Actoplus Met

Name: Actoplus Met

What other drugs will affect metformin and pioglitazone?

Tell your doctor if you use insulin. Taking metformin and pioglitazone while you are using insulin may increase your risk of serious heart problems.

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • gemfibrozil;

  • morphine;

  • ranitidine;

  • an antibiotic--rifampin, trimethoprim, vancomycin; or

  • heart or blood pressure medication--digoxin, nifedipine, procainamide, quinidine.

You may be more likely to have hyperglycemia (high blood sugar) if you also take other drugs that can raise blood sugar, such as:

  • isoniazid;

  • diuretics (water pills);

  • steroids (prednisone and others);

  • niacin (Advicor, Niaspan, Niacor, Simcor, Slo-Niacin, and others);

  • phenothiazines (Compazine and others);

  • thyroid medicine (Synthroid and others);

  • birth control pills and other hormones; and

  • diet pills or medicines to treat asthma, colds or allergies.

These lists are not complete and many other medicines can increase or decrease the effects of metformin and pioglitazone on lowering your blood sugar. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here. Give a list of all your medicines to any healthcare provider who treats you.

Commonly used brand name(s)

In the U.S.

  • Actoplus Met
  • Actoplus Met XR

Available Dosage Forms:

  • Tablet
  • Tablet, Extended Release

Therapeutic Class: Hypoglycemic

Chemical Class: Metformin

What are some other side effects of Actoplus Met?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

  • Upset stomach or throwing up.
  • Loose stools (diarrhea).
  • Gas.
  • Headache.
  • Signs of a common cold.
  • Weight gain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Actoplus Met Dosage and Administration

Recommendations for All Patients

Actoplus Met should be taken with meals to reduce the gastrointestinal side effects associated with metformin.

If therapy with a combination tablet containing pioglitazone and metformin is considered appropriate the recommended starting dose is:

15 mg/500 mg twice daily or 15 mg/850 mg once daily and gradually titrated, as needed, after assessing adequacy of therapeutic response and tolerability,

for patients with New York Heart Association (NYHA) Class I or Class II congestive heart failure: 15 mg/500 mg or 15 mg/850 mg once daily and gradually titrated, as needed, after assessing adequacy of therapeutic response and tolerability,

for patients inadequately controlled on metformin monotherapy: 15 mg/500 mg twice daily or 15 mg/850 mg once or twice daily (depending on the dose of metformin already being taken) and gradually titrated, as needed, after assessing adequacy of therapeutic response and tolerability,

for patients inadequately controlled on pioglitazone monotherapy: 15 mg/500 mg twice daily or 15 mg/850 mg once daily and gradually titrated, as needed, after assessing adequacy of therapeutic response and tolerability,

for patients who are changing from combination therapy of pioglitazone plus metformin as separate tablets: Actoplus Met should be taken at doses that are as close as possible to the dose of pioglitazone and metformin already being taken.

Actoplus Met may be titrated up to a maximum daily dose of 45 mg of pioglitazone and 2550 mg of metformin.

Metformin doses above 2000 mg may be better tolerated given three times a day.

After initiation of Actoplus Met or with dose increase, monitor patients carefully for adverse reactions related to fluid retention such as weight gain, edema, and signs and symptoms of congestive heart failure [see Boxed Warning and Warnings and Precautions (5.1)]. Liver tests (serum alanine and aspartate aminotransferases, alkaline phosphatase, and total bilirubin) should be obtained prior to initiating Actoplus Met. Routine periodic monitoring of liver tests during treatment with Actoplus Met is not recommended in patients without liver disease. Patients who have liver test abnormalities prior to initiation of Actoplus Met or who are found to have abnormal liver tests while taking Actoplus Met should be managed as described under Warnings and Precautions [see Warnings and Precautions (5.5) and Clinical Pharmacology (12.3)].

Recommendations for Use in Renal Impairment

Assess renal function prior to initiation of Actoplus Met and periodically thereafter.

Actoplus Met is contraindicated in patients with an estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m2.

Initiation of Actoplus Met in patients with an eGFR between 30 – 45 mL/min/1.73 m2 is not recommended.

In patients taking Actoplus Met whose eGFR later falls below 45 mL/min/1.73 m2, assess the benefit risk of continuing therapy.

Discontinue Actoplus Met if the patient's eGFR later falls below 30 mL/min/1.73 m2 [see Contraindications (4) and Warnings and Precautions (5.2)].

