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AVANDAMET- rosiglitazone maleate and metformin hydrochloride tablet, film coated


  1. Call Your Doctor Right Away If You Have Any Of The Following:
  2. Symptoms Of A Heart Attack Can Include The Following:
  3. 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 Avandamet If You:
  4. Avandamet Contains Two Prescription Medicines For Treating Diabetes, Rosiglitazone Maleate (avandia) And Metformin Hydrochloride. Avandamet Is Used, With Diet And Exercise, To Treat Certain Adults With Type 2 ( Adult-onset Or Non-insulin Dependent ) Diabetes ( High Blood Sugar ) Who Are:
  5. Do Not Take Avandamet If You:
  6. Before Taking Avandamet, Tell Your Doctor About All Your Medical Conditions, Including If You:
  7. Tell Your Doctor About All The Medicines You Take Including Prescription And Non-prescription Medicines, Vitamins Or Herbal Supplements. Avandamet And Certain Other Medicines Can Affect Each Other And May Lead To Serious Side Effects Including High Or Low Blood Sugar, Or Heart Problems. Your Doctor May Need To Change Your Dose Of Avandamet Or Your Other Medicines. Especially Tell Your Doctor If You Take:
  8. How Should I Take Avandamet?
  9. Avandamet May Cause Serious Side Effects, Including:
  10. What Are The Ingredients In Avandamet?
  11. Always Check To Make Sure That The Medicine You Are Taking Is The Correct One. Avandamet Tablets Are Oval And Look Like This:
  12. Revised: 8/2012document Id:

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

Myocardial Infarction ( Heart Attack )

Rosiglitazone, one of the medicines in AVANDAMET, may raise the risk of heart attack. The risk of having a heart attack may be higher in people who take AVANDAMET with insulin. Most people who take insulin should not also take AVANDAMET.

Symptoms Of A Heart Attack Can Include The Following: 

  • chest discomfort in the center of your chest that lasts for more than a few minutes, or that goes away or comes back
  • chest discomfort that feels like uncomfortable pressure, squeezing, fullness or pain
  • pain or discomfort in your arms, back, neck, jaw or stomach
  • shortness of breath with or without chest discomfort
  • breaking out in a cold sweat
  • nausea or vomiting
  • feeling lightheaded

Call your doctor or go to the nearest hospital emergency room right away if you think you are having a heart attack.

People with diabetes have a greater risk for heart problems. It is important to work with your doctor to manage other conditions, such as high blood pressure or high cholesterol.

Lactic acidosis

Metformin, one of the medicines in AVANDAMET, can cause a rare but serious condition called lactic acidosis (a build-up of an acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in the hospital.

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 Avandamet If You: 

  • have kidney problems or your kidneys are affected by certain X-ray tests that use injectable dye. People with kidney problems should not take AVANDAMET.
  • 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
  • are 80 years of age or older, and your kidneys are not working properly

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 AVANDAMET for a while if you have any of these things.

Lactic acidosis can be hard to diagnose early, because the early symptoms could

Avandamet Contains Two Prescription Medicines For Treating Diabetes, Rosiglitazone Maleate (avandia) And Metformin Hydrochloride. Avandamet Is Used, With Diet And Exercise, To Treat Certain Adults With Type 2 ( Adult-onset Or Non-insulin Dependent ) Diabetes ( High Blood Sugar ) Who Are: 

  • already taking rosiglitazone or rosiglitazone-containing products
  • unable to control their blood sugar on other diabetes medicines, and after talking with their doctor have decided not to take pioglitazone (ACTOS) or pioglitazone-containing products (ACTOPLUS MET, ACTOPLUS MET XR, DUETACT)

Metformin works mainly by decreasing the production of sugar by your liver. Rosiglitazone helps your body respond better to its natural insulin and does not cause your body to make more insulin. These medicines work together to help control your blood sugar. AVANDAMET may be used alone or with other diabetes medicines.

AVANDAMET is not for people with type 1 diabetes mellitus or to treat a condition called diabetic ketoacidosis.

It is not known if AVANDAMET is safe and effective in children under 18 years old.

Do Not Take Avandamet If You: 

  • have kidney problems. Before you take AVANDAMET and while you take it, your doctor should test your blood to check for signs of kidney problems.
  • have a condition known as metabolic acidosis, including diabetic ketoacidosis.
  • are going to have an x-ray procedure with an injection of dyes (contrast agents) in your vein with a needle. Talk to your doctor about when to stop AVANDAMET and when to start it again.

Many people with heart failure should not start taking AVANDAMET.

Before starting AVANDAMET, ask your doctor about what the choices are for diabetes medicines, and what the expected benefits and possible risks are for you in particular.

