SAXAGLIPTIN- saxagliptin tablet, film coated
Amneal Pharmaceuticals LLC
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Saxagliptin (sax” a glip’ tin) tablets, for oral use | |||
What is the most important information I should know about saxagliptin tablets? Serious side effects can happen to people taking saxagliptin tablets, including: 1) 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 saxagliptin tablets: Tell your healthcare provider if you have ever had |
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It is not known if having these medical problems will make you more likely to get pancreatitis with saxagliptin tablets. Stop taking saxagliptin tablets and contact 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. 2) Heart failure. Heart failure means your heart does not pump blood well enough. Before you start taking saxagliptin tablets: Tell your healthcare provider if you |
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Contact your healthcare provider right away if you have any of the following symptoms: |
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These may be symptoms of heart failure. | |||
What is saxagliptin tablets?
It is not known if saxagliptin tablets is safe and effective in children younger than 18 years old. |
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Who should not take saxagliptin tablets? Do not take saxagliptin tablets if you:
Symptoms of a serious allergic reaction to saxagliptin tablets may include: |
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If you have these symptoms, stop taking saxagliptin tablets and contact your healthcare provider right away. | |||
Before taking saxagliptin tablets, tell your healthcare provider about all of your medical conditions, including if you:
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. Saxagliptin tablets may affect the way other medicines work, and other medicines may affect how saxagliptin tablets works. Contact your healthcare provider if you will be starting or stopping certain other types of medications, such as antibiotics, or medicines that treat fungus or HIV/AIDS, because your dose of saxagliptin tablets might need to be changed. |
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How should I take saxagliptin tablets?
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What are the possible side effects of saxagliptin tablets? Saxagliptin tablets can cause serious side effects, including:
If you have these symptoms, stop taking saxagliptin tablets and contact your healthcare provider right away.
Common side effects of saxagliptin tablets include:
Low blood sugar (hypoglycemia) may become worse in people who also take another medication to treat diabetes, such as sulfonylureas or insulin. Tell your healthcare provider if you take other diabetes medicines. If you have symptoms of low blood sugar, you should check your blood sugar and treat if low, then call your healthcare provider. Symptoms of low blood sugar include: |
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Swelling or fluid retention in your hands, feet, or ankles (peripheral edema) may become worse in people who also take a thiazolidinedione to treat diabetes. If you do not know whether you are already on this type of medication, ask your healthcare provider. These are not all of the possible side effects of saxagliptin tablets. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. |
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How should I store saxagliptin tablets? Store saxagliptin tablets between 68° to 77°F (20° to 25°C).
Keep saxagliptin tablets and all medicines out of the reach of children. |
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General information about the use of saxagliptin tablets Medicines are sometimes prescribed for conditions that are not mentioned in Medication Guides. Do not use saxagliptin tablets for a condition for which it was not prescribed. Do not give saxagliptin tablets to other people, even if they have the same symptoms you have. It may harm them. You can ask your healthcare provider for additional information about saxagliptin tablets that is written for health professionals. |
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What are the ingredients of saxagliptin tablets? Active ingredient: saxagliptin Inactive ingredients: croscarmellose sodium, hydrochloric acid, magnesium stearate, mannitol, microcrystalline cellulose and povidone. In addition, the film coating contains the following inactive ingredients: hypromellose, iron oxide red, iron oxide yellow, polyethylene glycol, talc and titanium dioxide. The imprinting ink contains the following inactive ingredients: ammonium hydroxide, iron oxide black, isopropyl alcohol, propylene glycol and shellac. |
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What is type 2 diabetes? Type 2 diabetes is a condition in which your body does not make enough insulin, and the insulin that your body produces does not work as well as it should. Your body can also make too much sugar. When this happens, sugar (glucose) builds up in the blood. This can lead to serious medical problems. The main goal of treating diabetes is to lower your blood sugar so that it is as close to normal as possible. High blood sugar can be lowered by diet and exercise, and by certain medicines when necessary. Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad 382220, INDIA Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev. 04-2022-00 |
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Dispense with Medication Guide available at: documents.amneal.com/mg/saxagliptin.pdf