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AVANDIA 2MG- rosiglitazone maleate tablet, film coatedAVANDIA 4MG- rosiglitazone maleate tablet, film coated


  1. Patient Information
  2. Patients Should Be Informed Of The Following:
  3. Avandia May Cause Serious Side Effects, Including:
  4. Call Your Doctor Right Away If You Have Any Of The Following:
  5. What Is Avandia?
  6. Who Should Not Take Avandia?
  7. Before You Take Avandia, Tell Your Healthcare Provider About All Of Your Medical Conditions, Including If You:
  8. Tell Your Healthcare Provider About All Of The Medicines You Take Including Prescription And Over-the-counter Medicines, Vitamins, Or Herbal Supplements. Avandia And Certain Other Medicines Can Affect Each Other And May Lead To Serious Side Effects Including High Or Low Blood Sugar, Or Heart Problems. Especially Tell Your Healthcare Provider If You Take:
  9. How Should I Take Avandia?
  10. Avandia May Cause Serious Side Effects Including:
  11. What Are The Ingredients In Avandia?
  12. Always Check To Make Sure That The Medicine You Are Taking Is The Correct One. Avandia Tablets Are Triangles With Rounded Corners And Look Like This:
  13. Revised: 2/2019document Id:

Patient Information 

Advise the patient to read the FDA-approved patient labeling (Medication Guide).

There are multiple medications available to treat type 2 diabetes. The benefits and risks of each available diabetes medication should be taken into account when choosing a particular diabetes medication for a given patient.

Patients Should Be Informed Of The Following: 

AVANDIA is not recommended for patients with symptomatic heart failure.
A meta-analysis of mostly short-term trials suggested an increased risk for myocardial infarction with AVANDIA compared with placebo. Data from long-term clinical trials of AVANDIA versus other antidiabetes agents (metformin or sulfonylureas), including a cardiovascular outcome trial (RECORD), observed no difference in overall mortality or in major adverse cardiovascular events (MACE) and its components.
AVANDIA is not recommended for patients who are taking insulin.
Management of type 2 diabetes should include diet control. Caloric restriction, weight loss, and exercise are essential for the proper treatment of the diabetic patient because they help improve insulin sensitivity. This is important not only in the primary treatment of type 2 diabetes, but in maintaining the efficacy of drug therapy.
It is important to adhere to dietary instructions and to regularly have blood glucose and glycosylated hemoglobin tested. It can take 2 weeks to

Avandia May Cause Serious Side Effects, Including: 

New or worse heart failure

The risk of heart failure may be higher in people who take AVANDIA with insulin. Most people who take insulin should not also take AVANDIA.
AVANDIA 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.
If you have severe heart failure, you cannot start AVANDIA.
If you have heart failure with symptoms (such as shortness of breath or swelling), even if these symptoms are not severe, AVANDIA 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

What Is Avandia? 

AVANDIA is a prescription medicine used with diet and exercise to treat adults with type 2 ( adult-onset or non-insulin dependent ) diabetes mellitus ( high blood sugar ).

AVANDIA helps to control high blood sugar. AVANDIA may be used alone or with other diabetes medicines. AVANDIA can help your body respond better to insulin made in your body. AVANDIA does not cause your body to make more insulin.

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

It is not known if AVANDIA is safe and effective in children younger than 18 years old.

Who Should Not Take Avandia? 

Many people with heart failure should not start taking AVANDIA.

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

Before You Take Avandia, Tell Your Healthcare Provider About All Of Your Medical Conditions, Including If You: 

have heart problems or heart failure.
have type 1 ( juvenile ) diabetes or had diabetic ketoacidosis.These conditions should be treated with insulin.
have liver problems.Your healthcare provider should do blood tests to check your liver before you start taking AVANDIA and during treatment as needed.
have a type of diabetic eye disease called macular edema(swelling of the back of the eye).
are pregnant or plan to become pregnant.It is not known if AVANDIA can harm your unborn baby. You and your healthcare provider 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, AVANDIA may increase your chances of becoming pregnant. Talk to your healthcare provider about birth control choices while taking AVANDIA. Tell your healthcare provider right away if you become pregnant while taking AVANDIA.
are breastfeeding or planning to breastfeed.It is not known if AVANDIA passes into breast milk. You and your healthcare provider should decide if you will take AVANDIA or breastfeed. You should not do both.

Tell Your Healthcare Provider About All Of The Medicines You Take Including Prescription And Over-the-counter Medicines, Vitamins, Or Herbal Supplements. Avandia And Certain Other Medicines Can Affect Each Other And May Lead To Serious Side Effects Including High Or Low Blood Sugar, Or Heart Problems. Especially Tell Your Healthcare Provider 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 your medicines and show it to your healthcare provider and pharmacist before you start a new medicine. They will tell you if it is alright to take AVANDIA with other medicines.

How Should I Take Avandia? 

Take AVANDIA exactly as prescribed. Your healthcare provider will tell you how many tablets to take and how often. The usual daily starting dose is 4 mg a day taken one time each day or 2 mg taken two times each day. Your healthcare provider may need to adjust your dose until your blood sugar is better controlled.
AVANDIA may be prescribed alone or with other diabetes medicines. This will depend on how well your blood sugar is controlled.
Take AVANDIA with or without food.
It can take 2 weeks for AVANDIA to start lowering blood sugar. It may take 2 to 3 months to

Avandia May Cause Serious Side Effects Including: 

New or worse heart failure.

