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Rosiglitazone/glimepiride Generic Name & Formulations
Legal Class
Rx
General Description
Rosiglitazone (as maleate), glimepiride; 4mg/1mg, 4mg/2mg, 4mg/4mg, 8mg/2mg, 8mg/4mg; tabs.
Pharmacological Class
Thiazolidinedione + sulfonylurea.
How Supplied
Contact supplier.
Manufacturer
Rosiglitazone/glimepiride Indications
Indications
Adjunct to diet and exercise for type 2 diabetes when dual therapy is appropriate.
Rosiglitazone/glimepiride Dosage and Administration
Adult
≥18yrs: Take once daily with first meal of the day. Drug-naive: 4mg/1mg. Previously on thiazolidinedione monotherapy: initially 4mg/1mg or 4mg/2mg; if inadequate response after 1–2 weeks, may increase glimepiride component in ≤2mg increments at 1–2 week intervals. Previously on sulfonylurea monotherapy: initially 4mg/1mg or 4mg/2mg; if inadequate response, may increase rosiglitazone component after 8–12 weeks. Previously on rosiglitazone and glimepiride: switch on a mg/mg basis. Max 8mg rosiglitazone/4mg glimepiride per day. Elderly, debilitated, malnourished, renal, hepatic or adrenal insufficiency: initially 4mg/1mg once daily; titrate carefully to avoid hypoglycemia.
Children
<18yrs: not established.
Rosiglitazone/glimepiride Contraindications
Contraindications
NYHA Class III or IV heart failure. Sulfonamide allergy.
Rosiglitazone/glimepiride Boxed Warnings
Not Applicable
Rosiglitazone/glimepiride Warnings/Precautions
Warnings/Precautions
Not for treating type 1 diabetes or diabetic ketoacidosis. Symptomatic HF or acute coronary syndromes: not recommended; discontinue if occurs. CHF: NYHA Class I or II: increased risk of cardiovascular events (monitor). Edema. May increase plasma volume (monitor for heart failure); discontinue if cardiac status deteriorates. Monitor for weight gain/fluid retention. Risk of cardiovascular mortality. Hepatic disease. Do not start therapy in active liver disease or if ALT >2.5xULN. Monitor transaminases at baseline, then periodically. If ALT is mildly elevated (≤2.5xULN), follow-up and monitor closely; discontinue if ALT >3xULN or jaundice occurs. Not for use in patients with history of troglitazone-associated jaundice. Risk of fractures (esp. women). G6PD deficiency. Stress, uncompensated strenuous exercise, deficient caloric intake, or alcohol intoxication: increased risk of hypoglycemia. Resumption of premenopausal ovulation in anovulatory patients may occur (may result in unintended pregnancy). Reevaluate if menstrual dysfunction occurs. Elderly. Labor & delivery. Pregnancy (Cat.C) (consider using insulin instead), nursing mothers: not recommended.
Rosiglitazone/glimepiride Pharmacokinetics
See Literature
Rosiglitazone/glimepiride Interactions
Interactions
Concomitant insulin or nitrates: not recommended. Potentiated by CYP2C8 inhibitors (eg, gemfibrozil). Antagonized by CYP2C8 inducers (eg, rifampin). May be potentiated by alcohol, NSAIDs, highly protein bound drugs, oral miconazole, salicylates, sulfonamides, chloramphenicol, warfarin, probenecid, MAOIs, β-blockers. May be antagonized by diuretics, corticosteroids, phenothiazines, thyroid products, phenytoin, niacin, sympathomimetics, isoniazid, estrogens, oral contraceptives. May be affected by CYP2C9 substrates (eg, rifampin, fluconazole). Separate colesevelam dosing by ≥4 hours. Monitor for 1–2 weeks if transferring from long-acting sulfonylureas.
Rosiglitazone/glimepiride Adverse Reactions
Adverse Reactions
Headache, hypoglycemia, nasopharyngitis, upper respiratory tract infection, injury, edema, weight gain, anemia, macular edema (possible), hypersensitivity reactions (eg, angioedema, Stevens-Johnson syndrome); discontinue if occurs. See full labeling re: risk of myocardial ischemic events.
Rosiglitazone/glimepiride Clinical Trials
See Literature
Rosiglitazone/glimepiride Note
Notes
Formerly known under the brand name Avandaryl.
Rosiglitazone/glimepiride Patient Counseling
See Literature