Before Taking Avandamet, Tell Your Doctor About All Your Medical Conditions, Including If You: 

  • have heart problems or heart failure
  • have kidney problems
  • have type 1 ( juvenile ) diabetes or had diabetic ketoacidosis.These conditions should be treated with insulin.
  • are going to have dye injected into a vein for an X-ray, CAT scan, heart study, or other type of scanning
  • drink a lot of alcohol(all the time or short binge drinking).
  • develop a serious condition such as a heart attack, severe infection, or a stroke.
  • are 80 years old or older.People who are over 80 years old should not take AVANDAMET unless their kidney function is checked and it is normal.
  • have a type of diabetic eye disease called macular edema(swelling of the back of the eye).
  • have liver problems.Your doctor should do blood tests to check your liver before you start taking AVANDAMET and during treatment as needed.
  • had liver problems while taking REZULIN(troglitazone), another medicine for diabetes.
  • are pregnant or plan to become pregnant.AVANDAMET should not be used during pregnancy. It is not known if AVANDAMET can harm your unborn baby. You and your doctor should talk about the best way to control your diabetes during pregnancy. If you are a premenopausal woman (before the change of life ) who does not have regular monthly periods, AVANDAMET may increase your chances of becoming pregnant. Talk to your doctor about birth control choices while taking AVANDAMET. Tell your doctor right away if you become pregnant while taking AVANDAMET.
  • are breast-feeding or planning to breast-feed.It is not known if AVANDAMET passes into breast milk. You should not use AVANDAMET while breast-feeding.

Tell Your Doctor About All The Medicines You Take Including Prescription And Non-prescription Medicines, Vitamins Or Herbal Supplements. Avandamet And Certain Other Medicines Can Affect Each Other And May Lead To Serious Side Effects Including High Or Low Blood Sugar, Or Heart Problems. Your Doctor May Need To Change Your Dose Of Avandamet Or Your Other Medicines. Especially Tell Your Doctor If You Take: 

  • insulin.
  • any medicines for high blood pressure, high cholesterol or heart failure, or for prevention of heart disease or stroke.

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

How Should I Take Avandamet? 

  • Take AVANDAMET exactly as prescribed. Your doctor may need to change your dose until your blood sugar is better controlled.
  • AVANDAMET should be taken by mouth and with meals.
  • AVANDAMET may be prescribed alone or with other diabetes medicines. This will depend on how well your blood sugar is controlled.
  • It can take 2 weeks for AVANDAMET to start lowering your blood sugar. It may take 2 to 3 months to

    Do not drink a lot of alcohol while taking AVANDAMET. This means you should not binge drink , and you should not drink a lot of alcohol on a regular basis. Drinking a lot of alcohol can increase the chance of getting lactic acidosis.

Avandamet May Cause Serious Side Effects, Including: 

  • New or worse heart failure.

    • Store AVANDAMET at room temperature, 59 to 86 F (15 to 30 C).
    • Keep AVANDAMET in the container it comes in. Keep the container closed tightly.
    • Safely, throw away AVANDAMET that is out of date or no longer needed.

    Keep AVANDAMET and all medicines out of the reach of children.

    General information about AVANDAMET

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

    This Medication Guide summarizes important information about AVANDAMET. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about AVANDAMET that is written for healthcare professionals. You can also find out more about AVANDAMET by calling 1-888-825-5249.

What Are The Ingredients In Avandamet? 

Active Ingredients: Rosiglitazone maleate and metformin hydrochloride

Inactive Ingredients: Hypromellose 2910, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, povidone 29-32, sodium starch glycolate, titanium dioxide, and 1 or more of the following: Red and yellow iron oxides.

Always Check To Make Sure That The Medicine You Are Taking Is The Correct One. Avandamet Tablets Are Oval And Look Like This: 

  • 2 mg/500 mg pale pink, with gsk on one side and 2/500 on the other.
  • 4 mg/500 mg orange, with gsk on one side and 4/500 on the other
  • 2 mg/1,000 mg yellow, with gsk on one side and 2/1000 on the other
  • 4 mg/1,000 mg pink, with gsk on one side and 4/1000 on the other

AVANDAMET is a registered trademark of GlaxoSmithKline.

The other brands listed are trademarks of their respective owners and are not trademarks of GlaxoSmithKline. The makers of these brands are not affiliated with and do not endorse GlaxoSmithKline or its products.

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

GlaxoSmithKline

Research Triangle Park, NC 27709

2011, GlaxoSmithKline. All rights reserved.

February 2011

AVM:3MG

Principal Display Panel

Avandamet 2/500mg Label

Avandamet

Rosiglitazone maleate/metformin HCl

Tablets

2 mg/500 mg


Rxonly

Federal Law requires dispensing of AVANDAMETwith the Medication Guide provided with this Bottle.

Store at 25oC (77oF); excursions permitted to 15oC-30oC (59oF-86oF).

Each tablet contains rosiglitazone maleate equivalent to 2 mg rosiglitazone and 500 mg metformin hydrochloride.

Dispense in a tight, light-resistant container.

Dosage: See accompanying prescribing information.

Principal Display Panel

Avandamet 2/1000 mg Label

Avandamet

Rosiglitazone maleate/metformin HCl

Tablets

2 mg/1000 mg


Rxonly

Federal Law requires dispensing of AVANDAMETwith the Medication Guide provided with this Bottle.

