reformatory [18:<18 years of age. 118 137 Fixed combination with metformin hydrochloride: Safety and efficacy not established in pediatric patients. 110 ADA states that use of oral antidiabetic agents may be considered in children with type 2 diabetes mellitus because of the greater compliance and convenience and lack of evidence demonstrating better efficacy of insulin for type 2 diabetes mellitus. 107 Geriatric Use No substantial differences in safety and efficacy relative to younger adults. 1 (See Geriatric Patients under Dosage and Administration.) Hepatic Impairment Use with caution in patients with mild hepatic impairment (ALT 2.5 times the ULN). 1 110 118 Use not recommended in patients with ALT> 2.5 times ULN. 1 110 118 (See Hepatic Effects under Cautions.) Common Adverse Effects Upper respiratory tract infection, 1 30 injury, 1 headache. 1 Interactions for Rosiglitazone Maleate Metabolized principally by CYP2C8 and, to a lesser extent, by CYP2C9. 1 110 118 Does not inhibit CYP isoenzymes. 1 110 118 Drugs Affecting Hepatic Microsomal Enzymes Inhibitors or inducers of CYP2C8: Potential pharmacokinetic interaction. 104 Changes in antidiabetic therapy may be necessary when these drugs are initiated or discontinued during rosiglitazone therapy. 1 118 Drugs metabolized by CYP3A4: Pharmacokinetic interaction unlikely. 1 30 Specific Drugs Drug Interaction Comments Acarbose Clinically important pharmacokinetic interaction unlikely 1 Alcohol Pharmacologic interaction (i.e., increased risk of hypoglycemia) unlikely 1 Antidiabetic agents (See entries for acarbose, glimepiride, glyburide, and metformin) Possible hypoglycemia 1 May need to reduce dosage of concomitant antidiabetic agents 1 Calcium-channel blockers May cause hyperglycemia and lead to loss of glycemic control 110 Corticosteroids May cause hyperglycemia and lead to loss of glycemic control 110 118 Digoxin Pharmacokinetic interaction unlikely 1 30 Diuretics, thiazide May cause hyperglycemia and lead to loss of glycemic control 110 118 Gemfibrozil Potential increased AUC of rosiglitazone 1 110 May need to reduce rosiglitazone dosage when gemfibrozil therapy is initiated 1 110 Glimepiride Additive glycemic control 1 118 Pharmacokinetic interaction unlikely 1 118 Used to therapeutic advantage 118 Glyburide Variable effects on peak plasma concentrations and AUC of glyburide, depending on race 1 118 Enhanced glycemic control following long-term combined therapy 30 104 105 106 Insulin Increased risk of CHF 110 118 128 Concomitant use not recommended 1 Isoniazid May cause hyperglycemia and lead to loss of glycemic control 110 Metformin Pharmacokinetic interaction unlikely 1 Additive glycemic control 1 30 Used to therapeutic advantage 110 Niacin May cause hyperglycemia and lead to loss of glycemic control 110 Nifedipine Pharmacokinetic interaction unlikely 1 Oral contraceptives, hormonal (ethinyl estradiol, norethindrone) Pharmacokinetic interaction unlikely 1 Estrogens may cause hyperglycemia and lead to loss of glycemic control 110 118 Phenothiazines May cause hyperglycemia and lead to loss of glycemic control 110 118 Phenytoin May cause hyperglycemia and lead to loss of glycemic control 110 118 Ranitidine Pharmacokinetic interaction unlikely 1 Rifampin Potential decreased rosiglitazone AUC 1 110 118 May need to adjust dosage of rosiglitazone during initiation or discontinuance of rifampin 1 110 118 Sympathomimetic agents May cause hyperglycemia and lead to loss of glycemic control 110 118 Thyroid hormones May cause hyperglycemia and lead to loss of glycemic control 110 118 Warfarin Pharmacokinetic interaction unlikely 1 Rosiglitazone Maleate Pharmacokinetics Absorption Bioavailability Peak plasma concentrations attained about 1 hour after dosing. 1 Absolute bioavailability is 99%. 1 110 118 219 Fixed-combination preparation containing 4 mg of rosiglitazone and 4 mg of glimepiride is bioequivalent to the individual components administered separately at the same dosages in fasted state. 118 Fixed-combination preparation containing 4 mg of rosiglitazone and 500 mg of metformin hydrochloride is bioequivalent to the individual components administered separately at the same dosages in fasted state. 110 Onset A therapeutic response usually is apparent within 2 weeks. 1 110 118 136 Maximum response occurs within 2 3 months. 1 110 118 136 Food Food decreases peak plasma concentration and delays time to peak concentration; not clinically relevant. 1 110 118 (See Administration under Dosage and Administration.) Distribution Extent Distributed into milk in rats. 1 110 Not known whether the drug distributes into human milk. 1 110 118 Crosses human placenta and is detectable in fetal tissues. 1 110 118 Clinical importance unknown. 1 110 118 Plasma Protein Binding Approximately 99.8% (mainly albumin). 1 110 118 Elimination Metabolism Extensively metabolized, principally by CYP2C8 1 110 118 and, to a lesser extent, by CYP2C9. 1 110 118 Elimination Route Excreted primarily in urine (64%) and in feces (23%) as metabolites. 1 110 118 Half-life Approximately 3 4 hours. 1 110 118 219 Special Populations In patients with hepatic disease, elimination half-life is prolonged by about 2 hours. 1 110 118 In patients with moderate to severe hepatic impairment (Child-Pugh class B or C), clearance of unbound drug decreased. 1 110 118 Stability Storage Oral Tablets Tight, light-resistant containers at 25 C (may be exposed to 15 30 C). 