Metformin and sitagliptin

Metformin and sitagliptin is a combination medicine used along with diet and exercise to help control blood sugar in adults with type 2 diabetes mellitus (it is not for type 1 diabetes).

Metformin and sitagliptin 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. Your doctor may sometimes change your dose. Use the medicine exactly as directed.

Metformin and sitagliptin is usually taken either once or twice a day, depending on the form of this medicine. Follow your doctor's instructions.

Take metformin and sitagliptin with meals. Take the extended-release tablet once daily with your meal.

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

You may become dehydrated during a long illness. Call your doctor if you are sick with vomiting, diarrhea, fever, or if you drink less liquids than usual.

Call your doctor if you notice the extended-release tablet in your stool several times.

Blood sugar can be affected by stress, illness, surgery, exercise, alcohol use, or skipping meals.

Low blood sugar (hypoglycemia) can make you feel very hungry, dizzy, irritable, or shaky. To quickly treat hypoglycemia, eat or drink hard candy, crackers, raisins, fruit juice, or non-diet soda. Your doctor may prescribe a glucagon injection for severe hypoglycemia.

Tell your doctor if you have frequent symptoms of high blood sugar (hyperglycemia) such as increased thirst or urination. Ask your doctor before changing your medication dosage.

Your blood sugar will need to be checked regularly, and you may need other medical tests, including checking your kidney function.

You may be given other medications to help with your condition. Keep taking these medicines for as long as your doctor has prescribed.

Your treatment may also include diet, exercise, weight control, and special medical care.

Store at room temperature away from moisture and heat. Some brands must be stored in the original container and used within 1 to 3 months.

You should not use metformin and sitagliptin if you have severe kidney disease or metabolic acidosis (including diabetic ketoacidosis).

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 experience unusual muscle pain, trouble breathing, stomach pain, dizziness, feeling cold, or feeling very weak or tired.

You should not use metformin and sitagliptin if you are allergic to it, or if you have severe kidney disease or metabolic acidosis (including diabetic ketoacidosis).

Tell your doctor if you have or have ever had:

• heart problems such as heart attack, heart failure, or stroke;
• pancreatitis;
• low levels of vitamin B12 or calcium in your blood;
• high triglycerides (a type of fat in the blood);
• gallstones;
• alcoholism; or
• liver or kidney disease.

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 sitagliptin. Make sure that your healthcare provider knows ahead of time that you are using this medication.

It is not known if metformin and sitagliptin will harm an unborn baby. Follow your doctor's instructions about using metformin and sitagliptin if you are pregnant or you become pregnant. Controlling diabetes is very important during pregnancy.

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

Ask a doctor if it is safe to breastfeed while using this medicine.

Get emergency medical help if you have signs of an allergic reaction (hives, difficulty breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

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

Some people using metformin and sitagliptin develop lactic acidosis, which can be fatal. Get emergency medical help if you have: unusual muscle pain, trouble breathing, stomach pain, vomiting, irregular heartbeats, dizziness, feeling cold, or feeling very weak or tired.

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

• severe or ongoing pain in your joints;
• a severe skin reaction—itching, blisters, breakdown of the outer layer of skin;
• kidney problems or symptoms of heart failure—swelling, urinating less, rapid weight gain, feeling tired or short of breath; or
• severely low blood sugar—extreme weakness, confusion, tremors, sweating, fast heartbeats, trouble speaking, nausea, vomiting, rapid breathing, fainting, and seizures (convulsions).

Common side effects of metformin and sitagliptin may include:

• low blood sugar (if you also use insulin or another oral diabetes medication);
• upset stomach, indigestion, gas, diarrhea, nausea, vomiting;
• headache, weakness; 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:

Dose should be individualized based on patient's current regimen, effectiveness, and tolerability.IMMEDIATE-RELEASE: -Initial dose for patients not receiving metformin: sitagliptin 50 mg/metformin 500 mg orally twice a day-Initial dose for patients receiving metformin: sitagliptin 50 mg in combination with half the daily dose of metformin orally twice a day (i.e, equal to same total daily dose of metformin currently being administered) EXTENDED-RELEASE:-Initial dose for patients not receiving metformin: sitagliptin 100 mg/metformin 1000 mg orally once a day-Initial dose for patients receiving metformin: sitagliptin 100 mg in combination with current daily metformin dose orally once a dayTITRATE metformin dose slowly to reduce gastrointestinal side effects; titrate combination dose to achieve optimal glycemic control MAXIMUM: Sitagliptin 100 mg/day; Metformin 2000 mg/dayComments:-The same daily dose of metformin and sitagliptin should be maintained if need to change between immediate-release and extended-release products. -When initiating therapy, a dose adjustment of insulin secretagogue (e.g., sulfonylurea) or insulin may be necessary to reduce the risk of hypoglycemia.Use: As an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus.

Take the medicine 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 once.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

• Avoid drinking alcohol. It lowers blood sugar and may increase your risk of lactic acidosis.

Tell your doctor about all your other medicines, especially:

• insulin or oral diabetes medicine including rosiglitazone.

Many drugs can increase your risk of lactic acidosis or impact your blood sugar levels and may also affect metformin and sitagliptin. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all other medicines you are using. Not all possible interactions are listed here.