Actoplus Met XR

Actoplus Met XR is a prescription medication used to treat type 2 diabetes.

It is a single product containing 2 medications: immediate-release pioglitazone and extended-release metformin.

Pioglitazone belongs to a group of drugs called thiazolidinediones. These work by increasing the body’s sensitivity to insulin. Metformin belongs to a group of drugs called biguanides. These work by decreasing the amount of glucose absorbed from food and decreasing the amount of glucose that is produced by the liver.

This medication comes in tablet form and is taken one or two times a day, with food.

Common side effects of Actoplus Met XR include upper respiratory tract infection, edema, diarrhea, headache, muscle pain, and weight gain.

In combination with other medications to treat diabetes, Actoplus Met XR can also cause hypoglycemia (low blood sugar), which can cause blurred vision and dizziness. Do not drive or operate heavy machinery until you know how Actoplus Met XR affects you.

Actoplus Met XR is a prescription medication used to treat type 2 diabetes.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Takeda Pharmaceuticals America, Inc.

Serious side effects have been reported with Actoplus Met XR. See the “Actoplus Met XR Precautions” section.

Common side effects of Actoplus Met XR include the following:

• Upper respiratory tract infection
• Headache
• Sinusitis
• Muscle pain
• Sore throat
• Weight gain
• Diarrhea

This is not a complete list of Actoplus Met XR side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• acetazolamide (Diamox)
• amiloride (Midamor, in Moduretic)
• angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), and trandolapril (Mavik)
• atorvastatin (Lipitor)
• beta-blockers such as atenolol (Tenormin), labetalol (Normodyne), metoprolol (Lopressor, Toprol XL), nadolol (Corgard), and propranolol (Inderal)
• calcium channel blockers such as amlodipine (Norvasc), diltiazem (Cardizem, Dilacor, Tiazac, others), felodipine (Plendil), isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat, Procardia), nimodipine (Nimotop), nisoldipine (Sular), and verapamil (Calan, Isoptin, Verelan)
• cimetidine (Tagamet)
• digoxin (Lanoxin)
• diuretics ('water pills')
• furosemide (Lasix)
• gemfibrozil (Lopid)
• hormonal contraceptives (birth control pills, patches, rings, implants, and injections) or hormone replacement therapy
• insulin or other medications to treat diabetes
• isoniazid
• ketoconazole (Nizoral)
• medications for asthma and colds
• medications for mental illness and nausea
• medications for thyroid disease
• midazolam (Versed)
• morphine (MS Contin, others)
• nifedipine (Procardia)
• oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone)
• phenytoin (Dilantin, Phenytek)
• procainamide (Procanbid)
• quinidine
• quinine
• ranitidine (Zantac)
• rifampin (Rifadin, Rifater, in Rifamate)
• topiramate (Topamax)
• triamterene (Dyazide, Maxzide, others)
• trimethoprim (Primsol)
• vancomycin (Vancocin)
• zonisamide (Zonegran)

This is not a complete list of Actoplus Met XR drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Actoplus Met XR including the following:

• Congestive heart failure. Tell your healthcare provider right away if you have some or all of the following symptoms of congestive heart failure.
  • large weight gain in a short period of time
  • shortness of breath
  • swelling of the arms, hands, feet, ankles, or lower legs
  • swelling or pain in the stomach
  • waking up short of breath during the night
  • needing to sleep with extra pillows under your head in order to breathe easier while lying down
  • frequent dry cough or wheezing
  • difficulty thinking clearly or confusion
  • fast or racing heart beat
  • not able to walk or exercise as well
  • increased tiredness

• Lactic acidosis. Tell your healthcare provider right away if you have some or all of the following symptoms of congestive heart failure.
  • Extreme tiredness
  • Weakness or discomfort
  • Unusual or unexpected stomach pain
  • Decreased appetite
  • Deep and rapid breathing or shortness of breath
  • Dizziness
  • Lightheadedness
  • Fast or slow heart beat
  • Flushing of the skin
  • Muscle pain
  • Feeling cold

• Hypoglycemia (low blood sugar). Tell your healthcare provider right away if you have some or all of the following symptoms of hypoglycemia.
  • Lightheadedness
  • Dizziness
  • Shakiness
  • Hunger
  • Blurred vision

• Liver problems. Tell your healthcare provider right away if you have some or all of the following symptoms of liver problems.
  • Nausea
  • Vomiting
  • Loss of appetite
  • Pain in the upper right part of the abdomen
  • Flu-like symptoms
  • Dark urine
  • Yellowing of the skin or eyes
  • Unusual bleeding or bruising
  • Lack of energy

• Ovulation. Pioglitazone, like other thiazolidinediones, may stimulate ovulation in premenopausal women and increase the chance of pregnancy.

Do not take Actoplus Met XR if you:

• are allergic to Actoplus Met XR or to any of its ingredients
• have NYHA Class III or IV heart failure
• have kidney problems
• have metabolic acidosis

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Actoplus Met XR, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Actoplus Met XR, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Actoplus Met XR or to any of its ingredients
• have kidney problems
• have liver problems
• have heart problems
• have or have had bladder cancer
• have diabetic eye disease
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Actoplus Met XR falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

No studies of the combination of ingredients in Actoplus Met XR have been evaluated in nursing women. The individual components have been detected in human breast milk. Because of the possibility for adverse reactions in nursing infants from Actoplus Met XR, a choice should be made whether to stop nursing or to stop use of this medication. The importance of the drug to the mother should be considered. 

Take Actoplus Met XR exactly as prescribed.

This medication comes in tablet form and is taken one or two times a day, with food.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Actoplus Met XR at the same time.

Do not chew, divide, or break Actoplus Met XR. Swallow Actoplus Met XR tablets whole.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication

The recommended starting dose of Actoplus Met XR for the treatment of type 2 diabetes is 15 mg pioglitazone/1000 mg metformin or 30 mg pioglitazone/1000 mg metformin once daily. The dose should be gradually adjusted based on patient response, blood glucose levels, and other medications the patient is taking. The maximum dose of Actoplus Met XR is 45 mg pioglitazone/2000 mg metformin.

If you take too much Actoplus Met XR, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Actoplus Met XR is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store Actoplus Met XR at room temperature.
• Keep this and all medicines out of the reach of children.

WARNING: CONGESTIVE HEART FAILURE AND LACTIC ACIDOSIS

Congestive Heart Failure

Thiazolidinediones, including pioglitazone, which is a component of ACTOPLUS MET XR, cause or exacerbate congestive heart failure in some patients.

After initiation of ACTOPLUS MET XR, and after dose increases, monitor patients carefully for signs and symptoms of heart failure (e.g., excessive, rapid weight gain, dyspnea, and/or edema). If heart failure develops, it should be managed according to current standards of care and discontinuation or dose reduction of ACTOPLUS MET XR must be considered.

ACTOPLUS MET XR is not recommended in patients with symptomatic heart failure.

Initiation of ACTOPLUS MET XR in patients with established New York Heart Association (NYHA) Class III or IV heart failure is contraindicated.

Lactic Acidosis

Lactic acidosis is a rare, but serious complication that can occur due to metformin accumulation. The risk increases with conditions such as sepsis, dehydration, excess alcohol intake, hepatic impairment, renal impairment, and acute congestive heart failure.

The onset is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, increasing somnolence, and nonspecific abdominal distress. Laboratory abnormalities include low pH, increased anion gap and elevated blood lactate.

If acidosis is suspected, ACTOPLUS MET XR should be discontinued and the patient hospitalized immediately.