Jardiance 10mg Tablets
It is used to help control blood sugar in people with type 2 diabetes.It is used to lower the chance of death from heart disease in certain people.It is used to lower the chance of having to go to the hospital for heart failure in certain people.It is used in people with certain kidney problems to lower the risk of worsening kidney problems, hospital stays, and death.
Drug Class
Antidiabetic, Cardiovascular agent, Renal protectant
Pharmacologic Class
Sodium-glucose co-transporter 2 (SGLT2) inhibitor
Pregnancy Category
Not available
FDA Approved
Aug 2014
DEA Schedule
Not Controlled
Overview
What is this medicine?
Jardiance (empagliflozin) is a medication that helps your kidneys remove more sugar from your body through your urine. This helps lower blood sugar levels in people with type 2 diabetes. It also has important benefits for people with heart failure and chronic kidney disease, regardless of whether they have diabetes, by helping to protect the heart and kidneys.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. You can take this medication with or without food, and it's recommended to take it in the morning. Drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.
Continue taking this medication as directed by your doctor or healthcare provider, even if you're feeling well. If you're unable to eat or drink normally due to illness, fasting, or upcoming procedures or surgery, discuss this with your doctor.
It's essential to stay hydrated while taking this medication. If you're unable to drink liquids by mouth or experience persistent upset stomach, vomiting, or diarrhea, contact your doctor for guidance. Dehydration can lead to low blood pressure or worsen kidney problems.
Monitoring Your Health
Your doctor will schedule regular blood tests to monitor your health. Be sure to keep these appointments and discuss any concerns with your doctor. Inform all your healthcare providers and lab personnel that you're taking this medication, as it may affect certain lab tests.
Diet and Exercise
Follow the diet and exercise plan recommended by your doctor. If you're on a low-salt or salt-free diet, consult with your doctor to ensure you're making the best choices.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom. Keep all medications in a safe location, out of reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you're unsure about the best way to dispose of your medication, consult with your pharmacist. You may also want to explore drug take-back programs in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember. If it's close to the time for your next dose, skip the missed dose and return to your regular schedule. Do not take two doses at the same time or extra doses. If you're unsure about what to do if you miss a dose, contact your doctor for guidance.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions closely. You can take this medication with or without food, and it's recommended to take it in the morning. Drink plenty of non-caffeinated liquids, unless your doctor advises you to limit your fluid intake.
Continue taking this medication as directed by your doctor or healthcare provider, even if you're feeling well. If you're unable to eat or drink normally due to illness, fasting, or upcoming procedures or surgery, discuss this with your doctor.
It's essential to stay hydrated while taking this medication. If you're unable to drink liquids by mouth or experience persistent upset stomach, vomiting, or diarrhea, contact your doctor for guidance. Dehydration can lead to low blood pressure or worsen kidney problems.
Monitoring Your Health
Your doctor will schedule regular blood tests to monitor your health. Be sure to keep these appointments and discuss any concerns with your doctor. Inform all your healthcare providers and lab personnel that you're taking this medication, as it may affect certain lab tests.
Diet and Exercise
Follow the diet and exercise plan recommended by your doctor. If you're on a low-salt or salt-free diet, consult with your doctor to ensure you're making the best choices.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom. Keep all medications in a safe location, out of reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you're unsure about the best way to dispose of your medication, consult with your pharmacist. You may also want to explore drug take-back programs in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember. If it's close to the time for your next dose, skip the missed dose and return to your regular schedule. Do not take two doses at the same time or extra doses. If you're unsure about what to do if you miss a dose, contact your doctor for guidance.
Lifestyle & Tips
- Maintain a healthy diet as recommended by your doctor or dietitian.
- Engage in regular physical activity.
- Stay well-hydrated by drinking plenty of fluids, especially when exercising or in hot weather, to prevent dehydration.
- Monitor your blood sugar levels regularly as advised by your healthcare provider.