Concomitant Use with Strong CYP2C8 Inhibitors

Coadministration of pioglitazone (one of the ingredients in Actoplus Met) and gemfibrozil, a strong CYP2C8 inhibitor, increases pioglitazone exposure approximately 3-fold. Therefore, the maximum recommended dose of Actoplus Met is 15 mg/850 mg daily when used in combination with gemfibrozil or other strong CYP2C8 inhibitors [see Drug Interactions (7.1) and Clinical Pharmacology (12.3)].

Discontinuation for Iodinated Contrast Imaging Procedures

Discontinue Actoplus Met at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR between 30 and 60 mL/min/1.73 m2; in patients with a history of liver disease, alcoholism or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Re-evaluate eGFR 48 hours after the imaging procedure; restart Actoplus Met if renal function is stable [see Warnings and Precautions (5.2)].

Drug Interactions

Strong CYP2C8 Inhibitors

An inhibitor of CYP2C8 (e.g., gemfibrozil) significantly increases the exposure (area under the serum concentration-time curve or AUC) and half-life (t½) of pioglitazone. Therefore, the maximum recommended dose of pioglitazone is 15 mg daily if used in combination with gemfibrozil or other strong CYP2C8 inhibitors [see Dosage and Administration (2.3) and Clinical Pharmacology (12.3)].

CYP2C8 Inducers

An inducer of CYP2C8 (e.g., rifampin) may significantly decrease the exposure (AUC) of pioglitazone. Therefore, if an inducer of CYP2C8 is started or stopped during treatment with pioglitazone, changes in diabetes treatment may be needed based on clinical response without exceeding the maximum recommended daily dose of 45 mg for pioglitazone [see Clinical Pharmacology (12.3)].

Carbonic Anhydrase Inhibitors

Topiramate or other carbonic anhydrase inhibitors (e.g., zonisamide, acetazolamide or dichlorphenamide) frequently causes a decrease in serum bicarbonate and induce non-anion gap, hyperchloremic metabolic acidosis. Concomitant use of these drugs with Actoplus Met may increase the risk for lactic acidosis. Consider more frequent monitoring of these patients.

Drugs that Reduce Metformin Clearance

Drugs that are eliminated by renal tubular secretion (e.g., cationic drugs such as cimetidine) have the potential for interaction with metformin by competing for common renal tubular transport systems, and may increase the accumulation of metformin and the risk for lactic acidosis [see Clinical Pharmacology (12.3)]. Consider more frequent monitoring of these patients.

Alcohol

Alcohol is known to potentiate the effect of metformin on lactate metabolism. Warn patients against excessive alcohol intake while receiving Actoplus Met.

Insulin Secretagogues or Insulin

If hypoglycemia occurs in a patient coadministered Actoplus Met and an insulin secretagogue (e.g., sulfonylurea), the dose of the insulin secretagogue should be reduced.

If hypoglycemia occurs in a patient coadministered Actoplus Met and insulin, the dose of insulin should be decreased by 10% to 25%. Further adjustments to the insulin dose should be individualized based on glycemic response.

Drugs Affecting Glycemic Control

Certain drugs tend to produce hyperglycemia and may lead to loss of glycemic control. These drugs include the thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blockers, and isoniazid. When such drugs are administered to a patient receiving Actoplus Met, the patient should be closely observed for loss of blood glucose control. When such drugs are withdrawn from a patient receiving Actoplus Met, the patient should be observed closely for hypoglycemia.

How Supplied/Storage and Handling

Actoplus Met is available in 15 mg pioglitazone (as the base)/500 mg metformin hydrochloride and 15 mg pioglitazone (as the base)/850 mg metformin hydrochloride tablets as follows:

15 mg/500 mg tablet: white to off-white, oblong, film-coated tablet with "4833M" on one side and "15/500" on the other, available in:

Bottles of 60

NDC 64764-155-60

Bottles of 180

NDC 64764-155-18

15 mg/850 mg tablet: white to off-white, oblong, film-coated tablet with "4833M" on one side and "15/850" on the other, available in:

Bottles of 60

NDC 64764-158-60

Bottles of 180

NDC 64764-158-18

Storage: Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Keep container tightly closed, and protect from moisture and humidity.

Patient Counseling Information

See FDA-Approved Patient Labeling (Medication Guide).

