Asenza Plus

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 starting dose: 15 mg/2 mg once daily may be increased after assessing adequacy of therapeutic response. Max recommended daily dose: Pioglitazone 45 mg & glimepiride 8 mg.

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.

Promptly discontinue if hypersensitivity reaction is suspected. Should not be used to treat type 1 diabetes or diabetic ketoacidosis. Can cause dose-dependent fluid retention which may lead to or exacerbate CHF; discontinuation or dose reduction must be considered if it occurs. May cause severe hypoglycemia; caution when initiating & increasing doses in patients who may be predisposed to hypoglycemia (eg, elderly, patients w/ renal impairment, & those on other antidiabetic medications); in debilitated or malnourished patients & those w/ adrenal, pituitary, or hepatic impairment; when caloric intake is deficient, after severe or prolonged exercise, or when alcohol is ingested. Increased CV mortality w/ sulfonylureas. May be associated w/ increased risk of urinary bladder tumors; should not be used in patients w/ active bladder cancer. Risk of fracture especially in female patients. Can cause hemolytic anemia in patients w/ G6PD deficiency. Post-marketing reports of macular edema. Patients w/ diabetes should have regular eye exam by an ophthalmologist. May impair ability to concentrate & react; may present a risk in driving or operating machinery. Obtain & assess patient's liver test panel (ALT, AST, alkaline phosphatase, & total bilirubin) before initiating therapy; promptly measure in patients who report symptoms indicative of liver injury. Should not be initiated in patients w/ active liver disease or increased serum transaminase levels (ALT >2.5 times ULN) at the start of therapy. Caution in patients w/ liver disease or abnormal liver tests. Discontinue therapy at least 2 wk before expected delivery. Consider benefits of breastfeeding along w/ mother's clinical need for treatment & any potential adverse effects on the breastfed infant from treatment or from underlying maternal condition. Not recommended for ped patients.

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

Pioglitazone: Increased exposure & t_1/2 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. Glucose-lowering effect may be potentiated or weakened 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 (eg, fluconazole). Induced metabolism w/ CYP2C9 inducer (eg, rifampin). Reduced max plasma conc & total exposure w/ colesevelam.

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