SITAGLIPTIN- sitagliptin tablet
Zydus Lifesciences Limited
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| Medication Guide
Sitagliptin (sit" a glip' tin) tablets, for oral use |
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| What is the most important information I should know about Sitagliptin Tablets ?
Sitagliptin Tablets 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 Sitagliptin Tablets , tell your healthcare provider if you have ever had: o pancreatitis o stones in your gallbladder (gallstones) o high blood triglyceride levels o a history of alcoholism o kidney problems Stop taking Sitagliptin Tablets and call your healthcare provider 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 Sitagliptin Tablets , tell your healthcare provider if you have ever had heart failure or have problems with your kidneys. Contact your healthcare provider right away if you have any of the following symptoms: o increasing shortness of breath or trouble breathing, especially when you lie down o swelling or fluid retention, especially in the feet, ankles, or legs o an unusually fast increase in weight o unusual tiredness These may be symptoms of heart failure. |
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| What is Sitagliptin Tablets ?
Sitagliptin Tablets is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. Sitagliptin Tablets 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 Sitagliptin Tablets. It is not known if Sitagliptin Tablets is safe and effective in children. |
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| Do not take Sitagliptin Tablets if:
you are allergic to sitagliptin or any of the ingredients in Sitagliptin Tablets. See the end of this Medication Guide for a complete list of ingredients in Sitagliptin Tablets. Symptoms of a serious allergic reaction to Sitagliptin Tablets may include rash, raised red patches on your skin (hives), or swelling of the face, lips, tongue, and throat that may cause difficulty breathing or swallowing. |
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| Before you take Sitagliptin Tablets , tell your healthcare provider 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 Sitagliptin Tablets will harm your unborn baby. If you are pregnant, talk with your healthcare provider about the best way to control your blood sugar while you are pregnant. are breastfeeding or plan to breastfeed. It is not known if sitagliptin will pass into your breast milk. Talk with your healthcare provider about the best way to feed your baby if you are taking Sitagliptin Tablets. Tell your healthcare provider 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 healthcare provider and pharmacist when you get a new medicine. |
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| How should I take Sitagliptin Tablets ?
Take Sitagliptin Tablets 1 time each day exactly as your healthcare provider tells you. You can take Sitagliptin Tablets with or without food. Your healthcare provider will do blood tests to check how well your kidneys are working before and during your treatment with Sitagliptin Tablets. Your healthcare provider may tell you to take Sitagliptin Tablets along with other diabetes medicines. Low blood sugar can happen more often when Sitagliptin Tablets is taken with certain other diabetes medicines. See " What are the possible side effects of Sitagliptin Tablets ? ". If you take too much Sitagliptin Tablets, call your healthcare provider or the Poison Help Line at 1-800-222-1222 or go to the nearest hospital emergency room right away. |
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| What are the possible side effects of Sitagliptin Tablets ?
Sitagliptin Tablets may cause serious side effects, including: See "What is the most important information I should know about Sitagliptin Tablets ?" . Kidney problems , sometimes requiring dialysis. Low blood sugar (hypoglycemia). If you take Sitagliptin Tablets 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 Sitagliptin Tablets. Signs and symptoms of low blood sugar may include: |
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| o headache o drowsiness o irritability o hunger o dizziness | o confusion o sweating o feeling jittery o weakness o fast heartbeat |
| Serious allergic reactions. If you have any symptoms of a serious allergic reaction, stop taking Sitagliptin Tablets and call your healthcare provider right away or get emergency medical help. See " Do not take Sitagliptin Tablets if: ". Your healthcare provider may give you a medicine for your allergic reaction and prescribe a different medicine for your diabetes. Joint pain. Some people who take Sitagliptin Tablets, may develop joint pain that can be severe. Call your healthcare provider if you have severe joint pain. Skin reaction. Some people who take Sitagliptin Tablets may develop a skin reaction called bullous pemphigoid that can require treatment in a hospital. Tell your healthcare provider right away if you develop blisters or the breakdown of the outer layer of your skin (erosion). Your healthcare provider may tell you to stop taking Sitagliptin Tablets. The most common side effects of Sitagliptin Tablets include upper respiratory infection, stuffy or runny nose and sore throat, and headache. These are not all the possible side effects of Sitagliptin Tablets. For more information, ask your healthcare provider or pharmacist. Tell your healthcare provider if you have any side effect that bothers you or does not go away. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. |
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| How should I store Sitagliptin Tablets ?
Store Sitagliptin Tablets in the original container at room temperature between 68°F to 77°F (20°C to 25°C). Keep Sitagliptin Tablets in the original container to protect it from moisture Use Sitagliptin Tablets within 3 months of opening the bottle Keep Sitagliptin Tablets and all medicines out of the reach of children. |
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| General information about the safe and effective use of Sitagliptin Tablets
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use Sitagliptin Tablets for a condition for which it was not prescribed. Do not give Sitagliptin Tablets to other people, even if they have the same symptoms you have. It may harm them. You can ask your pharmacist or healthcare provider for information about Sitagliptin Tablets that is written for health professionals. |
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| What are the ingredients in Sitagliptin Tablets ?
Active ingredient: sitagliptin Inactive ingredients: anhydrous dibasic calcium phosphate, colloidal silicon dioxide, croscarmellose sodium, malic acid, magnesium stearate, microcrystalline cellulose, and povidone. In addition, the film coating contains the following inactive ingredients: polyethylene glycol, polyvinyl alcohol, talc, and titanium dioxide. The 50 mg tablet's film coating also contains ferrosoferric oxide and iron oxide yellow. The 100 mg tablet's film coating also contains FD&C Yellow #6 Aluminum Lake and iron oxide yellow. Manufactured by: Zydus Lifesciences Ltd., Pharmez, Matoda, Ahmedabad, India The trademarks depicted herein are owned by their respective companies. Please address medical inquiries to, (MedicalAffairs@zydususa.com) 1-877-993-8779. |
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| This Medication Guide has been approved by the U.S. Food and Drug Administration Issued: 10/2023 |
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