Trade Names:Duetact- Tablets pioglitazone hydrochloride 30 mg (as base)/glimepiride 2 mg- Tablets pioglitazone hydrochloride 30 mg (as base)/glimepiride 4 mg
Increases insulin sensitivity; inhibits hepatic gluconeogenesis.Glimepiride
Stimulates insulin release from the pancreas; may decrease hepatic glucose production; increases sensitivity to insulin.
Adjunct to diet and exercise to improve glycemic control in adult patients with type 2 diabetes mellitus who are already treated with a thiazolidinedione (eg, pioglitazone) plus a sulfonylurea or who have inadequate glycemic control on a thiazolidinedione or sulfonylurea alone.
Diabetic ketoacidosis with or without coma; hypersensitivity to any component of the product; patients with established New York Heart Association (NYHA) class III or IV heart failure.
The initial dosing, dose increments, and maintenance dosage should be conservative to avoid hypoglycemic reactions. The initial dose should be started at glimepiride 1 mg prior to prescribing pioglitazone/glimepiride.Patients Currently on Glimepiride MonotherapyAdults
PO Titrate the dose based on individual response to each component as monotherapy. Based on the usual starting dose of pioglitazone (15 or 30 mg daily), treatment may be started at 30 mg/2 mg or 30 mg/4 mg once daily and adjusted after assessing adequacy of therapeutic response.Patients Currently on Pioglitazone MonotherapyAdults
PO Titrate the dose based on individual response to each component as monotherapy. Based on the usual starting dose of glimepiride (1 or 2 mg daily) and pioglitazone 15 or 30 mg, treatment may be started at 30 mg/2 mg once daily and adjusted after assessing adequacy of therapeutic response.Patients Switching From Combination Therapy of Pioglitazone Plus Glimepiride as Separate TabletsAdults
PO Treatment may be started at 30 mg/2 mg or 30 mg/4 mg once daily based on the dose of pioglitazone and glimepiride already being taken.Patients Currently on a Different Sulfonylurea Monotherapy or Switching From Combination Therapy of Pioglitazone Plus a Different SulfonylureaAdults
PO Based on the max starting dose of glimepiride 2 mg, treatment may be started at 30 mg/2 mg once daily and adjusted after assessing adequacy of therapeutic response.
Store at 59° to 86°F. Keep container tightly closed. Protect from moisture and humidity.
The risk of hypoglycemia may be increased. Closely monitor glycemic control when these agents are started or stopped.Azole antifungal agents (eg, ketoconazole), trimethoprim
Pioglitazone plasma levels may be elevated, increasing pharmacologic effect and adverse reactions.Beta-blockers (eg, propranolol)
Glimepiride plasma levels may be elevated, increasing the pharmacologic effect and adverse reactions. Because some signs and symptoms of hypoglycemia may be attenuated, hypoglycemia may be difficult to recognize.Certain drugs that tend to produce hyperglycemia (eg, corticosteroids, diazoxide, estrogens, isoniazid, phenothiazines, phenytoin, sympathomimetics, thiazide diuretics, thyroid products)
Closely monitor glycemic control when these agents are started, stopped, or coadministered with glimepiride.Ciprofloxacin, gatifloxacin
Severe and persistent hypoglycemia may occur.Contraceptives, hormonal
Ethinyl estradiol levels may be decreased slightly by pioglitazone; however, the clinical importance of this interaction has not been established.Fluconazole, fluvoxamine, gemfibrozil, miconazole
Glimepiride plasma levels may be elevated, increasing the pharmacologic effect and adverse reactions.Drugs that may potentiate the hypoglycemic action of sulfonylureas (eg, glimepiride) such as chloramphenicol, MAOIs, NSAIDs, probenecid, salicylates, and sulfonamides
Closely monitor glycemic control when these agents are started, stopped, or coadministered with glimepiride.Inducers of CYP2C8 (eg, rifampin)
May decrease pioglitazone exposure, reducing the pharmacologic effect. Closely monitor glycemic control when these agents are started or stopped.Inhibitors of CYP2C8 (eg, gemfibrozil)
May increase pioglitazone exposure, increasing the pharmacologic effect and adverse reactions. Closely monitor glycemic control when these agents are started or stopped.Insulin
Incidence of edema may be increased, even after several months of combined therapy.Midazolam
Midazolam plasma levels may be reduced, decreasing the efficacy.Rifamycins (eg, rifampin)
Glimepiride or pioglitazone plasma levels may be reduced, decreasing glycemic control.
Pioglitazone may reduce mean Hgb values by 2% to 4%, usually in first 4 to 12 wk of therapy, then stabilize thereafter; rarely associated with significant hematologic clinical reactions.
Macular edema with blurred vision or decreased visual acuity (postmarketing).
Diarrhea (6%); nausea (5%).
Anemia (2% or less).
Hepatic enzyme elevations, hepatitis (postmarketing).
Increased incidence of bone fractures in women (postmarketing).
Hypoglycemia (16%); weight gain (13%).
Upper respiratory tract infection (15%).
Lower limb edema (12%); limb pain (5%); edema and worsening of edema (postmarketing).
Pioglitazone may cause or exacerbate CHF. Carefully observe patients for signs and symptoms of heart failure. Not recommended for use in patients with symptoms of heart failure.
Monitor liver enzymes prior to the initiation of therapy and periodically thereafter; periodically perform fasting blood glucose and hemoglobin A 1c measurements to monitor glycemic control and therapeutic response.
Category C .
Safety and efficacy not established.
Because elderly patients are particularly susceptible to hypoglycemic action of glucose-lowering agents, the initial dosing, dose increment, and maintenance dosage should be conservative and based upon blood glucose levels prior to and after initiation of treatment.
Start with glimepiride 1 mg in patients with renal function impairment.
Do not initiate therapy in patients with clinical evidence of active liver disease or increased serum transaminase levels at the start of therapy.
In elderly, debilitated, or malnourished patients, or patients with renal or hepatic insufficiency, the initial dose, dose increments, and maintenance dosage should be conservative to avoid hypoglycemic reactions. Start with glimepiride 1 mg prior to prescribing pioglitazone/glimepiride therapy. Carefully observe patients for hypoglycemia during initiation of pioglitazone/glimepiride therapy and any subsequent dose adjustment.
Oral hypoglycemic agents have been associated with increased CV mortality compared with diet alone or diet plus insulin.
Use with caution; can cause fluid retention.
An increased incidence of bone fracture was noted in women taking pioglitazone.
Decreases in hemoglobin (2% to 4%) have been reported in patients receiving pioglitazone.
Risk of hypoglycemia increases when used with other oral hypoglycemic agents or insulin; reduction in dose of concomitant agent may be necessary.
Exposure to stress, such as fever, trauma, infection, or surgery, may result in loss of blood glucose control.
Patients with diabetes should have regular eye exams by an ophthalmologist.
May result in ovulation in premenopausal, anovulatory women; adequate contraception is recommended.
Do not use in these patients.
Dose-related weight gain has been seen alone and in combination with other hypoglycemic agents.
Coma, seizures, or other neurological impairment; hypoglycemia; loss of consciousness.
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