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Avandaryl (glimepiride / rosiglitazone) Disease Interactions

There are 14 disease interactions with Avandaryl (glimepiride / rosiglitazone):

Major

Oral Hypoglycemic Agents (Includes Avandaryl) ↔ Cardiovascular Risk

Severe Potential Hazard, Moderate plausibility

Applies to: Cardiovascular Disease

The use of oral hypoglycemic agents may be associated with an increased risk of cardiovascular mortality compared to treatment with diet alone or diet with insulin. This warning is based on the University Group Diabetes Program (UGDP) study, a long-term prospective clinical trial designed to evaluate the effectiveness of glucose-lowering drugs in preventing or delaying vascular complications in patients with non-insulin-dependent diabetes. Patients treated with diet plus a fixed dosage of either tolbutamide (a sulfonylurea) or phenformin (a biguanide) for 5 to 8 years had a cardiovascular mortality rate approximately 2.5 times that of patients treated with diet alone, resulting in discontinuation of both these treatments in the study. Despite controversy regarding interpretation of these results, clinicians and patients should be aware of the potential risk when making treatment decisions for diabetes, particularly in the presence of underlying cardiovascular disease. Data are not available for other sulfonylureas or biguanides, nor for hypoglycemic agents belonging to other classes. However, given the similarities in chemical structure and/or mode of action, the same caution should be applied.

References

  1. "Product Information. Glucotrol (glipizide)." Pfizer US Pharmaceuticals, New York, NY.
  2. "Product Information. Prandin (repaglinide)." Novo Nordisk Pharmaceuticals Inc, Princeton, NJ.
  3. "Product Information. Diabeta (glyburide)." Hoechst Marion-Roussel Inc, Kansas City, MO.
  4. "Product Information. Tolinase (tolazamide)" Pharmacia and Upjohn, Kalamazoo, MI.
  5. "Product Information. Amaryl (glimepiride)." Hoechst Marion-Roussel Inc, Kansas City, MO.
  6. "Product Information. Diabinese (chlorpropamide)." Pfizer US Pharmaceuticals, New York, NY.
  7. "Product Information. Dymelor (acetohexamide)" Lilly, Eli and Company, Indianapolis, IN.
  8. "Product Information. Glucophage (metformin)." Bristol-Myers Squibb, Princeton, NJ.
View all 8 references
Major

Rosiglitazone (Includes Avandaryl) ↔ Myocardial Infarction

Severe Potential Hazard, Moderate plausibility

Applies to: History - Myocardial Infarction, Ischemic Heart Disease

Safety data from a pooled analysis of 42 randomized, controlled clinical studies suggest that patients treated with rosiglitazone may have an increased risk of myocardial infarction and/or death from heart-related causes. The overall incidence of myocardial ischemia was 1.99% in patients receiving rosiglitazone-containing therapies (n = 8,604) for at least 24 weeks, compared to 1.51% in patients receiving placebo or other antidiabetic therapies (n = 5,633) for a similar duration. The hazard ratio was 1.31 (95% CI, 1.01 to 1.70) for rosiglitazone-treated patients relative to the comparators, which represents a greater than 30% excess risk of myocardial ischemic events in the rosiglitazone group. However, other published and unpublished data from long-term clinical trials of rosiglitazone provide contradictory evidence about the potential risks. Until more data are available, caution may be advisable when rosiglitazone is prescribed to patients with underlying heart disease or a history of myocardial infarction.

