Jardiance (Empagliflozin)

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Jardiance is a prescription medication that contains empagliflozin. Empagliflozin belongs to a class of drugs called sodium-glucose co-transporter 2 (SGLT2) inhibitors.

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Jardiance is indicated for several important health conditions:

• Management of Type 2 Diabetes Mellitus: It helps lower blood sugar levels in adults and children aged 10 years and older with type 2 diabetes.
• Reduction of Cardiovascular Death Risk: In adults with type 2 diabetes who also have established cardiovascular disease, Jardiance is used to reduce the risk of death due to cardiovascular events.
• Management of Chronic Kidney Disease: In adult patients with chronic kidney disease, Jardiance is indicated to reduce the risk of progressive kidney disease, the development of end-stage kidney disease, and hospitalization events.

Jardiance works by targeting a specific protein in the kidneys called the sodium-glucose co-transporter 2 (SGLT2). Here’s a breakdown of the process:

1. Inhibition of SGLT2: The active ingredient in Jardiance, empagliflozin, acts as an inhibitor. This means it blocks the action of the SGLT2 protein.
2. Location of Action: SGLT2 is primarily located in the proximal renal tubules of the kidneys. These tubules are responsible for reabsorbing glucose back into the bloodstream as blood filters through the kidneys.
3. Reduced Glucose Reabsorption: By inhibiting SGLT2, Jardiance prevents the kidneys from reabsorbing as much glucose.
4. Lowering Blood Glucose Levels: By increasing the amount of glucose removed from the body via urine, Jardiance effectively lowers blood glucose levels. This is the primary mechanism by which it helps manage type 2 diabetes mellitus.

This is general information about how medications like Jardiance are typically administered. Always refer to your personal prescription and consult with your healthcare provider for precise instructions.

1. Take Exactly as Prescribed: Your doctor will tell you how much Jardiance to take and when to take it. Do not change your dose or stop taking Jardiance without talking to them first.
2. Timing of Dose: Jardiance is usually taken once a day. Your doctor may specify a particular time of day. It can typically be taken with or without food. Try to take it at the same time each day to help you remember.
3. Swallowing the Tablet: Swallow the Jardiance tablet whole with a glass of water. Do not crush, chew, or break the tablet unless specifically instructed by your doctor.
4. If You Miss a Dose:
   1. Take the missed dose as soon as you remember if it is still within a few hours of your usual time.
   2. If it is close to the time for your next dose, skip the missed dose and take your next dose at the regular time.
   3. Do not take two doses at the same time to make up for a missed dose.
5. Storage: Store Jardiance at room temperature, away from heat and moisture. Keep it out of the reach of children.

Available Dosages:

Jardiance tablets are available in two strengths:

• 10 mg of empagliflozin
• 25 mg of empagliflozin

Recommended Dosing Schedule:

Jardiance is typically taken once daily in the morning, with or without food.

The specific dosage and dosing schedule will be determined by your doctor based on your individual condition, kidney function, and response to treatment. Here are some general guidelines:

• Type 2 Diabetes Mellitus (Adults and Children ≥ 10 years):
  • The usual starting dose is 10 mg once daily.
  • Your doctor may increase the dose to 25 mg once daily if needed for additional glycemic control and if tolerated.
  • The maximum recommended daily dose is 25 mg.
• Reduction of Cardiovascular Death Risk in Adults with Type 2 Diabetes and Established Cardiovascular Disease:
  • The recommended dose is 10 mg once daily.
  • Treatment of Heart Failure in Adults:
  • The recommended dose is 10 mg once daily.
• Management of Chronic Kidney Disease in Adults:
  • The recommended dose is 10 mg once daily.

It is crucial to be aware of situations where Jardiance should not be used (contraindications) and conditions that require careful consideration before and during treatment (precautions).

This information is not exhaustive, and you must discuss your complete medical history with your doctor before taking Jardiance.

