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Generic Name

Empagliflozin

Brand Names
Glyxambi, Jardiance
FDA approval date: August 01, 2014
Classification: Sodium-Glucose Cotransporter 2 Inhibitor
Form: Tablet

What is Glyxambi (Empagliflozin)?

For people living with type 2 diabetes, managing blood sugar isn’t just about numbers, it’s about protecting long-term health and maintaining quality of life. Empagliflozin is one of the newer medications that has made a real difference for many patients. Belonging to a class of drugs called SGLT2 inhibitors (sodium-glucose co-transporter 2 inhibitors), it helps the body remove excess sugar through the urine. In addition to improving blood sugar control, empagliflozin has shown benefits for heart and kidney health, making it a significant advancement in diabetes care.

Empagliflozin is marketed under the brand name Jardiance, among others. It’s an oral medication typically used along with diet and exercise, and sometimes with other diabetes drugs, to help adults manage their condition safely and effectively.

What does Empagliflozin do?

Empagliflozin is prescribed primarily for adults with type 2 diabetes mellitus to help lower blood sugar levels when lifestyle measures alone aren’t enough. It can be used alone or in combination with other antidiabetic medications, such as metformin or insulin.

Beyond glucose control, empagliflozin plays a vital role in reducing the risk of cardiovascular death in adults with both type 2 diabetes and established heart disease. It’s also approved to reduce the risk of hospitalization and death from heart failure, even in people without diabetes.

Clinical studies have demonstrated that patients taking empagliflozin often experience better glycemic control, modest weight loss and lower blood pressure compared to those using placebo or some other diabetes medications (Zinman et al., 2015). These outcomes can translate to meaningful improvements in energy levels and overall well-being.

How does Empagliflozin work?

Empagliflozin works by targeting a natural system in the kidneys that regulates how the body handles glucose. Normally, the kidneys filter glucose from the blood and then reabsorb it back into the bloodstream through a protein called the SGLT2 transporter.

Empagliflozin blocks this transporter, preventing the kidneys from reabsorbing glucose. As a result, excess sugar is excreted through urine, helping lower blood sugar levels naturally.

Clinically, this mechanism is important because it reduces blood sugar independently of insulin, meaning the risk of low blood sugar (hypoglycemia) is relatively low when the drug is used alone. By reducing glucose reabsorption, the medication also encourages a small amount of caloric loss, which can aid in modest weight reduction, a benefit for many patients managing diabetes.

Additionally, research shows empagliflozin helps reduce strain on the heart and kidneys, possibly by lowering blood pressure, reducing body fluid overload, and improving vascular function.

Empagliflozin side effects

Most patients tolerate Empagliflozin well, but like all medications, it can cause side effects. Understanding these helps patients recognize when to contact their doctor.

Common side effects include:

  • Increased urination
  • Genital yeast infections (especially in women)
  • Mild urinary tract infections
  • Thirst or dehydration
  • Mild drops in blood pressure

Less common but serious side effects may include:

  • Ketoacidosis, a buildup of acids in the blood (even when blood sugar is not extremely high)
  • Severe urinary tract infections
  • Kidney problems in people with preexisting kidney disease
  • Fournier’s gangrene, a rare but serious genital infection

People with severe kidney disease, frequent urinary infections or dehydration should avoid or use the drug cautiously under close medical supervision.

Seek immediate medical attention if you experience symptoms like confusion, nausea, vomiting, abdominal pain, or unusual fatigue, as these may indicate serious complications such as ketoacidosis.

Despite these potential side effects, most patients tolerate Empagliflozin without major issues when prescribed and monitored properly (FDA, 2024).

Empagliflozin dosage

Empagliflozin comes in tablet form, taken once daily by mouth, usually in the morning with or without food. The exact dose is determined by your healthcare provider based on your blood sugar levels, kidney function, and overall treatment plan.

Because the drug acts through the kidneys, doctors typically perform regular kidney function tests (e.g., eGFR) before and during treatment. They may also monitor blood pressure and blood sugar to ensure the medication remains safe and effective.

For people with reduced kidney function, dosage adjustments or alternative therapies may be necessary. Older adults, who may be more sensitive to dehydration, should drink adequate fluids and be cautious during illness or hot weather.

Does Empagliflozin have a generic version?

As of now, no FDA-approved generic version of empagliflozin is available in the United States. The medication is primarily sold under the brand name Jardiance, developed by Boehringer Ingelheim and Eli Lilly.

However, other SGLT2 inhibitors such as dapagliflozin (Farxiga) and canagliflozin (Invokana) are available, offering similar benefits for some patients. When generic versions of Empagliflozin eventually become available, they are expected to be equally safe and effective as the brand-name drug, as the FDA ensures identical active ingredients and bioavailability.

Conclusion

Empagliflozin represents a major step forward in the management of type 2 diabetes and related heart conditions. By helping the body eliminate excess sugar naturally, it improves blood sugar control while offering added protection for the heart and kidneys, a combination not found in many older diabetes medications.

While side effects such as urinary infections or dehydration can occur, they are generally manageable with proper monitoring and communication with your healthcare provider.

Ultimately, Empagliflozin is a safe and effective option for many adults when prescribed appropriately. If you’ve been recommended this medication, maintaining open dialogue with your doctor, staying hydrated and attending regular checkups will help you get the most benefit from treatment and stay in control of your health.