  • It is important to instruct patients to adhere to dietary instructions and to have blood glucose and glycosylated hemoglobin tested regularly. During periods of stress such as fever, trauma, infection, or surgery, medication requirements may change and patients should be reminded to seek medical advice promptly.
  • Tell patients to promptly report any sign of macroscopic hematuria or other symptoms such as dysuria or urinary urgency that develop or increase during treatment as these may be due to bladder cancer.
  • Explain to patients the risks of lactic acidosis, its symptoms and conditions that predispose to its development, as noted in the Warnings and Precautions (5.2) section. Advise patients to discontinue Actoplus Met immediately and to promptly notify their healthcare professional if unexplained hyperventilation, myalgia, gastrointestinal symptoms, malaise, unusual somnolence, or other nonspecific symptoms occur. Instruct patients to inform their doctor that they are taking Actoplus Met prior to any surgical or radiological procedure, as temporary discontinuation of Actoplus Met may be required until renal function has been confirmed to be normal.
  • Counsel patients against excessive alcohol intake while receiving Actoplus Met.
  • Inform patients to immediately report symptoms of an unusually rapid increase in weight or edema, shortness of breath, or other symptoms of heart failure while receiving Actoplus Met.
  • Tell patients to promptly stop taking Actoplus Met and seek immediate medical advice if there is unexplained nausea, vomiting, abdominal pain, fatigue, anorexia, or dark urine as these symptoms may be due to hepatotoxicity.
  • Inform patients about the importance of regular testing of renal function and hematologic parameters when receiving treatment with Actoplus Met.
  • Inform female patients that treatment with Actoplus Met may result in an unintended pregnancy in some premenopausal anovulatory females due to its effect on ovulation [see Use in Specific Populations (8.3)].
  • Patients should be advised to notify their health practitioner or call the Poison Control Center immediately in case of Actoplus Met overdose.
  • Combination antihyperglycemic therapy may cause hypoglycemia. When initiating Actoplus Met, the risks of hypoglycemia, its symptoms and treatment, and conditions that predispose to its development should be explained to patients and their family members.
  • Patients should be told to take Actoplus Met as prescribed and instructed that any change in dosing should only be done if directed by their physician. If a dose is missed on one day, the dose should not be doubled the following day.

Distributed by:
Takeda Pharmaceuticals America, Inc.
Deerfield, IL 60015

ACTOS and Actoplus Met are trademarks of Takeda Pharmaceutical Company Limited registered with the U.S. Patent and Trademark Office and used under license by Takeda Pharmaceuticals America, Inc.

All other trademarks are the property of their respective owners.

©2009 - 2016 Takeda Pharmaceuticals America, Inc.

APM001 R14

MEDICATION GUIDE
Actoplus Met (ak-TŌ-plus-met)
(pioglitazone and metformin hydrochloride) tablets

Read this Medication Guide carefully before you start taking Actoplus Met and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or your treatment. If you have any questions about Actoplus Met, ask your doctor or pharmacist.

What is the most important information I should know about Actoplus Met?

Actoplus Met can cause serious side effects, including:

• new or worse heart failure. Pioglitazone, one of the medicines in Actoplus Met, can cause your body to keep extra fluid (fluid retention), which leads to swelling (edema) and weight gain. Extra body fluid can make some heart problems worse or lead to heart failure. Heart failure means your heart does not pump blood well enough. o Do not take Actoplus Met if you have severe heart failure o If you have heart failure with symptoms (such as shortness of breath or swelling), even if these symptoms are not severe, Actoplus Met may not be right for you.   Call your doctor right away if you have any of the following: o swelling or fluid retention, especially in the ankles or legs o shortness of breath or trouble breathing, especially when you lie down o an unusually fast increase in weight o unusual tiredness • lactic acidosis. Metformin, one of the medicines in Actoplus Met, can cause a rare but serious condition called lactic acidosis (a buildup of an acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in the hospital.   Call your doctor right away if you have any of the following symptoms, which could be signs of lactic acidosis: o you feel cold in your hands or feet o you feel dizzy or lightheaded o you have a slow or irregular heartbeat o you feel very weak or tired o you have unusual (not normal) muscle pain o you have trouble breathing o you feel sleepy or drowsy o you have stomach pains, nausea, or vomiting

Most people who have had lactic acidosis with metformin have other things that, combined with the metformin, led to the lactic acidosis. Tell your doctor if you have any of the following, because you have a higher chance for getting lactic acidosis with Actoplus Met if you:

  • have severe kidney problems or your kidneys are affected by certain x-ray tests that use injectable dye. have liver problems
  • drink alcohol very often, or drink a lot of alcohol in short-term "binge" drinking
  • dehydrated (lose a large amount of body fluids). This can happen if you are sick with a fever, vomiting, or diarrhea. Dehydration can also happen when you sweat a lot with activity or exercise and do not drink enough fluids
  • have surgery
  • have a heart attack, severe infection, or stroke

The best way to keep from having a problem with lactic acidosis from metformin is to tell your doctor if you have any of the problems in the list above. Your doctor may decide to stop your Actoplus Met for a while if you have any of these things.

