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Synjardy

Generic Name: empagliflozin and metformin (EM pa gli FLOE zin and met FOR min)
Brand Names: Synjardy

What is Synjardy?

Synjardy contains a combination of empagliflozin and metformin. Empagliflozin and metformin are oral diabetes medicines that help control blood sugar levels. Empagliflozin works by helping the kidneys get rid of glucose from your bloodstream. Metformin lowers glucose production in the liver and also causes your intestines to absorb less glucose.

Synjardy is used together with diet and exercise to treat type 2 diabetes.

Synjardy is not for treating type 1 diabetes.

Important information

You should not use Synjardy if you have severe kidney disease, or if you are in a state of diabetic ketoacidosis (call your doctor for treatment with insulin). Synjardy is not for treating type 1 diabetes.

If you need to have any type of x-ray or CT scan using a dye that is injected into your veins, you will need to temporarily stop taking Synjardy.

Synjardy may cause a serious condition called lactic acidosis. Get emergency medical help if you have even mild symptoms such as: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or uneven heart rate, dizziness, or feeling very weak or tired.

Before taking this medicine

You should not use Synjardy if you are allergic to empagliflozin (Jardiance, Glyxambi) or metformin (Glucophage, Actoplus Met, Avandamet, Fortamet, Glucovance, Janumet, Jentadueto, Kazano, Kombiglyze, Metaglip, PrandiMet, Riomet), or if you have:

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

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

If you need to have any type of x-ray or CT scan using a dye that is injected into your veins, you will need to temporarily stop taking Synjardy.

Some people taking metformin develop a serious condition called lactic acidosis. This may be more likely if you have liver or kidney disease, congestive heart failure, a severe infection, if you are dehydrated, or if you drink large amounts of alcohol. Talk with your doctor about your risk.

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

  • liver or kidney disease;

  • low blood pressure;

  • a history of bladder infections or urination problems;

  • high cholesterol levels;

  • a history of heart attack or stroke;

  • if you are on a low-salt diet;

  • if you take blood pressure medicine such as a diuretic (water pill); or

  • if you are 80 or older and your kidneys have not been tested.

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

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

Synjardy is not approved for use by anyone younger than 18 years old.

How should I take Synjardy?

Take Synjardy 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 take this medicine in larger or smaller amounts or for longer than recommended.

Your doctor may perform kidney function tests before you start taking Synjardy.

Take Synjardy with food to prevent upset stomach.

Your blood sugar will need to be checked often, and you may need other blood tests at your doctor's office.

Do not crush, chew, or break a Synjardy extended-release tablet. Swallow the tablet whole.

Your doctor may have you take extra vitamin B12 while you are taking Synjardy. Take only the amount of vitamin B12 that your doctor has prescribed.

Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking Synjardy, which can lead to severely low blood pressure or a serious electrolyte imbalance.

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

Low blood sugar (hypoglycemia) can happen to everyone who has diabetes. Symptoms include headache, hunger, sweating, pale skin, irritability, dizziness, feeling shaky, or trouble concentrating. 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.

Synjardy is only part of a treatment program that may also include diet, exercise, weight control, blood sugar testing, and special medical care. Follow your doctor's instructions very closely.

Store Synjardy t room temperature, away from moisture and heat.

Synjardy dosing information

Usual Adult Dose of Synjardy for Diabetes Type 2:

Initial dose: Individualize based on patient's current regimen; take orally twice a day:
-In patients on metformin, switch to empagliflozin-metformin containing empagliflozin 5 mg with a similar total daily dose of metformin
-In patients on empagliflozin, switch to empagliflozin-metformin containing metformin 500 mg with a similar total daily dose of empagliflozin
-In patients already treated with empagliflozin and metformin, switch to empagliflozin-metformin containing the same total daily doses of each component.
-Adjust dose based on efficacy and tolerability; a gradual dose escalation of metformin will help to reduce gastrointestinal side effects.
Maximum dose: Empagliflozin: 25 mg per day; Metformin: 2000 mg per day

Comments:
- When used in combination with insulin or an insulin secretagogue, a lower dose of insulin or insulin secretagogue may be considered to reduce the risk of hypoglycemia.
-Correct volume depletion prior to beginning this drug.

Use: An adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus who are not adequately controlled on a regimen containing empagliflozin or metformin, or in patients already being treated with both empagliflozin and metformin.

See also: Dosage Information (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember (be sure to take the medicine with food). 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.

An overdose of metformin may cause lactic acidosis. Get emergency medical help if you have any of these symptoms of lactic acidosis: weakness, increasing sleepiness, slow heart rate, cold feeling, muscle pain, shortness of breath, stomach pain, feeling light-headed, and fainting.

What should I avoid while taking Synjardy?

Avoid drinking alcohol. It lowers blood sugar and may increase your risk of lactic acidosis while taking Synjardy.

Synjardy side effects

Get emergency medical help if you have signs of an allergic reaction to Synjardy: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Early symptoms of lactic acidosis may get worse over time and this condition can be fatal. Get emergency medical help if you have even mild symptoms: muscle pain or weakness, numb or cold feeling in your arms and legs, trouble breathing, stomach pain, nausea with vomiting, slow or uneven heart rate, dizziness, or feeling very weak or tired.

Call your doctor at once if you have:

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

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

  • signs of a kidney problem - little or no urinating; painful or difficult urination; swelling in your feet or ankles; feeling tired or short of breath;

  • 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.

Side effects may be more likely to occur in older adults.

Common Synjardy side effects may include:

  • bladder infection or genital infection;

  • headache;

  • stomach pain, gas, indigestion, nausea, vomiting, diarrhea;

  • weakness; 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 Synjardy?

Other drugs may interact with empagliflozin and metformin, including prescription and over-the-counter medicines, vitamins, and herbal products. 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 Synjardy.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Synjardy 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: 1.02. Revision Date: 2016-04-19, 11:45:51 AM.

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