- Practice good genital hygiene to reduce the risk of infections.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
10 mg orally once daily in the morning
Dose Range:
10 - 25 mg
Condition-Specific Dosing:
Type 2 Diabetes Mellitus:
Initial dose: 10 mg orally once daily. May increase to 25 mg orally once daily if additional glycemic control is needed and 10 mg is well tolerated. For patients with eGFR < 30 mL/min/1.73 m², initiation is not recommended.
Heart Failure (HFrEF and HFpEF):
10 mg orally once daily.
Chronic Kidney Disease:
10 mg orally once daily.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
For Type 2 Diabetes Mellitus in patients 10 years and older: 10 mg orally once daily. May increase to 25 mg orally once daily if additional glycemic control is needed and 10 mg is well tolerated. For patients with eGFR < 30 mL/min/1.73 m², initiation is not recommended.
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment needed (eGFR ≥ 60 mL/min/1.73 m²).
Moderate:
No dosage adjustment needed (eGFR 30 to < 60 mL/min/1.73 m²). For T2DM, initiation is not recommended if eGFR < 30 mL/min/1.73 m². For HF/CKD, initiation is not recommended if eGFR < 20 mL/min/1.73 m².
Severe:
Not recommended for initiation in T2DM if eGFR < 30 mL/min/1.73 m². For HF/CKD, not recommended for initiation if eGFR < 20 mL/min/1.73 m². If eGFR falls below 20 mL/min/1.73 m² during treatment, discontinue.
Dialysis:
Contraindicated.
Hepatic Impairment:
Mild:
No dosage adjustment needed.
Moderate:
No dosage adjustment needed.
Severe:
No dosage adjustment needed.
Pharmacology
Mechanism of Action
Empagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor. SGLT2 is the predominant transporter responsible for 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 (RTG), thereby increasing urinary glucose excretion (UGE) and lowering blood glucose concentrations. This mechanism is independent of insulin secretion and insulin sensitivity. Additionally, SGLT2 inhibition leads to osmotic diuresis, natriuresis, and reduction in intraglomerular pressure, contributing to its cardiovascular and renal benefits.
Pharmacokinetics
Absorption:
Bioavailability:
Approximately 78%
Tmax:
1.5 hours
FoodEffect:
Food does not affect the area under the curve (AUC) of empagliflozin, but Tmax is delayed. Can be taken with or without food.
Distribution:
Vd:
73.8 L
ProteinBinding:
Approximately 86.2%
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 12.4 hours
Clearance:
Not available
ExcretionRoute:
Urine (54.4%) and feces (41.2%)
Unchanged:
Approximately 50% (urine), 6% (feces)
Pharmacodynamics
OnsetOfAction:
Within 30 minutes (glucose lowering)
PeakEffect:
1.5 hours (plasma concentration), 24 hours (maximal glucose excretion)
DurationOfAction:
24 hours
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of fluid and electrolyte problems: mood changes, confusion, muscle pain or weakness, fast or abnormal heartbeat, severe dizziness or fainting, increased thirst, seizures, feeling extremely tired or weak, decreased appetite, inability to pass urine or changes in urine output, dry mouth, dry eyes, or severe nausea and vomiting.
Signs of kidney problems: inability to pass urine, changes in urine output, blood in the urine, or sudden weight gain.
Signs of acidosis (too much acid in the blood): confusion, rapid breathing, rapid heartbeat, irregular heartbeat, severe stomach pain, nausea and vomiting, feeling extremely sleepy, shortness of breath, or extreme fatigue.
Signs of a urinary tract infection (UTI): blood in the urine, burning or pain while urinating, frequent or urgent need to urinate, fever, lower abdominal pain, or pelvic pain.
Vaginal yeast infection: report itching, unpleasant odor, or discharge.
Yeast infection of the penis: report pain, swelling, rash, or discharge.
Low blood sugar: may occur, especially when used with other diabetes medications. Signs include dizziness, headache, feeling sleepy or weak, shaking, rapid heartbeat, confusion, hunger, or sweating. If you experience any of these symptoms, contact your doctor immediately and follow their instructions for managing low blood sugar, which may include taking glucose tablets, liquid glucose, or certain fruit juices.
