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Generic Actoplus Met Metformin and pioglitazone 500mg

Diet and exercise are important for keeping your blood sugar levels under control.If you miss a dose...Take it as soon as you remember. If it is almost time for your next dose, take only that dose. Thiazolidinediones, including pioglitazone, which is a component of Actoplus Met, cause or exacerbate congestive heart failure in some patients After initiation of Actoplus Met, and after dose increases, observe patients carefully for signs and symptoms of heart failure (including excessive, rapid weight gain, dyspnea, and/or edema).

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What May Interact With This Medicine?

Side effects that you should report to your doctor or health care professional as soon as possible: allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue, breathing problems, dark urine, dizziness, feeling faint or lightheaded, falls, fever, chills, sore throat, low blood sugar (ask your doctor or healthcare professional for a list of these symptoms), muscle aches, pains, slow or irregular heartbeat, stomach pain, swelling of the hands, legs, or feet, unusually weak or tired, yellowing of the eyes or skin. Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome): diarrhea, headache, stomach gas, heartburn, nausea, problems with teeth.

Why Should ACTO Plus Met Not Be Prescribed?

Reported cases have occurred primarily in diabetic patients with significant renal insufficiency, including both intrinsic renal disease and renal hypoperfusion, often in the setting of multiple concomitant medical/surgical problems and multiple concomitant medications. Patients with congestive heart failure requiring pharmacologic management, in particular those with unstable or acute congestive heart failure who are at risk of hypoperfusion and hypoxemia, are at increased risk of lactic acidosis.

Special Information If You Are Pregnant Or Breastfeeding

Use of concomitant medications that may affect renal function or metformin disposition: Concomitant medication(s) that may affect renal function or result in significant hemodynamic change or may interfere with the disposition of metformin, such as cationic drugs that are eliminated by renal tubular secretion should be used with caution. Radiologic studies involving the use of intravascular iodinated contrast materials (for example, intravenous urogram, intravenous cholangiography, angiography, and computed tomography (CT) scans with intravascular contrast materials): Intravascular contrast studies with iodinated materials can lead to acute alteration of renal function and have been associated with lactic acidosis in patients receiving metformin Therefore, in patients in whom any such study is planned, Actoplus Met should be temporarily discontinued at the time of or prior to the procedure, and withheld for 48 hours subsequent to the procedure and reinstituted only after renal function has been re-evaluated and found to be normal.

Precautions

The risks of lactic acidosis, its symptoms and conditions that predispose to its development, as noted in the WARNINGS, Metformin hydrochloride and PRECAUTIONS, General : Metformin hydrochloride sections, should be explained to patients. When administered with metformin, the C max and AUC of furosemide were 31% and 12% smaller, respectively, than when administered alone and the terminal half-life was decreased by 32%, without any significant change in furosemide renal clearance. No information is available about the interaction of metformin and furosemide when co-administered chronically. Nifedipine: A single-dose, metformin-nifedipine drug interaction study in normal healthy volunteers demonstrated that co-administration of nifedipine increased plasma metformin C max and AUC by 20% and 9%, respectively and increased the amount excreted in the urine.

Adverse Reactions

An enzyme inhibitor of CYP2C8 (such as gemfibrozil) may significantly increase the AUC of pioglitazone and an enzyme inducer of CYP2C8 (such as rifampin) may significantly decrease the AUC of pioglitazone. Metformin had minimal effects on nifedipine. Cationic Drugs: Cationic drugs (e.g., amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, and vancomycin) that are eliminated by renal tubular secretion theoretically have the potential for interaction with metformin by competing for common renal tubular transport systems.