Glumetza

Glumetza is a prescription medication used to treat type 2 diabetes. Glumetza belongs to a group of drugs called biguanides, which work by helping your body respond better to the insulin it makes naturally, decreasing the amount of sugar your liver makes, and decreasing the amount of sugar your intestines absorb.

This medication comes in an extended-release tablet. It is taken typically once a day. Swallow Glumetza tablets whole.

Common side effects of Glumetza include diarrhea, nausea, and upset stomach.

Glumetza is a prescription medication used to treat type 2 diabetes.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Depomed, Inc.

• Santarus, Incorporated

Serious side effects have been reported including:

Lactic Acidosis. In rare cases, Glumetza can cause a serious side effect called lactic acidosis. This is caused by a buildup of lactic acid in your blood. This build-up can cause serious damage. Lactic acidosis caused by Glumetza 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 Glumetza over the course of a year. Although rare, if lactic acidosis does occur, it can be fatal in up to half the people who develop it.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• beta-blockers
• cough and cold products containing decongestants
• calcium channel blockers
• cimetidine (Tagamet)
• corticosteroids
• digoxin (Lanoxin)
• diuretics such as furosemide (Lasix)
• estrogens
• insulins or other medicines for diabetes
• isoniazid (INH, Nydrazid)
• morphine
• niacin (nicotinic acid, Niaspan)
• nifedipine
• oral contraceptives
• oral steroids
• phenothiazines such as promethazine (Phenergan)
• phenytoin (Dilantin)
• procainamide
• quinidine
• quinine
• ranitidine
• thyroid medicines such as levothyroxine (Levothroid, Levoxyl, Synthroid, Tirosint)
• triamterene
• trimethoprim
• vancomycin

This is not a complete list of Glumetza drug interactions. Ask your doctor or pharmacist for more information.

A small number of people who have taken Glumetza have developed a serious condition called lactic acidosis. Lactic acidosis is caused by a buildup of lactic acid in the blood. This happens more often in people with kidney problems. Most people with kidney problems should not take Glumetza. See "Side Effects".

Some conditions increase your chance of getting lactic acidosis, or cause other problems if you take Glumetza. Most of the conditions listed below can increase your chance of getting lactic acidosis.

Do not take Glumetza if you:

• have kidney problems
• have liver problems
• have heart failure that is treated with medicines, such as Lanoxin (digoxin) or Lasix (furosemide)
• drink a lot of alcohol. This means you binge drink for short periods or drink all the time.
• are seriously dehydrated (have lost a lot of water from your body)
• are going to have an x-ray procedure with injection of dyes (contrast agents)
• are going to have surgery
• develop a serious condition, such as heart attack, severe infection, or a stroke
• are 80 years or older and you have NOT had your kidney function tested

Do not drink a lot of alcohol drinks while taking this medication. This means you should not binge drink for short periods, and you should not drink a lot of alcohol on a regular basis. Alcohol can increase the chance of getting lactic acidosis.

Follow dietary (food) recommendations made by your doctor and dietitian which should include a healthy diet. Skipping meals should be avoided as this can cause problems maintaining blood sugar control. There are no specific foods to avoid while using Glumetza.

Before receiving Glumetza, tell your doctor if you:

• have kidney problems
• have liver problems
• have heart failure that is treated with medicines, such as Lanoxin (digoxin) or Lasix (furosemide)
• drink a lot of alcohol. This means you binge drink for short periods or drink all the time.
• are seriously dehydrated (have lost a lot of water from your body)
• are going to have an x-ray procedure with injection of dyes (contrast agents)
• are going to have surgery
• develop a serious condition, such as heart attack, severe infection, or a stroke
• are 80 years or older and you have NOT had your kidney function tested
• are pregnant or breastfeeding

While taking Glumetza, tell your doctor if you

• have an illness that causes severe vomiting, diarrhea or fever, or if you drink a much lower amount of liquid than normal. These conditions can lead to severe dehydration (loss of water in your body). You may need to stop taking Glumetza for a short time.
• plan to have surgery or an x-ray procedure with injection of dye (contrast agent). You may need to stop taking Glumetza for a short time.
• start to take other medicines or change how you take a medicine. Glumetza can affect how well other drugs work, and some drugs can affect how well Glumetza works. Some medicines may cause high blood sugar.

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if Glumetza will harm your unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known if Glumetza is excreted in human breastmilk or if it will harm your nursing baby.

Glumetza is taken by mouth and is available as an extended-release tablet. Glumetza is taken typically once a day. Glumetza should be taken at the same time each day. Glumetza tablets should not be chewed, split, or crushed. Swallow Glumetza tablets whole.

Your doctor will tell you how much medicine to take and when to take it. You will probably start out with a low dose of the medicine. Your doctor may slowly increase your dose until your blood sugar is better controlled. You should take Glumetza with meals.

Your doctor may have you take other medicines along with Glumetza to control your blood sugar. These medicines may include insulin shots. Taking Glumetza with insulin may help you better control your blood sugar while reducing the insulin dose.

Continue your exercise and diet program and test your blood sugar regularly while taking Glumetza.

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 Glumetza causes harm to the liver or kidneys.

Take Glumetza exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

For Glumetza, the starting dose is 500 mg once daily, and the maximum dosing is 2000 mg once daily (or 1000 mg twice daily).

The maximum total daily dose of Glumetza, 2000 mg is the maximum total daily dose with insulin.

If you take too much Glumetza, call your local Poison Control Center or seek emergency medical attention right away.

Store Glumetza at room temperature away from excess light and humidity.

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

WARNINGS