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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Empagliflozin And Metformin Hydrochloride
Brand Name
Synjardy
Generic Name
Empagliflozin And Metformin Hydrochloride
Active Ingredient
EmpagliflozinCategory
Sodium-Glucose Cotransporter 2 Inhibitor [EPC]
Variants
4
References used for this content
This page is for informational purposes only and does not replace medical advice. Before using any prescription or over-the-counter medication for Synjardy, you must consult a qualified healthcare professional.
| 5 mg/1 | TABLET | ORAL | 0597-0159 |
Detailed information about Synjardy
Empagliflozin is a potent Sodium-Glucose Cotransporter 2 (SGLT2) inhibitor used to improve glycemic control in type 2 diabetes and reduce the risk of cardiovascular death in patients with heart failure or chronic kidney disease.
The dosage of Empagliflozin is highly individualized based on the condition being treated and the patient's renal (kidney) function. According to the FDA-approved prescribing information, the standard recommendations are as follows:
Empagliflozin is FDA-approved for use in pediatric patients aged 10 years and older with type 2 diabetes mellitus.
Renal function must be assessed via eGFR (estimated glomerular filtration rate) before starting Empagliflozin and periodically thereafter.
No dosage adjustment is necessary for patients with mild, moderate, or severe hepatic (liver) impairment. However, exposure to the drug increases slightly in severe liver disease, so healthcare providers may monitor these patients more closely.
No specific dosage adjustment is recommended based on age alone. However, elderly patients (65 and older) are more likely to have decreased renal function and are at a higher risk for volume depletion (dehydration) and low blood pressure. Providers often start with the 10 mg dose and monitor closely.
If you miss a dose of Empagliflozin, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and return to your regular schedule. Do not take two doses at the same time to make up for a missed one, as this increases the risk of side effects like dehydration or low blood sugar.
In the event of an overdose, contact your local Poison Control Center or seek emergency medical attention immediately. Symptoms of overdose may include severe hypoglycemia (if taken with other diabetes drugs), extreme dehydration, and electrolyte imbalances. Treatment is generally supportive, focusing on maintaining hydration and monitoring blood glucose levels.
> Important: Follow your healthcare provider's dosing instructions exactly. Do not adjust your dose or stop taking the medication without medical guidance, as this can lead to a rapid increase in blood sugar or worsening of heart failure symptoms.
Because Empagliflozin works by increasing glucose excretion in the urine, the most common side effects involve the urinary tract and genital area.
Empagliflozin is a powerful medication that requires careful monitoring. Patients must stay hydrated while taking this drug, as it increases the amount of water leaving the body through urine. It is also vital to maintain proper genital hygiene to reduce the risk of yeast infections. If you are scheduled for surgery, your doctor will likely tell you to stop taking Empagliflozin at least 3 days before the procedure to reduce the risk of ketoacidosis.
As of 2026, there are no FDA black box warnings for Empagliflozin. It has a well-established safety profile when used as directed under medical supervision.
There are no absolute 'never-use' drug-drug contraindications listed in the standard FDA label for Empagliflozin. However, it should not be used in patients with a known severe hypersensitivity (allergy) to the drug or its components.
Empagliflozin must NEVER be used in the following situations:
These conditions require a careful risk-benefit analysis by a healthcare provider:
Based on animal data, Empagliflozin may cause harm to the developing fetus, particularly during the second and third trimesters when the kidneys are developing. Animal studies showed evidence of renal pelvis dilatation and tubule dilatation in the offspring of rats given Empagliflozin.
It is not known if Empagliflozin is excreted in human milk, but animal studies show it is present in rat milk. Because of the potential for serious adverse reactions in a nursing infant—specifically the risk to developing kidneys—breastfeeding is not recommended while taking Empagliflozin.
Empagliflozin is a reversible, highly potent, and selective competitive inhibitor of the sodium-glucose cotransporter 2 (SGLT2). SGLT2 is the predominant transporter responsible for the reabsorption of glucose from the glomerular filtrate back into the circulation. By inhibiting SGLT2, Empagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, thereby increasing urinary glucose excretion. Additionally, it inhibits sodium reabsorption, leading to natriuresis, which contributes to its beneficial effects on blood pressure and heart failure.
