Asenza Plus

Per 15 mg/2 mg tab Pioglitazone HCl 15 mg, glimepiride 2 mg. Per 30 mg/2 mg tab Pioglitazone HCl 30 mg, glimepiride 2 mg

Adjunct to diet & exercise to improve glycemic control in adults w/ type 2 DM who are already treated w/ thiazolidinedione & sulfonylurea or who have inadequate glycemic control on a thiazolidinedione or sulfonylurea alone.

Usual dose: 15 mg/2 mg once daily may be increased to 30 mg/4 mg once daily. Max dose: Pioglitazone 45 mg & glimepiride 8 mg once daily.

Should be taken with food: Take w/ 1st main meal of the day.

Hypersensitivity. Patients w/ NYHA Class III or IV heart failure; history of an allergic reaction to sulfonamide derivatives.

May cause fluid retention & lead to or exacerbation of CHF; it should be managed according to current standard & discontinuation or dose reduction must be considered if it occurs. Patients who may be predisposed to hypoglycemia (eg, the elderly, patients w/ renal impairment, & those on other antidiabetic medications); debilitated or malnourished patients & those w/ adrenal, pituitary, or hepatic impairment. Patients w/ abnormal liver tests; G6PD deficiency. Not to be used in patients w/ active bladder cancer. Concomitant use w/ insulin secretagogues or insulin. Obtain & assess patient's liver test panel (ALT, AST, alkaline phosphatase, & total bilirubin) before initiating therapy. Not to be initiated in patients w/ active liver disease or increased serum transaminase levels (ALT >2.5 x ULN) at the start of therapy. Discontinue therapy at least 2 wk before expected delivery. Lactation. Glimepiride: Associated w/ increased CV mortality. Pioglitazone: Associated w/ increased urinary bladder tumors. History of bladder cancer. Risk of fracture. Macular edema. Patients w/ diabetes should have regular eye exam by an ophthalmologist.

Hypoglycemia, URTI, increased wt, lower limb edema, headache, UTI, diarrhea, nausea, pain in limb.

Pioglitazone: Increased exposure & t½ w/ strong CYP2C8 inhibitors (eg, gemfibrozil). Decreased exposure w/ CYP2C8 inducers (eg, rifampin); topiramate. Glimepiride: Increased glucose-lowering effect w/ oral anti-diabetic medications, pramlintide acetate, insulin, ACE inhibitors, H₂ receptor antagonists, fibrates, propoxyphene, pentoxifylline, somatostatin analogs, anabolic steroids & androgens, cyclophosphamide, phenyramidol, guanethidine, fluconazole, sulfinpyrazone, tetracyclines, clarithromycin, disopyramide, quinolones, & highly protein-bound drugs, eg, fluoxetine, NSAIDs, salicylates, sulfonamides, chloramphenicol, coumarins, probenecid & MAOIs. Decreased glucose-lowering effect w/ danazol, glucagon, somatropin, PIs, atypical antipsychotic medications (eg, olanzapine & clozapine), barbiturates, diazoxide, laxatives, rifampin, thiazides & other diuretics, corticosteroids, phenothiazines, thyroid hormones, estrogens, OCs, phenytoin, nicotinic acid, sympathomimetics (eg, epinephrine, albuterol, terbutaline), & INH. May potentiate or weaken effect w/ β-blockers, clonidine, & reserpine; acute & chronic alcohol intake. Signs of hypoglycemia may be reduced w/ sympatholytic drugs eg, β-blockers, clonidine, guanethidine & reserpine. Potential interaction leading to severe hypoglycemia w/ miconazole. Inhibited metabolism w/ CYP2C9 inhibitor & inducers. Concomitant use w/ colesevelam may reduce max plasma conc & total exposure.

Antidiabetic Agents

A10BD06 - glimepiride and pioglitazone ; Belongs to the class of combinations of oral blood glucose lowering drugs. Used in the treatment of diabetes.

Rx