Actoplus Met can have other serious side effects. See "What are the possible side effects of Actoplus Met?"

What is Actoplus Met?

Actoplus Met contains two prescription diabetes medicines called pioglitazone (ACTOS) and metformin hydrochloride (GLUCOPHAGE). Actoplus Met can be used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes.

Actoplus Met is not for people with type 1 diabetes.

Actoplus Met is not for people with diabetic ketoacidosis (increased ketones in your blood or urine).

It is not known if Actoplus Met is safe and effective in children under the age of 18. Actoplus Met is not recommended for use in children.

Who should not take Actoplus Met?

See "What is the most important information I should know about Actoplus Met?"

Do not take Actoplus Met if you:

• have severe heart failure • are allergic to pioglitazone, metformin, or any of the ingredients in Actoplus Met. See the end of this Medication Guide for a complete list of ingredients in Actoplus Met • have severe kidney problems • have a condition called metabolic acidosis, including diabetic ketoacidosis. Diabetic ketoacidosis should be treated with insulin

Tell your doctor before taking Actoplus Met if you have any of these conditions.

What should I tell my doctor before taking Actoplus Met?

Before you take Actoplus Met, tell your doctor if you:

• have heart failure • have severe kidney problems • are going to have dye injected into a vein for an x-ray, CAT scan, heart study, or other type of scanning • will be undergoing a surgical procedure • drink a lot of alcohol (all the time or short binge drinking) • have type 1 ("juvenile") diabetes or had diabetic ketoacidosis • have a type of diabetic eye disease that causes swelling in the back of the eye (macular edema) • have liver problems • have or have had cancer of the bladder • are pregnant or plan to become pregnant. It is not known if Actoplus Met can harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant about the best way to control your blood glucose levels while pregnant • are a premenopausal woman (before the "change of life") who does not have periods regularly or at all. Actoplus Met may increase your chance of becoming pregnant. Talk to your doctor about birth control choices while taking Actoplus Met. Tell your doctor right away if you become pregnant while taking Actoplus Met • are breastfeeding or plan to breastfeed. It is not known if Actoplus Met passes into your milk and if it can harm your baby. Talk to your doctor about the best way to control your blood glucose levels while breastfeeding

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

Actoplus Met and some of your other medicines can affect each other. You may need to have your dose of Actoplus Met or certain other medicines changed.

Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist before you start a new medicine. They will tell you if it is okay to take Actoplus Met with other medicines.

How should I take Actoplus Met?

• Take Actoplus Met exactly as your doctor tells you to take it • Your doctor may need to change your dose of Actoplus Met. Do not change your Actoplus Met dose unless your doctor tells you to • Actoplus Met may be prescribed alone or with other diabetes medicines. This will depend on how well your blood sugar is controlled • Take Actoplus Met with meals to lower your chance of an upset stomach • If you miss a dose of Actoplus Met, take your next dose as prescribed unless your doctor tells you differently. Do not take two doses at one time the next day • If you take too much Actoplus Met, call your doctor or go to the nearest hospital emergency room right away • If your body is under stress such as from a fever, infection, accident, or surgery, the dose of your diabetes medicines may need to be changed. Call your doctor right away • Stay on your diet and exercise programs and test your blood sugar regularly while taking Actoplus Met • Your doctor should do certain blood tests before you start and while you take Actoplus Met • Your doctor should also do hemoglobin A1C testing to check how well your blood sugar is controlled with Actoplus Met • Your doctor should check your eyes regularly while you take Actoplus Met

What are the possible side effects of Actoplus Met?

