Jardiance 25mg Tablets

Manufacturer BOEHRINGER INGELHEIM Active Ingredient Empagliflozin(em pa gli FLOE zin) Pronunciation em pa gli FLOE zin
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.
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Drug Class
Antidiabetic, Cardiovascular agent, Renal protectant
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Pharmacologic Class
Sodium-glucose co-transporter 2 (SGLT2) inhibitor
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Pregnancy Category
Not available
FDA Approved
Aug 2014
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Jardiance (empagliflozin) is a medication used to lower blood sugar in adults with type 2 diabetes. It also helps reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure, and slows the progression of kidney disease in adults with chronic kidney disease. It works by helping your kidneys remove more sugar from your body through your urine.
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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 avoid dehydration, especially if you're experiencing vomiting, diarrhea, or unable to drink liquids by mouth. Dehydration can lead to low blood pressure or worsen kidney problems. If you're experiencing any of these symptoms, contact your doctor for guidance.

Monitoring Your Health

Your doctor will likely recommend regular blood tests to monitor your health while taking this medication. Be sure to keep these appointments and discuss any concerns with your doctor. Additionally, 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 out of the 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. However, 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.
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Lifestyle & Tips

  • Maintain adequate hydration by drinking plenty of fluids, especially when exercising or in hot weather, to reduce the risk of dehydration.
  • Follow a healthy diet and exercise plan as recommended by your doctor.
  • Monitor blood glucose levels regularly if you have diabetes, as advised by your healthcare provider.
  • Be aware of the symptoms of low blood sugar (hypoglycemia) if taking with insulin or sulfonylureas.
  • Practice good personal hygiene, especially in the genital area, to reduce the risk of infections.
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: 10 mg orally once daily
Dose Range: 10 - 25 mg

Condition-Specific Dosing:

Type 2 Diabetes Mellitus: Initial 10 mg orally once daily; can increase to 25 mg orally once daily for additional glycemic control if 10 mg is well-tolerated and eGFR ≥ 30 mL/min/1.73m².
Heart Failure (HFrEF or HFpEF): 10 mg orally once daily.
Chronic Kidney Disease: 10 mg orally once daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established
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Dose Adjustments

Renal Impairment:

Mild: No dose adjustment needed (eGFR ≥ 60 mL/min/1.73m²).
Moderate: No dose adjustment needed for eGFR 30 to < 60 mL/min/1.73m². For T2DM, initiation not recommended if eGFR < 30 mL/min/1.73m². For HF/CKD, initiation not recommended if eGFR < 20 mL/min/1.73m².
Severe: Not recommended to initiate if eGFR < 20 mL/min/1.73m². If already on therapy for HF or CKD and eGFR falls below 20 mL/min/1.73m², continue 10 mg once daily.
Dialysis: Not recommended for patients on dialysis.

Hepatic Impairment:

Mild: No dose adjustment needed.
Moderate: No dose adjustment needed.
Severe: No dose adjustment needed.

Pharmacology

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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. It also promotes osmotic diuresis, leading to reductions in intravascular volume and blood pressure, and has direct effects on cardiac and renal physiology independent of glycemic control.
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Pharmacokinetics

Absorption:

Bioavailability: Approximately 78%
Tmax: 1.5 hours
FoodEffect: No clinically meaningful effect of food on empagliflozin exposure.

Distribution:

Vd: Approximately 73.8 L
ProteinBinding: Approximately 86.2%
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 12.4 hours
Clearance: Approximately 10.6 L/h (apparent oral clearance)
ExcretionRoute: Approximately 50% renal and 50% fecal
Unchanged: Approximately 50% (renal)
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Pharmacodynamics

OnsetOfAction: Within hours (glucose lowering)
PeakEffect: Approximately 1.5 hours (plasma concentration), sustained effect over 24 hours
DurationOfAction: 24 hours

Safety & Warnings

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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 urinate or changes in urine output, dry mouth, dry eyes, or severe nausea and vomiting.
Signs of kidney problems: inability to urinate, changes in urine output, blood in the urine, or sudden weight gain.
Signs of too much acid in the blood (acidosis): confusion, rapid breathing, rapid heartbeat, irregular heartbeat, severe abdominal pain, nausea and vomiting, excessive sleepiness, shortness of breath, or feeling extremely tired or weak.
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 some 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 have any side effects that bother you or do not go away, contact your doctor or seek medical help. This is not an exhaustive list of possible side effects. If you have questions or concerns, contact your doctor.

