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All about: Metformin/Pioglitazone

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Generic Name: Metformin/Pioglitazone (MET-fore-min/pye-oh-GLI-ta-zone)
Brand Name: ActoPlus Met

Lactic acidosis, which can be fatal, may occur while taking Metformin/Pioglitazone . Symptoms include general body discomfort, muscle pain, breathing problems, increasing drowsiness, upset stomach, cold skin, dizziness, tiredness, lightheadedness, and slowed heartbeat. If any of these symptoms occur, seek medical attention at once.

Lactic acidosis is more likely to occur in patients who have heart failure, kidney or liver problems, a lack of body fluids or dehydration, x-ray or scanning procedures that require an injectable iodinated contrast drug, surgery, serious infection, heart attack, stroke, or who use alcohol excessively. Also at higher risk are the elderly, especially those older than 80 years of age who have not had kidney and liver function tests.

Thiazolidinedione antidiabetics such as Metformin/Pioglitazone may cause or worsen heart failure in some patients. Tell your doctor if you have a history of heart failure. Metformin/Pioglitazone should not be used to treat patients with moderate to severe heart failure. You will be monitored for signs of heart failure when you start Metformin/Pioglitazone and when your dose increases. Contact your doctor at once if you develop swelling of the hands, ankles, or feet; shortness of breath; or sudden unexplained weight gain. Your doctor may need to stop your medicine or change your dose.

Metformin/Pioglitazone is used for:

Improving blood sugar levels, with diet and exercise, in patients with type 2 diabetes who are already being treated with both of these medications, who are not adequately controlled on metformin alone, or who have responded to pioglitazone alone but require additional control.

Metformin/Pioglitazone is a combination of an insulin resistance reducer and a biguanide. This combination medicine works in 2 ways to improve blood glucose levels (sugar). Pioglitazone helps the cells use glucose, and metformin slows the liver's production of glucose. Controlling high blood sugar helps prevent heart disease, strokes, kidney disease, blindness, circulation problems, and sexual function problems (impotence).

Do NOT use Metformin/Pioglitazone if:

  • you are allergic to any ingredient in Metformin/Pioglitazone
  • you have kidney problems
  • you have type 1 diabetes; lactic acidosis; metabolic acidosis, including diabetic ketoacidosis; or diabetic coma
  • you have congestive heart failure that requires treatment with medications

Contact your doctor or health care provider right away if any of these apply to you.

Before using Metformin/Pioglitazone :

Some medical conditions may interact with Metformin/Pioglitazone . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you are debilitated or dehydrated
  • if you will be having surgery
  • if you have liver disease, a history of swelling, heart failure, or a family history of heart failure
  • if you have experienced yellowing of the skin or eyes caused by similar medications (eg, troglitazone)
  • if you have low iron or low blood counts, diarrhea, gastroparesis, hypercorticoidism, hyperthyroidism, hypothyroidism, hypoxia, intestinal obstruction, malnutrition, vitamin B12 deficiency, problems relating to ovulation, high cholesterol, burns, cardiopulmonary insufficiency, blood or tissue infection, vascular collapse, or vomiting
  • if you are premenopausal
  • if you have experienced severe trauma or shock

Some MEDICINES MAY INTERACT with Metformin/Pioglitazone . Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Rifampin because the effectiveness of Metformin/Pioglitazone may be decreased
  • Angiotensin-converting enzyme (ACE) inhibitors (eg, captopril), cimetidine, gemfibrozil, or maprotiline because the actions and side effects of Metformin/Pioglitazone may be increased and very low blood sugar may occur
  • Iodine-containing radiopaque agents used for x-ray or scanning procedures because the risk of sudden kidney failure may be increased and lactic acidosis may occur. Metformin/Pioglitazone should not be used within 48 hours of iodine-containing radiopaque agents
  • Nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, celecoxib) because the risk of sudden kidney failure and lactic acidosis may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Metformin/Pioglitazone may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Metformin/Pioglitazone :

Use Metformin/Pioglitazone as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take Metformin/Pioglitazone with meals.
  • Metformin/Pioglitazone may take effect within 1 to 2 weeks after beginning therapy. However, full effects may not occur for 2 to 3 months.
  • Carefully follow the dietary guidelines and exercise plan given to you by your health care provider.
  • For best results, it is important to take Metformin/Pioglitazone regularly. To help you remember, take your dose at the same time each day.
  • If a dose is missed, take it as soon as possible. If several hours have passed or if it is nearing time for the next dose, do not double the dose to catch up, unless advised by your doctor. If more than one dose is missed, restart medication and advise your doctor or pharmacist at your next appointment.

