ACTOplus met

Generic name: Pioglitazone hydrochloride and metformin hydrochloride

What is ACTOplus met?

ACTOplus met contains 2 anti-diabetic medicines, pioglitazone hydrochloride (Actos) and metformin hydrochloride (Glucophage). ACTOplus met is used to treat people with type 2 diabetes in conjunction with diet, exercise, and, if needed, weight reduction. ACTOplus met is used in patients already treated with a combination of pioglitazone and metformin, or whose diabetes is not adequately controlled with metformin alone, or who have initially responded to pioglitazone alone and require additional glycemic control.

What is the most important information I should know about ACTOplus met?

ACTOplus met may cause or worsen congestive heart failure (CHF) in some people. If you have the most severe form of CHF (New York Association Class III or IV heart failure), you should not start taking ACTOplus met. If you have less serious CHF (New York Association Class I or II heart failure), your doctor will observe you carefully while on ACTOplus met therapy. If you are taking ACTOplus met and you develop serious CHF, your doctor will decide whether you should continue therapy.

A small number of people who have taken metformin, one of the two drugs that make up ACTOplus met, have developed a serious and potentially fatal condition called lactic acidosis. Lactic acidosis is caused by a buildup of lactic acid in the blood. Lactic acidosis may trigger early symptoms such as feeling very weak (malaise), muscle pain, breathing problems, increased sleepiness, abdominal distress with nausea and vomiting or diarrhea, feeling cold (especially in the arms and legs), feeling dizzy or lightheaded, having a slow or irregular heartbeat, or your medical condition suddenly changes. You have a greater risk of developing lactic acidosis with ACTOplus met if you have kidney or liver problems, have CHF that requires treatment with medicines, drink a lot of alcohol, get dehydrated (lose a large amount of body fluids), have certain x-ray tests using injectable dyes, have surgery, have a heart attack, severe infection or stroke, are older than 80 years old and have not had your kidney function checked. Lactic acidosis happens most often in diabetic individuals with kidney problems. People with kidney problems should not take ACTOplus met.

Who should not take ACTOplus met?

Do not take ACTOplus met if you have type 1 diabetes, kidney problems, acute or chronic metabolic acidosis, including diabetic ketoacidosis, or if you are hypersensitive to pioglitazone, metformin, or any other component of ACTOplus met.

If you are going to have an x-ray procedure with an injection of contrast dyes, or if you are planning to have surgery performed, you should temporarily discontinue taking ACTOplus met.

What should I tell my doctor before I take the first dose of ACTOplus met?

Tell your doctor about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with ACTOplus met. Also, talk to your doctor about your complete medical history, especially if you have a history of alcoholism, kidney or liver problems, a heart condition (especially Class III/IV heart failure), a type of diabetic eye disease called macular edema (swelling of the back of the eye), pregnant or planning to become pregnant, breastfeeding, if you are a premenopausal woman not having periods regularly or at all, or a woman who has gone through menopause. Tell your doctor if you are taking insulin or oral hypoglycemic drugs.

What is the usual dosage?

The information below is based on the dosage guidelines your doctor uses. Depending on your condition and medical history, your doctor may prescribe a different regimen. Do not change the dosage or stop taking your medication without your doctor's approval.

Adults: ACTOplus met may be started at either the 15 milligram (mg)/500 mg or 15 mg/850 mg tablet strength once or twice daily. Your starting dose will be based on your current regimen of pioglitazone and/or metformin and will be gradually adjusted according to how you respond to the medication.

How should I take ACTOplus met?

Take ACTOplus met in divided doses with meals to reduce the gastrointestinal side effects associated with metformin. Take ACTOplus exactly as your doctor prescribes. Follow your doctor's recommendations regarding diet,exercise, and testing your blood glucose regularly while you are taking ACTOplus met.

What should I avoid while taking ACTOplus met?

Avoid taking in too few calories, especially if you're also engaging in regular strenuous exercise, since this can result in hypoglycemia while taking ACTOplus met. Also, avoid drinking a lot of alcohol while taking ACTOplus met because this can increase your chance of getting lactic acidosis.

What are possible food and drug interactions associated with ACTOplus met?

If ACTOplus met is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining ACTOplus met with: alcohol, calcium channel blocking drugs, cationic medications (eg, amiloride, digoxin, morphine, procainamide, quinidine, quinine, ranitidine, triamterene, trimethoprim, and vancomycin), corticosteroids, diuretics such as thiazides, enzyme inhibitors or enzyme inducers of CYP2C8 (such as gemfibrozil and rifampin, respectively), estrogens, insulin, isoniazid, medications containing ethanol, nicotinic acid, nifedipine, oral contraceptives, oral hypoglycemic drugs, phenothiazines, phenytoin, sympathomimetics, and thyroid products.

What are the possible side effects of ACTOplus met?

Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking this drug.

Side effects may include:

Upper respiratory tract infection, diarrhea, nausea, upset stomach, water retention, headache, urinary tract infection, sinusitis, dizziness, weight gain, cold-like symptoms, decreased levels of red blood cells (anemia), low blood sugar, liver problems, bone fractures

Symptoms of lactic acidosis (call your doctor immediately):

Dizziness or light-headedness, feeling very weak or tired (malaise), low body temperature, low blood pressure, muscle pain or tenderness, unexplained hyperventilation, slow or uneven heartbeat, stomach problems, unusual sleepiness

Can I receive ACTOplus met if I am pregnant or breastfeeding?

Talk to your doctor if you are pregnant, planning to become pregnant, or breastfeeding. If you are not having periods, talk to your doctor. ACTOplus met may increase your chances of becoming pregnant.

What should I do if I miss a dose of ACTOplus met?

If you miss a dose of ACTOplus met, take your next dose as prescribed unless told otherwise by your doctor.

How should I store ACTOplus met?

Store tightly closed at room temperature.