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Drug Interactions between Baxdela and dulaglutide

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

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Interactions between your drugs

Moderate

dulaglutide delafloxacin

Applies to: dulaglutide and Baxdela (delafloxacin)

MONITOR: Quinolone antibiotics may interfere with the therapeutic effects of insulin and other antidiabetic agents. The use of quinolones has been associated with disturbances in blood glucose homeostasis possibly stemming from effects on pancreatic beta cell ATP-sensitive potassium channels that regulate insulin secretion. Both hyperglycemia and hypoglycemia have been reported, usually in diabetic patients receiving concomitant treatment with an oral hypoglycemic agent (e.g., sulfonylurea) or insulin. Although hyperglycemia is significantly more common and infection itself may be an underlying risk factor, hypoglycemia may cause greater morbidity and mortality. An internal safety review conducted by the U.S. Food and Drug Administration (FDA) identified at least 67 reports of severe hypoglycemia associated with quinolone use resulting in coma, death, or permanent and disabling injuries, primarily in elderly and diabetic patients with renal impairment and/or complicated infections. This is in addition to the numerous cases that have been reported for gatifloxacin, which led to its withdrawal from the U.S. market in 2008. Of the five quinolones that the FDA reviewed, levofloxacin had the most cases (44), followed by ciprofloxacin (12), moxifloxacin (9), ofloxacin (2), and gemifloxacin (0). Other quinolones such as nalidixic acid and norfloxacin, as well as some others that have never been marketed or are no longer marketed such as clinafloxacin and temafloxacin, have also been associated with dysglycemia, thus it is generally believed to be a class effect, albeit with varying risks amongst the individual agents. Available data also seem to indicate different time frames for the development of hypo- and hyperglycemia, with the former generally occurring within 1 to 3 days following quinolone initiation and the latter within 4 to 10 days later.

MANAGEMENT: Blood glucose should be closely monitored whenever quinolones are prescribed to diabetic patients, especially if they are elderly, have renal impairment, or are severely ill. Patients should be apprised of the increased risk of dysglycemia and be particularly alert to potential signs and symptoms of hypoglycemia such as headache, dizziness, drowsiness, nervousness, confusion, tremor, hunger, weakness, perspiration, palpitation, and tachycardia. If hypoglycemia occurs, patients should initiate appropriate remedial therapy immediately, discontinue the quinolone, and contact their physician. Alternative antibiotics may need to be considered.

