Synjardy

The active ingredients in Synjardy are empagliflozin and metformin hydrochloride. Empagliflozin is considered a sodium-glucose co-transporter 2 or SGLT2 inhibitor, while metformin is a biguanide. Synjardy has several mechanisms of action to help keep blood glucose and sodium levels from getting too high in the body.

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. However, the following is a synopsis of the general guidelines for the use of Synjardy:

• Take this medication orally with food exactly as directed by your physician.
• Immediate-release (Synjardy) tablets can be used for people 10 years of age and older, but the extended-release (Synjardy XR) tablets are only for adults. Depending on which formulation you're using, dosing can be once or twice daily.
• If you miss a dose, take it with food as soon as you remember. If it is almost time for your next dose, skip the missed dose and take your next dose at its regular scheduled time. Do not take extra doses to make up for a missed dose.

The most common side effects of Synjardy include:

• Low blood sugar. You are at a higher risk if you take Synjardy with insulin or a sulfonylurea.
• Urinary tract infections.
• Upper respiratory tract infection.
• Vaginal yeast infection in females.
• Genital fungal infections in males.
• Joint pain.
• Frequent urination.
• Nausea.
• Vomiting.
• Diarrhea.
• Excessive gas.
• Belly discomfort.
• Indigestion.
• Lack of energy.
• Headache.

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

• Severe, life-threatening allergic reaction - hives, itching, rash, swelling, feeling lightheaded.
• Diabetic ketoacidosis (DKA) - high ketone levels in the blood.
• Lactic acidosis - buildup of lactic acid leading to muscle pain, trouble breathing, stomach pain, irregular heartbeats.
• Kidney problems and dehydration.
• Low blood sugar (hypoglycemia) - fast heartbeat, lightheadedness, lower dose of your other diabetes medicine to reduce your risk of hypoglycemia.
• Necrotizing fasciitis (Fournier’s Gangrene).
• Low vitamin B12 levels.
• Serious genital infection.
• Increased risk of amputations.

These are not all of the possible side effects of Synjardy. 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, 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 whether any of the following apply:

• Kidney problems.
• Liver problems.
• Heart problems (congestive heart failure, heart attack, heart disease).
• Drink alcohol often or in large amounts.
• Genital infection (penis or vagina).
• Stroke.
• Anemia.
• Diabetic ketoacidosis.
• A diet low in salt.
• Having surgery.
• High cholesterol.
• History of pancreas problems.
• Low blood pressure.
• Polycystic ovary syndrome.
• Problems urinating.
• Type 1 diabetes.

Boxed Warning

• Increaseed risk of lactic acidosis. If not treated properly, it can lead to other serious health problems, including organ failure, which can be life-threatening.

• Renal Impairment, ESRD, or on dialysis.
• Metabolic acidosis, including diabetic ketoacidosis.
• History of previous serious allergic reaction/hypersensitivity reaction to empagliflozin or metformin.

Synjardy starts working in your body shortly after you take it. However, it may take several days or even 1 to 2 weeks before Synjardy has its full effect on lowering your blood sugar level.

When Synjardy 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:

• Cationic drugs eliminated by renal tubular secretion.
• Lithium.
• Diuretics (water pills) that are used to reduce edema (fluid retention) and blood pressure.
• Carbonic anhydrase inhibitor.
• Other antidiabetic medications.

Synjardy and Synjardy XR are available in the following dosage forms and strengths:

• 5 mg empagliflozin/500 mg metformin hydrochloride immediate release tablets.
• 5 mg empagliflozin/1000 mg metformin hydrochloride immediate release tablets.
• 12.5 mg empagliflozin/500 mg metformin hydrochloride immediate release tablets.
• 12.5 mg empagliflozin/1000 mg metformin hydrochloride immediate release tablets.
• 5 mg empagliflozin/1000 mg metformin extended-release oral tablets.
• 10 mg empagliflozin/1000 mg metformin extended-release oral tablets.
• 12.5 mg empagliflozin/1000 mg metformin extended-release oral tablets.
• 25 mg empagliflozin/1000 mg metformin extended-release oral tablets.

Store this medication at room temperature and keep it out of reach of children.

Boehringer Ingelheim Pharmaceuticals is the company that manufactures Synjardy.

There are no lower-cost generics available for the brand-name Synjardy.

Do not stop or adjust your use of this medication without first consulting with your doctor.

Synjardy may cause harm to your unborn baby. 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.

It is unknown if Synjardy passes into breast milk, but it is generally not recommended for use if you are breastfeeding.. 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.