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Drug Interactions between lixisenatide and Nydrazid

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

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Moderate

isoniazid lixisenatide

Applies to: Nydrazid (isoniazid) and lixisenatide

MONITOR: The efficacy of insulin and other antidiabetic agents may be diminished by certain drugs, including atypical antipsychotics, corticosteroids, diuretics, estrogens, gonadotropin-releasing hormone agonists, human growth hormone, phenothiazines, progestins, protease inhibitors, sympathomimetic amines, thyroid hormones, L-asparaginase, alpelisib, copanlisib, danazol, diazoxide, isoniazid, megestrol, omacetaxine, phenytoin, sirolimus, tagraxofusp, temsirolimus, as well as pharmacologic dosages of nicotinic acid and adrenocorticotropic agents. These drugs may interfere with blood glucose control because they can cause hyperglycemia, glucose intolerance, new-onset diabetes mellitus, and/or exacerbation of preexisting diabetes.

MANAGEMENT: Caution is advised when drugs that can interfere with glucose metabolism are prescribed to patients with diabetes. Close clinical monitoring of glycemic control is recommended following initiation or discontinuation of these drugs, and the dosages of concomitant antidiabetic agents adjusted as necessary. Patients should be advised to notify their physician if their blood glucose is consistently high or if they experience symptoms of severe hyperglycemia such as excessive thirst and increases in the volume or frequency of urination. Likewise, patients should be observed for hypoglycemia when these drugs are withdrawn from their therapeutic regimen.

References

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  13. Jones IG, Pickens PT "Diabetes mellitus following oral diuretics." Practitioner 199 (1967): 209-10
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  36. Goldman JA, Ovadia JL "The effect of estrogen on intravenous glucose tolerance in woman." Am J Obstet Gynecol 103 (1969): 172-8
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  51. "Product Information. Amaryl (glimepiride)." Hoechst Marion Roussel PROD (2001):
  52. Charan VD, Desai N, Singh AP, Choudhry VP "Diabetes mellitus and pancreatitis as a complication of L- asparaginase therapy." Indian Pediatr 30 (1993): 809-10
  53. Seifer DB, Freedman LN, Cavender JR, Baker RA "Insulin-dependent diabetes mellitus associated with danazol." Am J Obstet Gynecol 162 (1990): 474-5
  54. "Product Information. Crixivan (indinavir)." Merck & Co., Inc PROD (2001):
  55. Pickkers P, Schachter M, Hughes AD, Feher MD, Sever PS "Thiazide-induced hyperglycaemia: a role for calcium-activated potassium channels?" Diabetologia 39 (1996): 861-4
  56. "Product Information. Viracept (nelfinavir)." Agouron Pharma Inc PROD (2001):
  57. Dube MP, Johnson DL, Currier JS, Leedom JM "Protease inhibitor-associated hyperglycaemia." Lancet 350 (1997): 713-4
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  59. "Product Information. Prandin (repaglinide)." Novo Nordisk Pharmaceuticals Inc PROD (2001):
  60. "Product Information. Elspar (asparaginase)." Merck & Co., Inc PROD (2001):
  61. "Product Information. Hyperstat (diazoxide)." Apothecon Inc (2022):
  62. "Product Information. Megace (megestrol)." Bristol-Myers Squibb PROD (2001):
  63. Walli R, Demant T "Impaired glucose tolerance and protease inhibitors." Ann Intern Med 129 (1998): 837-8
  64. "Product Information. Agenerase (amprenavir)." Glaxo Wellcome PROD (2001):
  65. Mauss S, Wolf E, Jaeger H "Impaired glucose tolerance in HIV-positive patients receiving and those not receiving protease inhibitors." Ann Intern Med 130 (1999): 162-3
  66. Kaufman MB, Simionatto C "A review of protease inhibitor-induced hyperglycemia." Pharmacotherapy 19 (1999): 114-7
  67. "Product Information. Tolinase (tolazamide)." Pharmacia and Upjohn PROD (2001):
  68. "Product Information. Orinase (tolbutamide)." Pharmacia and Upjohn PROD (2001):
  69. "Product Information. Dymelor (acetohexamide)." Lilly, Eli and Company PROD (2001):
  70. Wehring H, Alexander B, Perry PJ "Diabetes mellitus associated with clozapine therapy." Pharmacotherapy 20 (2000): 844-7
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  72. "Product Information. Fortovase (saquinavir)." Roche Laboratories PROD (2001):
  73. "Product Information. Starlix (nateglinide)." Novartis Pharmaceuticals PROD (2001):
  74. Hardy H, Esch LD, Morse GD "Glucose disorders associated with HIV and its drug therapy." Ann Pharmacother 35 (2001): 343-51
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  76. "Product Information. NovoLOG Mix 70/30 (insulin aspart-insulin aspart protamine)." Novo Nordisk Pharmaceuticals Inc (2022):
  77. "Product Information. Reyataz (atazanavir)." Bristol-Myers Squibb (2003):
  78. "Product Information. Lexiva (fosamprenavir)." GlaxoSmithKline (2003):
  79. "Product Information. Apidra (insulin glulisine)." Aventis Pharmaceuticals (2004):
  80. "Product Information. Prezista (darunavir)." Ortho Biotech Inc (2006):
  81. "Product Information. Zolinza (vorinostat)." Merck & Co., Inc (2006):
  82. "Product Information. Torisel (temsirolimus)." Wyeth-Ayerst Laboratories (2007):
  83. "Product Information. Rexulti (brexpiprazole)." Otsuka American Pharmaceuticals Inc (2015):
  84. "Product Information. Elzonris (tagraxofusp)." Stemline Therapeutics (2019):
  85. "Product Information. Piqray (alpelisib)." Novartis Pharmaceuticals (2019):
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Drug and food interactions