In patients with type 2 diabetes, urinary glucose excretion increases immediately after the first dose and is maintained over the 24-hour dosing interval. At a dose of 25 mg, the increase in urinary glucose excretion is approximately 64 grams per day. The effect is dose-dependent but reaches a plateau at higher doses. Importantly, Empagliflozin does not impair the body's natural response to hypoglycemia (low blood sugar).
| Parameter | Value |
|---|---|
Common questions about Synjardy
Empagliflozin is primarily used to manage type 2 diabetes by helping the kidneys remove excess sugar through the urine. Beyond blood sugar control, it is FDA-approved to reduce the risk of cardiovascular death in adults with type 2 diabetes and heart disease. It is also a cornerstone treatment for adults with heart failure, where it helps reduce the risk of hospitalization and death regardless of the heart's pumping strength. Additionally, it is used to slow the progression of chronic kidney disease and reduce the risk of end-stage renal failure. Your doctor will determine which of these indications applies to your specific health profile.
The most common side effects of Empagliflozin are related to the increased sugar in the urine, which can lead to genital yeast infections and urinary tract infections (UTIs). Women may notice vaginal itching or discharge, while men may experience redness or irritation of the penis. Other frequent side effects include an increase in the frequency or volume of urination, which can lead to mild dehydration and thirst. Some patients also report a slight increase in cholesterol levels or upper respiratory tract infections. Most of these effects are manageable, but it is important to maintain good hygiene and stay hydrated.
Drinking alcohol while taking Empagliflozin should be done with extreme caution and only after discussing it with your healthcare provider. Alcohol can increase the risk of a rare but serious condition called ketoacidosis, even if your blood sugar levels are not very high. It also increases the risk of hypoglycemia (low blood sugar) and can contribute to dehydration, which may worsen the side effects of the medication. If you choose to drink, it is generally recommended to do so in moderation and never on an empty stomach. Always monitor your symptoms closely for nausea, vomiting, or excessive dizziness.
Empagliflozin is generally not recommended during pregnancy, especially during the second and third trimesters. Based on animal studies, the medication may interfere with the development of the fetal kidneys during these stages. If you are planning to become pregnant or find out that you are pregnant while taking Empagliflozin, you should contact your doctor immediately to discuss safer alternatives for managing your blood sugar or heart condition. Breastfeeding is also not recommended while taking this drug, as it may pass into breast milk and affect the nursing infant's kidney development. Your doctor will weigh the risks and benefits for your specific situation.
Empagliflozin begins to work shortly after the first dose, with urinary glucose excretion increasing within hours of administration. For patients with type 2 diabetes, a noticeable reduction in daily blood sugar levels and fasting glucose can often be seen within 1 to 2 weeks. However, the full effect on HbA1c (long-term blood sugar) is typically measured after 3 months of consistent use. For heart failure and kidney disease, the protective benefits develop over weeks and months, and the medication is intended for long-term use to prevent serious complications. Consistency is key to achieving the best clinical outcomes.
You should not stop taking Empagliflozin suddenly without first consulting your healthcare provider. If you are taking it for diabetes, stopping the medication can cause your blood sugar levels to rise quickly, potentially leading to hyperglycemia. If you are taking it for heart failure or kidney disease, discontinuation can lead to increased fluid retention, worsening shortness of breath, and a higher risk of hospitalization. If you need to stop the medication for a scheduled surgery or due to side effects, your doctor will provide a specific plan to manage your condition during that time. Always follow professional medical guidance for any changes to your treatment.
If you miss a dose of Empagliflozin, take it as soon as you remember that same day. However, if you do not remember until the next day, you should skip the missed dose and simply take your next regularly scheduled dose at the usual time. Do not take two doses at once to make up for the one you missed, as this can increase your risk of dehydration, low blood pressure, or low blood sugar. To help you remember your medication, try taking it at the same time every morning, perhaps with breakfast. If you frequently miss doses, talk to your pharmacist about using a pill organizer or reminder app.
No, Empagliflozin does not cause weight gain; in fact, most patients experience a modest weight loss while taking the medication. Because the drug causes the body to excrete glucose (sugar) in the urine, you are effectively losing calories that would otherwise be stored as fat. On average, patients may lose between 2 to 3 percent of their body weight over the first six months of treatment. This weight loss is generally considered a beneficial side effect for patients with type 2 diabetes or heart failure. However, this loss is often a combination of fat loss and fluid loss, so it is important to stay hydrated.