Reporting Side Effects

You can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can also provide guidance on managing side effects and offer medical advice.
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Seek Immediate Medical Attention If You Experience:

  • Signs of dehydration: severe dizziness, lightheadedness, feeling faint, dry mouth, excessive thirst.
  • Signs of urinary tract infection: burning sensation when urinating, frequent urination, urgent need to urinate, pain in the lower abdomen or back, fever.
  • Signs of genital yeast infection: itching or redness in the genital area, rash, unusual discharge.
  • Signs of diabetic ketoacidosis (DKA): nausea, vomiting, stomach pain, excessive thirst, frequent urination, difficulty breathing, confusion, unusual tiredness or sleepiness, fruity-smelling breath.
  • Signs of Fournier's gangrene (a rare but serious infection): pain, tenderness, redness, or swelling in the genital or perineal area, fever, feeling unwell.
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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 will help identify any potential interactions with this medication. Always check with your doctor before starting, stopping, or changing the dose of any medication to ensure your safety.
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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 need to stop this medication before certain surgical procedures, and will advise you when to resume taking it after the surgery or procedure.

Low Blood Sugar and Driving

Do not drive if you have experienced low blood sugar, as this can increase your risk of being involved in an accident.

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 prevent 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, and consult with your doctor about the most suitable glucose tests to use.

Ketoacidosis

This medication can cause a life-threatening condition called ketoacidosis, which may require hospitalization. This can occur even if your blood sugar levels are below 250. People with diabetes or pancreas problems are at higher risk, as are those who are dehydrated, cannot eat or drink normally, skip meals, follow a ketogenic diet, or have undergone surgery. The risk is also increased in individuals who use insulin and take less than their usual dose or miss a dose. 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. Consult with your doctor before consuming alcohol.

Fournier's Gangrene

A rare but potentially life-threatening infection called Fournier's gangrene has been associated with medications like this one. Seek immediate medical attention if you experience tenderness, redness, or swelling in the genital or perineal 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 amputation, 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 Precautions

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.
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Overdose Information

Overdose Symptoms:

  • Hypoglycemia (if taken with insulin or sulfonylureas)
  • Volume depletion/dehydration
  • Hypotension

What to Do:

In case of overdose, contact a poison control center immediately. Call 1-800-222-1222. Treatment should be supportive and based on the patient's clinical presentation.

Drug Interactions

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Major Interactions

  • Loop diuretics (increased risk of volume depletion and hypotension)
  • Insulin and insulin secretagogues (e.g., sulfonylureas) (increased risk of hypoglycemia)
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Moderate Interactions

  • Lithium (may decrease lithium serum concentrations)
  • Other antihypertensive agents (additive hypotensive effects)

Monitoring

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Baseline Monitoring

Renal function (eGFR)

Rationale: To assess baseline kidney function and guide dosing, especially important for patients with CKD or at risk of renal impairment.

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 low blood pressure.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Renal function (eGFR)

Frequency: Periodically (e.g., annually, or more frequently in patients with impaired renal function or those at risk of acute kidney injury)

Target: Maintain eGFR ≥ 20 mL/min/1.73m² for continued use in HF/CKD; ≥ 30 mL/min/1.73m² for continued use in T2DM.

Action Threshold: Consider dose adjustment or discontinuation if eGFR falls below recommended thresholds or if acute kidney injury develops.

Signs and symptoms of volume depletion

Frequency: Regularly, especially during initial therapy and with dose increases

Target: Not applicable

Action Threshold: If symptomatic hypotension or significant volume depletion occurs, manage appropriately (e.g., fluid intake, dose adjustment of empagliflozin or concomitant diuretics).