References

  1. "Product Information. Cipro (ciprofloxacin)." Bayer PROD (2002):
  2. "Product Information. Noroxin (norfloxacin)." Merck & Co., Inc PROD (2001):
  3. "Product Information. Floxin (ofloxacin)." Ortho McNeil Pharmaceutical PROD (2001):
  4. "Product Information. Levaquin (levofloxacin)." Ortho McNeil Pharmaceutical PROD (2001):
  5. "Product Information. Raxar (grepafloxacin)." Glaxo Wellcome PROD (2001):
  6. "Product Information. Trovan (trovafloxacin)." Pfizer U.S. Pharmaceuticals PROD (2001):
  7. Edwards DJ, Bowles SK, Svensson CK, Rybak MJ "Inhibition of drug metabolism by quinolone antibiotics." Clin Pharmacokinet 15 (1988): 194-204
  8. "Product Information. Tequin (gatifloxacin)." Bristol-Myers Squibb PROD (2001):
  9. Gajjar DA, LaCreta FP, Kollia GD, et al. "Effect of multiple-dose gatifloxacin or ciprofloxacin on glucose homeostasis and insulin production in patients with noninsulin-dependent diabetes mellitus maintained with diet and exercise." Pharmacotherapy 20 (6 Pt 2) (2000): s76-86
  10. Roberge RJ, Kaplan R, Frank R, Fore C "Glyburide-ciprofloxacin interaction with resistant hypoglycemia." Ann Emerg Med 36 (2000): 160-3
  11. Rubinstein E "History of quinolones and their side effects." Chemotherapy 47 Suppl 3 (2001): 3-8
  12. Menzies DJ, Dorsainvil PA, Cunha BA, Johnson DH "Severe and persistent hypoglycemia due to gatifloxacin interaction with oral hypoglycemic agents." Am J Med 113 (2002): 232-4
  13. Baker SE, Hangii MC "Possible gatifloxacin-induced hypoglycemia." Ann Pharmacother 36 (2002): 1722-6
  14. "Product Information. Factive (gemifloxacin)." *GeneSoft Inc (2003):
  15. "Hypoglycemia and hyperglycemia with fluoroquinolones." Med Lett Drugs Ther 45 (2003): 64
  16. Donaldson AR, Vandiver JR, Finch CK "Possible gatifloxacin-induced hyperglycemia." Ann Pharmacother 38 (2004): 602-5
  17. LeBlanc M, Belanger C, Cossette P "Severe and resistant hypoglycemia associated with concomitant gatifloxacin and glyburide therapy." Pharmacotherapy 24 (2004): 926-31
  18. Biggs WS "Hypoglycemia and hyperglycemia associated with gatifloxacin use in elderly patients." J Am Board Fam Pract 16 (2004): 455-7
  19. Gavin JR 3rd, Kubin R, Choudhri S, et al. "Moxifloxacin and glucose homeostasis: a pooled-analysis of the evidence from clinical and postmarketing studies." Drug Saf 27 (2004): 671-86
  20. Saraya A, Yokokura M, Gonoi T, Seino S "Effects of fluoroquinolones on insulin secretion and beta-cell ATP-sensitive K(+) channels." Eur J Pharmacol 497 (2004): 111-7
  21. Lin G, Hays DP, Spillane L "Refractory hypoglycemia from ciprofloxacin and glyburide interaction." J Toxicol Clin Toxicol 42 (2004): 295-7
  22. Friedrich LV, Dougherty R "Fatal hypoglycemia associated with levofloxacin." Pharmacotherapy 24 (2004): 1807-12
  23. Khovidhunkit W, Sunthornyothin S "Hypoglycemia, hyperglycemia, and gatifloxacin." Ann Intern Med 141 (2004): 969
  24. Happe MR, Mulhall BP, Maydonovitch CL, Holtzmuller KC "Gatifloxacin-induced hyperglycemia." Ann Intern Med 141 (2004): 968-9
  25. Greenberg AL, Decerbo M, Fan J "Gatifloxacin therapy associated with hypoglycemia." Clin Infect Dis 40 (2005): 1210-1
  26. Blommel AL, Lutes RA "Severe hyperglycemia during renally adjusted gatifloxacin therapy." Ann Pharmacother 39 (2005): 1349-52
  27. Brogan SE, Cahalan MK "Gatifloxacin as a possible cause of serious postoperative hypoglycemia." Anesth Analg 101 (2005): 635-6
  28. Graumlich JF, Habis S, Avelino RR, et al. "Hypoglycemia in inpatients after gatifloxacin or levofloxacin therapy: nested case-control study." Pharmacotherapy 25 (2005): 1296-302
  29. Frothingham R "Glucose homeostasis abnormalities associated with use of gatifloxacin." Clin Infect Dis 41 (2005): 1269-76
  30. Bhasin R, Arce FC, Pasmantier R "Hypoglycemia associated with the use of gatifloxacin." Am J Med Sci 330 (2005): 250-3
  31. McMorran M, Morrison H, Letourneau G "Gatifloxacin (Tequin): hypoglycemia and hyperglycemia. http://www.hc-sc.gc.ca/dhp-mps/medeff/bulletin/carn-bcei_v13n3_e.html#1" (2006):
  32. Park-Wyllie LY, Juurlink DN, Kopp A, et al. "Outpatient gatifloxacin therapy and dysglycemia in older adults." N Engl J Med 354 (2006): 1352-61
  33. Wang S, Rizvi AA "Levofloxacin-induced hypoglycemia in a nondiabetic patient." Am J Med Sci 331 (2006): 334-5
  34. Kanbay M, Aydogan T, Bozalan R, et al. "A rare but serious side effect of levofloxacin: hypoglycemia in a geriatric patient." Diabetes Care 29 (2006): 1716-7
  35. Zvonar R "Gatifloxacin-induced dysglycemia." Am J Health Syst Pharm 63 (2006): 2087-2092
  36. Zhanel GG, Fontaine S, Adam H, et al. "A Review of New Fluoroquinolones : Focus on their Use in Respiratory Tract Infections." Treat Respir Med 5 (2006): 437-465
  37. Yip C, Lee AJ "Gatifloxacin-induced hyperglycemia: a case report and summary of the current literature." Clin Ther 28 (2006): 1857-66
  38. Tomita T, Onishi M, Sato E, Kimura Y, Kihira K "Gatifloxacin induces augmented insulin release and intracellular insulin." Biol Pharm Bull 30 (2007): 644-7
  39. Kelesidis T, Canseco E "Quinolone-induced hypoglycemia: a life-threatening but potentially reversible side effect." Am J Med 123 (2010): e5-6
  40. "Product Information. Baxdela (delafloxacin)." Melinta Therapeutics, Inc. (2017):
  41. "Product Information. Ciprofloxacin Hydrochloride (ciprofloxacin)." Aurobindo Pharma USA Inc (2021):
  42. FDA. Food and Drug Admnistration "FDA reinforces safety information about serious low blood sugar levels and mental health side effects with fluoroquinolone antibiotics; requires label changes. https://www.fda.gov/drugs/drug-safety-and-availability/fda-reinforces-safety-information-about" (2023):
View all 42 references