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you notice any side effects that bother you or do not go away, contact your doctor or seek medical attention. This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor.
To report side effects, you can contact the FDA at 1-800-332-1088 or visit their website at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of fluid and electrolyte problems: mood changes, confusion, muscle pain or weakness, fast or abnormal heartbeat, severe dizziness or fainting, increased thirst, seizures, feeling extremely tired or weak, decreased appetite, inability to pass urine or changes in urine output, dry mouth, dry eyes, or severe nausea and vomiting.
Signs of kidney problems: inability to pass urine, changes in urine output, blood in the urine, or sudden weight gain.
Signs of acidosis (too much acid in the blood): confusion, rapid breathing, rapid heartbeat, irregular heartbeat, severe stomach pain, nausea and vomiting, feeling extremely sleepy, shortness of breath, or extreme fatigue.
Signs of a urinary tract infection (UTI): blood in the urine, burning or pain while urinating, frequent or urgent need to urinate, fever, lower abdominal pain, or pelvic pain.
Vaginal yeast infection: report itching, unpleasant odor, or discharge.
Yeast infection of the penis: report pain, swelling, rash, or discharge.
Low blood sugar: may occur, especially when used with other diabetes medications. Signs include dizziness, headache, feeling sleepy or weak, shaking, rapid heartbeat, confusion, hunger, or sweating. If you experience any of these symptoms, contact your doctor immediately and follow their instructions for managing low blood sugar, which may include taking glucose tablets, liquid glucose, or certain fruit juices.
Other Possible Side Effects
Like all medications, this drug can cause side effects. However, many people do not experience any side effects or only have mild ones. If you notice any side effects that bother you or do not go away, contact your doctor or seek medical attention. This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor.
To report side effects, you can contact the FDA at 1-800-332-1088 or visit their website at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Signs of dehydration: unusual thirst, dizziness, lightheadedness, feeling faint, dry mouth.
- Signs of urinary tract infection (UTI): burning sensation when urinating, frequent urination, urgent need to urinate, pain in the lower abdomen or back, fever.
- Signs of genital yeast infection: itching, redness, swelling, or rash in the genital area; unusual discharge.
- Signs of diabetic ketoacidosis (DKA): nausea, vomiting, stomach pain, unusual tiredness, trouble breathing, fruity-smelling breath.
- Signs of Fournier's gangrene (a rare but serious infection): tenderness, redness, or swelling in the genital or anal area, accompanied by fever or feeling unwell. Seek immediate medical attention if these occur.
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction you experienced.
If you have type 1 diabetes, as this medication is not intended to treat this condition.
If you have a condition that affects the acidity of your blood.
If you have kidney disease or are undergoing dialysis.
If you are dehydrated, as this may require special consideration.
If you are taking or have recently taken immunosuppressive medications to treat kidney disease.
If you are pregnant or think you might be pregnant. Note that this medication should not be taken during the second or third trimester of pregnancy.
If you are breast-feeding, as you should not breast-feed while taking this medication.
Additionally, it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This includes any health problems you have, as they may interact with this medication. Always check with your doctor before starting, stopping, or changing the dose of any medication to ensure your safety.
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction you experienced.
If you have type 1 diabetes, as this medication is not intended to treat this condition.
If you have a condition that affects the acidity of your blood.
If you have kidney disease or are undergoing dialysis.
If you are dehydrated, as this may require special consideration.
If you are taking or have recently taken immunosuppressive medications to treat kidney disease.
If you are pregnant or think you might be pregnant. Note that this medication should not be taken during the second or third trimester of pregnancy.
If you are breast-feeding, as you should not breast-feed while taking this medication.
Additionally, it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This includes any health problems you have, as they may interact with this medication. Always check with your doctor before starting, stopping, or changing the dose of any medication to ensure your safety.