1 110 118 Actions Structurally and pharmacologically related to pioglitazone and troglitazone (no longer commercially available in the US); unrelated to other antidiabetic agents (e.g., sulfonylureas, biguanides, α-glucosidase inhibitors). 1 2 3 4 6 7 9 10 11 13 14 16 20 30 A peroxisome proliferator-activated receptor γ (PPAR γ ) agonist; increases transcription of insulin-responsive genes. 1 2 3 4 9 13 14 16 20 30 Increases insulin sensitivity in target tissues and decreases hepatic gluconeogenesis. 1 2 6 7 10 11 13 16 20 30 Ameliorates insulin resistance associated with type 2 diabetes mellitus without increasing insulin secretion from pancreatic β cells. 1 7 10 13 Does not lower glucose concentrations below euglycemia. 1 7 Reduces circulating concentrations of insulin and C-peptide. 1 10 Ineffective in absence of endogenous insulin. 1 Advice to Patients Importance of patient reading medication guide before starting rosiglitazone and each time prescription is refilled. 146 Importance of informing patients of the current state of knowledge regarding the cardiovascular risk of rosiglitazone, and that although there is some evidence suggesting an increased risk of MI compared with placebo, data from long-term clinical trials, including a cardiovascular outcomes trial, generally have not confirmed these findings. 1 Importance of informing patients that rosiglitazone is not recommended for patients with symptomatic heart failure. 1 146 149 150 Importance of identifying and reporting to a clinician potential symptoms of CHF (e.g., unusually rapid increase in weight, edema, unusual fatigue, shortness of breath). 1 128 136 137 146 Importance of patients not taking rosiglitazone if they are allergic to the drug or any ingredients in the tablet. 1 146 Signs and symptoms of severe allergic reaction include swelling of the face, lips, tongue, or throat; problems breathing or swallowing; rash, itching, or hives; blisters on the skin or in the mouth, nose, or eyes; skin peeling; faintness or dizziness; rapid heartbeat. 1 146 Importance of taking exactly as prescribed. 136 Importance of immediately contacting a clinician or a poison control center if accidental overdosage occurs. 136 137 Importance of taking a missed dose as soon as possible, unless it is almost time for next dose. 1 137 146 Do not double dose to make up for the missed dose. 137 146 Importance of diet and exercise regimen adherence. 1 110 136 137 146 Importance of regular monitoring of blood glucose and HbA 1c . 1 110 136 137 146 Importance of informing patients that rosiglitazone is not recommended in patients taking insulin due to potentially increased risk of CHF. 1 146 Importance of continuing rosiglitazone therapy even if response is not evident in 2 weeks; full therapeutic response may not be evident for 2 3 months after initiation of therapy. 1 136 137 146 Importance of regular eye examinations. 1 110 118 136 137 Importance of reporting change in vision. 1 146 Importance of liver function test monitoring and immediate reporting of potential manifestations of hepatotoxicity (e.g., nausea or vomiting, abdominal pain, unusual fatigue, loss of appetite, dark urine, yellowing of skin or whites of eyes). 1 110 118 136 137 Risk of fractures (e.g., hand, upper arm, foot) in women. 1 110 118 136 137 145 146 147 Risk of hypoglycemia in patients receiving concomitant antidiabetic agent therapy. 1 Provide instructions regarding management of hypoglycemia, including recognition of symptoms, predisposing conditions, and treatment. 1 136 Risk of pregnancy in premenopausal anovulatory women. 1 110 137 Advise patients regarding use of effective contraception during therapy. 1 110 118 136 137 Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs (e.g., insulin and other drugs that affect glucose concentrations; antihypertensive agents; antilipemic agents; agents for heart failure, prevention of CHD, or stroke) and dietary or herbal supplements, 137 as well as any concomitant illnesses (e.g., heart failure or other cardiac disease, type 1 diabetes mellitus, history of diabetic ketoacidosis, macular edema, liver disease, irregular menstrual periods). 1 136 137 146 Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed. 1 110 136 137 146 Importance of informing patients of other important precautionary information. 1 110 118 (See Cautions.) Preparations Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. Rosiglitazone Maleate Routes Dosage Forms Strengths Brand Names Manufacturer Oral Tablets, film-coated 2 mg (of rosiglitazone) Avandia GlaxoSmithKline 4 mg (of rosiglitazone) Avandia GlaxoSmithKline 8 mg (of rosiglitazone) Avandia GlaxoSmithKline Rosiglitazone Maleate Combinations Routes Dosage Forms Strengths Brand Names Manufacturer Oral Tablets, film-coated 2 mg (of rosiglitazone) with 500 mg Metformin Hydrochloride Avandamet GlaxoSmithKline 2 mg (of rosiglitazone) with 1 g Metformin Hydrochloride Avandamet GlaxoSmithKline 4 mg (of rosiglitazone) with 1 mg Glimepiride Avandaryl GlaxoSmithKline 4 mg (of rosiglitazone) with 2 mg Glimepiride Avandaryl GlaxoSmithKline 4 mg of (rosiglitazone) with 4 mg Glimepiride Avandaryl GlaxoSmithKline 4 mg (of rosiglitazone) with 500 mg Metformin Hydrochloride Avandamet GlaxoSmithKline 4 mg (of rosiglitazone) with 1 g Metformin Hydrochloride Avandamet GlaxoSmithKline 8 mg of (rosiglitazone) with 2 mg Glimepiride Avandaryl GlaxoSmithKline 8 mg of (rosiglitazone) with 4 mg Glimepiride Avandaryl GlaxoSmithKline AHFS DI Essentials. 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