Signs and symptoms of urinary tract infections (UTIs) and genital mycotic infections

Frequency: Regularly

Target: Not applicable

Action Threshold: Promptly treat any suspected infections.

Signs and symptoms of diabetic ketoacidosis (DKA)

Frequency: Regularly, especially in patients with T2DM

Target: Not applicable

Action Threshold: If suspected, discontinue empagliflozin immediately and evaluate for DKA.

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Symptom Monitoring

  • Signs of dehydration (dizziness, lightheadedness, weakness, dry mouth)
  • Symptoms of urinary tract infection (painful urination, frequent urination, urgency, fever)
  • Symptoms of genital yeast infection (itching, redness, discharge)
  • Symptoms of diabetic ketoacidosis (nausea, vomiting, abdominal pain, excessive thirst, rapid breathing, unusual fatigue, fruity breath odor)
  • Symptoms of Fournier's gangrene (pain, tenderness, redness, or swelling in the genital or perineal area, fever, malaise)

Special Patient Groups

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Pregnancy

Not recommended during the second and third trimesters of pregnancy due to potential adverse effects on renal development in the fetus. Use only if the potential benefit justifies the potential risk to the fetus during the first trimester.

Trimester-Specific Risks:

First Trimester: Limited human data. Animal studies show no adverse effects at clinically relevant exposures.
Second Trimester: Animal studies show adverse renal developmental effects (renal pelvic and tubule dilatations) at exposures 13-fold the clinical exposure. Human data are insufficient.
Third Trimester: Animal studies show adverse renal developmental effects. Human data are insufficient. Avoid use.
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Lactation

Not recommended during breastfeeding. It is unknown if empagliflozin is excreted in human milk. Due to the potential for serious adverse reactions in a breastfed infant, advise women not to breastfeed during treatment.

Infant Risk: Potential for serious adverse reactions (e.g., renal developmental effects, hypoglycemia) in the breastfed infant.
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Pediatric Use

Safety and effectiveness have not been established in pediatric patients for any indication.

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Geriatric Use

No dose adjustment is recommended based on age. However, elderly patients may be at increased risk for volume depletion and hypotension due to age-related decline in renal function and concomitant diuretic use. Monitor volume status and renal function more frequently.

Clinical Information

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Clinical Pearls

  • Empagliflozin has demonstrated significant cardiovascular and renal benefits beyond glycemic control, making it a cornerstone therapy for patients with T2DM and established CVD, heart failure, or CKD.
  • Educate patients on the importance of hydration to mitigate the risk of volume depletion and hypotension, especially during illness or in hot weather.
  • Be vigilant for symptoms of euglycemic DKA, which can occur with SGLT2 inhibitors even with near-normal blood glucose levels. Promptly evaluate patients presenting with symptoms like nausea, vomiting, abdominal pain, or fatigue.
  • Counsel patients on proper hygiene to reduce the risk of genital mycotic infections and urinary tract infections, which are common side effects.
  • While the risk of lower limb amputation was observed with canagliflozin, studies with empagliflozin have not shown a similar increased risk.
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Alternative Therapies

  • Other SGLT2 inhibitors (e.g., dapagliflozin, canagliflozin, ertugliflozin)
  • GLP-1 receptor agonists (e.g., liraglutide, semaglutide)
  • DPP-4 inhibitors (e.g., sitagliptin, saxagliptin)
  • Metformin
  • Sulfonylureas (e.g., glipizide, glyburide)
  • Insulin
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Cost & Coverage

Average Cost: Price varies, typically $500-$700 per 30 tablets
Insurance Coverage: Tier 2 or Tier 3 (Preferred or Non-Preferred Brand)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. This medication is accompanied by a Medication Guide, a patient fact sheet that provides crucial information. Please read this guide carefully and review it again whenever you receive a refill of this medication. If you have any questions or concerns about this medication, consult 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 quantity, and the time it occurred.