Store at 25oC (77oF); excursions permitted to 15oC-30oC (59oF-86oF).

Each tablet contains rosiglitazone maleate equivalent to 2 mg rosiglitazone and 1000 mg metformin hydrochloride.

Dispense in a tight, light-resistant container.

Dosage: See accompanying prescribing information.

Principal Display Panel

Avandamet 4/500mg Label

Avandamet

Rosiglitazone maleate/metformin HCl

Tablets

4 mg/500 mg

60 Tablets

Rxonly

Federal Law requires dispensing of AVANDAMETwith the Medication Guide provided with this Bottle.

Store at 25oC (77oF); excursions permitted to 15oC-30oC (59oF-86oF).

Each tablet contains rosiglitazone maleate equivalent to 4 mg rosiglitazone and 500 mg metformin hydrochloride.

Dispense in a tight, light-resistant container.

Dosage: See accompanying prescribing information.

Principal Display Panel

Avandamet 4/1000mg Label

Avandamet

Rosiglitazone maleate/metformin HCl

Tablets

4 mg/1000 mg

60 Tablets

Rxonly

Federal Law requires dispensing of AVANDAMETwith the Medication Guide provided with this Bottle.

Store at 25oC (77oF); excursions permitted to 15oC-30oC (59oF-86oF).

Each tablet contains rosiglitazone maleate equivalent to 4 mg rosiglitazone and 1000 mg metformin hydrochloride.

Dispense in a tight, light-resistant container.

Dosage: See accompanying prescribing information.

AVANDAMET
rosiglitazone maleate and metformin hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:54868-4965(NDC:0007-3167)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ROSIGLITAZONE MALEATE(UNII: KX2339DP44) (ROSIGLITAZONE - UNII:05V02F2KDG)ROSIGLITAZONE2 mg
METFORMIN HYDROCHLORIDE(UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)METFORMIN HYDROCHLORIDE500 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE 2910 (3 MPA.S)(UNII: 0VUT3PMY82)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
POVIDONE K29/32(UNII: 390RMW2PEQ)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
ColorPINK (pale pink)Scoreno score
ShapeOVALSize15mm
FlavorImprint Codegsk;2;500
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54868-4965-060 in 1 BOTTLE
2NDC:54868-4965-120 in 1 BOTTLE
3NDC:54868-4965-230 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02141012/04/2003
AVANDAMET
rosiglitazone maleate and metformin hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:54868-5157(NDC:0007-3168)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ROSIGLITAZONE MALEATE(UNII: KX2339DP44) (ROSIGLITAZONE - UNII:05V02F2KDG)ROSIGLITAZONE4 mg
METFORMIN HYDROCHLORIDE(UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)METFORMIN HYDROCHLORIDE500 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE 2910 (3 MPA.S)(UNII: 0VUT3PMY82)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
POVIDONE K29/32(UNII: 390RMW2PEQ)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
ColorORANGEScoreno score
ShapeOVALSize15mm
FlavorImprint Codegsk;4;500
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54868-5157-060 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02141008/25/2006
AVANDAMET
rosiglitazone maleate and metformin hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:54868-5376(NDC:0007-3163)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ROSIGLITAZONE MALEATE(UNII: KX2339DP44) (ROSIGLITAZONE - UNII:05V02F2KDG)ROSIGLITAZONE2 mg
METFORMIN HYDROCHLORIDE(UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)METFORMIN HYDROCHLORIDE1000 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE 2910 (3 MPA.S)(UNII: 0VUT3PMY82)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
POVIDONE K29/32(UNII: 390RMW2PEQ)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
ColorYELLOWScoreno score
ShapeOVALSize19mm
FlavorImprint Codegsk;2;1000
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54868-5376-060 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02141008/03/2005
AVANDAMET
rosiglitazone maleate and metformin hydrochloride tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:54868-5262(NDC:0007-3164)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ROSIGLITAZONE MALEATE(UNII: KX2339DP44) (ROSIGLITAZONE - UNII:05V02F2KDG)ROSIGLITAZONE4 mg
METFORMIN HYDROCHLORIDE(UNII: 786Z46389E) (METFORMIN - UNII:9100L32L2N)METFORMIN HYDROCHLORIDE1000 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE 2910 (3 MPA.S)(UNII: 0VUT3PMY82)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400(UNII: B697894SGQ)
POVIDONE K29/32(UNII: 390RMW2PEQ)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
ColorPINKScoreno score
ShapeOVALSize19mm
FlavorImprint Codegsk;4;1000
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54868-5262-160 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02141008/25/200506/30/2012
Labeler -Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIBusiness Operations
Physicians Total Care, Inc.194123980relabel(54868-4965, 54868-5157, 54868-5376, 54868-5262) , repack(54868-4965, 54868-5157, 54868-5376, 54868-5262)

Revised: 8/2012document Id: 

775e2b02-fe2c-4563-a982-c57f34996cc7Set id: 0789dc6b-db34-44a6-8a5d-fdcc8e4ce8fdVersion: 6Effective Time: 20120830Physicians Total Care, Inc.



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