Precautions & Cautions
Important Warnings and Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Your doctor may advise you to stop taking this drug before certain surgical procedures. If you need to stop taking this medication, your doctor will provide guidance on when to resume taking it after your surgery or procedure.
Driving and Blood Sugar Levels
Do not drive if you have experienced low blood sugar, as this can increase your risk of being involved in an accident.
Preventing Dizziness and Dehydration
To minimize the risk of feeling dizzy or fainting, stand up slowly after sitting or lying down. Be cautious when climbing stairs, and take extra precautions in hot weather or during physical activity. Drink plenty of fluids to avoid dehydration.
High Cholesterol
This medication may cause high cholesterol. If you have concerns, discuss them with your doctor.
Blood Sugar Control
During times of stress, such as illness, infection, injury, or surgery, it may be more challenging to control your blood sugar levels. Changes in physical activity, exercise, or diet can also affect your blood sugar. Monitor your blood sugar levels as directed by your doctor.
Glucose Testing
Consult with your doctor to determine the most suitable glucose tests for you to use.
Ketoacidosis
This medication can increase the risk of ketoacidosis, a condition characterized by excessive acid in the blood or urine. This condition can be life-threatening and may require hospitalization. Ketoacidosis can occur even if your blood sugar levels are below 250. People with diabetes, pancreas problems, or those who are sick, dehydrated, or have skipped meals are at a higher risk of developing ketoacidosis. Additionally, individuals on a ketogenic diet, undergoing surgery, or taking insulin and missing doses are also at increased risk. Check your ketone levels as directed by your doctor, and consult with your doctor if you have any questions.
Urinary Tract Infections and Kidney Problems
Severe urinary tract infections (UTIs) have been reported with this medication, and in some cases, hospitalization was necessary. Kidney problems have also occurred, which may require hospitalization or dialysis. Before consuming alcohol, discuss the risks with your doctor.
Fournier's Gangrene
A rare but potentially life-threatening infection, known as Fournier's gangrene, has been associated with this medication. Seek immediate medical attention if you experience tenderness, redness, or swelling in the genital area, accompanied by fever or a general feeling of illness.
Lower Limb Amputations
This medication may increase the risk of lower limb amputations, particularly toe and foot amputations. Consult with your doctor about proper foot care and inform them if you have a history of amputations, blood vessel disease, nerve disease, or foot ulcers caused by diabetes. If you experience new pain, tenderness, sores, ulcers, or infections in your legs or feet, contact your doctor promptly.
Special Considerations
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. In children, this medication may increase the risk of low blood sugar. If you are pregnant or become pregnant while taking this medication, contact your doctor immediately, as it may harm the unborn baby.
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Your doctor may advise you to stop taking this drug before certain surgical procedures. If you need to stop taking this medication, your doctor will provide guidance on when to resume taking it after your surgery or procedure.
Driving and Blood Sugar Levels
Do not drive if you have experienced low blood sugar, as this can increase your risk of being involved in an accident.
Preventing Dizziness and Dehydration
To minimize the risk of feeling dizzy or fainting, stand up slowly after sitting or lying down. Be cautious when climbing stairs, and take extra precautions in hot weather or during physical activity. Drink plenty of fluids to avoid dehydration.
High Cholesterol
This medication may cause high cholesterol. If you have concerns, discuss them with your doctor.
Blood Sugar Control
During times of stress, such as illness, infection, injury, or surgery, it may be more challenging to control your blood sugar levels. Changes in physical activity, exercise, or diet can also affect your blood sugar. Monitor your blood sugar levels as directed by your doctor.
Glucose Testing
Consult with your doctor to determine the most suitable glucose tests for you to use.
Ketoacidosis
This medication can increase the risk of ketoacidosis, a condition characterized by excessive acid in the blood or urine. This condition can be life-threatening and may require hospitalization. Ketoacidosis can occur even if your blood sugar levels are below 250. People with diabetes, pancreas problems, or those who are sick, dehydrated, or have skipped meals are at a higher risk of developing ketoacidosis. Additionally, individuals on a ketogenic diet, undergoing surgery, or taking insulin and missing doses are also at increased risk. Check your ketone levels as directed by your doctor, and consult with your doctor if you have any questions.
