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Drug Interactions between UroAv-B and vamorolone

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

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Major

sodium biphosphate phenyl salicylate

Applies to: UroAv-B (hyoscyamine / methenamine / methylene blue / phenyl salicylate / sodium biphosphate) and UroAv-B (hyoscyamine / methenamine / methylene blue / phenyl salicylate / sodium biphosphate)

MONITOR CLOSELY: The following interaction applies only to products containing sodium biphosphate that are used for bowel cleansing. It does not apply to products containing sodium biphosphate that are used for other, non-laxative related purposes.

Coadministration with agents that affect renal function or perfusion such as diuretics, ACE inhibitors, angiotensin receptor blockers, and nonsteroidal anti-inflammatory drugs (NSAIDs) may increase the risk of acute phosphate nephropathy associated with the use of bowel-cleansing phosphate solutions. The risk and/or severity of fluid and electrolyte disturbances may also be increased, which can lead to serious adverse events including cardiac arrhythmias, seizures, and renal impairment. Acute phosphate nephropathy is a rare adverse event that presents as acute renal failure with minimal proteinuria and a bland urine sediment. Renal biopsy findings are consistent with nephrocalcinosis and include acute and/or chronic renal tubular injury, calcium-phosphate crystal deposition in the distal tubules and collecting ducts, and no other pattern of histological injury. The risk of acute phosphate nephropathy stems from the large phosphate load, fluid shifts, and decreased intravascular volume, which can be exacerbated in the presence of medications that affect renal perfusion or function. In reported cases, acute renal failure was typically diagnosed within two to five months of colonoscopy. These cases often resulted in permanent impairment of renal function, some requiring long-term dialysis.

MANAGEMENT: Caution is advised when bowel-cleansing phosphate preparations are prescribed in patients treated with agents that affect renal function or perfusion, particularly if they are frail or elderly. Bowel-cleansing phosphate preparations should not be used in patients who have impaired renal function or perfusion, dehydration, or uncorrected electrolyte abnormalities. In patients at risk for acute phosphate nephropathy, baseline and postprocedure labs including serum electrolytes, calcium, phosphate, BUN, and creatinine should be performed. Patients should be advised not to exceed the recommended dosage of their bowel-cleansing preparation and to drink sufficient quantities of clear fluids during before, during, and after bowel cleansing. Limited data suggest that administration of an electrolyte rehydration solution may attenuate the electrolyte abnormalities and hypovolemia. Hospitalization and intravenous fluid hydration may be appropriate for frail or elderly patients who may be unable to drink an adequate volume of fluid.

References

  1. (2007) "Product Information. Fleet Phospho Soda (sodium acid phophate-sodium phosphate)." Fleet, CB
  2. (2007) "Product Information. Visicol (sodium acid phophate-sodium phosphate)." Salix Pharmaceuticals
  3. FDA. Food and Drug Admnistration (2007) Oral sodium phosphate products for bowel cleansing. http://www.fda.gov/cder/drug/InfoSheets/HCP/OSP_solutionHCP.pdf

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Moderate

sodium biphosphate vamorolone

Applies to: UroAv-B (hyoscyamine / methenamine / methylene blue / phenyl salicylate / sodium biphosphate) and vamorolone

MONITOR: The overuse or abuse of laxatives can cause significant loss of electrolytes and potentiate the risk of hypokalemia associated with corticosteroid therapy. Corticosteroids promote the retention of sodium and water and the excretion of potassium. Although these effects are primarily associated with mineralocorticoids like fludrocortisone, they may also occur with higher dosages of glucocorticoids or adrenocorticotropic agents, particularly if given systemically for longer than brief periods.

MANAGEMENT: In general, laxatives should only be used on a short-term, intermittent basis in recommended dosages. During concomitant therapy with corticosteroids, particularly if fludrocortisone or large doses of a glucocorticoid or adrenocorticotropic agent is given, patients should be counseled to recognize potential signs and symptoms of hypokalemia such as fatigue, myalgia, and muscle weakness. If maintenance of bowel regularity is required, patients should be advised to exercise and increase fiber in the diet and/or consider the use of bulk-forming laxatives.

