Zoliget

Zoliget

pioglitazone + glimepiride

Manufacturer:

Getz Pharma

Distributor:

Getz Pharma
Concise Prescribing Info
Contents
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
Indications/Uses
Adjunct to diet & exercise to improve glycemic control in patients w/ type 2 diabetes who are already treated w/ combination of pioglitazone HCl & sulfonylurea; whose diabetes is not adequately controlled w/ sulfonylurea alone; patients who have initially responded to pioglitazone HCl alone who require additional glycemic control.
Dosage/Direction for Use
Max daily dose: 45 mg/8 mg. Patient currently on pioglitazone monotherapy Initially 15 mg/2 mg once daily. Patient currently on glimepiride monotherapy Initially 15 mg/2 mg once daily. Patient switching from combination therapy of pioglitazone plus glimepiride as separate tab Initially 15 mg/2 mg. Patient currently on a different sulfonylurea monotherapy or switching from combination therapy of pioglitazone plus a different sulfonylurea Initially 15 mg/2 mg once daily.
Administration
Should be taken with food: Take w/ the 1st main meal.
Contraindications
Hypersensitivity. Type 1 diabetes, diabetic ketoacidosis w/ or w/o coma. Moderate to severe heart failure or liver problems. NYHA class III or IV heart failure. Pregnancy & lactation. Childn. Pioglitazone: Active bladder cancer.
Special Precautions
Patients w/ symptomatic heart failure. Monitor patients w/ adrenal, pituitary, renal or hepatic insufficiency. Debilitated or malnourished patients. Alcohol ingestion, severe or prolonged exercise, deficient caloric intake or use of >1 antidiabetic agent. Periodically measure fasting blood glucose & HbA1c to determine the min effective dose of pioglitazone + glimepiride. Monitor liver enzyme prior to initiation of therapy. Pioglitazone: May cause fluid retention when used alone or in combination w/ other antidiabetic agents; anemia. Patients w/ history of bladder cancer. Increased incidence of bone fracture in female patients.
Adverse Reactions
Anxiety, bladder pain, bloody or cloudy urine, blurred vision, chills, cold sweats, coma, confusion, cool pale skin, depression, difficult/burning or painful urination, fast heartbeat, frequent urge to urinate, headache, increased hunger, wt gain, lower back or side pain, nausea, nervousness, nightmares, seizures, shakiness, slurred speech, swelling of feet or legs, unusual tiredness or weakness, cough, ear congestion, hoarseness, joint pain, loss of voice, nasal congestion, tooth disorder, voice changes.
Drug Interactions
Risk of severe & persistent hypoglycemia w/ ciprofloxacin & gatifloxacin. Pioglitazone HCl: CYP2C8 inhibitor (eg, gemfibrozil) & inducer (eg, rifampin). Ketoconazole, atorvastatin Ca. Reduced midazolam Cmax & AUC. Glimepiride: Potentiated hypoglycemic action w/ NSAIDs & other highly protein bound drugs eg, salicylates, sulfonamides, chloramphenicol, coumarins, probenecid, MAOIs, β-blockers. Risk of hyperglycemia w/ thiazides & other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, OCs, phenytoin, nicotinic acid, sympathomimetics, INH. Potential hypoglycemia w/ β-blockers (eg, propranolol). Oral miconazole; fluconazole.
MIMS Class
Antidiabetic Agents
ATC Classification
A10BD06 - glimepiride and pioglitazone ; Belongs to the class of combinations of oral blood glucose lowering drugs. Used in the treatment of diabetes.
Presentation/Packing
Form
Zoliget 15 mg/2 mg tab
Packing/Price
14's (P385.07/box)
Form
Zoliget 30 mg/2 mg tab
Packing/Price
14's (P458.45/pack)
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