Metaglip

Name: Metaglip

Metaglip Drug Class

Metaglip is part of the drug class:

  • Combinations of oral blood glucose lowering drugs

Side Effects of Metaglip

Serious side effects have been reported with Metaglip. See the “Metaglip Precautions” section.

Common side effects of Metaglip include the following:

  • stomach pain
  • nausea or vomiting
  • diarrhea
  • dizziness

This is not a complete list of Metaglip side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Metaglip Precautions

Serious side effects have been reported with Metaglip including the following: 

  • Lactic acidosis. Tell your healthcare provider right away if you have some or all of the following symptoms of lactic acidosis.
    • Extreme tiredness
    • Weakness or discomfort
    • Unusual or unexpected stomach pain
    • Decreased appetite
    • Deep and rapid breathing or shortness of breath
    • Dizziness
    • Lightheadedness
    • Fast or slow heart beat
    • Flushing of the skin
    • Muscle pain
    • Feeling cold
  • Hypoglycemia (low blood sugar). Tell your healthcare provider right away if you have some or all of the following symptoms of hypoglycemia.
    • Lightheadedness
    • Dizziness
    • Shakiness
    • Hunger
  • Chest pain
  • Rash
  • Yellowing of the skin or eyes
  • Light-colored stools
  • Dark urine
  • Pain in the upper right part of the abdomen
  • Unusual bleeding or bruising
  • Fever
  • Sore throat
  • Swelling of the eyes, face, tongue, or throat

 

Metaglip can cause dizziness. Do not drive or operate heavy machinery until you know how Metaglip affects you.

 

Do not take Metaglip if you:

  • are allergic to Metaglip or to any of its ingredients
  • have liver or kidney disease
  • have acute or chronic metabolic acidosis
  • have congestive heart failure that is treated with digoxin (Lanoxin) or furosemide (Lasix)
  • drink alcohol excessively
  • are dehydrated
  • are going to have procedures (such as an X-ray) with injectable contrast agents
  • are going to have surgery
  • have a heart attack, stroke, or severe infection
  • are older than 80 years and have not had your kidney function tested

 

Metaglip and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Metaglip falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Metaglip Usage

Take Metaglip exactly as prescribed.

Metaglip comes in tablet form and is taken once or twice daily with meals.

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of Metaglip at the same time.

What is Metaglip (glipizide and metformin)?

Glipizide and metformin is a combination of two oral diabetes medicines that help control blood sugar levels.

Glipizide and metformin is used together with diet and exercise to improve blood sugar control in adults with type 2 diabetes. This medicine is not for treating type 1 diabetes.

Glipizide and metformin may also be used for purposes not listed in this medication guide.

Contraindications

Metaglip is contraindicated in patients with:

  1. Renal disease or renal dysfunction (eg, as suggested by serum creatinine levels ≥1.5 mg/dL [males], ≥1.4 mg/dL [females], or abnormal creatinine clearance) which may also result from conditions such as cardiovascular collapse (shock), acute myocardial infarction, and septicemia (see WARNINGS and PRECAUTIONS).
  2. Known hypersensitivity to glipizide or metformin hydrochloride.
  3. Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma. Diabetic ketoacidosis should be treated with insulin.

Metaglip should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function. (See also PRECAUTIONS.)

Metaglip Dosage and Administration

General Considerations

Dosage of Metaglip must be individualized on the basis of both effectiveness and tolerance while not exceeding the maximum recommended daily dose of 20 mg glipizide/2000 mg metformin. Metaglip should be given with meals and should be initiated at a low dose, with gradual dose escalation as described below, in order to avoid hypoglycemia (largely due to glipizide), reduce GI side effects (largely due to metformin), and permit determination of the minimum effective dose for adequate control of blood glucose for the individual patient.

With initial treatment and during dose titration, appropriate blood glucose monitoring should be used to determine the therapeutic response to Metaglip and to identify the minimum effective dose for the patient. Thereafter, HbA1c should be measured at intervals of approximately 3 months to assess the effectiveness of therapy. The therapeutic goal in all patients with type 2 diabetes is to decrease FPG, PPG, and HbA1c to normal or as near normal as possible. Ideally, the response to therapy should be evaluated using HbA1c, which is a better indicator of long-term glycemic control than FPG alone.

No studies have been performed specifically examining the safety and efficacy of switching to Metaglip therapy in patients taking concomitant glipizide (or other sulfonylurea) plus metformin. Changes in glycemic control may occur in such patients, with either hyperglycemia or hypoglycemia possible. Any change in therapy of type 2 diabetes should be undertaken with care and appropriate monitoring.

