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Jardiance

Highlights for Jardiance

  1. Jardiance is used along with diet and exercise to help lower blood sugar levels in adults with type 2 diabetes.
  2. Jardiance works in your kidneys to remove sugar from your blood and moves the sugar into your urine.
  3. The most common side effect that occurs with Jardiance is a urinary tract infection. Symptoms include a burning sensation when urinating, cloudy urine, or pain in your pelvis or back.
  4. This medication can increase your cholesterol levels. If you already have high cholesterol, your doctor will monitor your cholesterol closely and treat it if necessary.
  5. If you take Jardiance with other diabetes medications, your blood sugar might get too low (hypoglycemia). Symptoms may include shakiness, confusion, sweating, rapid heartbeat, nervousness, headache, weakness, or fatigue. Contact your doctor if you experience these symptoms.

IMPORTANT INFORMATION


This drug can cause some people to lose body water and salt (dehydration). Symptoms of dehydration include dizziness, feeling faint, lightheadedness, or weakness, especially when you stand up. If you notice these symptoms, contact your doctor.

Yeast infection

Talk to your doctor about what to do if you get symptoms of a yeast infection:

  • Symptoms in women include vaginal odor, white or yellowish vaginal discharge, and vaginal itching.
  • Symptoms in men include redness, itching, swelling, and rash of the penis. They may also include pain in the skin around the penis and foul-smelling discharge from the penis.

Ketoacidosis
This drug may cause diabetic ketoacidosis. This is a serious complication of diabetes that can be fatal. It happens when your body makes high levels of the blood acids called ketones. This condition should be treated with insulin. If you develop ketoacidosis, your doctor may have you stop taking this drug temporarily or permanently.

Urinary tract infections
This drug can cause severe urinary tract infections. If you have any signs of a urinary tract infection, tell your doctor right away. Symptoms can include a burning sensation when you urinate, cloudy urine, and pain in your pelvis or back.


What is Jardiance?

This drug is a prescription drug. It’s available as an oral tablet.

This drug may be used as part of a combination therapy. That means you need to take it with other drugs.

Why it's used

This drug belongs to a class of drugs called sodium-glucose co-transporter 2 (SGLT2).

Amlodipine is also used to help blood flow more easily to your heart when the arteries in your heart are blocked.

How it works

This drug belongs to a class of drugs called sodium-glucose co-transporter 2 (SGLT2). A class of drugs refers to medications that work similarly. They’re often used to treat similar conditions. This drug works in your kidneys to remove sugar from your blood and moves the sugar into your urine.

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Side effects

Jardiance side effects

More common side effects

The most common side effects that occur with amlodipine include:

  • urinary tract infection. Symptoms may include:
    • a burning sensation when you urinate
    • cloudy urine
    • pain in your pelvis or back

Serious side effects

If you experience any of these serious side effects, call your doctor right away. If your symptoms are potentially life-threatening or if you think you’re experiencing a medical emergency, call 9-1-1.

  • Dehydration. Symptoms may include:
    • dizziness
    • feeling faint
    • lightheadedness
    • weakness, especially when you stand up
  • yeast infection. Symptoms in women may include:
    • vaginal odor
    • white or yellowish vaginal discharge
    • vaginal itching
  • Symptoms in men may include:
    • redness, itching, or swelling of the penis
    • rash of the penis
    • foul-smelling discharge from the penis
    • pain in the skin around the penis
  • low blood sugar (hypoglycemia). Symptoms may include:
    • drowsiness
    • headache
    • confusion
    • weakness
    • hunger
    • irritability
    • sweating
    • feeling jittery
    • fast heartbeat
  • allergic reactions. Symptoms may include:
    • swelling of your face, throat, lips, and other areas on your skin
    • difficulty swallowing or breathing
    • raised, red areas on your skin (hives)
    • skin rash
  • kidney problems
  • increased cholesterol levels
  • diabetic ketoacidosis. Symptoms can include:
    • excessive thirst
    • urinating more often than normal
    • nausea
    • vomiting
    • stomach pain
    • weakness
    • shortness of breath
    • breath that smells fruity
    • confusion
Pharmacist's Advice
This drug doesn’t cause drowsiness.
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Interactions

Jardiance may interact with other medications

Jardiance can interact with other medications, herbs, or vitamins you might be taking. That’s why your doctor should manage all of your medications carefully. If you’re curious about how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.

