Synjardy

What is Synjardy?

Synjardy is a combination of metformin and empagliflozin. Metformin and empagliflozin are two oral diabetes medications that control blood sugar. Empagliflozin helps your kidneys remove glucose from the bloodstream. Metformin reduces the production of glucose in your liver, and it also makes your intestines absorb less glucose.

The combination of Synjardy, diet, and exercise is used to control blood sugar levels in patients with type II diabetes. Synjardy can also be used to reduce the risk of heart attacks, strokes, and heart failure among adults with type 2 diabetes who also have heart problems.

Warnings

If you experience even mild symptoms, such as muscle pain or weakness or numbness or coldness in your arms or legs, difficulty breathing, stomach discomfort, nausea and vomiting, slow heartbeats or irregular beats, dizziness, or feeling extremely weak or tired, seek emergency medical attention. If you feel sick and have diarrhea or vomiting, tell your doctor. Also, let him know if you're eating or drinking less than normal.

This medicine may cause severe infections of the vagina or penis in rare cases. Seek medical attention immediately if there is any burning, itching, or discharge, pain or tenderness around the genital area or the rectal region, swelling or redness, or fever.

Synjardy should not be used if you suffer from moderate-to-severe kidney problems, are on dialysis, or have diabetic ketoacidosis. (Call your doctor immediately for treatment.) You may have to temporarily stop using Synjardy if you are going to undergo an x-ray, CT scan, or any other type of test that uses a dye injected directly into your veins.

Similar/related drugs

Metformin, Trulicity, Lantus, Victoza, Tresiba, and Levemir

Before you take this drug

Synjardy should not be used if:

• If you have severe kidney disease and/or are receiving dialysis treatments, or are currently on dialysis treatments, here is some important information for you.
• Metabolic acidosis or diabetic ketoacidosis (call your doctor for treatment).

You may have to temporarily stop using this medication if you are going to undergo surgery or any type of x-ray or CT scan that uses a dye injected directly into your veins. Make sure that your caregivers are aware of the fact that you use Synjardy.

Tell your doctor about any of the following to ensure that Synjardy will be safe for you:

• Liver or kidney disease
• Bladder inflammation, or urination issues;
• Congestive heart failure is caused by a stroke or heart attack.
• A genital infection, either penis or vaginal;
• Pancreas problems, including surgery
• If you're on a diet that is low in salt,
• If you are over 65 years old,

Lactic acidosis is a potentially dangerous accumulation of lactic acids in your blood. Consult your doctor to determine your risk. If you're pregnant or planning to become pregnant, you should follow your doctor's advice about using Synjardy.

Do not use Synjardy in the second or third trimester. Metformin can stimulate ovulation and increase the risk of unintended pregnancies in women who are not yet menopausal. Speak to your doctor about the risks. Synjardy should not be used while breastfeeding. No one under 18 may use this product.

How to take Synjardy?

Follow the instructions on your prescription label and read all medication guides or instruction sheets. Read all the instructions and directions that come with your medication. Sometimes your doctor will change the dose. Take with meals. Do not chew, crush, break, or dissolve the Synjardy Extended-Release Tablet. If you are having trouble swallowing, tell your doctor.

You will need to check your blood sugar often, and you may need to test for ketones in your urine. Empagliflozin may cause life-threatening ketoacidosis. If your blood sugar level is normal but a urine test indicates that you have high levels of ketones, call your doctor. Stress, illness or surgery, alcohol, exercise, and skipping meals can all affect blood sugar levels.

A low blood sugar may make you feel irritable or shaky. Eat or drink hard candies, raisins, fruit, non-diet soda, crackers, or other foods to treat hyperglycemia. In the case of severe hypoglycemia, your doctor may prescribe glucagon. During prolonged illness, you may become dehydrated. If you have diarrhea or vomiting or are eating or drinking less than normal, call your doctor. Inform your doctor of any planned surgeries.

Certain medical tests can be affected by Synjardy. Inform any doctor that you see about your use of this medication. You may be prescribed extra vitamin B12 by your doctor if you are taking Synjardy. Only take the prescribed amount of vitamin B12. Diet, exercise, weight management, and other medical treatments may be part of your treatment. Store away from heat and moisture at room temperature.