Contraindications:

• Severe Renal Impairment or End-Stage Renal Disease (ESRD) requiring dialysis: Jardiance is not recommended in patients with severely impaired kidney function (eGFR < 30 mL/min/1.73 m²) or those on dialysis as it is unlikely to be effective in lowering blood glucose in this population.
• Hypersensitivity to Empagliflozin or any of the excipients in Jardiance: If you have had a serious allergic reaction to empagliflozin or any of the inactive ingredients in the tablet, you should not take Jardiance.

Precautions:

• Renal Impairment: Jardiance can cause a decrease in kidney function.
• Hypotension (Low Blood Pressure): Jardiance can cause a decrease in blood volume due to its diuretic effect, which can lead to symptomatic hypotension, especially in patients with known cardiovascular disease, low baseline blood pressure, or those taking other medications that lower blood pressure.
• Volume Depletion: Conditions that can lead to volume depletion (such as gastrointestinal illness with vomiting or diarrhea) may increase the risk of hypotension.
• Ketoacidosis: There have been postmarketing reports of ketoacidosis (a serious condition where the body produces high levels of blood acids called ketones) in patients with type 1 and type 2 diabetes taking SGLT2 inhibitors, including Jardiance. Patients should be educated on the signs and symptoms of ketoacidosis (such as nausea, vomiting, abdominal pain, unusual tiredness, and difficulty breathing).
• Urogenital Infections: SGLT2 inhibitors increase the risk of urinary tract infections (UTIs), including serious infections like pyelonephritis, and genital yeast infections in both men and women.
• Increased Risk of Amputation of the Lower Limb: An increased risk of lower limb amputation (primarily of the toe and midfoot) has been observed in clinical trials with another SGLT2 inhibitor. While this risk has not been consistently observed with Jardiance across its clinical development program, it is still important to discuss your risk factors for amputation with your doctor.
• Hypoglycemia with Concomitant Insulin or Insulin Secretagogues: When Jardiance is used with insulin or insulin secretagogues (such as sulfonylureas), the risk of hypoglycemia (low blood sugar) is increased. A lower dose of the insulin or insulin secretagogue may be necessary to minimize this risk.
• Geriatric Patients: Elderly patients may be at a higher risk of volume depletion and renal impairment.
• Pediatric Patients: The safety and efficacy of Jardiance have been established in pediatric patients aged 10 years and older with type 2 diabetes mellitus.

Common Side Effects:

• Urinary tract infections (UTIs)
• Genital yeast infections
• Increased urination
• Thirst
• Nausea

Serious Side Effects:

• Ketoacidosis: Symptoms may include:
  • Nausea
  • Vomiting
  • Abdominal pain
  • Unusual tiredness or drowsiness
  • Trouble breathing
  • Confusion
  • Fruity-smelling breath
  • High levels of ketones in your urine or blood
  • If you experience any symptoms of ketoacidosis, seek medical help immediately.
• Severe allergic reaction: Symptoms may include:
  • Rash
  • Hives
  • Swelling of the face, lips, tongue, or throat
  • Difficulty breathing or swallowing
  • If you experience any symptoms of a severe allergic reaction, get emergency medical help right away.
• Kidney problems: Symptoms may include:
  • Decreased urination
  • Swelling in your legs or ankles
  • Fatigue
  • Confusion
  • Nausea
• Low blood pressure (hypotension)
• Serious urinary tract infections (UTIs)
• Increased risk of amputation of the lower limb

It’s important to inform your doctor and pharmacist about all the medications you are currently taking, including prescription drugs, over-the-counter medications, vitamins, and herbal supplements, as Jardiance can interact with other drugs.

Here’s how Jardiance may interact with the specific drug classes:

• Diuretics: When Jardiance is used in combination with diuretics (such as hydrochlorothiazide, furosemide, etc.), there is an increased risk of volume depletion (dehydration) and consequently, hypotension (low blood pressure).
• Insulin or Insulin Secretagogues (e.g., Sulfonylureas like glipizide, glyburide, glimepiride): Combining Jardiance with insulin or insulin secretagogues can lead to an increased risk of hypoglycemia (low blood sugar).
• Lithium: Co-administration of Jardiance with lithium may result in lower lithium blood concentrations. This could potentially reduce the therapeutic effect of lithium, which is used to treat certain psychiatric conditions.