Note: You can reduce your chances of drug interactions by having all of your prescriptions filled at the same pharmacy. That way, a pharmacist can check for possible drug interactions.

Alcohol interaction

Limit your use of alcohol. Drinking alcohol can lower your blood glucose control and increase your risk of hypoglycemia if you take medication for diabetes.

Medications that might interact with this drug

Drugs for water retention (diuretics)

  • hydrochlorothiazide
  • furosemide

These drugs increase urination. Jardiance can also increase urination, so taking these drugs together can increase your risk of dehydration.

Insulin or drugs that cause the release of insulin

  • chlorpropamide
  • glipizide
  • glimepiride
  • glyburide
  • tolbutamide
  • tolazamide
  • repaglinide
  • nateglinide
>

Jardiance and these drugs all decrease your blood sugar level. Taking Jardiance with these drugs could cause your blood sugar level to be too low (hypoglycemia).


AMLODIPINE WARNINGS

People with high cholesterol
This medication can increase your cholesterol levels. If you already have high cholesterol, your doctor will monitor your cholesterol closely and treat it if necessary.

Pregnant women
Amlodipine is a category C pregnancy drug. That means two things:

  1. Research in animals has shown adverse effects to the fetus when the mother takes the drug.
  2. There haven’t been enough studies done in humans to be certain how the drug might affect the fetus.

Tell your doctor if you’re pregnant or plan to become pregnant. This drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Women who are breast-feeding
It isn’t known if this drug passes through breast milk. You and your doctor should decide if you’ll take this drug or breastfeed.

For children
The safety and effectiveness of this drug in children haven’t been established.

Allergies
This drug can cause a severe allergic reaction, causing symptoms such as:

  • trouble breathing
  • swelling of your throat or tongue
  • hives

Don’t take this drug again if you’ve ever had an allergic reaction to empagliflozin or any other ingredient. Taking it again could be fatal.


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Dosage

How to take Jardiance

All possible dosages and forms may not be included here. Your dose, form, and how often you take it will depend on:

  • your age
  • the condition being treated
  • how severe your condition is
  • other medical conditions you have
  • how you react to the first dose

What are you taking this medication for?

Type 2 diabetes

Brand: Jardiance
Form: Oral tablet
Strengths: 10 mg, 25 mg

Adult Dosage (ages 18 years and older)

  • Jardiance tablets:
    • Initial dose is 10 mg, taken once per day in the morning.
    • Doses may be increased up to 25 mg, taken once per day in the morning.

Child Dosage (ages 0-17 years)

  • Jardiance tablets: Dosage for people younger than 18 years old hasn’t been established.

Special considerations

Kidney Problems:

  • Jardiance tablets: If your kidney function decreases, your doctor may have you stop taking this drug. Don’t take this medication if you have severe kidney disease or if you’re on dialysis.
Pharmacist's Advice
This drug comes with serious risks if you don't take it as prescribed.

If you don't take it at all
If you don’t take this drug, your blood sugar levels can reach dangerously high levels. This can lead to complications such as nerve damage, heart disease, heart attack, stroke, and damage to your eyes.

If you skip or miss doses
The medication may not work as well and your blood sugar levels may not be controlled properly.

If you take too much
If you take too much, your blood sugar levels may become too low.

What to do if you miss a dose
If you miss a dose, take it as soon as you remember. If you don’t remember until your next dose, skip the missed dose and go back to your regular schedule. Don’t take two doses of this drug at the same time. Talk with your doctor if you have questions about a missed dose.

How to tell if the drug is working
If the drug is working, your blood sugar levels will go down, or they will stay within the normal range.