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Drug and food interactions

Moderate

dulaglutide food

Applies to: dulaglutide

MONITOR: Glucagon-like peptide-1 (GLP-1) receptor agonists and dual GLP-1 and glucose-dependent insulinotropic polypeptide (GIP) receptor agonists can delay gastric emptying, which may impact the absorption of concomitantly administered oral medications. Mild to moderate decreases in plasma concentrations of coadministered drugs have been demonstrated in pharmacokinetic studies for some GLP-1 receptor agonists (e.g., exenatide, lixisenatide), but not others. According to the prescribing information, liraglutide did not affect the absorption of several orally administered drugs to any clinically significant extent, including acetaminophen, atorvastatin, digoxin, griseofulvin, lisinopril, and an oral contraceptive containing ethinyl estradiol-levonorgestrel. Likewise, no clinically relevant effect on absorption was observed for concomitantly administered oral drugs studied with albiglutide (digoxin, ethinyl estradiol-norethindrone, simvastatin, warfarin), dulaglutide (acetaminophen, atorvastatin, digoxin, ethinyl estradiol-norelgestromin, lisinopril, metformin, metoprolol, sitagliptin, warfarin), or semaglutide (atorvastatin, digoxin, ethinyl estradiol-levonorgestrel, metformin, warfarin). The impact of dual GLP-1 and GIP receptor agonist tirzepatide on gastric emptying was reported to be dose- and time-dependent, with the greatest effect observed after a single 5 mg dose but diminished after subsequent doses. When acetaminophen was administered following a single 5 mg dose of tirzepatide, acetaminophen peak plasma concentration (Cmax) was decreased by 50% and its median time to peak plasma concentration (Tmax) delayed by 1 hour. However, no significant impact on acetaminophen Cmax and Tmax was observed after 4 consecutive weekly doses of tirzepatide (5 mg/5 mg/8 mg/10 mg), and the overall exposure (AUC) of acetaminophen was unaffected. Tirzepatide at lower doses of 0.5 mg and 1.5 mg also had minimal effects on acetaminophen exposure.

MANAGEMENT: Although no specific dosage adjustment of concomitant medications is generally recommended based on available data, potential clinical impact on some oral medications cannot be ruled out, particularly those with a narrow therapeutic index or low bioavailability, those that depend on threshold concentrations for efficacy (e.g., antibiotics), and those that require rapid gastrointestinal absorption (e.g., hypnotics, analgesics). Pharmacologic response to concomitantly administered oral medications should be monitored more closely following initiation, dose adjustment, or discontinuation of a GLP-1 receptor agonist or a dual GLP-1 and GIP receptor agonist.

References

  1. "Product Information. Byetta (exenatide)." Amylin Pharmaceuticals Inc (2005):
  2. "Product Information. Victoza (liraglutide)." Novo Nordisk Pharmaceuticals Inc (2010):
  3. "Product Information. Tanzeum (albiglutide)." GlaxoSmithKline (2014):
  4. "Product Information. Trulicity (dulaglutide)." Eli Lilly and Company (2014):
  5. "Product Information. Adlyxin (lixisenatide)." sanofi-aventis (2016):
  6. "Product Information. Ozempic (1 mg dose) (semaglutide)." Novo Nordisk Pharmaceuticals Inc (2022):
  7. "Product Information. Mounjaro (tirzepatide)." Eli Lilly and Company Ltd (2023):
  8. "Product Information. Mounjaro (tirzepatide)." Lilly, Eli and Company (2023):
  9. Eli Lilly Canada Inc. "Product monograph including patient medication information MOUNJARO tirzepatide injection. https://pdf.hres.ca/dpd_pm/00068421.PDF" (2023):
View all 9 references

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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.

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