Urinary Tract Infections and Kidney Problems
Severe urinary tract infections (UTIs) have been reported with this medication, and in some cases, hospitalization was necessary. Kidney problems have also occurred, which may require hospitalization or dialysis. Before consuming alcohol, discuss the risks with your doctor.
Fournier's Gangrene
A rare but potentially life-threatening infection, known as Fournier's gangrene, has been associated with this medication. Seek immediate medical attention if you experience tenderness, redness, or swelling in the genital area, accompanied by fever or a general feeling of illness.
Lower Limb Amputations
This medication may increase the risk of lower limb amputations, particularly toe and foot amputations. Consult with your doctor about proper foot care and inform them if you have a history of amputations, blood vessel disease, nerve disease, or foot ulcers caused by diabetes. If you experience new pain, tenderness, sores, ulcers, or infections in your legs or feet, contact your doctor promptly.
Special Considerations
If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. In children, this medication may increase the risk of low blood sugar. If you are pregnant or become pregnant while taking this medication, contact your doctor immediately, as it may harm the unborn baby.
Overdose Information
Overdose Symptoms:
- Hypoglycemia (if taken with insulin or sulfonylureas)
- Volume depletion/dehydration
- Hypotension
What to Do:
There is no specific antidote for empagliflozin overdose. Treatment should be supportive and based on the patient's clinical presentation. In case of overdose, contact a poison control center (e.g., 1-800-222-1222) or seek emergency medical attention immediately.
Drug Interactions
Major Interactions
- Loop diuretics (increased risk of volume depletion and hypotension)
- Insulin and insulin secretagogues (e.g., sulfonylureas) (increased risk of hypoglycemia)
Moderate Interactions
- Thiazide diuretics (additive diuretic effect, increased risk of volume depletion)
- ACE inhibitors/ARBs (potential for increased risk of hypotension, especially in volume-depleted patients)
Monitoring
Baseline Monitoring
Renal function (eGFR)
Rationale: To assess baseline kidney function and determine appropriate dosing/initiation criteria.
Timing: Prior to initiation of therapy.
Volume status/Blood pressure
Rationale: To assess risk of hypotension, especially in patients on diuretics or with pre-existing volume depletion.
Timing: Prior to initiation of therapy.
HbA1c (for T2DM)
Rationale: To establish baseline glycemic control.
Timing: Prior to initiation of therapy.
Routine Monitoring
Renal function (eGFR)
Frequency: At least annually, or more frequently in patients with impaired renal function or those receiving concomitant medications that may affect renal function.
Target: Maintain eGFR within acceptable range for continued therapy (e.g., > 20 mL/min/1.73 m² for HF/CKD, > 30 mL/min/1.73 m² for T2DM).
Action Threshold: Discontinue if eGFR falls persistently below 20 mL/min/1.73 m² (for HF/CKD) or 30 mL/min/1.73 m² (for T2DM).
Blood glucose/HbA1c (for T2DM)
Frequency: Periodically (e.g., every 3-6 months for HbA1c, daily for blood glucose if on insulin/sulfonylurea).
Target: Individualized glycemic targets.
Action Threshold: Adjust concomitant antidiabetic medications if hypoglycemia occurs or if glycemic targets are not met.
Signs and symptoms of volume depletion/hypotension
Frequency: Regularly, especially during initiation and dose titration of diuretics.
Target: Not applicable
Action Threshold: If symptomatic hypotension occurs, consider temporary interruption or dose reduction of empagliflozin or concomitant diuretics.
Signs and symptoms of genitourinary infections (UTIs, genital mycotic infections)
Frequency: Regularly.
Target: Not applicable
Action Threshold: Promptly treat infections; consider discontinuation if recurrent or severe.
Signs and symptoms of diabetic ketoacidosis (DKA)
Frequency: Regularly, especially in patients with risk factors.
