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|Pioglitazone Hydrochloride/Metformin Hydrochloride |
Drugs search, click the first letter of a drug name: | A | B | C | D | E | F | G | H | I | J | K | L | M | N | O | P | Q | R | S | T | U | V | W | X | Y | Z | 1 | 2 | 3 | 4 | 5 | 6 | 8 | 9 Home Pioglitazone Hydrochloride/Metformin HydrochloridePronouncation: (pye-oh-GLI-ta-zone HIGH-droe-KLOR-ide/met-FORE-min HIGH-droe-KLOR-ide)Class: Antidiabetic combination Trade Names: Mechanism of ActionPharmacologyRosiglitazone, a thiazolidinedione, increases insulin sensitivity in the liver, skeletal muscle, and adipose tissues. Metformin, a biguanide, decreases hepatic glucose production, decreases intestinal absorption of glucose, and improves insulin sensitivity by increasing peripheral glucose uptake and utilization. Indications and UsageAdjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes who are already treated with pioglitazone plus metformin or whose diabetes is not adequately controlled with metformin alone, or for those patients who initially responded to pioglitazone alone and require additional glycemic control. ContraindicationsRenal disease or dysfunction (eg, serum creatine levels 1.5 mg/dL or higher in men, 1.4 mg/dL or higher in women, or abnormal Ccr); acute MI and septicemia; acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma; patients undergoing radiologic studies involving IV administration of iodinated contrast materials; hypersensitivity to any component of the product. Dosage and AdministrationAdultsPO Starting dose is based on patient"s current regimen of pioglitazone and/or metformin. Patients inadequately controlled on metformin monotherapyPioglitazone 15 mg and metformin 500 mg or pioglitazone 15 mg and metformin 850 mg once daily or bid, then gradually titrate based on therapeutic response. Patients who initially responded to pioglitazone monotherapy and need additional glycemic controlPioglitazone 15 mg and metformin 500 mg bid or pioglitazone 15 mg and metformin 850 mg once daily, then gradually titrate based on therapeutic response. Patients switching from combination therapy of pioglitazone plus metformin as separate tabletsPioglitazone 15 mg and metformin 500 mg or pioglitazone 15 mg and metformin 850 mg based on dose of pioglitazone and metformin already being taken. Max dosePioglitazone 45 mg/day, metformin 2,550 mg/day. Heart failureInitiate therapy at lowest dose if used in patients with systolic heart failure (New York Heart Association [NYHA] class 2). Increase dose only after several months of therapy with careful monitoring for weight gain, edema, or signs and symptoms of heart failure exacerbation. General Advice
Storage/StabilityStore tablets at controlled room temperature (59° to 86°F). Protect from moisture and humidity. Drug InteractionsAlcoholEffect of metformin on lactate metabolism may be potentiated. Cationic drugs (eg, amiloride, digoxin, quinidine)May increase metformin serum levels by competing for tubular secretion. Cimetidine, nifedipineMetformin serum levels may be elevated, increasing pharmacologic and adverse effects. CYP3A4 systemPioglitazone may be a weak inducer of CYP3A4, which may decrease serum levels of other drugs metabolized by this isozyme. Drugs that cause hyperglycemia (eg, calcium channel blockers, corticosteroids, diuretics, estrogens, isoniazid, nicotinic acid, oral contraceptives, phenothiazines, phenytoin, sympathomimetics, thyroid products)May lead to loss of glycemic control. FurosemideMay increase metformin serum levels; metformin may reduce furosemide levels. InsulinRisk of edema may be increased, even after several months of combined therapy. Oral contraceptivesHormone components may decrease, potentially reducing contraceptive effectiveness. Adverse ReactionsUnless otherwise stated, the following adverse reactions were reported with combined use of pioglitazone plus metformin. CNSDizziness, headache (at least 5%). EENTPharyngitis, tooth disorder (pioglitazone) (at least 5%). GIDiarrhea, nausea (at least 5%). GenitourinaryUTI (at least 5%). HematologicAnemia (less than 2%). Lab TestsDecreased serum vitamin B 12 levels (metformin) (at least 5%). Metabolic-NutritionalIncreased weight (at least 5%). MusculoskeletalMyalgia (pioglitazone) (at least 5%). RespiratorySinusitis, upper respiratory tract infection (at least 5%). MiscellaneousEdema/peripheral edema, lower limb edema (at least 5%). Precautions
PregnancyCategory C . Not recommended for use in pregnant patients. LactationUndetermined. ChildrenSafety and efficacy not established. ElderlyInitial and maintenance doses should be conservative because of potential for reduced renal function; avoid titration to max dose if possible. Renal FunctionRisk of metformin accumulation and lactic acidosis increases with degree of renal impairment. Patients with serum creatinine levels above ULN for age should not receive metformin-containing products. Hepatic FunctionDo not initiate therapy in patients with clinical evidence of active liver disease or baseline ALT more than 2.5 × ULN. Initiation or continuation of therapy in patients with mildly elevated liver enzymes (ALT less than 2.5 × ULN) should proceed with caution; discontinue therapy in these patients if ALT increases to more than 3 × ULN and persists, or if patient develops jaundice. Cardiac effectsPioglitazone may cause fluid retention that may lead to or exacerbate heart failure. Discontinue therapy if any deterioration in cardiac status occurs. Pioglitazone is not recommended in patients with NYHA class 3 or 4 cardiac status. EdemaPioglitazone may cause fluid retention. Use with caution in patients with edema or at risk of heart failure. HematologicDecreases in hemoglobin (2% to 4%) have been reported in patients receiving pioglitazone. HypoglycemiaRisk of hypoglycemia increases when used with other oral hypoglycemic agents or insulin; reduction in dose of concomitant agent may be necessary. Type 1 diabetesDo not use in these patients. Hypoxic statesCV shock and other conditions characterized by hypoxemia have been associated with lactic acidosis and also may cause prerenal azotemia. Promptly discontinue therapy if such events occur. Intravascular iodinated contrast materialsCan lead to acute alteration of renal function and have been associated with metformin-induced lactic acidosis. Temporarily discontinue therapy at time of or prior to the procedure, and withhold for 48 hr after the procedure; restart only after renal function has returned to normal. Loss of glucose controlConsider temporarily withholding therapy and administering insulin in patients who lose glycemic control as result of fever, trauma, infection, or surgery. OvulationPioglitazone therapy may result in resumption of ovulation in premenopausal, anovulatory women with insulin resistance. Consider contraceptive measures in such patients. Surgical proceduresTemporarily suspend therapy for any surgical procedure (except minor procedures not associated with restricted intake of food and fluids). Do not restart until patient"s oral intake has resumed and renal function has been evaluated as normal. Vitamin B 12 levelsMetformin may interfere with B 12 absorption from the B 12 -intrinsic factor complex. Weight gainDose-related weight gain has been reported. Assess patients who experience unusually rapid increases in weight for fluid accumulation and volume-related events (eg, edema, heart failure). OverdosageSymptomsLactic acidosis. Patient Information
Where can I get more information about Pioglitazone Hydrochloride/Metformin Hydrochloride ? 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