Moderate

isoniazid food

Applies to: Nydrazid (isoniazid)

GENERALLY AVOID: Concurrent use of isoniazid (INH) in patients who ingest alcohol daily may result in an increased incidence of both hepatotoxicity and peripheral neuropathy. The increase in hepatotoxicity may be due to an additive risk as both alcohol and INH are individually associated with this adverse reaction. INH-associated hepatotoxicity is believed to be due to an accumulation of toxic metabolites and may also be partly immune mediated, though the exact mechanisms are not universally agreed upon. INH is metabolized by N-acetyltransferase and CYP450 2E1. The rate of acetylation is genetically determined and generally classified as slow or rapid. Slow acetylators have been identified by some studies as having a higher risk of hepatotoxicity; therefore, this interaction may be more significant for patients who fall into this category. Other studies have postulated that alcohol-mediated CYP450 2E1 induction may play a role, as this isoenzyme is involved in INH metabolism and may be responsible for producing hepatotoxic metabolites. However, available literature is conflicting. The labeling for some INH products lists daily alcohol use or chronic alcoholism as a risk factor for hepatitis, but not all studies have found a significant association between alcohol use and INH-induced hepatotoxicity. Additionally, INH and alcohol are both associated with pyridoxine (B6) deficiency, which may increase the risk of peripheral neuropathy.

GENERALLY AVOID: Concomitant administration of isoniazid (INH) with foods containing tyramine and/or histamine may increase the risk of symptoms relating to tyramine- and/or histamine toxicity (e.g., headache, diaphoresis, flushing, palpitations, and hypotension). The proposed mechanism is INH-mediated inhibition of monoamine oxidase (MAO) and diamine oxidase (DAO), enzymes responsible for the metabolism of tyramine and histamine, respectively. Some authors have suggested that the reactions observed are mainly due to INH's effects on DAO instead of MAO or the amounts of histamine instead of tyramine present in the food. A Japanese case report recorded an example in 8 out of 25 patients on the tuberculosis ward who developed an accidental histamine poisoning after ingesting a fish paste (saury). Patients developed allergy-like symptoms, which started between 20 minutes and 2 hours after ingesting the food. A high-level of histamine (32 mg/100 g of fish) was confirmed in the saury paste and all 8 patients were both on INH and had reduced MAO concentrations. The 17 remaining patients were not on INH (n=5) or reported not eating the saury paste (n=12).

ADJUST DOSING INTERVAL: Administration with food significantly reduces oral isoniazid (INH) absorption, increasing the risk of therapeutic failure or resistance. The mechanism is unknown. Pharmacokinetic studies completed in both healthy volunteers (n=14) and tuberculosis patients (n=20 treatment-naive patients during days 1 to 3 of treatment) have resulted in almost doubling the time to reach INH's maximum concentration (tmax) and a reduction in isoniazid's maximum concentration (Cmax) of 42%-51% in patients who consumed high-fat or high-carbohydrate meals prior to INH treatment.