References

  1. Nissen SE, Wolski K "Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes." N Engl J Med 356 (2007): 2457-71
  2. FDA. United States Food and Drug Administration "Rosiglitazone maleate (marketed as Avandia, Avandamet, and Avandaryl) Available from: URL: http://www.fda.gov/cder/drug/InfoSheets/HCP/rosiglitazoneHCP.pdf." ([2007 Jun]):
Major

Sulfonylureas (Includes Avandaryl) ↔ Renal/Liver Disease

Severe Potential Hazard, High plausibility

Applies to: Renal Dysfunction, Liver Disease

Sulfonylureas are metabolized in the liver, and their metabolites (some with pharmacologic activity) are excreted in the urine and feces. Patients with impaired liver and/or renal function treated with sulfonylureas may be exposed to higher serum drug concentrations, which can increase the potential for severe hypoglycemic episodes induced by these agents. In the presence of hepatic impairment, gluconeogenic capacity may also be diminished, further compounding the risk. Therapy with sulfonylureas should be administered cautiously in patients with liver and/or renal disease. Reduced dosages and longer intervals between dosage adjustments may be required. Hypoglycemia, if it occurs during treatment, may be prolonged in these patients because of slowed metabolism and/or excretion of the drugs.

References

  1. "Product Information. Diabeta (glyburide)." Hoechst Marion-Roussel Inc, Kansas City, MO.
  2. Prendergast BD "Glyburide and glipizide, second-generation oral sulfonylurea hypoglycemic agents." Clin Pharm 3 (1984): 473-85
  3. Neuvonen PJ, Karkkainen S, Lehtovaara R "Pharmacokinetics of chlorpropamide in epileptic patients: effects of enzyme induction and urine pH on chlorpropamide elimination." Eur J Clin Pharmacol 32 (1987): 297-301
  4. "Product Information. Dymelor (acetohexamide)" Lilly, Eli and Company, Indianapolis, IN.
  5. Johnson PC, Hennes AR, Driscoll T, West KM "Metabolic fate of chlorpropamide in man." Ann N Y Acad Sci 74 (1959): 459-72
  6. "Product Information. Amaryl (glimepiride)." Hoechst Marion-Roussel Inc, Kansas City, MO.
  7. Brotherton PM, Grieveson P, McMartin C "A study of the metabolic fate of chlorpropamide in man." Clin Pharmacol Ther 10 (1970): 505-14
  8. Lebovitz HE "Glipizide: a second-generation sulfonylurea hypoglycemic agent. Pharmacology, pharmacokinetics and clinical use." Pharmacotherapy 5 (1985): 63-77
  9. Kobayashi KA, Bauer LA, Horn JR, Opheim K, Wood F, Jr Kradjan WA "Glipizide pharmacokinetics in young and elderly volunteers." Clin Pharm 7 (1988): 224-8
  10. Petitpierre B, Perrin L, Rudhardt M, et al "Behaviour of chlorpropamide in renal insufficiency and under the effect of associated drug therapy." Int J Clin Pharmacol 6 (1972): 120-4
  11. "Product Information. Tolinase (tolazamide)" Pharmacia and Upjohn, Kalamazoo, MI.
  12. Balant L, Zahnd G, Gorgia A, Schwarz R, Fabre J "Pharmacokinetics of glipizide in man: influence of renal insufficiency." Diabetologia Sep (1973): 331-8
  13. "Product Information. Micronase (glyburide)." Pharmacia and Upjohn, Kalamazoo, MI.
  14. Pearson JG, Antal EJ, Raehl CL, Gorsch HK, Craig WA, Albert KS, Welling PG "Pharmacokinetic disposition of 14C-glyburide in patients with varying renal function." Clin Pharmacol Ther 39 (1986): 318-24
  15. "Glibenclamide: a review." Drugs 1 (1971): 116-40
  16. Rydberg T, Jonsson A, Melander A "Comparison of the kinetics of glyburide and its active metabolites in humans." J Clin Pharm Ther 20 (1995): 283-95
  17. "Product Information. Diabinese (chlorpropamide)." Pfizer US Pharmaceuticals, New York, NY.
  18. Rydberg T, Jonsson A, Roder M, Melander A "Hypoglycemic activity of glyburide (glibenclamide) metabolites in humans." Diabetes Care 17 (1994): 1026-30
  19. Pentikainen PJ, Neuvonen PJ, Penttila A "Pharmacokinetics and pharmacodynamics of glipizide in healthy volunteers." Int J Clin Pharmacol Ther Toxicol 21 (1983): 98-107
  20. Badian M, Korn A, Lehr KH, Malerczyk V, Waldhausl W "Determination of the absolute bioavailability of glimepiride (HOE 490), a new sulphonylurea." Int J Clin Pharmacol Ther Toxicol 30 (1992): 481-2
  21. Huupponen R, Lammintausta R "Chlorpropamide bioavailability and pharmacokinetics." Int J Clin Pharmacol Ther Toxicol 19 (1981): 331-3
  22. "Product Information. Glucotrol (glipizide)." Pfizer US Pharmaceuticals, New York, NY.
  23. Sartor G, Melander A, Schersten B, Wahlin-Boll E "Comparative single-dose kinetics and effects of four sulfonylureas in healthy volunteers." Acta Med Scand 208 (1980): 301-7
View all 23 references
Major

