Empagliflozin & Metformin

Empagliflozin/metformin is a prescription medication used to treat type 2 diabetes. It is a combination of two medications in one tablet. Empagliflozin, a sodium glucose co-transporter-2 (SGLT2) inhibitor, removes excess glucose through the urine by blocking glucose re-absorption in the kidney. Metformin, a commonly prescribed initial treatment for T2D, lowers glucose production by the liver and its absorption in the intestine.

Empagliflozin/metformin comes in tablet form in several dosage strengths. It is taken twice daily with meals.

This medication is also available in an extended-release tablet and is taken once a day with a meal in the morning. Swallow the extended-release tablet whole; do not split, crush, dissolve, or chew.

The most common side effects include stuffy or runny nose and sore throat, urinary tract infections, female genital infections, diarrhea, headache, nausea, and vomiting.

Empagliflozin/metformin is a prescription medication used to treat type 2 diabetes.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• other medical conditions you have
• other medications you are taking
• how you respond to this medication

The recommended starting dose of empagliflozin/metformin is based on a patient’s current dose of either component (metformin or empagliflozin) alone. The dose can be gradually increased based on the patient’s response and side effects to the medication.

WARNING: RISK OF LACTIC ACIDOSIS

Serious side effects can happen in people taking SYNJARDY.

Metformin, one of the medicines in SYNJARDY, can cause a rare but serious condition called lactic acidosis (a build-up of lactic acid in the blood) that can cause death. Lactic acidosis is a medical emergency and must be treated in a hospital.

Stop taking SYNJARDY and call your doctor right away if you get any of the following symptoms of lactic acidosis: you feel very weak or tired; have unusual muscle pain; have trouble breathing; are very sleepy or sleep longer than usual; have sudden stomach pains, nausea and vomiting or diarrhea; feel cold, especially in your arms or legs; feel dizzy or lightheaded; or have a slow or irregular heartbeat, as these could be symptoms of lactic acidosis.

You have a higher chance of getting lactic acidosis with SYNJARDY if you have kidney problems, liver problems, congestive heart failure that requires medicines, drink alcohol very often, or drink a lot of alcohol in short-term "binge" drinking, get dehydrated (lose a large amount of body fluids), have certain x-ray tests with dyes or contrast agents that are injected into your body, have surgery, have a heart attack, severe infection, or stroke, are 80 years of age or older and have not had your kidneys tested.

Serious side effects have been reported with empagliflozin/metformin including the following:

• Lactic acidosis. Rarely, metformin can cause a serious side effect called lactic acidosis. This is caused by a buildup of lactic acid in your blood. This build-up can cause serious damage. Make sure you tell your doctor before you use metformin if you have kidney or liver problems. Lactic acidosis is a medical emergency that must be treated in a hospital. You should also stop using metformin and call your doctor right away if you have signs of lactic acidosis including:
  • feeling very weak, tired, or uncomfortable
  • unusual muscle pain
  • trouble breathing
  • unusual or unexpected stomach discomfort
  • feeling cold
  • feeling dizzy or lightheaded
  • suddenly developing a slow or irregular heartbeat
• Decreased blood pressure (hypotension). Tell your healthcare provider right away if you have some or all of the following symptoms of low blood pressure.
  • dizziness or lightheadedness
  • fainting (syncope)
  • lack of concentration
  • blurred vision
  • nausea
  • cold, clammy, pale skin
  • rapid, shallow breathing
  • fatigue
  • depression
  • thirst
• Impaired renal function. Changes in kidney function can occur with empagliflozin/metformin, especially in people older than 75 years of age and those with existing kidney problems.

Empagliflozin/metformin can cause low blood sugar, which can cause dizziness and drowsiness. Do not drive or operate heavy machinery until you know how empagliflozin/metformin affects you.

Do not take empagliflozin/metformin if you:

• are allergic to empagliflozin/metformin or to any of its ingredients
• have serious kidney problems or are on dialysis
• have metabolic acidosis or diabetic ketoacidosis

Serious side effects have been reported with empagliflozin/metformin. See the “Empagliflozin/metformin Precautions” section.

Common side effects of empagliflozin/metformin include the following:

• runny or stuffy nose
• diarrhea
• nausea/vomiting
• flatulence
• abdominal discomfort
• indigestion
• asthenia
• headache

This medication may also cause urinary tract infections and female genital yeast infections.

This is not a complete list of empagliflozin/metformin side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• beta-blockers such as metoprolol (Toprol XL, Lopressor), carvedilol (Coreg), bisoprolol (Zebeta) betaxolol (Kerlone), nebivolol (Bystolic), propranolol (Inderal)
• cough and cold products containing decongestants
• calcium channel blockers
• cimetidine (Tagamet)
• corticosteroids
• digoxin (Lanoxin)
• diuretics such as acetazolamide (Diamox), amiloride (Midamor), bumetanide (Bumex), chlorothiazide (Diuril), chlorthalidone (Thalitone), ethacrynic acid (Edecrin), furosemide (Lasix), hydrochlorothiazide (Microzide, HCTZ), metolazone (Zaroxolyn), or torsemide (Demadex)
• estrogens
• Insulin or insulin-releasing drugs that can lower blood sugar such as glipizide (Glucotrol), glimepiride (Amaryl), repaglinide (Prandin), and nateglinide (Starlix)
• isoniazid (INH, Nydrazid)
• morphine
• niacin (nicotinic acid, Niaspan)
• nifedipine
• oral contraceptives
• oral steroids
• phenothiazines such as promethazine (Phenergan)
• phenytoin (Dilantin)
• procainamide
• quinidine
• quinine
• ranitidine
• thyroid medicines such as levothyroxine (Levothroid, Levoxyl, Synthroid)
• triamterene
• trimethoprim
• vancomycin

This is not a complete list of empagliflozin/metformin drug interactions. Ask your doctor or pharmacist for more information.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X - are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Empagliflozin/metformin falls into category C. There are no well-controlled studies that have been done in pregnant women. Empagliflozin/metformin should be used during pregnancy only if the possible benefit outweighs the possible risk to the unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if empagliflozin/metformin crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using empagliflozin/metformin.