Ask your health care provider any questions you may have about how to use Metformin/Pioglitazone .

Important safety information:

  • Avoid drinking alcohol while taking Metformin/Pioglitazone . Actions of Metformin/Pioglitazone , such as lowering blood sugar, may be increased if excessive alcohol is consumed while taking Metformin/Pioglitazone .
  • Before you have any medical or dental treatments, emergency care, or surgery, tell your doctor or dentist that you are using Metformin/Pioglitazone .
  • Carry an identification card at all times that says you are diabetic.
  • Metformin/Pioglitazone usually does not cause low blood sugar or hypoglycemia, but this effect may occur if you do not consume enough calories from food, juices, fruit, or other sources. The symptoms of low blood sugar include chills, cold sweat, dizziness, drowsiness, shaking, rapid heart rate, weakness, headache, fainting, tingling of the hands or feet, or hunger. It is a good habit to carry glucose tablets or gel to treat low blood sugar. If you are in a situation where you don't have these reliable forms of glucose, eat a quick source of sugar such as table sugar, honey, candy, or drink a glass of orange juice or non-diet soda to quickly raise your blood sugar level. Tell your doctor immediately about the reaction. To help prevent hypoglycemia, eat meals on a regular schedule and do not skip meals.
  • During times of stress, such as fever, infection, injury or surgery, it may be more difficult to control your blood sugar. Consult your doctor, as a change in your medicine may be required.
  • Symptoms of high blood sugar or hyperglycemia include thirst, increased urination, confusion, drowsiness, flushing, rapid breathing, or fruity breath odor. If these symptoms occur, tell your doctor immediately. Your medication dosage may need to be increased.
  • Metformin/Pioglitazone may increase the chance of pregnancy by causing ovulation to resume in women who have not been ovulating. In women of childbearing age, it is important to consider effective birth control methods while taking Metformin/Pioglitazone .
  • Lab tests, including liver and kidney function tests, fasting blood sugar, glycosylated hemoglobin (hemoglobin A1c), or complete blood cell counts, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Metformin/Pioglitazone with caution in the ELDERLY because they may be more sensitive to its effects
  • Metformin/Pioglitazone is not recommended for use in CHILDREN. Safety and effectiveness have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Metformin/Pioglitazone during pregnancy. Insulin therapy may be preferred to control blood sugar during pregnancy. Discuss your treatment options with your doctor. It is unknown if Metformin/Pioglitazone is excreted in breast milk. Do not breast-feed while taking Metformin/Pioglitazone .

Possible side effects of Metformin/Pioglitazone :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; metallic taste; weight gain.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abdominal or stomach pain; appetite loss; fluid retention; heart problems; liver problems (dark urine, yellowing of the skin or eyes); muscle pain; nausea; rapid weight gain; shortness of breath; swelling of the hands, ankles, or feet; vomiting; unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include rapid or difficult breathing; severe drowsiness; slow or irregular heartbeat.

Proper storage of Metformin/Pioglitazone :

Store Metformin/Pioglitazone at 77 degrees F (25 degrees C) in a tightly closed container. Store away from heat, moisture, and light. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Do not store in bathroom. Keep Metformin/Pioglitazone out of the reach of children and away from pets.

General information:

  • If you have any questions about Metformin/Pioglitazone , please talk with your doctor, pharmacist, or other health care provider.
  • Metformin/Pioglitazone is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • If using Metformin/Pioglitazone for an extended period of time, obtain refills before your supply runs out.

This information is a summary only. It does not contain all information about Metformin/Pioglitazone . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: September 5, 2007
Database Edition
Copyright © 2007 Wolters Kluwer Health, Inc.

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