Metaglip in Patients with Inadequate Glycemic Control on Diet and Exercise Alone

For patients with type 2 diabetes whose hyperglycemia cannot be satisfactorily managed with diet and exercise alone, the recommended starting dose of Metaglip is 2.5 mg/250 mg once a day with a meal. For patients whose FPG is 280 mg/dL to 320 mg/dL a starting dose of Metaglip 2.5 mg/500 mg twice daily should be considered. The efficacy of Metaglip in patients whose FPG exceeds 320 mg/dL has not been established. Dosage increases to achieve adequate glycemic control should be made in increments of 1 tablet per day every 2 weeks up to maximum of 10 mg/1000 mg or 10 mg/2000 mg Metaglip per day given in divided doses. In clinical trials of Metaglip as initial therapy, there was no experience with total daily doses >10 mg/2000 mg per day.

Metaglip in Patients with Inadequate Glycemic Control on a Sulfonylurea and/or Metformin

For patients not adequately controlled on either glipizide (or another sulfonylurea) or metformin alone, the recommended starting dose of Metaglip is 2.5 mg/500 mg or 5 mg/500 mg twice daily with the morning and evening meals. In order to avoid hypoglycemia, the starting dose of Metaglip should not exceed the daily doses of glipizide or metformin already being taken. The daily dose should be titrated in increments of no more than 5 mg/500 mg up to the minimum effective dose to achieve adequate control of blood glucose or to a maximum dose of 20 mg/2000 mg per day.

Patients previously treated with combination therapy of glipizide (or another sulfonylurea) plus metformin may be switched to Metaglip 2.5 mg/500 mg or 5 mg/500 mg; the starting dose should not exceed the daily dose of glipizide (or equivalent dose of another sulfonylurea) and metformin already being taken. The decision to switch to the nearest equivalent dose or to titrate should be based on clinical judgment. Patients should be monitored closely for signs and symptoms of hypoglycemia following such a switch and the dose of Metaglip should be titrated as described above to achieve adequate control of blood glucose.

Specific Patient Populations

Metaglip is not recommended for use during pregnancy or for use in pediatric patients. The initial and maintenance dosing of Metaglip should be conservative in patients with advanced age, due to the potential for decreased renal function in this population. Any dosage adjustment requires a careful assessment of renal function. Generally, elderly, debilitated, and malnourished patients should not be titrated to the maximum dose of Metaglip to avoid the risk of hypoglycemia. Monitoring of renal function is necessary to aid in prevention of metformin-associated lactic acidosis, particularly in the elderly. (See WARNINGS.)

How is Metaglip Supplied

Metaglip™(glipizide and metformin HCl) Tablets

Metaglip 2.5 mg/250 mg tablet is a pink oval-shaped, biconvex film-coated tablet with "BMS" debossed on one side and "6081" debossed on the opposite side.

Metaglip 2.5 mg/500 mg tablet is a white oval-shaped, biconvex film-coated tablet with "BMS" debossed on one side and "6077" debossed on the opposite side.

Metaglip 5 mg/500 mg tablet is a pink oval-shaped, biconvex film-coated tablet with "BMS" debossed on one side and "6078" debossed on the opposite side.

Metaglip NDC 0087-xxxx-xx for unit of use
Glipizide (mg) Metformin hydrochloride (mg) Bottle of 100
2.5 250 6081-31
2.5 500 6077-31
5.0 500 6078-31

STORAGE

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature.]



Metaglip™ is a trademark of Merck Santé S.A.S., an associate of Merck KGaA of Darmstadt, Germany. Licensed to Bristol-Myers Squibb Company.

GLUCOPHAGE® is a registered trademark of Merck Santé S.A.S., an associate of Merck KGaA of Darmstadt, Germany. Licensed to Bristol-Myers Squibb Company.

GLUCOTROL® is a registered trademark of Pfizer Inc.



Distributed by:
Bristol-Myers Squibb Company
Princeton, NJ 08543 USA

Rev Aug 2010




PATIENT INFORMATION ABOUT
Metaglip™
(glipizide and 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 Metaglip. (See Question Nos. 9-13.)

Q1. Why do I need to take Metaglip?

Your doctor has prescribed Metaglip 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, a number of oral medications, and insulin injections. Before taking Metaglip you should first try to control your diabetes by exercise and weight loss. Even if you are taking Metaglip, you should still exercise and follow the diet recommended for your diabetes.

Q5. Does Metaglip work differently from other glucose-control medications?

Yes, it does. Metaglip combines 2 glucose-lowering drugs, glipizide and metformin. These 2 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 to achieve better glucose control.

Q6. What happens if my blood sugar is still too high?

