracts, glaucoma, bone loss, and growth retardation in children and adolescents.

MANAGEMENT: Until further information is available, it may be advisable for patients to avoid the consumption of large amounts of grapefruit and grapefruit juice during vamorolone therapy unless otherwise directed by their doctor, as the interaction is unreliable and subject to a high degree of interpatient variation. If coadministration is considered necessary, patients should be closely monitored for signs and symptoms of corticosteroid adverse effects. Patients should also 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, and depression. Signs and symptoms of adrenal insufficiency include anorexia, hypoglycemia, nausea, vomiting, weight loss, muscle wasting, fatigue, weakness, dizziness, postural hypotension, depression, and adrenal crisis manifested as an inability to respond to stress (e.g., illness, infection, surgery, trauma). Consultation with product labeling for specific recommendations is advisable.

References

  1. Zurcher RM, Frey BM, Frey FJ "Impact of ketoconazole on the metabolism of prednisolone." Clin Pharmacol Ther 45 (1989): 366-72
  2. Yamashita SK, Ludwig EA, Middleton E Jr, Jusko WJ "Lack of pharmacokinetic and pharmacodynamic interactions between ketoconazole and prednisolone." Clin Pharmacol Ther 49 (1991): 558-70
  3. Ulrich B, Frey FJ, Speck RF, Frey BM "Pharmacokinetics/pharmacodynamics of ketoconazole-prednisolone interaction." J Pharmacol Exp Ther 260 (1992): 487-90
  4. Kandrotas RJ, Slaughter RL, Brass C, Jusko WJ "Ketoconazole effects on methylprednisolone disposition and their joint suppression of endogenous cortisol." Clin Pharmacol Ther 42 (1987): 465-70
  5. Glynn AM, Slaughter RL, Brass C, et al. "Effects of ketoconazole on methylprednisolone pharmacokinetics and cortisol secretion." Clin Pharmacol Ther 39 (1986): 654-9
  6. Itkin IH, Menzel ML "The use of macrolide antibiotic substances in the treatment of asthma." J Allergy Clin Immunol 45 (1970): 146-62
  7. LaForce CF, Szefler SJ, Miller MF, Ebling W, Brenner M "Inhibition of methylprednisolone elimination in the presence of erythromycin therapy." J Allergy Clin Immunol 72 (1983): 34-9
  8. Finkenbine RD, Frye MD "Case of psychosis due to prednisone-clarithromycin interaction." Gen Hosp Psychiat 20 (1998): 325-6
  9. Varis T, Kaukonen KM, Kivisto KT, Neuvonen PJ "Plasma concentrations and effects of oral methylprednisolone are considerably increased by itraconazole." Clin Pharmacol Ther 64 (1998): 363-8
  10. Hillebrand-Haverkort ME, Prummel MF, ten Veen JH "Ritonavir-induced Cushing's syndrome in a patient treated with nasal fluticasone." AIDS 13 (1999): 1803
  11. Varis T, Kivisto KT, Neuvonen PJ "The effect of itraconazole on the pharmacokinetics and pharmacodynamics of oral prednisolone." Eur J Clin Pharmacol 56 (2000): 57-60
  12. Varis T, Backman JT, Kivisto KT, Neuvonen PJ "Diltiazem and mibefradil increase the plasma concentrations and greatly enhance the adrenal-suppressant effect of oral methylprednisolone." Clin Pharmacol Ther 67 (2000): 215-21
  13. Garey KW, Rubinstein I, Gotfried MH, Khan IJ, Varma S, Danziger LH "Long-term clarithromycin decreases prednisone requirements in elderly patients with prednisone-dependent asthma." Chest 118 (2000): 1826-7
  14. Lebrun-Vignes B, Archer VC, Diquest B, et al. "Effect of itraconazole on the pharmacokinetics of prednisolone and methylprednisolone and cortisol secretion in healthy subjects." Br J Clin Pharmacol 51 (2001): 443-50
  15. Couturier J, Steele M, Hussey L, Pawliuk G "Steroid-induced mania in an adolescent: risk factors and management." Can J Clin Pharmacol 8 (2001): 109-12
  16. Gupta SK, Dube MP "Exogenous Cushing syndrome mimicking human immunodeficiency virus lipodystrophy." Clin Infect Dis 35 (2002): E69-71
  17. Raaska K, Niemi M, Neuvonen M, Neuvonen PJ, Kivisto KT "Plasma concentrations of inhaled budesonide and its effects on plasma cortisol are increased by the cytochrome P4503A4 inhibitor itraconazole." Clin Pharmacol Ther 72 (2002): 362-369
  18. Main KM, Skov M, Sillesen IB, et al. "Cushing's syndrome due to pharmacological interaction in a cystic fibrosis patient." Acta Paediatr 91 (2002): 1008-11
  19. Skov M, Main KM, Sillesen IB, Muller J, Koch C, Lanng S "Iatrogenic adrenal insufficiency as a side-effect of combined treatment of itraconazole and budesonide." Eur Respir J 20 (2002): 127-33
  20. Kotlyar M, Brewer ER, Golding M, Carson SW "Nefazodone inhibits methylprednisolone disposition and enhances its adrenal-suppressant effect." J Clin Psychopharmacol 23 (2003): 652-6
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  22. Edsbacker S, Andersson T "Pharmacokinetics of budesonide (Entocort EC) capsules for Crohn's disease." Clin Pharmacokinet 43 (2004): 803-21
  23. Samaras K, Pett S, Gowers A, McMurchie M, Cooper DA "Iatrogenic Cushing's syndrome with osteoporosis and secondary adrenal failure in HIV-infected patients receiving inhaled corticosteroids and ritonavir-boosted protease inhibitors: six cases." J Clin Endocrinol Metab 90 (2005): 4394-8
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View all 30 references
Moderate

ISOtretinoin food

Applies to: isotretinoin

Ask your doctor before using ISOtretinoin together with ethanol. Do not drink alcohol while you are taking ISOtretinoin. You may have unpleasant side effects such as fast heartbeats, warmth or redness under your skin, tingly feeling, nausea, and vomiting. Check your food and medicine labels to be sure these products do not contain alcohol. 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.

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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.

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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

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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