Thiazolidinediones (Includes Avandaryl) ↔ Chf

Severe Potential Hazard, Moderate plausibility

Applies to: Congestive Heart Failure

The use of thiazolidinediones, alone or in combination with other antidiabetic agents, has been associated with fluid retention and new onset or exacerbation of heart failure. An increased risk of cardiovascular events (heart failure worsening; new or worsening edema; new or worsening dyspnea; increases in heart failure medication; myocardial infarction; angina; cardiovascular hospitalization and deaths) has been reported with rosiglitazone therapy in type II diabetic patients with New York Heart Association (NYHA) Class I or II congestive heart failure compared to placebo. Likewise, overnight hospitalization for CHF was observed in 9.9% of diabetic patients with NYHA Class II and III heart failure on pioglitazone compared to 4.7% of patients on glyburide. An increased incidence of cardiovascular adverse events including edema and cardiac failure has also been reported in patients receiving a thiazolidinedione in combination with insulin relative to insulin and placebo. Therapy with thiazolidinediones should be administered cautiously and initiated at the lowest recommended dosage in patients with congestive heart failure. Thiazolidinediones are contraindicated for the treatment of patients with NYHA Class III or IV cardiac status. Patients should be monitored for signs of worsening heart failure such as increased dyspnea, edema, and weight gain. Therapy should be discontinued if any deterioration in cardiac status occurs.

References

  1. "Product Information. Avandia (rosiglitazone)" SmithKline Beecham, Philadelphia, PA.
  2. "Product Information. Actos (pioglitazone)" Takeda Pharmaceuticals America, Lincolnshire, IL.
Major

Thiazolidinediones (Includes Avandaryl) ↔ Type I Diabetes

Severe Potential Hazard, Moderate plausibility

Applies to: Diabetic Ketoacidosis, Diabetes Type 1

Thiazolidinediones exert their hypoglycemic effect only in the presence of insulin. Therefore, these agents should not be used in patients with type I diabetes or for the treatment of diabetic ketoacidosis.

References

  1. "Product Information. Avandia (rosiglitazone)" SmithKline Beecham, Philadelphia, PA.
  2. "Product Information. Actos (pioglitazone)" Takeda Pharmaceuticals America, Lincolnshire, IL.
Moderate

Insulin/Oral Hypoglycemic Agents (Includes Avandaryl) ↔ Hypoglycemia

Moderate Potential Hazard, Moderate plausibility

Applies to: Adrenal Insufficiency, Malnourished, Autonomic Neuropathy, Panhypopituitarism, Anorexia/Feeding Problems

Hypoglycemia may commonly occur during treatment with insulin and/or oral hypoglycemic agents. Care should be taken in patients who may be particularly susceptible to the development of hypoglycemic episodes during the use of these drugs, including those who are debilitated or malnourished, those with defective counterregulatory mechanisms (e.g., autonomic neuropathy and adrenal or pituitary insufficiency), and those receiving beta-adrenergic blocking agents.