Store AVANDIA at room temperature, 59 F to 86 F (15 C to 30 C). Keep AVANDIA in the container it comes in.
Safely, throw away AVANDIA that is out of date or no longer needed.
Keep AVANDIA and all medicines out of the reach of children.

General information about AVANDIA

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

If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about AVANDIA that is written for health professionals.

What Are The Ingredients In Avandia? 

Active Ingredient: rosiglitazone maleate.

Inactive Ingredients: hypromellose 2910, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol 3000, sodium starch glycolate, titanium dioxide, triacetin, and 1 or more of the following: synthetic red and yellow iron oxides and talc.

Always Check To Make Sure That The Medicine You Are Taking Is The Correct One. Avandia Tablets Are Triangles With Rounded Corners And Look Like This: 

2 mg pink with GSK on one side and 2 on the other.

4 mg orange with GSK on one side and 4 on the other.

GlaxoSmithKline

Research Triangle Park, NC 27709

For more information call 1-888-825-5249.

AVANDIA is a trademark owned by or licensed to the GSK group of companies.

REZULIN is a trademark owned by or licensed to its respective owner and is not a trademark of the GSK group of companies. The maker of this brand is not affiliated with and does not endorse the GSK group of companies or its products.

2019 GSK group of companies or its licensor.

AVD: 10MG

This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: 02/2019

PRINCIPAL DISPLAY PANEL

NDC 0173-0861-18

AVANDIA

ROSIGLITAZONE MALEATE TABLETS

2 mg

60 TiltabTablets

Rxonly

Federal Law requires dispensing of AVANDIAwith the Medication Guide provided with this bottle.

Store at 25oC (77oF); excursions 15o30oC (59o86oF).

Do not use if printed safety seal under cap is broken or missing.

Each Tiltabtablet contains rosiglitazone maleate equivalent to 2 mg rosiglitazone.

Dispense in a tight, light-resistant container.

Dosage:See accompanying prescribing information.

GlaxoSmithKline

Research Triangle Park, NC 27709

Made in Canada

Rev. 1/17

10000000143763

Avandia 2mg 60 count label

PRINCIPAL DISPLAY PANEL

NDC 0173-0863-13

AVANDIA

ROSIGLITAZONE MALEATE TABLETS

4 mg

30 TiltabTablets

Rxonly

Federal Law requires dispensing of AVANDIAwith the Medication Guide provided with this bottle.

Store at 25oC (77oF); excursions 15o30oC (59o86oF).

Do not use if printed safety seal under cap is broken or missing.

Each Tiltabtablet contains rosiglitazone maleate equivalent to 4 mg rosiglitazone.

Dispense in a tight, light-resistant container.

Dosage:See accompanying prescribing information.

GlaxoSmithKline

Research Triangle Park, NC 27709

Made in Canada

Rev. 1/17

10000000143762

Avandia 4mg 30 count label
AVANDIA 2MG
rosiglitazone maleate tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0173-0861
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ROSIGLITAZONE MALEATE(UNII: KX2339DP44) (ROSIGLITAZONE - UNII:05V02F2KDG)ROSIGLITAZONE2 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE 2910 (3 MPA.S)(UNII: 0VUT3PMY82)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 3000(UNII: SA1B764746)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
TALC(UNII: 7SEV7J4R1U)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
ColorPINKScoreno score
ShapeFREEFORM (pentagonal)Size10mm
FlavorImprint CodeGSK;2
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0173-0861-1860 in 1 BOTTLE; Type 0: Not a Combination Product05/25/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02107105/25/2011
AVANDIA 4MG
rosiglitazone maleate tablet, film coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0173-0863
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ROSIGLITAZONE MALEATE(UNII: KX2339DP44) (ROSIGLITAZONE - UNII:05V02F2KDG)ROSIGLITAZONE4 mg
Inactive Ingredients
Ingredient NameStrength
HYPROMELLOSE 2910 (3 MPA.S)(UNII: 0VUT3PMY82)
LACTOSE MONOHYDRATE(UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE(UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE(UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 3000(UNII: SA1B764746)
SODIUM STARCH GLYCOLATE TYPE A POTATO(UNII: 5856J3G2A2)
TITANIUM DIOXIDE(UNII: 15FIX9V2JP)
TRIACETIN(UNII: XHX3C3X673)
TALC(UNII: 7SEV7J4R1U)
FERRIC OXIDE RED(UNII: 1K09F3G675)
FERRIC OXIDE YELLOW(UNII: EX438O2MRT)
Product Characteristics
ColorORANGEScoreno score
ShapeFREEFORM (pentagonal)Size10mm
FlavorImprint CodeGSK;4
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0173-0863-1330 in 1 BOTTLE; Type 0: Not a Combination Product05/25/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02107105/25/2011
Labeler -GlaxoSmithKline LLC (167380711)

Revised: 2/2019document Id: 

227f6090-7f83-43bf-9abd-842b8c5b0808Set id: ec682aec-e98f-41a1-9d21-eb7580ea3a8aVersion: 13Effective Time: 20190205GlaxoSmithKline LLC



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