Target: Not applicable
Action Threshold: Educate patients on symptoms; discontinue empagliflozin immediately if DKA is suspected or confirmed.
Symptom Monitoring
- Increased thirst
- Frequent urination
- Dizziness or lightheadedness (signs of dehydration/hypotension)
- Weakness or fatigue
- Nausea, vomiting, abdominal pain (signs of DKA)
- Shortness of breath (signs of DKA)
- Fruity breath odor (signs of DKA)
- Genital itching, burning, discharge, or rash (signs of genital mycotic infection)
- Painful urination, frequent urination, urgency, fever, back pain (signs of UTI)
- Tenderness, redness, or swelling in the genital or perineal area, accompanied by fever or malaise (signs of Fournier's gangrene)
Special Patient Groups
Pregnancy
Not recommended during the second and third trimesters of pregnancy due to potential adverse effects on renal development in the fetus. Limited data on first trimester use.
Trimester-Specific Risks:
First Trimester:
Limited human data; animal studies do not indicate direct teratogenicity at clinically relevant exposures.
Second Trimester:
Not recommended; animal studies show adverse renal developmental effects (renal pelvic and tubule dilatations) at exposures 13-fold the clinical AUC at 25 mg/day.
Third Trimester:
Not recommended; animal studies show adverse renal developmental effects (renal pelvic and tubule dilatations) at exposures 13-fold the clinical AUC at 25 mg/day.
Lactation
Not recommended during lactation. It is unknown if empagliflozin is excreted in human milk. Due to the potential for serious adverse reactions in a breastfed infant (e.g., renal developmental effects), a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
Potential for serious adverse reactions (e.g., renal developmental effects, hypoglycemia).
Pediatric Use
Approved for Type 2 Diabetes Mellitus in patients 10 years and older. Safety and effectiveness for other indications (heart failure, chronic kidney disease) have not been established in pediatric patients. Not recommended for use in patients younger than 10 years with T2DM.
Geriatric Use
No dosage adjustment is recommended based on age. However, elderly patients (≥65 years) may be at increased risk for volume depletion and hypotension, especially those on diuretics or with impaired renal function. Monitor volume status and renal function more frequently in this population.
Clinical Information
Clinical Pearls
- Empagliflozin offers significant cardiovascular and renal benefits beyond glycemic control, making it a preferred agent for patients with T2DM and established ASCVD, heart failure, or CKD.
- Educate patients on the signs and symptoms of diabetic ketoacidosis (DKA), even in the absence of severe hyperglycemia (euglycemic DKA), and instruct them to seek immediate medical attention if suspected.
- Advise patients to maintain adequate hydration to mitigate the risk of volume depletion and hypotension, especially during illness or in hot weather.
- Consider temporary discontinuation of empagliflozin in patients undergoing surgery, prolonged fasting, or acute severe illness to reduce the risk of DKA.
- Monitor renal function before initiation and periodically thereafter, as SGLT2 inhibitors can cause an initial transient decrease in eGFR, which typically stabilizes or improves over time.
- Counsel patients on proper genital hygiene to reduce the risk of genital mycotic infections, a common side effect.
Alternative Therapies
- Other SGLT2 inhibitors (e.g., dapagliflozin, canagliflozin, ertugliflozin)
- GLP-1 receptor agonists (e.g., semaglutide, liraglutide)
- DPP-4 inhibitors (e.g., sitagliptin, linagliptin)
- Metformin
- Sulfonylureas (e.g., glipizide, glyburide)
- Thiazolidinediones (e.g., pioglitazone)
- Insulin
Cost & Coverage
Average Cost:
$550 - $650 per 30 tablets
Insurance Coverage:
Tier 2 or Tier 3 (preferred or non-preferred brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor promptly. To ensure your safety, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, which provides crucial information. Please read this guide carefully and review it again whenever you receive a refill. If you have any questions or concerns about this medication, don't hesitate to consult with your doctor, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.