References

  1. "Product Information. Novolog (insulin aspart)" Novo Nordisk Pharmaceuticals Inc, Princeton, NJ.
  2. "Product Information. Glucophage (metformin)." Bristol-Myers Squibb, Princeton, NJ.
  3. Fauci AS, Braunwald E, Isselbacher KJ, Wilson JD, Martin JB, Kasper DL, Hauser SL, Longo DL, eds. "Harrison's Principles of Internal Medicine. 14th ed." New York, NY: McGraw-Hill Health Professionals Division (1998):
  4. "Product Information. Glucotrol (glipizide)." Pfizer US Pharmaceuticals, New York, NY.
  5. "Product Information. Prandin (repaglinide)." Novo Nordisk Pharmaceuticals Inc, Princeton, NJ.
  6. "Product Information. Lantus (insulin glargine)" Aventis Pharmaceuticals, Swiftwater, PA.
  7. "Product Information. Humulin BR (insulin)." Lilly, Eli and Company, Indianapolis, IN.
  8. "Product Information. Diabeta (glyburide)." Hoechst Marion-Roussel Inc, Kansas City, MO.
  9. "Product Information. Dymelor (acetohexamide)" Lilly, Eli and Company, Indianapolis, IN.
  10. "Product Information. Amaryl (glimepiride)." Hoechst Marion-Roussel Inc, Kansas City, MO.
  11. "Product Information. Tolinase (tolazamide)" Pharmacia and Upjohn, Kalamazoo, MI.
  12. "Product Information. Micronase (glyburide)." Pharmacia and Upjohn, Kalamazoo, MI.
  13. "Product Information. Starlix (nateglinide)" Novartis Pharmaceuticals, East Hanover, NJ.
  14. "Product Information. Diabinese (chlorpropamide)." Pfizer US Pharmaceuticals, New York, NY.
  15. "Multum Information Services, Inc. Expert Review Panel"
View all 15 references
Moderate

Sulfonylureas (Includes Avandaryl) ↔ G6Pd Deficiency

Moderate Potential Hazard, Moderate plausibility

Applies to: G-6-PD Deficiency

Sulfonylureas can cause hemolytic anemia in patients with glucose 6-phosphate dehydrogenase (G6PD) deficiency. Therapy with these agents should be used with caution in patients with G6PD deficiency and consider the use of a non-sulfonylurea alternative. There have been postmarketing reports of hemolytic anemia in patients receiving these drugs who did not have known G6PD deficiency.

Moderate

Sulfonylureas (Includes Avandaryl) ↔ Hyponatremia

Moderate Potential Hazard, Moderate plausibility

Applies to: SIADH, Hyponatremia, Dehydration

Treatment with sulfonylureas may cause hyponatremia, in patients who are on other medications or have medical conditions known to cause hyponatremia or increase release of antidiuretic hormone. The syndrome of inappropriate antidiuretic hormone (SIADH) secretion has been reported with certain sulfonylureas and these drugs may augment the peripheral (antidiuretic) action of ADH and/or increase release of ADH. Caution should be used when treating patients with hyponatremia or at greater risk of developing hyponatremia such as elderly patients, patients taking diuretics or those who are volume-depleted.

Moderate

Thiazolidinediones (Includes Avandaryl) ↔ Edema

Moderate Potential Hazard, Moderate plausibility

Applies to: Hypertension, Pleural Effusion, Pulmonary Edema, Fluid Retention

Thiazolidinediones can cause dose-related edema. Therapy with thiazolidinediones should be administered cautiously in patients at risk for congestive heart failure as well as those with fluid overload or other conditions that may be adversely affected by excess fluid such as hypertension. Patients should be monitored for signs and symptoms of heart failure such as dyspnea, swelling of legs or ankles, and weight gain.

