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GLIPIZIDE AND METFORMIN HYDROCHLORIDE tablet


  1. Patient Information
  2. Warning:
  3. Q2. What Is Type 2 Diabetes?
  4. Q3. Why Is It Important To Control Type 2 Diabetes?
  5. Q4. How Is Type 2 Diabetes Usually Controlled?
  6. Q5. Does Glipizide/metformin Hcl Tablet Work Differently From Other Glucose-control Medications?
  7. Q6. What Happens If My Blood Sugar Is Still Too High?
  8. Q7. Can Glipizide/metformin Hcl Tablet Cause Side Effects?
  9. Q9. Are There Any Serious Side Effects That Glipizide/metformin Hcl Tablet Can Cause?
  10. Q10. What Is Lactic Acidosis And Can It Happen To Me?
  11. Your Risk Of Developing Lactic Acidosis From Taking Glipizide/metformin Hcl Tablet Is Very Low As Long As Your Kidneys And Liver Are Healthy. However, Some Factors Can Increase Your Risk Because They Can Affect Kidney And Liver Function. You Should Discuss Your Risk With Your Physician.you Should Not Take Glipizide/metformin Hcl Tablet If:
  12. Q12. What Are The Symptoms Of Lactic Acidosis?
  13. Q13. What Does My Doctor Need To Know To Decrease My Risk Of Lactic Acidosis?
  14. Q14. Can I Take Glipizide/metformin Hcl Tablet With Other Medications?
  15. Q15. What If I Become Pregnant While Taking Glipizide/metformin Hcl Tablet?
  16. Q16. How Do I Take Glipizide/metformin Hcl Tablet?
  17. Q17. Where Can I Get More Information About Glipizide/metformin Hcl Tablet?
  18. Revised: 2/2009document Id:

Patient Information 

PATIENT INFORMATION ABOUT

Glipizide/Metformin HCl Tablets

Warning: 

A small number of people who have taken metformin hydrochloride have developed a serious condition called lactic acidosis. Properly functioning kidneys are needed to help prevent lactic acidosis. Most people with kidney problems should not take Glipizide/Metformin HCl Tablet. (

Your doctor has prescribed Glipizide/Metformin HCl Tablet to treat your type 2 diabetes. This is also known as non-insulin-dependent diabetes mellitus.

Q2. What Is Type 2 Diabetes? 

People with diabetes are not able to make enough insulin and/or respond normally to the insulin their body does make. When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems including kidney damage, amputations, and blindness. Diabetes is also closely linked to heart disease. The main goal of treating diabetes is to lower your blood sugar to a normal level.

Q3. Why Is It Important To Control Type 2 Diabetes? 

The main goal of treating diabetes is to lower your blood sugar to a normal level. Studies have shown that good control of blood sugar may prevent or delay complications such as heart disease, kidney disease, or blindness.

Q4. How Is Type 2 Diabetes Usually Controlled? 

High blood sugar can be lowered by diet and exercise, by a number of oral medications, and by insulin injections. Before taking Glipizide/Metformin HCl Tablet you should first try to control your diabetes by exercise and weight loss. Even if you are taking Glipizide/Metformin HCl Tablet, you should still exercise and follow the diet recommended for your diabetes.

Q5. Does Glipizide/metformin Hcl Tablet Work Differently From Other Glucose-control Medications? 

Yes it does. Glipizide/Metformin HCl Tablet combines two glucose lowering drugs, glipizide and metformin hydrochloride. These two drugs work together to improve the different metabolic defects found in type 2 diabetes. Glipizide lowers blood sugar primarily by causing more of the body s own insulin to be released, and metformin lowers blood sugar, in part, by helping your body use your own insulin more effectively. Together, they are efficient in helping you achieve better glucose control.

Q6. What Happens If My Blood Sugar Is Still Too High? 

When blood sugar cannot be lowered enough by Glipizide/Metformin HCl Tablet your doctor may prescribe injectable insulin or take other measures to control your diabetes.

Q7. Can Glipizide/metformin Hcl Tablet Cause Side Effects? 

Glipizide/Metformin HCl Tablet, like all blood sugar-lowering medications, can cause side effects in some patients. Most of these side effects are minor. However, there are also serious, but rare, side effects related to Glipizide/Metformin HCl Tablet (

The most common side effects of Glipizide/Metformin HCl Tablet are normally minor ones such as diarrhea, nausea, and upset stomach. If these side effects occur, they usually occur during the first few weeks of therapy. Taking your Glipizide/Metformin HCl Tablet with meals can help reduce these side effects. Symptoms of hypoglycemia (low blood sugar), such as lightheadedness, dizziness, shakiness, or hunger may occur. The risk of hypoglycemic symptoms increases when meals are skipped, too much alcohol is consumed, or heavy exercise occurs without enough food. Following the advice of your doctor can help you to avoid these symptoms.

