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ACTOPLUS MET XR- pioglitazone and metformin hydrochloride tablet, film coated, extended release


  1. Actoplus Met Xr Can Cause Serious Side Effects, Including:
  2. Call Your Doctor Right Away If You Have Any Of The Following:
  3. Call Your Doctor Right Away If You Have Any Of The Following Symptoms, Which Could Be Signs Of Lactic Acidosis:
  4. 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 Xr If You:
  5. Before You Take Actoplus Met Xr, Tell Your Doctor If You:
  6. How Should I Take Actoplus Met Xr?
  7. Actoplus Met Xr May Cause Serious Side Effects Including:
  8. Active Ingredients:
  9. Inactive Ingredients:
  10. Distributed By:
  11. Revised: 10/2019document Id:

Actoplus Met Xr Can Cause Serious Side Effects, Including: 

new or worse heart failure.Pioglitazone, one of the medicines in ACTOPLUS MET XR, 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
Do not take ACTOPLUS MET XR if you have severe heart failure
If you have heart failure with symptoms (such as shortness of breath or swelling), even if these symptoms are not severe, ACTOPLUS MET XR may not be right for you

Call Your Doctor Right Away If You Have Any Of The Following: 

swelling or fluid retention, especially in the ankles or legs
shortness of breath or trouble breathing, especially when you lie down
an unusually fast increase in weight
unusual tiredness
lactic acidosis. Metformin, one of the medicines in ACTOPLUS MET XR, 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: 

you feel cold in your hands or feet
you feel dizzy or lightheaded
you have a slow or irregular heartbeat
you feel very weak or tired
you have unusual (not normal) muscle pain
you have trouble breathing
you feel sleepy or drowsy
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 Xr 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
get 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 XR for a while if you have any of these things.

ACTOPLUS MET XR can have other serious side effects.

ACTOPLUS MET XR contains 2 prescription diabetes medicines called pioglitazone (ACTOS) and metformin hydrochloride extended-release. ACTOPLUS MET XR can be used with diet and exercise to improve blood sugar (glucose) control in adults with type 2 diabetes.

ACTOPLUS MET XR is not for people with type 1 diabetes.

ACTOPLUS MET XR is not for people with diabetic ketoacidosis (increased ketones in your blood or urine).

It is not known if ACTOPLUS MET XR is safe and effective in children under the age of 18. ACTOPLUS MET XR is not recommended for use in children.

Before You Take Actoplus Met Xr, 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 XR 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 XR may increase your chance of becoming pregnant. Talk to your doctor about birth control choices while taking ACTOPLUS MET XR. Tell your doctor right away if you become pregnant while taking ACTOPLUS MET XR
are breast-feeding or plan to breast-feed.It is not known if ACTOPLUS MET XR 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 breast-feeding

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

ACTOPLUS MET XR and some of your other medicines can affect each other. You may need to have your dose of ACTOPLUS MET XR 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 XR with other medicines.

How Should I Take Actoplus Met Xr? 

Take ACTOPLUS MET XR exactly as your doctor tells you to take it
Your doctor may need to change your dose of ACTOPLUS MET XR. Do not change your ACTOPLUS MET XR dose unless your doctor tells you to
ACTOPLUS MET XR may be prescribed alone or with other diabetes medicines. This will depend on how well your blood sugar is controlled
Take ACTOPLUS MET XR once a day with meals to lower your chance of an upset stomach
Take ACTOPLUS MET XRtablets whole. Do not chew, cut, or crush the tablets.If you cannot swallow ACTOPLUS MET XR whole, tell your doctor. You may need a different medicine.
If you take ACTOPLUS MET XR, you may

Actoplus Met Xr May Cause Serious Side Effects Including: 

Store ACTOPLUS MET XR at 68 F to 77 F (20 C to 25 C). Keep ACTOPLUS MET XR in the original container to protect from light
Keep the ACTOPLUS MET XR bottle tightly closed and keep tablets dry

Keep ACTOPLUS MET XR and all medicines out of the reach of children.

General information about the safe and effective use of ACTOPLUS MET XR

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ACTOPLUS MET XR for a condition for which it was not prescribed. Do not give ACTOPLUS MET XR 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 XR. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about ACTOPLUS MET XR that is written for healthcare professionals. For more information, go to www.actoplusmetxr.com or call 1-877-825-3327.

Active Ingredients: 

pioglitazone and metformin hydrochloride.

Inactive Ingredients: 

candelilla wax, cellulose acetate, povidone, hydroxypropyl cellulose, lactose monohydrate, magnesium stearate, hypromellose, polyethylene glycols (PEG 400, PEG 8000), sodium lauryl sulfate, titanium dioxide, and triacetin. Ink contains shellac, iron-oxide red (15 mg/1000 mg tablet strength), FD&C Blue No. 2 Lake (30 mg/1000 mg tablet strength), propylene glycol, and ammonium hydroxide.

ACTOS and ACTOPLUS MET XR 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 - 2017 Takeda Pharmaceuticals America, Inc.