References

  1. Seale JP, Compton MR (1986) "Side-effects of corticosteroid agents." Med J Aust, 144, p. 139-42
  2. Lieberman P, Patterson R, Kunske R (1972) "Complications of long-term steroid therapy for asthma." J Allergy Clin Immunol, 49, p. 329-36
  3. Ramsahoye BH, Davies SV, el-Gaylani N, Sandeman D, Scanlon MF (1995) "The mineralocorticoid effects of high dose hydrocortisone." BMJ, 310, p. 656-7
  4. Swartz SL, Dluhy RG (1978) "Corticosteroids: clinical pharmacology and therapeutic use." Drugs, 16, p. 238-55
  5. Brinckmann J, Blumenthal M, eds., Goldberg A (2000) "Herbal Medicine: Expanded Commission E Monographs." Newton, MA: Integrative Medicine Communications
  6. Chin RL (1998) "Laxative-induced hypokalemia." Ann Emerg Med, 32, p. 517-8
  7. Muller-Lissner SA (1993) "Adverse effects of laxatives: fact and fiction." Pharmacology, 47, p. 138-45
View all 7 references

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Moderate

phenyl salicylate vamorolone

Applies to: UroAv-B (hyoscyamine / methenamine / methylene blue / phenyl salicylate / sodium biphosphate) and vamorolone

MONITOR: Coadministration with corticosteroids may decrease the serum concentrations and therapeutic effects of salicylates. Likewise, serum salicylate levels may increase following withdrawal of corticosteroid therapy, potentially resulting in salicylate toxicity. This interaction has been reported in patients receiving intra-articular as well as oral corticosteroids. One or more mechanisms may be involved, including an increase in the renal clearance and/or an induction of hepatic metabolism of salicylates caused by corticosteroids. Pharmacologically, the potential for increased gastrointestinal (GI) toxicity, including inflammation, bleeding, ulceration and perforation, should be considered due to additive ulcerogenic effects of these agents (especially aspirin) on the GI mucosa.

MANAGEMENT: Patients treated concomitantly with a corticosteroid may require higher dosages of salicylates or salicylate-like drugs. Pharmacologic response to these agents should be monitored more closely whenever a corticosteroid is added to or withdrawn from therapy in patients stabilized on their existing salicylate regimen, and the salicylate dosage adjusted as necessary. During concomitant therapy, patients should be advised to take the medications with food and to immediately report signs and symptoms of GI ulceration and bleeding such as severe abdominal pain, dizziness, lightheadedness, and the appearance of black, tarry stools. The selective use of prophylactic anti-ulcer therapy (e.g., antacids, H2-antagonists) may be appropriate, particularly in patients with a prior history of peptic ulcer disease or GI bleeding and in elderly and debilitated patients.

References

  1. Baer PA, Shore A, Ikeman RL (1987) "Transient fall in serum salicylate levels following intraarticular injection of steroid in patients with rheumatoid arthritis." Arthritis Rheum, 30, p. 345-7
  2. Koren G, Roifman C, Gelfand E, Lavi S, Suria D, Stein L (1987) "Corticosteroids-salicylate interaction in a case of juvenile rheumatoid arthritis." Ther Drug Monit, 9, p. 177-9
  3. Edelman J, Potter JM, Hackett LP (1986) "The effect of intra-articular steroids on plasma salicylate concentrations." Br J Clin Pharmacol, 21, p. 301-7
  4. Piper JM, Ray WA, Daugherty JR, Griffin MR (1991) "Corticosteroid use and peptic ulcer disease: role of nonsteroidal ani-inflammatory drugs." Ann Intern Med, 114, p. 735-40
  5. Hansen RA, Tu W, Wang J, Ambuehl R, McDonald CJ, Murray MD (2008) "Risk of adverse gastrointestinal events from inhaled corticosteroids." Pharmacotherapy, 28, p. 1325-34
View all 5 references

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Drug and food interactions

Moderate

sodium biphosphate food

Applies to: UroAv-B (hyoscyamine / methenamine / methylene blue / phenyl salicylate / sodium biphosphate)

ADJUST DOSING INTERVAL: Bowel cleansing products can increase the gastrointestinal transit rate. Oral medications administered within one hour of the start of administration of the bowel cleansing solution may be flushed from the gastrointestinal tract and not properly absorbed.