Actoplus Met may cause serious side effects, including:

• See "What is the most important information I should know about Actoplus Met?" • low blood sugar (hypoglycemia). This can happen if you skip meals, if you also use another medicine that lowers blood sugar, or if you have certain medical problems. Lightheadedness, dizziness, shakiness, or hunger may happen if your blood sugar is too low. Call your doctor if low blood sugar levels are a problem for you • liver problems. Call your doctor right away if you have: o nausea or vomiting o stomach pain o unusual or unexplained tiredness o loss of appetite o dark urine o yellowing of your skin or the whites of your eyes • bladder cancer. There may be an increased chance of having bladder cancer when you take Actoplus Met. You should not take Actoplus Met if you are receiving treatment for bladder cancer. Tell your doctor right away if you have any of the following symptoms of bladder cancer: o blood or a red color in your urine o an increased need to urinate o pain while you urinate • broken bones (fractures). Usually in the hand, upper arm, or foot in women. Talk to your doctor for advice on how to keep your bones healthy • diabetic eye disease with swelling in the back of the eye (macular edema). Tell your doctor right away if you have any changes in your vision. Your doctor should check your eyes regularly • release of an egg from an ovary in a woman (ovulation) leading to pregnancy. Ovulation may happen when premenopausal women who do not have regular monthly periods take Actoplus Met. This can increase your chance of getting pregnant. • low red blood cell count (anemia).

The most common side effects of Actoplus Met include:

  • cold-like symptoms (upper respiratory tract infection)
  • swelling (edema)
  • diarrhea
  • headache
  • increased weight

Tell your doctor if you have any side effect that bothers you or that does not go away. These are not all the side effects of Actoplus Met. For more information, ask your doctor or pharmacist.

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

How should I store Actoplus Met?

• Store Actoplus Met at 68°F to 77°F (20°C to 25°C). Keep Actoplus Met in the original container and protect from light

Keep the Actoplus Met bottle tightly closed and keep tablets dry

Keep Actoplus Met and all medicines out of the reach of children.

General information about the safe and effective use of Actoplus Met

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Actoplus Met for a condition for which it was not prescribed. Do not give Actoplus Met to other people, even if they have the same symptoms you have. It may harm them.

This Medication Guide summarizes the most important information about Actoplus Met. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Actoplus Met that is written for healthcare professionals.

For more information, go to www.actoplusmet.com or call 1-877-825-3327.

What are the ingredients in Actoplus Met?

Active Ingredients: pioglitazone hydrochloride and metformin hydrochloride

Inactive Ingredients: povidone, microcrystalline cellulose, croscarmellose sodium, magnesium stearate, hypromellose 2910, polyethylene glycol 8000, titanium dioxide, and talc

ACTOS and Actoplus Met are trademarks of Takeda Pharmaceutical Company Limited registered with the U.S. Patent and Trademark Office and used under license by Takeda Pharmaceuticals America, Inc.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Distributed by:
Takeda Pharmaceuticals America, Inc.
Deerfield, IL 60015

Revised: December 2016

© 2009 - 2016 Takeda Pharmaceuticals America, Inc.

APM001 R14

PRINCIPAL DISPLAY PANEL 15 mg / 500 mg 60 Tablet Bottle

NDC 64764-155-60
60 Tablets

actoplus met

pioglitazone 15 mg and
metformin HCl 500 mg tablets

Each film-coated tablet contains
pioglitazone hydrochloride
equivalent to 15 mg pioglitazone
and 500 mg metformin HCl.

Dispense with Medication Guide
available in package insert or at
www.actoplusmet.com

Takeda Logo

Rx Only

PRINCIPAL DISPLAY PANEL 15 mg / 850 mg 60 Tablet Bottle

NDC 64764-158-60
60 Tablets

actoplus met

pioglitazone 15 mg and
metformin HCl 850 mg tablets

Each film-coated tablet contains
pioglitazone hydrochloride
equivalent to 15 mg pioglitazone
and 850 mg metformin HCl.

Dispense with Medication Guide
available in package insert or at
www.actoplusmet.com

