Synjardy XR

The active ingredients in Synjardy XR are empagliflozin and metformin, which work through two different mechanisms of action. Empagliflozin is an SGLT2 inhibitor that helps the kidneys remove extra glucose from the body through the urine. This process lowers blood sugar levels and may also improve heart failure symptoms in certain adults. Metformin reduces the amount of sugar produced by the liver and helps the body use insulin more effectively. Together, these effects improve blood glucose control, lower A1C levels, and help reduce long-term health complications linked to uncontrolled diabetes mellitus.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Synjardy XR. However, the following is a synopsis of the general guidelines for the use of Synjardy XR:

• Synjardy XR is taken once daily with a meal.
• Swallow the extended-release tablets whole. Do not crush, split, or chew them.
• If there’s a missed dose, take it as soon as you remember, unless it is almost time for your next dose. Do not take two doses at the same time.
• Your healthcare provider may check your kidney function and vitamin B12 levels regularly.
• Stay hydrated to help reduce the risk of low blood pressure or dehydration.

Your doctor may adjust your dose if you are also taking a sulfonylurea or insulin to lower the risk of hypoglycemia.

Some mild or common side effects of Synjardy XR include:

• Urinary tract infection.
• Yeast infection.
• Increased urination.
• Nausea.
• Diarrhea.
• Upset stomach.
• Headache.
• Muscle pain.

Some individuals may experience serious side effects while using Synjardy XR. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Signs of diabetic ketoacidosis, such as nausea, vomiting, stomach pain, fatigue, or trouble breathing.
• Symptoms of lactic acidosis, including weakness, fast heartbeat, unusual muscle pain, dizziness, or feeling cold.
• Severe urinary tract infection, urosepsis, or pyelonephritis.
• Symptoms of low blood pressure, such as dizziness or lightheadedness.
• Vitamin B12 deficiency.
• Severe liver problems.
• Signs of Fournier's gangrene or necrotizing fasciitis of the perineum, including redness, swelling, or worsening pain.
• Signs of a severe, life-threatening allergic reaction, such as rash, swelling, or shortness of breath.
• Worsening kidney problems or sudden changes in kidney function.
• Increased risk of lower-limb amputation.

These are not all of the possible adverse reactions of Synjardy XR. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Synjardy XR, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including if you have:

• Kidney problems or chronic kidney disease.
• Liver problems.
• Heart failure or congestive heart failure.
• A history of diabetic ketoacidosis.
• Frequent urinary tract infections or yeast infections.
• Dehydration or low blood pressure (hypotension).
• Anemia or low vitamin B12 levels.
• Risk factors for lactic acidosis.
• Type 1 diabetes.
• A history of alcohol use disorder.
• If you take diuretics or water pills.

Your doctor may run blood tests to check your vitamin B12 levels, blood glucose, kidney function, and ketones if needed.

Synjardy XR should not be used in people who:

• Have severe kidney problems.
• Have metabolic acidosis or diabetic ketoacidosis.
• Have acute or chronic conditions that increase the risk of lactic acidosis.
• Are allergic to empagliflozin, metformin, or any ingredient in the medication.
• Are using it to treat type 1 diabetes.

Synjardy XR begins working within the first few days of use, but full blood sugar improvements may take several weeks. Your healthcare provider may check your A1C level after a few months to see how well the medication is working. Some effects, such as increased urination from empagliflozin, may occur sooner.

When Synjardy XR is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Diuretics, which may increase the risk of dehydration and low blood pressure.
• Carbonic anhydrase inhibitors such as topiramate or acetazolamide, which increase the risk of metabolic acidosis.
• Cimetidine, which may raise metformin levels.
• Dolutegravir, which may reduce metformin clearance.

Synjardy XR is available as an extended-release tablet dosage form in several different strengths of empagliflozin and metformin. Your healthcare provider will choose the dose that best fits your treatment plan and medical history.

It should be stored at room temperature, away from the reach of children or pets.

Synjardy XR is manufactured by Boehringer Ingelheim Pharmaceuticals, Inc.

There is currently no generic version of Synjardy XR available. Only brand-name Synjardy XR is approved at this time.

Do not stop taking Synjardy XR without speaking to your healthcare provider. Stopping suddenly may cause blood sugar levels to rise or increase the risk of hyperglycemia. Your doctor will tell you the safest way to stop or switch medications if needed.

Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you. Synjardy XR is not recommended during the second or third trimester of pregnancy because empagliflozin may affect kidney development in the unborn baby.

Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you. Metformin can pass into breast milk, while it is unknown if empagliflozin does, so your healthcare provider will determine whether this medication is appropriate for you.