FDA Approves Tradjenta

The U.S. Food and Drug Administration (FDA) has approved Tradjenta (linagliptin) tablets, a prescription medication used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
Tradjenta can be used as monotherapy or in combination with other commonly prescribed medications for type 2 diabetes — metformin, sulfonylurea or pioglitazone — and demonstrated reductions in hemoglobin A1C (HbA1C or A1C) levels up to 0.7 percent (compared to placebo). A1C is measured in people with diabetes to provide an index of blood sugar control for the previous two to three months. Tradjenta should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis (increased ketones in the blood or urine). It has not been studied in combination with insulin.

Tradjenta belongs to a class of prescription medications called dipeptidyl peptidase-4 (DPP-4) inhibitors and is the first member of its class to be approved at one dosage strength (5 mg, once daily). With Tradjenta, no dose adjustment is recommended for patients with kidney or liver impairment. Tradjenta is a tablet that can be taken with or without food. Tradjenta lowers blood sugar in a glucose-dependent manner by increasing incretin levels, which increase insulin levels after meals and throughout the day.

Tradjenta Patient Information

Read this Patient Information before you start taking Tradjenta and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.

What is Tradjenta?

  • Tradjenta is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
  • Tradjenta is not for people with type 1 diabetes.
  • Tradjenta is not for people with diabetic ketoacidosis (increased ketones in the blood or urine).
  • It is not known if Tradjenta is safe and effective when used with insulin.
  • It is not known if Tradjenta is safe and effective in children.

Who should not take Tradjenta?

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

Before using Tradjenta

Before you take Tradjenta, tell your doctor if you:
  • have any other medical conditions
  • are pregnant or planning to become pregnant. It is not known if Tradjenta 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 Tradjenta passes into your breast milk. Talk with your doctor about the best way to feed your baby if you take Tradjenta.
Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
Tradjenta may affect the way other medicines work, and other medicines may affect how Tradjenta works.
Especially tell your doctor if you take
  • other medicines that can lower your blood sugar
  • rifampin (Rifadin, Rimactane, Rifater, Rifamate), an antibiotic that is used to treat tuberculosis
Ask your doctor or pharmacist for a list of these medicines if you are not sure if your medicine is one that is listed above.
Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.

How should I take Tradjenta?

  • Take Tradjenta one time each day exactly as your doctor tells you to take it.
  • Talk with your doctor if you do not understand how to take Tradjenta.
  • Your doctor will tell you when to take Tradjenta.
  • Take Tradjenta with or without food.
  • 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 Tradjenta at the same time.
  • Your doctor may tell you to take Tradjenta along with other diabetes medicines. Low blood sugar can happen more often when Tradjenta is taken with certain other diabetes medicines. See Tradjenta side effects
  • If you take too much Tradjenta, call your doctor or Poison Control Center at 1-800-222-1222 or go to the nearest hospital emergency room 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 Tradjenta.
  • Talk to your doctor about how to prevent, recognize and manage low blood sugar (hypoglycemia), high blood sugar (hyperglycemia), and complications of diabetes.
  • Your doctor will check your diabetes with regular blood tests, including your blood sugar levels and your hemoglobin A1C.
http://www.drugs.com/tradjenta.html

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