MANAGEMENT: Patients should be advised that absorption of oral medications may be impaired during bowel cleansing treatment. Oral medications (e.g., anticonvulsants, oral contraceptives, antidiabetic agents, antibiotics) should not be administered during and within one hour of starting bowel cleansing treatment whenever possible. However, if concomitant use cannot be avoided, monitoring for reduced therapeutic effects may be advisable.

References

  1. "Product Information. Golytely (polyethylene glycol 3350 with electrolytes)." Braintree
  2. (2022) "Product Information. Prepopik (citric acid/Mg oxide/Na picosulfate)." Ferring Pharmaceuticals Inc

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Moderate

vamorolone food

Applies to: vamorolone

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 (1989) "Impact of ketoconazole on the metabolism of prednisolone." Clin Pharmacol Ther, 45, p. 366-72
  2. Yamashita SK, Ludwig EA, Middleton E Jr, Jusko WJ (1991) "Lack of pharmacokinetic and pharmacodynamic interactions between ketoconazole and prednisolone." Clin Pharmacol Ther, 49, p. 558-70
  3. Ulrich B, Frey FJ, Speck RF, Frey BM (1992) "Pharmacokinetics/pharmacodynamics of ketoconazole-prednisolone interaction." J Pharmacol Exp Ther, 260, p. 487-90
  4. Kandrotas RJ, Slaughter RL, Brass C, Jusko WJ (1987) "Ketoconazole effects on methylprednisolone disposition and their joint suppression of endogenous cortisol." Clin Pharmacol Ther, 42, p. 465-70
  5. Glynn AM, Slaughter RL, Brass C, et al. (1986) "Effects of ketoconazole on methylprednisolone pharmacokinetics and cortisol secretion." Clin Pharmacol Ther, 39, p. 654-9
  6. Itkin IH, Menzel ML (1970) "The use of macrolide antibiotic substances in the treatment of asthma." J Allergy Clin Immunol, 45, p. 146-62
  7. LaForce CF, Szefler SJ, Miller MF, Ebling W, Brenner M (1983) "Inhibition of methylprednisolone elimination in the presence of erythromycin therapy." J Allergy Clin Immunol, 72, p. 34-9
  8. Finkenbine RD, Frye MD (1998) "Case of psychosis due to prednisone-clarithromycin interaction." Gen Hosp Psychiat, 20, p. 325-6
  9. Varis T, Kaukonen KM, Kivisto KT, Neuvonen PJ (1998) "Plasma concentrations and effects of oral methylprednisolone are considerably increased by itraconazole." Clin Pharmacol Ther, 64, p. 363-8
  10. Hillebrand-Haverkort ME, Prummel MF, ten Veen JH (1999) "Ritonavir-induced Cushing's syndrome in a patient treated with nasal fluticasone." AIDS, 13, p. 1803
  11. Varis T, Kivisto KT, Neuvonen PJ (2000) "The effect of itraconazole on the pharmacokinetics and pharmacodynamics of oral prednisolone." Eur J Clin Pharmacol, 56, p. 57-60
  12. Varis T, Backman JT, Kivisto KT, Neuvonen PJ (2000) "Diltiazem and mibefradil increase the plasma concentrations and greatly enhance the adrenal-suppressant effect of oral methylprednisolone." Clin Pharmacol Ther, 67, p. 215-21
  13. Garey KW, Rubinstein I, Gotfried MH, Khan IJ, Varma S, Danziger LH (2000) "Long-term clarithromycin decreases prednisone requirements in elderly patients with prednisone-dependent asthma." Chest, 118, p. 1826-7
  14. Lebrun-Vignes B, Archer VC, Diquest B, et al. (2001) "Effect of itraconazole on the pharmacokinetics of prednisolone and methylprednisolone and cortisol secretion in healthy subjects." Br J Clin Pharmacol, 51, p. 443-50
  15. Couturier J, Steele M, Hussey L, Pawliuk G (2001) "Steroid-induced mania in an adolescent: risk factors and management." Can J Clin Pharmacol, 8, p. 109-12