References

  1. U.S. Food and Drug Administration (FDA). (2024). Empagliflozin: Prescribing Information. https://www.fda.gov/
  2. Mayo Clinic. (2024). Empagliflozin (Oral Route): Uses, Side Effects, and Precautions. https://www.mayoclinic.org/
  3. Zinman, B. et al. (2015). Empagliflozin, Cardiovascular Outcomes, and Mortality in Type 2 Diabetes. New England Journal of Medicine, 373(22), 2117–2128. https://www.nejm.org/
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Brand Information

    Glyxambi (empagliflozin and linagliptin)
    1INDICATIONS AND USAGE
    GLYXAMBI is a combination of empagliflozin and linagliptin indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus
    Empagliflozin is indicated to reduce the risk of cardiovascular (CV) death in adults with type 2 diabetes mellitus and established CV disease
    2DOSAGE FORMS AND STRENGTHS
    GLYXAMBI tablets available as:
    • 10 mg empagliflozin/5 mg linagliptin are pale yellow, arc triangular, flat-faced, bevel-edged, film-coated tablets. One side is debossed with the Boehringer Ingelheim company symbol; the other side is debossed with "10/5".
    • 25 mg empagliflozin/5 mg linagliptin are pale pink, arc triangular, flat-faced, bevel-edged, film-coated tablets. One side is debossed with the Boehringer Ingelheim company symbol; the other side is debossed with "25/5".
    3CONTRAINDICATIONS
    GLYXAMBI is contraindicated in patients:
    • with a hypersensitivity to empagliflozin, linagliptin, or any of the excipients in GLYXAMBI, reactions such as anaphylaxis, angioedema, exfoliative skin conditions, urticaria, or bronchial hyperreactivity have occurred
    4ADVERSE REACTIONS
    The following important adverse reactions are described below and elsewhere in the labeling:
    • Diabetic Ketoacidosis in Patients with Type 1 Diabetes Mellitus and Other Ketoacidosis
    • Pancreatitis
    • Volume Depletion
    • Genitourinary Infections, including Urosepsis, Pyelonephritis, Necrotizing Fasciitis of the Perineum (Fournier's Gangrene), and Genital Mycotic Infections
    • Hypoglycemia with Concomitant Use with Insulin and Insulin Secretagogues
    • Lower Limb Amputation
    • Hypersensitivity Reactions
    • Severe and Disabling Arthralgia
    • Bullous Pemphigoid
    • Heart Failure
    4.1Clinical Trials Experience
    Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
    4.2Postmarketing Experience
    Additional adverse reactions have been identified during postapproval use of linagliptin and empagliflozin. Because these reactions are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
    Gastrointestinal Disorders: Acute pancreatitis, including fatal pancreatitis [see , constipation, mouth ulceration, stomatitis
    Immune System Disorders: Hypersensitivity reactions including anaphylaxis, angioedema, and exfoliative skin conditions
    Infections: Necrotizing fasciitis of the perineum (Fournier's gangrene), urosepsis and pyelonephritis
    Metabolism and Nutrition Disorders: Ketoacidosis
    Musculoskeletal and Connective Tissue Disorders: Rhabdomyolysis, severe and disabling arthralgia
    Renal and Urinary Disorders: Acute kidney injury
    Skin and Subcutaneous Tissue Disorders: Bullous pemphigoid, skin reactions (e.g., rash, urticaria)
    5DRUG INTERACTIONS
    Table 3 describes clinically relevant interactions with GLYXAMBI.
    6OVERDOSAGE
    In the event of an overdose with GLYXAMBI, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations. Removal of empagliflozin by hemodialysis has not been studied, and removal of linagliptin by hemodialysis or peritoneal dialysis is unlikely.
    7DESCRIPTION
    GLYXAMBI tablets for oral use contain: empagliflozin and linagliptin.
    8HOW SUPPLIED/STORAGE AND HANDLING
    GLYXAMBI tablets are available as follows:
    10 mg/5 mg tablets: pale yellow, arc triangular, flat-faced, bevel-edged, film-coated tablets. One side is debossed with the Boehringer Ingelheim company symbol; the other side is debossed with "10/5".
    Bottles of 30 (NDC 0597-0182-30)
    25 mg/5 mg tablets: pale pink, arc triangular, flat-faced, bevel-edged, film-coated tablets. One side is debossed with the Boehringer Ingelheim company symbol; the other side is debossed with "25/5".
    Bottles of 30 (NDC 0597-0164-30)
    If repackaging is required, dispense in a tight container as defined in USP.
    9PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Medication Guide).
    10PRINCIPAL DISPLAY PANEL - 10 mg/5 mg Tablet Bottle Label
    NDC 0597-0182-90
    Glyxambi
    (empagliflozin and
    10 mg/5 mg
    DISPENSE WITH ACCOMPANYING MEDICATION GUIDE
    90 tablets
    Boehringer
    PRINCIPAL DISPLAY PANEL - 10 mg/5 mg Tablet Bottle Label
    11PRINCIPAL DISPLAY PANEL - 25 mg/5 mg Tablet Bottle Label
    NDC 0597-0164-90
    Glyxambi
    (empagliflozin and
    25 mg/5 mg
    DISPENSE WITH ACCOMPANYING MEDICATION GUIDE
    90 tablets
    Boehringer
    PRINCIPAL DISPLAY PANEL - 25 mg/5 mg Tablet Bottle Label
    Glyxambi has been selected.