AMX002 R11

PRINCIPAL DISPLAY PANEL 15 mg/1000 mg Tablet Bottle Label

30 Tablets NDC64764-510-30

actoplus met XR
(pioglitazone and metformin HCl
extended-release) Tablets

15 mg/1000 mg

Each film-coated tablet contains
pioglitazone hydrochloride equivalent
to 15 mg pioglitazone and 1000 mg
metformin hydrochloride.

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

Takeda logo

Rx Only

15-1000-30count.jpg

PRINCIPAL DISPLAY PANEL - 30 mg/1000 mg Tablet Bottle Label

30 Tablets NDC64764-310-30

actoplus met XR
(pioglitazone and metformin HCl
extended-release) Tablets

30 mg/1000 mg

Each film-coated tablet contains
pioglitazone hydrochloride equivalent
to 30 mg pioglitazone and 1000 mg
metformin hydrochloride.

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

Takeda logo

Rx Only

30-1000-30count.jpg
ACTOPLUS MET XR
pioglitazone and metformin hydrochloride tablet, film coated, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:64764-510
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
pioglitazone hydrochloride(UNII: JQT35NPK6C) (pioglitazone - UNII:X4OV71U42S)pioglitazone15 mg
metformin hydrochloride(UNII: 786Z46389E) (metformin - UNII:9100L32L2N)metformin hydrochloride1000 mg
Inactive Ingredients
Ingredient NameStrength
candelilla wax(UNII: WL0328HX19)
cellulose acetate(UNII: 3J2P07GVB6)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
lactose monohydrate(UNII: EWQ57Q8I5X)
magnesium stearate(UNII: 70097M6I30)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
polyethylene glycol 400(UNII: B697894SGQ)
polyethylene glycol 8000(UNII: Q662QK8M3B)
sodium lauryl sulfate(UNII: 368GB5141J)
titanium dioxide(UNII: 15FIX9V2JP)
triacetin(UNII: XHX3C3X673)
shellac(UNII: 46N107B71O)
propylene glycol(UNII: 6DC9Q167V3)
ammonia(UNII: 5138Q19F1X)
ferric oxide red(UNII: 1K09F3G675)
Product Characteristics
ColorWHITE (white to off-white)Scoreno score
ShapeROUNDSize13mm
FlavorImprint Code4833X;15;1000
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64764-510-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/11/201009/30/2022
2NDC:64764-510-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/11/201009/30/2022
3NDC:64764-510-9090 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/11/201009/30/2022
4NDC:64764-510-071 in 1 CARTON06/11/201009/30/2022
47 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:64764-510-3330 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/11/201009/30/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02202406/11/201009/30/2022
ACTOPLUS MET XR
pioglitazone and metformin hydrochloride tablet, film coated, extended release
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:64764-310
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
pioglitazone hydrochloride(UNII: JQT35NPK6C) (pioglitazone - UNII:X4OV71U42S)pioglitazone30 mg
metformin hydrochloride(UNII: 786Z46389E) (metformin - UNII:9100L32L2N)metformin hydrochloride1000 mg
Inactive Ingredients
Ingredient NameStrength
candelilla wax(UNII: WL0328HX19)
cellulose acetate(UNII: 3J2P07GVB6)
POVIDONE, UNSPECIFIED(UNII: FZ989GH94E)
HYDROXYPROPYL CELLULOSE (1600000 WAMW)(UNII: RFW2ET671P)
lactose monohydrate(UNII: EWQ57Q8I5X)
magnesium stearate(UNII: 70097M6I30)
HYPROMELLOSE, UNSPECIFIED(UNII: 3NXW29V3WO)
polyethylene glycol 400(UNII: B697894SGQ)
polyethylene glycol 8000(UNII: Q662QK8M3B)
sodium lauryl sulfate(UNII: 368GB5141J)
titanium dioxide(UNII: 15FIX9V2JP)
triacetin(UNII: XHX3C3X673)
shellac(UNII: 46N107B71O)
propylene glycol(UNII: 6DC9Q167V3)
ammonia(UNII: 5138Q19F1X)
FD&C Blue No. 2(UNII: L06K8R7DQK)
Aluminum Oxide(UNII: LMI26O6933)
Product Characteristics
ColorWHITE (white to off-white)Scoreno score
ShapeROUNDSize13mm
FlavorImprint Code4833X;30;1000
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:64764-310-3030 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/11/201009/30/2022
2NDC:64764-310-6060 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/11/201009/30/2022
3NDC:64764-310-9090 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/11/201009/30/2022
4NDC:64764-310-071 in 1 CARTON06/11/201009/30/2022
47 in 1 BLISTER PACK; Type 0: Not a Combination Product
5NDC:64764-310-3330 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/11/201009/30/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02202406/11/201009/30/2022
Labeler -Takeda Pharmaceuticals America, Inc. (830134016)

Revised: 10/2019document Id: 

12f6dfdd-309c-44a9-86bf-664c449f5ddbSet id: f986164c-51a7-41c2-8952-511b8f46d593Version: 14Effective Time: 20191004Takeda Pharmaceuticals America, Inc.



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