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Glyxambi

Generic Name: empagliflozin and linagliptin (EM pa gli FLOE zin and LIN a GLIP tin)
Brand Names: Glyxambi

What is Glyxambi?

Glyxambi contains a combination of empagliflozin and linagliptin are oral diabetes medicines that help control blood sugar levels. Empagliflozin works by helping the kidneys get rid of glucose from your bloodstream. Linagliptin works by regulating the levels of insulin your body produces after eating.

Glyxambi is used together with diet and exercise to treat type 2 diabetes. This medicine is not for treating type 1 diabetes.

Glyxambi may also be used for purposes not listed in this medication guide.

Important information

You should not use Glyxambi if you have severe kidney disease (or if you are on dialysis), if you have ever had a severe allergic reaction to empagliflozin or linagliptin, or if you are in a state of diabetic ketoacidosis.

Call your doctor at once if you have signs of a serious side effect, such as severe pain in your upper stomach spreading to your back, vomiting, fast heart rate, dizziness, feeling very thirsty or hot, decreased urination, heavy sweating, or hot and dry skin.

Before taking this medicine

You should not use Glyxambi if you are allergic to empagliflozin and linagliptin, or if you have:

  • severe kidney disease (or if you are on dialysis);

  • a history of severe allergic or skin reaction after taking linagliptin; or

  • if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin).

To make sure Glyxambi is safe for you, tell your doctor if you have:

  • kidney disease;

  • liver disease;

  • a pancreas disorder;

  • low blood pressure;

  • gallstones;

  • high cholesterol or triglycerides (a type of fat in the blood);

  • a history of alcoholism;

  • a history of genital infection (penis or vagina);

  • if you are on a low salt diet; or

  • if you are 65 or older.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether empagliflozin and linagliptin passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How should I take Glyxambi?

Take Glyxambi exactly as it was prescribed for you. Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Glyxambi is usually taken in the morning. You may take this medicine with or without food.

While using Glyxambi, you may need frequent medical tests.

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, confusion, irritability, dizziness, or feeling shaky. Always keep a source of sugar with you in case you have low blood sugar. Sugar sources include fruit juice, hard candy, crackers, raisins, and non-diet soda. Be sure your family and close friends know how to help you in an emergency.

If you have severe hypoglycemia and cannot eat or drink, use a glucagon injection. Your doctor can prescribe a glucagon emergency injection kit and tell you how to use it.

Also watch for signs of high blood sugar (hyperglycemia) such as increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, and weight loss.

Check your blood sugar carefully during times of stress, travel, illness, surgery or medical emergency, vigorous exercise, or if you drink alcohol or skip meals. These things can affect your glucose levels and your dose needs may also change. Do not change your medication dose or schedule without your doctor's advice.

Glyxambi can cause unusual results with certain lab tests for glucose (sugar) in the urine. Tell any doctor who treats you that you are using Glyxambi.

Store at room temperature away from moisture and heat.

Glyxambi dosing information

Usual Adult Dose of Glyxambi for Diabetes Type 2:

Initial dose: Empagliflozin 10 mg-linagliptin 5 mg orally once daily in the morning
-May increase to empagliflozin 25 mg-linagliptin 5 mg orally once daily if the lower dose is tolerated
Maximum dose: Empagliflozin 25 mg-linagliptin 5 mg once daily

Comments: When used in combination with insulin or insulin secretagogues, a lower dose of the insulin secretagogues or insulin may be necessary to reduce the risk of hypoglycemia.

Use: As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both Glyxambi is appropriate.

See also: Dosage Information (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A Glyxambi overdose can cause life threatening hypoglycemia.

Symptoms of severe hypoglycemia include extreme weakness, confusion, tremors, sweating, fast heart rate, trouble speaking, nausea, vomiting, rapid breathing, fainting, and seizure (convulsions).

What should I avoid while taking Glyxambi?

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Glyxambi side effects

Get emergency medical help if you have signs of an allergic reaction to Glyxambi: hives, itching, flaking or peeling skin; trouble swallowing, difficult breathing; swelling of your face, lips, tongue, or throat.

Stop taking this medicine and call your doctor at once if you have:

  • severe or ongoing pain in your joints;

  • a light-headed feeling, like you might pass out;

  • ketoacidosis (too much acid in the blood) - nausea, vomiting, stomach pain, confusion, unusual drowsiness, or trouble breathing;

  • pancreatitis - severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;

  • dehydration symptoms - feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;

  • signs of a bladder infection - pain or burning when you urinate, urine that looks cloudy, pain in pelvis or back; or

  • signs of a genital infection (penis or vagina) - pain, burning, itching, rash, redness, odor, or discharge.

Common Glyxambi side effects may include:

  • urination problems;

  • sinus pain; or

  • cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

What other drugs will affect Glyxambi?

Other drugs may increase or decrease the effects of Glyxambi on lowering your blood sugar.

Tell your doctor about all your current medicines and any you start or stop using, especially:

  • other oral diabetes medicine;

  • insulin;

  • rifampin (to treat tuberculosis); or

  • heart or blood pressure medication, including a diuretic or "water pill".

Other drugs may interact with empagliflozin and linagliptin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your pharmacist can provide more information about Glyxambi.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Glyxambi only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2016 Cerner Multum, Inc. Version: 1.04. Revision Date: 2016-01-13, 3:57:17 PM.

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