Q9. Are There Any Serious Side Effects That Glipizide/metformin Hcl Tablet Can Cause? 

Glipizide/Metformin HCl Tablet rarely causes serious side effects. The most serious side effect that Glipizide/Metformin HCl Tablet can cause is called lactic acidosis.

Q10. What Is Lactic Acidosis And Can It Happen To Me? 

Lactic acidosis is caused by a buildup of lactic acid in the blood. Lactic acidosis associated with metformin is rare and has occurred mostly in people whose kidneys were not working normally. Lactic acidosis has been reported in about one in 33,000 patients taking metformin over the course of a year. Although rare, if lactic acidosis does occur, it can be fatal in up to half the cases.

It's also important for your liver to be working normally when you take Glipizide/Metformin HCl Tablet. Your liver helps remove lactic acid from your bloodstream.

Your doctor will monitor your diabetes and may perform blood tests on you from time to time to make sure your kidneys and your liver are functioning normally.

There is no evidence that Glipizide/Metformin HCl Tablet causes harm to the kidneys or liver.

Your Risk Of Developing Lactic Acidosis From Taking Glipizide/metformin Hcl Tablet Is Very Low As Long As Your Kidneys And Liver Are Healthy. However, Some Factors Can Increase Your Risk Because They Can Affect Kidney And Liver Function. You Should Discuss Your Risk With Your Physician.you Should Not Take Glipizide/metformin Hcl Tablet If: 

  • You have chronic kidney or liver problems
  • You have congestive heart failure which is treated with medications, e.g., digoxin (Lanoxin) or furosemide (Lasix)
  • You drink alcohol excessively (all the time or short-term binge drinking)
  • You are seriously dehydrated (have lost a large amount of body fluids)
  • You are going to have certain x-ray procedures with injectable contrast agents
  • You are going to have surgery
  • You develop a serious condition such as a heart attack, severe infection, or a stroke
  • You are 80 years of age and have NOT had your kidney function tested

Q12. What Are The Symptoms Of Lactic Acidosis? 

Some of the symptoms include: feeling very weak, tired or uncomfortable; unusual muscle pain, trouble breathing, unusual or unexpected stomach discomfort, feeling cold, feeling dizzy or lightheaded, or suddenly developing a slow or irregular heartbeat.

If you notice these symptoms, or if your medical condition has suddenly changed, stop taking Glipizide/Metformin HCl Tablet and call your doctor right away. Lactic acidosis is a medical emergency that must be treated in a hospital.

Q13. What Does My Doctor Need To Know To Decrease My Risk Of Lactic Acidosis? 

Tell your doctor if you have an illness that results in severe vomiting, diarrhea, and/or fever, or if your intake of fluids is significantly reduced. These situations can lead to severe dehydration, and it may be necessary to stop taking Glipizide/Metformin HCl Tablet temporarily.

You should let your doctor know if you are going to have any surgery or specialized x-ray procedures that require injection of contrast agents. Glipizide/Metformin HCl Tablet therapy will need to be stopped temporarily in such instances.

Q14. Can I Take Glipizide/metformin Hcl Tablet With Other Medications? 

Remind your doctor that you are taking Glipizide/Metformin HCl Tablet when any new drug is prescribed or a change is made in how you take a drug already prescribed.

Glipizide/Metformin HCl Tablet may interfere with the way some drugs work and some drugs may interfere with the action of Glipizide/Metformin HCl Tablets.

Q15. What If I Become Pregnant While Taking Glipizide/metformin Hcl Tablet? 

Tell your doctor if you plan to become pregnant or have become pregnant. As with other oral glucose-control medications, you should not take Glipizide/Metformin HCl Tablet during pregnancy.

Usually your doctor will prescribe insulin while you are pregnant. As with all medications, you and your doctor should discuss the use of Glipizide/Metformin HCl Tablet if you are nursing a child.

Q16. How Do I Take Glipizide/metformin Hcl Tablet? 

Your doctor will tell you how many Glipizide/Metformin HCl Tablet tablets to take and how often.

This should also be printed on the label of your prescription. You will probably be started on a low dose of Glipizide/Metformin HCl Tablet and your dosage will be increased gradually until your blood sugar is controlled.

Q17. Where Can I Get More Information About Glipizide/metformin Hcl Tablet? 

This leaflet is a summary of the most important information about Glipizide/Metformin HCl Tablet.

If you have any questions or problems, you should talk to your doctor or other healthcare provider about type 2 diabetes as well as Glipizide/Metformin HCl Tablet and its side effects. There is also a leaflet (package insert) written for health professionals that your pharmacist can let you read.

