Metformin and saxagliptin

Metformin and saxagliptin are oral medicines for diabetes that help manage blood sugar levels.

Metformin lowers the production of glucose (sugar) in the liver and reduces the absorption of glucose in the intestines. Saxagliptin helps control the amount of insulin your body makes after you eat.

Metformin and saxagliptin is a combination medicine used along with diet and exercise to better control blood sugar in adults with type 2 diabetes mellitus. Metformin and saxagliptin is not for treating type 1 diabetes.

Metformin and saxagliptin may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take metformin and saxagliptin with food.

Swallow the tablet whole and do not crush, chew, or break it.

You may experience low blood sugar (hypoglycemia) and feel very hungry, dizzy, irritable, confused, anxious, or shaky. To quickly treat hypoglycemia, eat or drink a fast-acting source of sugar (fruit juice, hard candy, crackers, raisins, or non-diet soda).

Your doctor may prescribe a glucagon injection kit in case you have severe hypoglycemia. Make sure your family or close friends know how to give you this injection in an emergency.

Also, watch for signs of high blood sugar (hyperglycemia) such as increased thirst or urination.

Blood sugar levels can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals. Ask your doctor before changing your dose or medication schedule.

metformin and saxagliptin is only part of a complete treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor's instructions very closely.

Store at room temperature away from moisture and heat.

You should not use metformin and saxagliptin if you have severe kidney disease or diabetic ketoacidosis (call your doctor for treatment).

You may develop lactic acidosis, which is a serious build-up of lactic acid in your blood. Call your doctor or seek emergency medical help if you have unusual muscle pain, trouble breathing, stomach pain, dizziness, feeling cold, or feeling very weak or tired.

You should not use this medicine if you are allergic to metformin or saxagliptin (Onglyza), or if you have severe kidney disease or diabetic ketoacidosis (call your doctor for treatment with insulin).

Tell your doctor if you have ever had:

• kidney disease (your kidney function may need to be checked before you take this medicine);
• liver disease;
• heart disease;
• pancreatitis;
• high triglycerides (a type of fat in the blood);
• gallstones; or
• alcoholism.

You may develop lactic acidosis, a dangerous build-up of lactic acid in your blood. This may be more likely if you have other medical conditions, a severe infection, chronic alcoholism, or if you are 65 or older. Ask your doctor about your risk.

If you need to have surgery or any type of x-ray or CT scan using a dye that is injected into your veins, you may need to temporarily stop taking metformin and saxagliptin. Be sure your caregivers know ahead of time that you are using this medication.

Follow your doctor's instructions about using this medicine if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy, and having high blood sugar may cause complications in both the mother and the baby.

Metformin may stimulate ovulation in a premenopausal woman and may increase the risk of unintended pregnancy. Talk to your doctor about your risk.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

This medicine is not approved for use by anyone younger than 18 years old.

Get emergency medical help if you have signs of an allergic reaction: hives, itching, peeling skin; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop taking this medicine and call your doctor right away if you have symptoms of pancreatitis: severe pain in your upper stomach spreading to your back, nausea and vomiting, loss of appetite, or fast heartbeats.

Some people using metformin develop lactic acidosis, which can be fatal. Get emergency medical help if you have even mild symptoms such as:

• unusual muscle pain;
• feeling cold;
• trouble breathing;
• feeling dizzy, light-headed, tired, or very weak;
• stomach pain, vomiting; or
• irregular heart rate.

Call your doctor at once if you have any of these serious side effects:

• severe autoimmune reaction--itching, blisters, breakdown of the outer layer of skin;
• severe or ongoing pain in your joints;
• pain or burning when you urinate; or
• symptoms of heart failure--shortness of breath (even while lying down), swelling in your legs or feet, rapid weight gain.

Common side effects of metformin and saxagliptin may include:

• diarrhea, nausea;
• headache; or
• cold symptoms such as runny or stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Diabetes Type 2:

Individualize dose based patient's current regimen, effectiveness, and tolerability; gradual dose titration of metformin is advised to reduce gastrointestinal side effects. Saxagliptin-Metformin XR:Usual dose: 1 tablet orally once a day with the evening mealMaximum dose: saxagliptin 5 mg-metformin 2000 mg orally once a dayMaximum dose with concomitant strong CYP450 3A4/5 inhibitors: saxagliptin 2.5-metformin 1000 mg orally once a day-Patients not currently treated with metformin: Initial dose saxagliptin 5 mg-metformin 500 mg orally once daily -Patients currently treated with metformin: Initial dose: saxagliptin 5 mg plus the dose of metformin that is already being taken, or the nearest therapeutically appropriate dose. Comments:-Patients requiring saxagliptin 2.5 mg per day AND are either metformin-naive or require a dose of metformin greater than 1000 mg per day should use the individual components.-Following a switch from metformin immediate-release to metformin extended release, glycemic control should be closely monitored and dosage adjustments made according.-When used in combination with a sulfonylurea or insulin, a lower dose of the sulfonylurea or insulin may be considered to reduce the risk of hypoglycemia. -Note: There are saxagliptin-metformin combination products available internationally that contain immediate-release metformin; saxagliptin-metformin products containing immediate-release metformin should be dosed twice a day. Use: An adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes when treatment with both saxagliptin and metformin is appropriate.

Take the medicine (with food) as soon as you remember, but skip the missed dose if it is nearly time for your next dose. Do not take two doses at the same time.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222. You might have very low blood sugar if you experience extreme weakness, nausea, tremors, sweating, confusion, trouble speaking, fast heartbeats, or a seizure.

Do not drink alcohol. It can lower blood sugar and may raise your risk of lactic acidosis.

Many drugs can change how metformin and saxagliptin work, which can make metformin and saxagliptin less effective or raise your risk of lactic acidosis.

Tell your doctor about all the other medicines you take, especially:

• an antibiotic or antifungal medicine;
• insulin or oral diabetes medicine; or
• medicine to treat HIV or AIDS.

This list is not complete. Other drugs may also affect metformin and saxagliptin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.