  16. Gupta SK, Dube MP (2002) "Exogenous Cushing syndrome mimicking human immunodeficiency virus lipodystrophy." Clin Infect Dis, 35, E69-71
  17. 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
  18. 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
  19. 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
  20. Kotlyar M, Brewer ER, Golding M, Carson SW (2003) "Nefazodone inhibits methylprednisolone disposition and enhances its adrenal-suppressant effect." J Clin Psychopharmacol, 23, p. 652-6
  21. 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
  22. Edsbacker S, Andersson T (2004) "Pharmacokinetics of budesonide (Entocort EC) capsules for Crohn's disease." Clin Pharmacokinet, 43, p. 803-21
  23. Samaras K, Pett S, Gowers A, McMurchie M, Cooper DA (2005) "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, p. 4394-8
  24. Soldatos G, Sztal-Mazer S, Woolley I, Stockigt J (2005) "Exogenous glucocorticoid excess as a result of ritonavir-fluticasone interaction." Intern Med J, 35, p. 67-8
  25. Penzak SR, Formentini E, Alfaro RM, Long M, Natarajan V, Kovacs J (2005) "Prednisolone pharmacokinetics in the presence and absence of ritonavir after oral prednisone administration to healthy volunteers." J Acquir Immune Defic Syndr, 40, p. 573-80
  26. EMEA. European Medicines Agency (2007) EPARs. European Union Public Assessment Reports. http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/medicines/medicines_landingpage.jsp&mid
  27. Bhumbra NA, Sahloff EG, Oehrtman SJ, Horner JM (2007) "Exogenous Cushing syndrome with inhaled fluticasone in a child receiving lopinavir/ritonavir." Ann Pharmacother, 41, p. 1306-9
  28. Busse KH, Formentini E, Alfaro RM, Kovacs JA, Penzak SR (2008) "Influence of antiretroviral drugs on the pharmacokinetics of prednisolone in HIV-infected individuals." J Acquir Immune Defic Syndr, 48, p. 561-6
  29. Agencia EspaƱola de Medicamentos y Productos Sanitarios Healthcare (2008) Centro de informaciĆ³n online de medicamentos de la AEMPS - CIMA. https://cima.aemps.es/cima/publico/home.html
  30. (2023) "Product Information. Agamree (vamorolone)." Santhera Pharmaceuticals (US)
View all 30 references

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Moderate

hyoscyamine food

Applies to: UroAv-B (hyoscyamine / methenamine / methylene blue / phenyl salicylate / sodium biphosphate)

GENERALLY AVOID: Use of anticholinergic agents with alcohol may result in sufficient impairment of attention so as to render driving and operating machinery more hazardous. In addition, the potential for abuse may be increased with the combination. The mechanism of interaction is not established but may involve additive depressant effects on the central nervous system. No effect of oral propantheline or atropine on blood alcohol levels was observed in healthy volunteers when administered before ingestion of a standard ethanol load. However, one study found impairment of attention in subjects given atropine 0.5 mg or glycopyrrolate 1 mg in combination with alcohol.

MANAGEMENT: Alcohol should generally be avoided during therapy with anticholinergic agents. Patients should be counseled to avoid activities requiring mental alertness until they know how these agents affect them.

References

  1. Linnoila M (1973) "Drug effects on psychomotor skills related to driving: interaction of atropine, glycopyrrhonium and alcohol." Eur J Clin Pharmacol, 6, p. 107-12

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Therapeutic duplication warnings

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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.