Sitagliptin

What it is used for

ZITUVIMET is a combination of sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and metformin hydrochloride (HCl), a biguanide, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use: ZITUVIMET is not recommended in patients with type 1 diabetes mellitus.

ZITUVIMET has not been studied in patients with a history of pancreatitis. ZITUVIMET is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use ZITUVIMET is not recommended in patients with type 1 diabetes mellitus. ZITUVIMET has not been studied in patients with a history of pancreatitis.

It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using ZITUVIMET..

The most important thing to know

JANUVIA can cause serious side effects, including: Inflammation of the pancreas (pancreatitis) which may be severe and lead to death. Certain medical problems make you more likely to get pancreatitis. Before you start taking JANUVIA, tell your doctor if you have ever had: pancreatitis high blood triglyceride levels stones in your gallbladder (gallstones) kidney problems a history of alcoholism Stop taking JANUVIA and call your doctor right away if you have pain in your stomach area (abdomen) that is severe and will not go away.

The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis. Heart failure. Heart failure means your heart does not pump blood well enough. Before you start taking JANUVIA, tell your doctor if you have ever had heart failure or have problems with your kidneys.

Contact your doctor right away if you have any of the following symptoms: increasing shortness of breath or trouble breathing, especially when you lie down swelling or fluid retention, especially in the feet, ankles or legs an unusually fast increase in weight unusual tiredness These may be symptoms of heart failure. What is JANUVIA?

JANUVIA is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. JANUVIA is not for people with type 1 diabetes. If you have had pancreatitis (inflammation of the pancreas) in the past, it is not known if you have a higher chance of getting pancreatitis while you take JANUVIA.

The safety and effectiveness of JANUVIA have not been established in pediatric patients.

How to take it

Take JANUVIA 1 time each day exactly as your doctor tells you. You can take JANUVIA with or without food. Your doctor will do blood tests to check how well your kidneys are working before and during your treatment with JANUVIA. Your doctor may tell you to take JANUVIA along with other diabetes medicines. Low blood sugar can happen more often when JANUVIA is taken with certain other diabetes medicines.

See "

Side effects, and when to stop

". If you miss a dose, take it as soon as you remember. If you do not remember until it is time for your next dose, skip the missed dose and go back to your regular schedule. Do not take two doses of JANUVIA at the same time. If you take too much JANUVIA, call your doctor or local Poison Control Center right away. When your body is under some types of stress, such as fever, trauma (such as a car accident), infection or surgery, the amount of diabetes medicine that you need may change.

Tell your doctor right away if you have any of these conditions and follow your doctor's instructions. Check your blood sugar as your doctor tells you to. Stay on your prescribed diet and exercise program while taking JANUVIA. Talk to your doctor about how to prevent, recognize and manage low blood sugar (hypoglycemia), high blood sugar (hyperglycemia), and problems you have because of your diabetes.

Your doctor will check your diabetes with regular blood tests, including your blood sugar levels and your hemoglobin A1C. What are the possible side effects of JANUVIA? JANUVIA may cause serious side effects, including:. Kidney problems, sometimes requiring dialysis. Low blood sugar (hypoglycemia). If you take JANUVIA with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher.

The dose of your sulfonylurea medicine or insulin may need to be lowered while you use JANUVIA. Signs and symptoms of low blood sugar may include: headache drowsiness irritability hunger dizziness confusion sweating feeling jittery weakness fast heart beat Serious allergic reactions. If you have any symptoms of a serious allergic reaction, stop taking JANUVIA and call your doctor right away or get emergency medical help.

See " Who should not take JANUVIA? ". Your doctor may give you a medicine for your allergic reaction and prescribe a different medicine for your diabetes. Joint pain. Some people who take medicines called DPP-4 inhibitors like JANUVIA, may develop joint pain that can be severe. Call your doctor if you have severe joint pain.

Skin reaction. Some people who take medicines called DPP-4 inhibitors like JANUVIA may develop a skin reaction called bullous pemphigoid that can require treatment in a hospital. Tell your doctor right away if you develop blisters or the breakdown of the outer layer of your skin (erosion). Your doctor may tell you to stop taking JANUVIA.

The most common side effects of JANUVIA include upper respiratory infection, stuffy or runny nose and sore throat, and headache. JANUVIA may have other side effects, including stomach upset and diarrhea, swelling of the hands or legs, when JANUVIA is used with metformin and rosiglitazone (Avandia). Rosiglitazone is another type of diabetes medicine.

Tell your doctor if you have any side effect that bothers you or does not go away. These are not all the possible side effects of JANUVIA. For more information, ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Who should not take it

Do not take JANUVIA if: you are allergic to any of the ingredients in JANUVIA. See the end of this Medication Guide for a complete list of ingredients in JANUVIA. Symptoms of a serious allergic reaction to JANUVIA may include rash, raised red patches on your skin (hives), or swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing.

What to say before you start

Before you take JANUVIA, tell your doctor about all of your medical conditions, including if you: have or have had inflammation of your pancreas (pancreatitis). have kidney problems. have heart failure. are pregnant or plan to become pregnant. It is not known if JANUVIA will harm your unborn baby. If you are pregnant, talk with your doctor about the best way to control your blood sugar while you are pregnant.

are breastfeeding or plan to breastfeed. It is not known if JANUVIA will pass into your breast milk. Talk with your doctor about the best way to feed your baby if you are taking JANUVIA. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.

Storing it

Store JANUVIA at room temperature, between 68°F to 77°F (20°C to 25°C). Keep JANUVIA and all medicines out of the reach of children.