Takeda Logo

Rx Only

Actoplus Met 
pioglitazone and metformin hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:64764-155
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PIOGLITAZONE HYDROCHLORIDE (pioglitazone) pioglitazone 15 mg
metformin hydrochloride (metformin) metformin hydrochloride 500 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONE, UNSPECIFIED  
microcrystalline cellulose  
croscarmellose sodium  
magnesium stearate  
hypromellose 2910 (6 MPA.S)  
polyethylene glycol 8000  
titanium dioxide  
talc  
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape OVAL (oblong) Size 14mm
Flavor Imprint Code 4833M;15;500
Contains     
Packaging
# Item Code Package Description
1 NDC:64764-155-60 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
2 NDC:64764-155-18 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
3 NDC:64764-155-41 4 CARTON in 1 TRAY
3 1 BLISTER PACK in 1 CARTON
3 7 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021842 08/29/2005
Actoplus Met 
pioglitazone and metformin hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:64764-158
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PIOGLITAZONE HYDROCHLORIDE (pioglitazone) pioglitazone 15 mg
metformin hydrochloride (metformin) metformin hydrochloride 850 mg
Inactive Ingredients
Ingredient Name Strength
POVIDONE, UNSPECIFIED  
microcrystalline cellulose  
croscarmellose sodium  
magnesium stearate  
hypromellose 2910 (6 MPA.S)  
polyethylene glycol 8000  
titanium dioxide  
talc  
Product Characteristics
Color WHITE (white to off-white) Score no score
Shape OVAL (oblong) Size 18mm
Flavor Imprint Code 4833M;15;850
Contains     
Packaging
# Item Code Package Description
1 NDC:64764-158-60 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
2 NDC:64764-158-18 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
3 NDC:64764-158-41 4 CARTON in 1 TRAY
3 1 BLISTER PACK in 1 CARTON
3 7 TABLET, FILM COATED in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021842 08/29/2005
Labeler - Takeda Pharmaceuticals America, Inc. (830134016)
Revised: 12/2016   Takeda Pharmaceuticals America, Inc.

Actoplus Met and Lactation

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

No studies of the combination of ingredients in Actoplus Met 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, 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.

 

Important information

You should not use Actoplus Met if you have severe or uncontrolled heart failure, kidney problems, active bladder cancer, metabolic acidosis, or diabetic ketoacidosis (call your doctor for treatment with insulin). Actoplus Met is not for treating type 1 diabetes.

Actoplus Met can cause or worsen congestive heart failure. Call your doctor at once if you have shortness of breath (even with mild exertion), swelling, or rapid weight gain.

If you need to have any type of x-ray or CT scan using a dye that is injected into your veins, you will need to temporarily stop taking Actoplus Met.

Some people develop lactic acidosis while taking metformin. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or uneven heart rate, dizziness, or feeling very weak or tired.

Actoplus Met dosing information

Usual Adult Dose of Actoplus Met for Diabetes Type 2:

Individualize dose based on safety, efficacy, and prior therapy; asses the risk versus benefit of initiating with combination therapy versus monotherapy

Initial dose: metformin 500 mg-pioglitazone 15 mg orally twice a day OR metformin 850 mg-pioglitazone 15 mg orally once a day
Maintenance dose: Gradually titrate dose based on safety and efficacy
Maximum dose: Metformin 2550 mg-Pioglitazone 45 mg per day

Extended-release:
Initial dose: metformin 1000 mg-pioglitazone 15 mg OR metformin 1000 mg-pioglitazone 30 mg orally once a day
Maintenance dose: Gradually titrate dose based on safety and efficacy
Maximum dose: Metformin 2000 mg-Pioglitazone 45 mg per day

Comments:
-Initial doses for patients receiving combination therapy as separate tablets should be as close as possible to current regimen.
-Metformin doses above 2000 mg may be better tolerated given 3 times a day.

Use: Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both pioglitazone and metformin is appropriate.

What other drugs will affect Actoplus Met?

Tell your doctor if you use insulin. Taking Actoplus Met while you are using insulin may increase your risk of serious heart problems.

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • gemfibrozil;

  • morphine;

  • ranitidine;

  • an antibiotic - rifampin, trimethoprim, vancomycin; or

  • heart or blood pressure medication - digoxin, nifedipine, procainamide, quinidine.

You may be more likely to have hyperglycemia (high blood sugar) if you also take other drugs that can raise blood sugar, such as:

  • isoniazid;

  • diuretics (water pills);

  • steroids (prednisone and others);

  • niacin (Advicor, Niaspan, Niacor, Simcor, Slo-Niacin, and others);

  • phenothiazines (Compazine and others);

  • thyroid medicine (Synthroid and others);

  • birth control pills and other hormones; and

  • diet pills or medicines to treat asthma, colds or allergies.

These lists are not complete and many other medicines can increase or decrease the effects of Actoplus Met on lowering your blood sugar. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here. Give a list of all your medicines to any healthcare provider who treats you.

In Summary

More frequent side effects include: dental disease, edema, myalgia, pharyngitis, decreased vitamin b12 serum concentrate, and weight gain. See below for a comprehensive list of adverse effects.

(web3)