MANAGEMENT: The manufacturer of oral forms of isoniazid (INH) recommends administration on an empty stomach (i.e., 30 minutes before or 2 hours after meals). Patients should be encouraged to avoid alcohol or strictly limit their intake. Patients who use alcohol and INH concurrently or have a history of alcohol use disorder may require additional monitoring of their liver function during treatment with INH. Concomitant pyridoxine (B6) administration is also recommended to reduce the risk of peripheral neuropathy, with some authorities suggesting a dose of at least 10 mg/day. Patients should be advised to avoid foods containing tyramine (e.g., aged cheese, cured meats such as sausages and salami, fava beans, sauerkraut, soy sauce, beer, or red wine) or histamine (e.g., skipjack, tuna, mackerel, salmon) during treatment with isoniazid. Consultation of product labeling for combination products containing isoniazid and/or relevant guidelines may be helpful for more specific recommendations.

References

  1. Smith CK, Durack DT "Isoniazid and reaction to cheese." Ann Intern Med 88 (1978): 520-1
  2. Dimartini A "Isoniazid, tricyclics and the ''cheese reaction''." Int Clin Psychopharmacol 10 (1995): 197-8
  3. Uragoda CG, Kottegoda SR "Adverse reactions to isoniazid on ingestion of fish with a high histamine content." Tubercle 58 (1977): 83-9
  4. Self TH, Chrisman CR, Baciewicz AM, Bronze MS "Isoniazid drug and food interactions." Am J Med Sci 317 (1999): 304-11
  5. "Product Information. Isoniazid/Rifapentine 300 mg/300 mg (Macleods) (isoniazid-rifapentine)." Imported (India) 2 (2021):
  6. "Product Information. Isoniazid (isoniazid)." Chartwell RX, LLC. (2023):
  7. "Product Information. Isoniazid (Arrotex) (isoniazid)." Arrotex Pharmaceuticals Pty Ltd (2023):
  8. "Product Information. Isoniazid (isoniazid)." RPH Pharmaceuticals AB (2023):
  9. Saukkonen JJ, Cohn DL, Jasmer RM, et al. "An official ATS statement: hepatotoxicity of antituberculosis therapy." Am J Respir Crit Care Med 174 (2006): 935-52
  10. Bouazzi OE, Hammi S, Bourkadi JE, et al. "First line anti-tuberculosis induced hepatotoxicity: incidence and risk factors. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5326068/" (2024):
  11. Wang P, Pradhan K, Zhong XB, Ma X "Isoniazid metabolism and hepatoxicity." Acta Pharm Sin B 6 (2016): 384-92
  12. Saktiawati AM, Sturkenboom MG, Stienstra Y, et al. "Impact of food on the pharmacokinetics of first-line anti-TB drugs in treatment naive TB patients: a randomized cross-over trial." J Antimicrob Chemother 71 (2016): 703-10
  13. Hahn JA, Ngabirano C, Fatch R, et al. "Safety and tolerability of isoniazid preventive therapy for tuberculosis for persons with HIV with and without alcohol use." AIDS 37 (2023): 1535-43
  14. Huang YS, Chern HD, Su WJ, et al. "Cytochrome P450 2E1 genotype and the susceptibility to antituberculosis drug-induced hepatitis." Hepatology 37 (2003): 924-30
  15. Sousou JM, Griffith EM, Marsalisi C, Reddy P "Pyridoxine deficiency and neurologic dysfunction: an unlikely association. https://www.cureus.com/articles/188310-pyridoxine-deficiency-and-neurologic-dysfunction-an-unlikely-association?score_article=true#!/" (2024):
  16. Miki M, Ishikawa T, Okayama H "An outbreak of histamine poisoning after ingestion of the ground saury paste in eight patients taking isoniazid in tuberculous ward." Intern Med 44 (2005): 1133-6
  17. "Product Information. Isotamine (isoniazid)." Bausch Health, Canada Inc. (2021):
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Moderate

lixisenatide food

Applies to: lixisenatide

ADJUST DOSING INTERVAL: Lixisenatide slows gastric emptying, which may impact the absorption of concomitantly administered oral medications. The interaction has been studied with various medications, which demonstrated primarily an effect on the rate rather than the overall extent of absorption.