References

  1. "Product Information. Rezulin (troglitazone)." Parke-Davis, Morris Plains, NJ.
  2. "Product Information. Avandia (rosiglitazone)" SmithKline Beecham, Philadelphia, PA.
  3. "Product Information. Actos (pioglitazone)" Takeda Pharmaceuticals America, Lincolnshire, IL.
  4. Thomas ML, Lloyd SJ "Pulmonary edema associated with rosiglitazone and troglitazone." Ann Pharmacother 35 (2001): 123-4
View all 4 references
Moderate

Thiazolidinediones (Includes Avandaryl) ↔ Liver Disease

Moderate Potential Hazard, Moderate plausibility

Applies to: Liver Disease

Initiation of rosiglitazone or pioglitazone therapy is not recommended in patients who exhibit clinical evidence of active liver disease or increased baseline serum transaminase levels (ALT exceeding 2.5 times upper limit of normal). Use of these agents is also not recommended in patients who have experienced jaundice during treatment with troglitazone. The use of troglitazone, another agent in the thiazolidinedione class, has been associated with clinically significant elevations in liver enzymes, reversible jaundice, and idiosyncratic hepatocellular injury including rare cases of liver failure, liver transplants, and death. Injury has occurred after both short- and long-term treatment. While these effects have not been associated with other thiazolidinediones in clinical trials, concerns exist because of their structural similarities. In addition, isolated cases of hepatitis and hepatic enzyme elevations to 3 or more times the upper limit of normal have been reported with both rosiglitazone and pioglitazone during postmarketing use. Rarely, these events have involved hepatic failure with and without fatal outcome, although causality has not been established. Until more safety data are available, patients who are prescribed thiazolidinedione therapy should have serum transaminase levels checked at baseline and periodically thereafter as clinically necessary. Mild to moderate elevations (ALT less than or equal to 2.5 times ULN) require cautious use with more frequent monitoring to determine if the elevations resolve or worsen. Patients who develop potential symptoms of hepatic injury such as unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, and dark urine should have liver enzymes checked. Therapy should be withdrawn if ALT is elevated and persists above 3 times ULN or if jaundice develops.

References

  1. Gitlin N, Julie NL, Spurr CL, Lim KN, Juarbe HM "Two cases of severe clinical and histologic hepatotoxicity associated with troglitazone." Ann Intern Med 129 (1998): 36-8
  2. "Product Information. Avandia (rosiglitazone)" SmithKline Beecham, Philadelphia, PA.
  3. Watkins PB, Whitcomb RW "Hepatic dysfunction associated with troglitazone." N Engl J Med 338 (1998): 916-7
  4. NeuschwanderTetri BA, Isley WL, Oki JC, Ramrakhiani S, Quiason SG, Phillips NJ, Brunt EM "Troglitazone-induced hepatic failure leading to liver transplantation - A case report." Ann Intern Med 129 (1998): 38-41
  5. Forman LM, Simmons DA, Diamond RH "Hepatic failure in a patient taking rosiglitazone." Ann Intern Med 132 (2000): 118-21
  6. Neuschwander-Tetre BA, Isley WL, Oki JC, et al. "Troglitazone-induced hepatic failure leading to liver transplantation: a case report." Ann Intern Med 129 (1998): 38-41
  7. Hachey DM, O'Neil MP, Force RW "Isolated elevation of alkaline level associated with rosiglitazone." Ann Intern Med 133 (2000): 752
  8. St. Peter JV, Neafus KL, Khan MA, Vessey JT, Lockheart SK "Factors associated with the risk of liver enzyme elevation in patients with type 2 diabetes treated with a thiazolidinedione." Pharmacotherapy 21 (2001): 183-88
  9. Maeda K "Hepatocellular injury in a patient receiving pioglitazone." Ann Intern Med 135 (2001): 306
  10. Prendergast KA, Berg CL, Wisniewski R "Troglitazone-associated hepatotoxicity treated successfully with steroids." Ann Intern Med 133 (2000): 751
  11. "Product Information. Actos (pioglitazone)" Takeda Pharmaceuticals America, Lincolnshire, IL.
View all 11 references
Moderate