When blood sugar cannot be lowered enough by Metaglip, your doctor may prescribe injectable insulin or take other measures to control your diabetes.

Q7. Can Metaglip cause side effects?

Metaglip, 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 Metaglip (see Question Nos. 9-13).

Q8. What are the most common side effects of Metaglip?

The most common side effects of Metaglip 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 Metaglip 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 Metaglip can cause?

People who have a condition known as glucose-6-phosphate dehydrogenase (G6PD) deficiency and who take Metaglip may develop hemolytic anemia (fast breakdown of red blood cells). G6PD deficiency usually runs in families. Tell your doctor if you or any members of your family have been diagnosed with G6PD deficiency before you start taking Metaglip.

Metaglip rarely causes serious side effects. The most serious side effect that Metaglip 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 1 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 Metaglip. 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 Metaglip causes harm to the kidneys or liver.

Q11. Are there other risk factors for lactic acidosis?

Your risk of developing lactic acidosis from taking Metaglip 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 doctor.

You should not take Metaglip if:

  • You have chronic kidney or liver problems
  • You have congestive heart failure which is treated with medications, eg, 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 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 Metaglip tablets 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 Metaglip 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. Metaglip therapy will need to be stopped temporarily in such instances.

Q14. Can I take Metaglip with other medications?

Remind your doctor that you are taking Metaglip when any new drug is prescribed or a change is made in how you take a drug already prescribed.

Metaglip may interfere with the way some drugs work and some drugs may interfere with the action of Metaglip.

Q15. What if I become pregnant while taking Metaglip?

Tell your doctor if you plan to become pregnant or have become pregnant. As with other oral glucose-control medications, you should not take Metaglip 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 Metaglip if you are nursing a child.

Q16. How do I take Metaglip?

Your doctor will tell you how many Metaglip 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 Metaglip and your dosage will be increased gradually until your blood sugar is controlled.

Q17. Where can I get more information about Metaglip?

This leaflet is a summary of the most important information about Metaglip.

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



Metaglip™ is a trademark of Merck Santé S.A.S., an associate of Merck KGaA of Darmstadt, Germany. Licensed to Bristol-Myers Squibb Company.

Other brands listed are the trademarks of their respective owners.



Distributed by:
Bristol-Myers Squibb Company
Princeton, NJ 08543 USA

Rev Aug 2010

-----------------------------------------
REPRESENTATIVE PACKAGING

See How Supplied section for a complete list of available packages of Metaglip.

100 Tablets
NDC 0087-6077-31
Metaglip™
(glipizide & metformin HCl)
2.5 mg/500 mg
Rx only
Bristol-Myers Squibb

Metaglip 
glipizide and metformin hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0087-6081
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
glipizide (glipizide) glipizide 2.5 mg
metformin hydrochloride (metformin) metformin hydrochloride 250 mg
Inactive Ingredients
Ingredient Name Strength
cellulose, microcrystalline  
povidone  
croscarmellose sodium  
magnesium stearate  
Product Characteristics
Color PINK Score no score
Shape OVAL Size 12mm
Flavor Imprint Code BMS;6081
Contains     
Packaging
# Item Code Package Description
1 NDC:0087-6081-31 100 TABLET, FILM COATED (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021460 12/15/2008 02/28/2011
Metaglip 
glipizide and metformin hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0087-6077
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
glipizide (glipizide) glipizide 2.5 mg
metformin hydrochloride (metformin) metformin hydrochloride 500 mg
Inactive Ingredients
Ingredient Name Strength
cellulose, microcrystalline  
povidone  
croscarmellose sodium  
magnesium stearate  
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 16mm
Flavor Imprint Code BMS;6077
Contains     
Packaging
# Item Code Package Description
1 NDC:0087-6077-31 100 TABLET, FILM COATED (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021460 12/15/2008 04/30/2013
Metaglip 
glipizide and metformin hydrochloride tablet, film coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0087-6078
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
glipizide (glipizide) glipizide 5 mg
metformin hydrochloride (metformin) metformin hydrochloride 500 mg
Inactive Ingredients
Ingredient Name Strength
cellulose, microcrystalline  
povidone  
croscarmellose sodium  
magnesium stearate  
Product Characteristics
Color PINK Score no score
Shape OVAL Size 16mm
Flavor Imprint Code BMS;6078
Contains     
Packaging
# Item Code Package Description
1 NDC:0087-6078-31 100 TABLET, FILM COATED (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA021460 12/15/2008 01/31/2013
Labeler - Bristol-Myers Squibb Company (938368834)
Revised: 08/2010   Bristol-Myers Squibb Company
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