Lanoxinis a trademark of GlaxoSmithKline, Research Triangle Park, NC 27709
Lasixis a trademark of Aventis Pharmaceuticals NJ, Bridgewater, NJ 08807 USA

Manufactured by:
Caraco Pharmaceutical Laboratories, Ltd.
1150 Elijah McCoy Drive
Detroit, MI 48202

GLIPIZIDE AND METFORMIN HYDROCHLORIDE
glipizide and metformin hydrochloride tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:57664-727
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
glipizide(UNII: X7WDT95N5C) (glipizide - UNII:X7WDT95N5C)2.5 mg
metformin hydrochloride(UNII: 786Z46389E) (metformin - UNII:9100L32L2N)250 mg
Inactive Ingredients
Ingredient NameStrength
microcrystalline cellulose(UNII: OP1R32D61U)
povidone(UNII: FZ989GH94E)
croscarmellose sodium(UNII: M28OL1HH48)
polyehtylene glycol()
magnesium stearate(UNII: 70097M6I30)
polyvinyl alcohol()
titanium dioxide(UNII: 15FIX9V2JP)
polyethylene glycol 3350(UNII: G2M7P15E5P)
talc(UNII: 7SEV7J4R1U)
lecithin()
iron oxide yellow(UNII: EX438O2MRT)
iron oxide red()
Product Characteristics
Colorbrown (PEACH)Scoreno score
ShapeOVALSize13mm
FlavorImprint Code727;C
Contains
CoatingtrueSymbolfalse
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57664-727-88100 in 1 BOTTLE
2NDC:57664-727-13500 in 1 BOTTLE
3NDC:57664-727-181000 in 1 BOTTLE
GLIPIZIDE AND METFORMIN HYDROCHLORIDE
glipizide and metformin hydrochloride tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:57664-725
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
glipizide(UNII: X7WDT95N5C) (glipizide - UNII:X7WDT95N5C)2.5 mg
metformin hydrochloride(UNII: 786Z46389E) (metformin - UNII:9100L32L2N)500 mg
Inactive Ingredients
Ingredient NameStrength
microcrystalline cellulose(UNII: OP1R32D61U)
povidone(UNII: FZ989GH94E)
croscarmellose sodium(UNII: M28OL1HH48)
polyehtylene glycol()
magnesium stearate(UNII: 70097M6I30)
polyvinyl alcohol()
titanium dioxide(UNII: 15FIX9V2JP)
polyethylene glycol 3350(UNII: G2M7P15E5P)
talc(UNII: 7SEV7J4R1U)
Product Characteristics
Colorwhite (white to off-white)Scoreno score
ShapeOVALSize16mm
FlavorImprint Code725;C
Contains
CoatingtrueSymbolfalse
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57664-725-88100 in 1 BOTTLE
2NDC:57664-725-13500 in 1 BOTTLE
3NDC:57664-725-181000 in 1 BOTTLE
GLIPIZIDE AND METFORMIN HYDROCHLORIDE
glipizide and metformin hydrochloride tablet
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:57664-724
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
glipizide(UNII: X7WDT95N5C) (glipizide - UNII:X7WDT95N5C)5 mg
metformin hydrochloride(UNII: 786Z46389E) (metformin - UNII:9100L32L2N)500 mg
Inactive Ingredients
Ingredient NameStrength
microcrystalline cellulose(UNII: OP1R32D61U)
povidone(UNII: FZ989GH94E)
croscarmellose sodium(UNII: M28OL1HH48)
polyehtylene glycol()
magnesium stearate(UNII: 70097M6I30)
polyvinyl alcohol()
titanium dioxide(UNII: 15FIX9V2JP)
polyethylene glycol 3350(UNII: G2M7P15E5P)
talc(UNII: 7SEV7J4R1U)
lecithin()
iron oxide yellow(UNII: EX438O2MRT)
iron oxide red()
Product Characteristics
Colorbrown (PEACH)Scoreno score
ShapeOVALSize16mm
FlavorImprint Code724;C
Contains
CoatingtrueSymbolfalse
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:57664-724-88100 in 1 BOTTLE
2NDC:57664-724-13500 in 1 BOTTLE
3NDC:57664-724-181000 in 1 BOTTLE
Labeler -CARACO PHARMACEUTICAL LABORATORIES, LTD

Revised: 2/2009document Id: 

F4FF2095-7EED-3EAD-4161-5B59A13BADB7Set id: 9af42271-1846-496e-ae33-f566e11e75fcVersion: 1Effective Time: 20090217CARACO PHARMACEUTICAL LABORATORIES, LTD



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