Thiazolidinediones (Includes Avandaryl) ↔ Macular Edema

Moderate Potential Hazard, Moderate plausibility

Applies to: Diabetes Mellitus, Diabetic Macular Edema

New onset or worsening diabetic macular edema with decreased visual acuity have been reported in postmarketing reports in some diabetic patients who were taking thiazolidinedione drugs. Some patients presented with blurred vision or decreased visual acuity, but some patients appear to have been diagnosed on routine ophthalmologic examination. Most patients had peripheral edema at the time macular edema was diagnosed. Some patients had improvement in their macular edema after discontinuation of their thiazolidinedione. Patients with diabetes should have regular eye exams by an ophthalmologist according to current standards of care. Additionally, any diabetic who reports any kind of visual symptom should be promptly referred to an ophthalmologist, regardless of the patient's underlying medications or other physical findings.

Moderate

Thiazolidinediones (Includes Avandaryl) ↔ Premenopausal Anovulation

Moderate Potential Hazard, Moderate plausibility

Applies to: Premenopausal Anovulation

In premenopausal, anovulatory patients with insulin resistance, treatment with thiazolidinediones may result in resumption of ovulation. Due to improved insulin sensitivity, pregnancy can occur if adequate contraception is not used.

References

  1. "Product Information. Avandia (rosiglitazone)" SmithKline Beecham, Philadelphia, PA.
  2. "Product Information. Actos (pioglitazone)" Takeda Pharmaceuticals America, Lincolnshire, IL.
  3. "Product Information. Rezulin (troglitazone)." Parke-Davis, Morris Plains, NJ.
Moderate

Thiazolidinediones (Includes Avandaryl) ↔ Weight Gain

Moderate Potential Hazard, Moderate plausibility

Applies to: Obesity

Thiazolidinediones can cause dose-related weight gain, which may be undesirable in obese patients attempting to lose weight. The mechanism of weight gain is unclear but probably involves a combination of fluid retention and fat accumulation. In postmarketing experience with rosiglitazone, there have been reports of unusually rapid increases in weight, greater than those generally observed in clinical trials. Patients who experience such increases should be assessed for fluid retention and volume-related events such as excessive edema and congestive heart failure.

References

  1. "Product Information. Avandia (rosiglitazone)" SmithKline Beecham, Philadelphia, PA.
  2. "Product Information. Actos (pioglitazone)" Takeda Pharmaceuticals America, Lincolnshire, IL.
Moderate

Thiazolidinediones (Includes Avandaryl) ↔ Anemia

Minor Potential Hazard, Moderate plausibility

Applies to: Anemia

Thiazolidinediones can cause slight decreases in hemoglobin and hematocrit. In clinical studies, hemoglobin levels were reduced primarily within the first 4 to 12 weeks of therapy but remained relatively constant thereafter. These changes may be related to increased plasma volume and have rarely been associated with any significant hematologic clinical effects. Nevertheless, caution may be advisable when thiazolidinediones are prescribed to patients with certain anemias.

References

  1. "Product Information. Avandia (rosiglitazone)" SmithKline Beecham, Philadelphia, PA.
  2. "Product Information. Actos (pioglitazone)" Takeda Pharmaceuticals America, Lincolnshire, IL.

Avandaryl (glimepiride / rosiglitazone) drug Interactions

There are 991 drug interactions with Avandaryl (glimepiride / rosiglitazone)

Avandaryl (glimepiride / rosiglitazone) alcohol/food Interactions

There are 3 alcohol/food interactions with Avandaryl (glimepiride / rosiglitazone)

Drug Interaction Classification

The classifications below are a general guideline only. It is difficult to determine the relevance of a particular drug interaction to any individual given the large number of variables.
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 information available.

Do not stop taking any medications without consulting your healthcare provider.

Further information

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

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