Acetaminophen: When acetaminophen 1000 mg was administered 1 hour and 4 hours after lixisenatide 10 mcg injection, acetaminophen peak plasma concentration (Cmax) was decreased by 29% and 31%, respectively; and median time to peak plasma concentration (Tmax) was delayed by 2 hours and 1.75 hours, respectively. The Cmax and Tmax of acetaminophen were not significantly altered when acetaminophen was given one hour before lixisenatide injection, and systemic exposure (AUC) was not affected whether administered before or after lixisenatide administration. Based on these results, no dose adjustment for acetaminophen is required; however, it may be advisable to take acetaminophen at least one hour before lixisenatide if a rapid onset of action is required.

Oral Contraceptives: When an oral contraceptive containing ethinyl estradiol 0.03 mg and levonorgestrel 0.15 mg was administered 1 hour and 4 hours after lixisenatide 10 mcg injection, ethinyl estradiol Cmax was decreased by 52% and 39%, respectively, while levonorgestrel Cmax was decreased by 46% and 20%, respectively. Median Tmax values were delayed by 1 to 3 hours, but overall exposure (AUC) and mean terminal half-life (T1/2) of ethinyl estradiol and levonorgestrel were not significantly altered. Administration of the oral contraceptive 1 hour before or 11 hours after lixisenatide had no effect on any of the measured pharmacokinetic parameters of either ethinyl estradiol or levonorgestrel. Based on these results, no dose adjustment for oral contraceptives is required; however, some authorities recommend that oral contraceptives be administered at least 1 hour before or 11 hours after lixisenatide.

Atorvastatin: When atorvastatin 40 mg and lixisenatide 20 mcg were coadministered in the morning for 6 days, atorvastatin Cmax was decreased by 31% and Tmax was delayed by 3.25 hours, but AUC was not affected. When atorvastatin was administered in the evening and lixisenatide in the morning, the AUC and Cmax of atorvastatin were increased by 27% and 66%, respectively, but there was no change in Tmax. Based on these results, no dose adjustment for atorvastatin is required; however, some authorities recommend that atorvastatin be administered at least 1 hour before lixisenatide.

Warfarin: When warfarin 25 mg was coadministered with repeated dosing of lixisenatide 20 mcg, warfarin Cmax was decreased by 19% and Tmax was delayed by 7 hours, but there were no effects on AUC or International Normalized Ratio (INR). Based on these results, no dose adjustment for warfarin is required; however, closer monitoring of INR may be appropriate following initiation or discontinuation of lixisenatide treatment.

Digoxin: When digoxin 0.25 mg and lixisenatide 20 mcg were coadministered at steady state, digoxin Cmax was decreased by 26% and Tmax was delayed by 1.5 hours, but AUC was not affected. Based on these results, no dose adjustment for digoxin is required.

Ramipril: When ramipril 5 mg and lixisenatide 20 mcg were coadministered for 6 days, ramipril Cmax was decreased by 63% and AUC was increased by 21%, while Cmax and AUC of the active metabolite (ramiprilat) were not affected. The Tmax values of ramipril and ramiprilat were delayed by approximately 2.5 hours. Based on these results, no dose adjustment for ramipril is required.

MANAGEMENT: Caution is advised during concomitant use of lixisenatide with oral medications that have a narrow therapeutic index or that require careful clinical monitoring. These medications should be administered on a consistent schedule relative to lixisenatide, and blood levels and/or pharmacologic effects should be closely monitored. In addition, if they are to be administered with food, patients should be advised to take them with a meal or snack when lixisenatide is not administered. Oral medications that are particularly dependent on threshold concentrations for efficacy, such as antibiotics, or medications for which a delay in effect is undesirable, such as acetaminophen, should be administered at least 1 hour before lixisenatide. Gastro-resistant formulations containing substances sensitive to stomach degradation should be administered 1 hour before or 4 hours after lixisenatide. Patients taking oral contraceptives should be advised to take them at least 1 hour before or 11 hours after lixisenatide.

References

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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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.

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