Details on dosage

Adult dosage for diabetes type 2:

Individualize dosage according to the patient's current regimen.
Synjardy Immediate Release:
Metformin for Patients on Metformin
Initial dose: switch to 10 mg of empagliflozin per day plus a similar daily dose total of metformin. Give two equally divided oral doses twice a week.
Empagliflozin for Patients Already on Empagliflozin
Initial dose: switch to metformin plus 1000 mg/day of empagliflozin in two equally divided oral doses twice daily.
Patients are already on Synjardy.
Initial dose: Give two equal, divided doses twice daily in two equally divided doses.
Maintenance: Adjust dosage based on effectiveness and tolerability. A gradual dose increase of metformin can help reduce gastrointestinal side effects.
Maximum dose: empagliflozin: 25 mg/day; metformin: 2000 mg/day
Synjardy Extended Release:
Metformin for Patients on Metformin
Initial dose: switch to 10 mg of empagliflozin plus a similar daily total dose of metformin, orally.
Empagliflozin for Patients Already on Empagliflozin
Initial dose: switch to metformin 1,000 mg/day plus empagliflozin 1000 mg/day.
Patients are already on Synjardy.
Initial dose: Orally, switch to the same daily total dose for each component (or the nearest dose of metformin).
Maintenance: Adjust the dose according to efficacy and tolerance; a gradual increase in metformin dose will reduce side effects.
Maximum dose: empagliflozin: 25 mg/day; metformin: 2000 mg/day.

Usual Adult Dose for Cardiovascular Risk Reduction:

Individualize dosage according to the patient's current regimen.
Synjardy Immediate Release:
Metformin for Patients on Metformin
Initial dose: switch to 10 mg/day of empagliflozin plus a similar daily dose total of metformin. Give in two equally divided oral doses twice a day.
Empagliflozin for Patients Already on Empagliflozin
Initial dose: switch to metformin plus 1000 mg/day of empagliflozin in two equally divided oral doses twice daily.
Patients are already on Synjardy.
Initial dose: Give two equal, divided doses twice daily in two equally-sized doses.
Maintenance: Adjust dosage based on effectiveness and tolerability. A gradual dose increase of metformin can help reduce gastrointestinal side effects.
Maximum dose: empagliflozin: 25 mg/day; metformin: 2000 mg/day
Synjardy Extended Release:
Metformin for Patients on Metformin
Initial dose: switch to 10 mg of empagliflozin plus a similar daily total dose of metformin, orally.
Empagliflozin for Patients Already on Empagliflozin
Initial dose: switch to metformin 1,000 mg/day plus empagliflozin 1000 mg/day.
Patients are already on Synjardy.
Initial dose: Orally, switch to the same daily total dose for each component (or the nearest dose of metformin).
Maintenance: Adjust the dose according to efficacy and tolerance; a gradual increase in metformin dose will reduce side effects.
Maximum dose: empagliflozin: 25 mg/day; metformin: 2000 mg/day
Comments:
When used with insulin or an insulagogue in combination, a reduced dose of insulin should be considered. Thus lowering the risk of hypoglycemia.
Assess renal function and correct volume depletion before starting therapy.
Uses:
As an adjunct to diet, exercise, and weight loss in adults with diabetes type 2,
Empagliflozin reduces the risk of death from cardiovascular causes in adults with diabetes type 2 and cardiovascular disease.

What happens if I miss the dose?

If you are close to your next dose, skip the missed dose. Never take two doses of the same medicine at once.

What happens if I overdose?

Call 1-800-222-1222 for poison help or seek immediate medical attention. An overdose may cause lactic acidosis. You may experience unusual muscle pains, difficulty breathing, irregular heartbeats, or feel weak.

What should be avoided?

Avoid alcohol. Alcohol can increase the risk of lactic acidosis.

You may get dizzy if you stand up quickly from a seated or lying position.

Side effects of Synjardy

If you experience any of the following symptoms of an allergic reaction: hives, difficulty breathing, swelling of your lips, face, tongue, or throat, or trouble swallowing. If you experience any of these symptoms, seek medical attention immediately. The symptoms can get worse very quickly.

If you experience any of the following symptoms, stop taking Synjardy immediately and contact your doctor.

• A feeling of lightheadedness, as if you could pass out.
• Dehydration, confusion, feeling thirsty, and less urination.
• Ketoacidosis (too many acids in the bloodstream) nausea or vomiting, stomach pains, confusion, unusual sleepiness, or difficulty breathing.
• Lactic acidosis: unexplained muscle pain, difficulty breathing, stomach pains, vomiting, an irregular heartbeat, dizziness, or feeling cold; or
• Signs of a bladder infection include pain or burning while urinating, blood in urine, and back or pelvic pain.

Some side effects are more common in older adults.

Synjardy may cause side effects such as:

• Low blood sugar
• Indigestion, stomach pain, gas, nausea, vomiting, diarrhea
• A bladder infection
• Women with yeast infections (vaginal itching and discharge);
• Headache weakness
• Sore throat.

There may be other side effects. For medical advice on side effects, call your doctor. The FDA can be contacted at 1-800-FDA-1088 to report side effects.

Interaction with other drug

Other drugs can increase or decrease Synjardy's ability to lower your blood sugar. Tell your doctor if you are taking any new medicines or if you will stop using any of your existing medications.

• Insulin, or any other oral diabetes medication;
• A diuretic, or "water pill."

This list is incomplete. There are other drugs that may interact with metformin and empagliflozin, such as prescription and over-the-counter medicines, vitamins, and herbal products. This list does not include all possible drug interactions.