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Sitagliptin Phosphate Oral tablet

It helps to control blood sugar

Generic Name: sitagliptin

Brand Names: Januvia

There is an FDA Alert for this drug. Click here to view it.

Special Alerts:

[Posted 09/25/2009] FDA notified healthcare professionals and patients of revisions to the prescribing information for sitagliptin (Januvia) and sitagliptin/metformin (Janumet) to include information on reported cases of acute pancreatitis in patients using these products. Eighty-eight post-marketing cases of acute pancreatitis, including two cases of hemorrhagic or necrotizing pancreatitis in patients using sitagliptin, were reported to the Agency between October 2006 and February 2009. It is recommended that healthcare professionals monitor patients carefully for the development of pancreatitis after initiation or dose increases of sitagliptin or sitagliptin/metformin. Sitagliptin has not been studied in patients with a history of pancreatitis. Therefore, it is not known whether these patients are at an increased risk for developing pancreatitis and the medication should be used with caution and with appropriate monitoring in patients with a history of pancreatitis. Considerations for healthcare professionals, information for patients, and a Data Summary are provided. For more information visit the FDA website at: [Web] and [Web].

REMS:

FDA approved a REMS for sitagliptin to ensure that the benefits of a drug outweigh the risks. However, FDA later rescinded REMS requirements. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).

What is this medicine?

SITAGLIPTIN (sit a GLIP tin) helps to treat type 2 diabetes. It helps to control blood sugar. Treatment is combined with diet and exercise.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
  • diabetic ketoacidosis
  • kidney disease
  • pancreatitis
  • previous swelling of the tongue, face, or lips with difficulty breathing, difficulty swallowing, hoarseness, or tightening of the throat
  • type 1 diabetes
  • an unusual or allergic reaction to sitagliptin, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. You can take it with or without food. Do not cut, crush or chew this medicine. Take your dose at the same time each day. Do not take more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:
  • gatifloxacin

This medicine may also interact with the following medications:

  • alcohol
  • digoxin
  • insulin
  • sulfonylureas like glimepiride, glipizide, glyburide

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. Learn how to check your blood sugar. Learn the symptoms of low and high blood sugar and how to manage them. If you are sick or exercising more than usual, you might need to change the dose of your medicine. Do not skip meals. Ask your doctor or health care professional if you should avoid alcohol. If you have symptoms of low blood sugar, eat or drink something containing sugar at once and contact your doctor or health care professional. Make sure family members know that you can choke if you eat or drink when you develop serious symptoms of low blood sugar, like seizures or unconsciousness. They must get medical help at once.

Wear a medical identification bracelet or chain to say you have diabetes, and carry a card that lists all your medications.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:
  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
  • breathing problems
  • fever
  • loss of appetite
  • low blood sugar (ask your doctor or healthcare professional for a list of these symptoms)
  • nausea, vomiting
  • unusual stomach pain or discomfort

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • diarrhea
  • headache
  • stuffy or runny nose

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.


Last Updated: April 16, 2012
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