Empagliflozin is frequently prescribed alongside other medications like metformin, insulin, or blood pressure drugs. However, some combinations require careful monitoring. For example, taking Empagliflozin with insulin or sulfonylureas increases the risk of low blood sugar, while taking it with diuretics (water pills) can increase the risk of dehydration. It may also interact with lithium, requiring more frequent blood tests. You must provide your doctor with a complete list of all prescription drugs, over-the-counter medicines, and herbal supplements you are taking to ensure there are no dangerous interactions. Your doctor will adjust your regimen to ensure all your medications work safely together.
As of 2024 and 2025, generic versions of Empagliflozin have been approved by the FDA, but their widespread availability may depend on patent litigation and manufacturer agreements. The brand name version, Jardiance, remains widely prescribed. Generic medications contain the same active ingredient and meet the same strict standards for safety and effectiveness as the brand-name drug. When a generic becomes available, it is typically offered at a lower cost, which can improve access for many patients. You should check with your pharmacist or insurance provider to see if a generic version is covered under your specific plan.
Other drugs with the same active ingredient (Empagliflozin)
> Warning: Stop taking Empagliflozin and call your doctor immediately if you experience any of these serious conditions.
No FDA black box warnings currently exist for Empagliflozin. While some other drugs in the SGLT2 class previously carried a black box warning for lower limb amputation, this was removed after further review, and Empagliflozin was never required to carry it.
Report any unusual symptoms or persistent side effects to your healthcare provider immediately. Early intervention, especially for infections or dehydration, is key to safely continuing therapy.
Your healthcare provider will order regular laboratory tests to ensure the medication is working safely:
Empagliflozin itself does not usually cause drowsiness or impair your ability to drive. However, if you experience low blood pressure (dizziness) or low blood sugar (if taking other diabetes meds), your ability to react may be impaired. Ensure you know how the drug affects you before driving.
Alcohol should be consumed with extreme caution. Alcohol can increase the risk of ketoacidosis and hypoglycemia. It also contributes to dehydration, which can compound the effects of Empagliflozin. Discuss your alcohol consumption habits with your doctor.
Do not stop taking Empagliflozin abruptly without consulting your doctor. For patients with heart failure, stopping the medication can lead to a rapid return of fluid retention and worsening shortness of breath. For those with diabetes, it can lead to a spike in blood sugar levels. There is no 'withdrawal syndrome,' but the underlying conditions the drug treats may worsen quickly.
> Important: Discuss all your medical conditions, including any history of pancreas problems, kidney disease, or frequent infections, with your healthcare provider before starting Empagliflozin.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking. The combination of multiple drugs that affect the kidneys or fluid balance requires professional oversight.
There is no documented cross-sensitivity between Empagliflozin and other classes of diabetes medications (like metformin or DPP-4 inhibitors). However, patients who have had a severe reaction to other SGLT2 inhibitors (like Canagliflozin or Dapagliflozin) should exercise extreme caution, as the chemical structures are similar.
> Important: Your healthcare provider will evaluate your complete medical history, including your kidney function and history of infections, before prescribing Empagliflozin.
Empagliflozin is approved for children 10 years and older for type 2 diabetes. It has not been studied for heart failure or CKD in children. Pediatric patients may be at higher risk for dehydration and should be encouraged to maintain adequate fluid intake, especially during illness or hot weather.
Patients aged 65 and older are at an increased risk for volume depletion and renal impairment. In clinical trials, a higher incidence of adverse reactions related to volume depletion was observed in patients 75 and older. Doctors often monitor elderly patients more frequently for blood pressure changes and kidney function.
The efficacy of Empagliflozin for glucose lowering decreases as kidney function declines. However, its benefits for heart failure and slowing the progression of kidney disease remain significant even in moderate renal impairment.
Empagliflozin exposure increases by approximately 23% to 48% in patients with severe hepatic impairment (Child-Pugh Class C). While no dose adjustment is required, these patients should be monitored for signs of toxicity or excessive dehydration.
> Important: Special populations require individualized medical assessment. Always inform your doctor if you are pregnant, planning to become pregnant, or breastfeeding.
| Bioavailability | ~75% |
| Protein Binding | ~86% |
| Half-life | ~12.4 hours |
| Tmax | ~1.5 hours |
| Metabolism | UGT2B7, UGT1A3, UGT1A8, UGT1A9 (Glucuronidation) |
| Excretion | Renal 54.4%, Fecal 41.2% |
Empagliflozin is classified as a Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitor. Other medications in this class include Canagliflozin (Invokana), Dapagliflozin (Farxiga), and Ertugliflozin (Steglatro). It is considered a 'cardiorenal protective' agent due to its benefits beyond glucose control.