This drug is a long-term drug treatment.

Take it in the morning

You can cut or crush the tablet

Store this drug from 68–77°F (20–25°C).

  • Don’t freeze this drug.
  • Keep it away from high temperature.
  • Keep container tightly closed.
  • Keep your drugs away from areas where they could get wet, such as bathrooms. Store your drugs away from moisture and damp locations.

Prescription is refillable

When traveling with your medication:

  • Always carry your medication with you or in your carry-on bag.
  • Don’t worry about airport X-ray machines; they can’t hurt your medication.
  • You may need to produce your pharmacy’s preprinted label clearly identifying the medication. Keep the original pharmacy prescription-labeled box when traveling with your medication.
  • Don’t put this medicine in your glove compartment or leave it in the car, especially when the temperature is hot or freezing.

Clinical monitoring:

Blood sugar: Your doctor will check your blood sugar levels regularly to make sure empagliflozin is working. You may also monitor your own blood sugar level at home if your doctor has asked you to use a blood glucose meter.

Kidney function: Your doctor will check your kidney function with blood tests before you take empagliflozin and periodically during treatment. If your kidney function is poor, or worsens during therapy, your doctor may not start or continue your empagliflozin therapy.

Cholesterol level: Your doctor will check your cholesterol levels, because this medication may cause your cholesterol to increase.

Not every pharmacy stocks this drug, so call ahead.

Many insurance companies will require a prior authorization before they approve the prescription for brand name Norvasc

Are there any alternatives?

There are other drugs available to treat your condition. Some may be more suitable for you than others. Talk to your doctor about possible alternatives.

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For Professionals

Jardiance professional information

Empagliflozin professional information

Brand name: Jardiance

Indications for use

Adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Do not use in patients with type 1 diabetes or in treatment of ketoacidosis

Contraindications

History of hypersensitivity reaction to empagliflozin, severe renal impairment, end-stage renal disease or dialysis

Warnings/precautions

Hypotension: Empagliflozin causes intravascular volume contraction. Symptomatic hypotension may occur after initiating empagliflozin. This is more common in patients with renal impairment, the elderly, patients with low systolic blood pressure, and patients on diuretics.

Ketoacidosis: Ketoacidosis is a serious life-threatening condition requiring urgent hospitalization. It has been reported with empagliflozin and other sodium glucose cotransporter-2 (SGLT2) inhibitors.

Impaired renal function: Empagliflozin increases serum creatinine and decreases eGFR. The risk of impaired renal function is increased in elderly patients and patients with moderate renal impairment receiving the drug.

Urosepsis and pyelonephritis: Empagliflozin has been associated with reports of serious urinary tract infections, including urosepsis and pyelonephritis requiring hospitalization.

Hypoglycemia with concomitant use with insulin and sulfonylureas: Insulin and sulfonylureas are known to cause hypoglycemia. The risk of hypoglycemia is increased when empagliflozin is combined with any of these agents. Therefore, a lower dose of the sulfonylurea or insulin may be required to reduce the risk of hypoglycemia.

Genital mycotic infections: Empagliflozin increases the risk for genital mycotic infections. Patients with a history of chronic or recurrent genital mycotic infections were more likely to develop mycotic genital infections. Monitor and treat as appropriate.

Increased low-density lipoprotein cholesterol (LDL-C): Increases in LDL-C have been reported with empagliflozin. Monitor and treat as appropriate.

Mechanism of action

Sodium-glucose cotransporter 2 (SGLT2) is the predominant transporter responsible for reabsorption of glucose from the glomerular filtrate back into the circulation. Empagliflozin is an inhibitor of SGLT2. By inhibiting SGLT2, empagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, and thereby increases urinary glucose excretion.

Dosing in adults

The recommended dose of empagliflozin is 10 mg once per day in the morning. It may be taken without regard to meals. The dose may be increased to 25 mg once per day if well-tolerated. Correct volume depletion before starting empagliflozin.

Dosing in children

The safety and effectiveness of empagliflozin has not been established in patients younger than 18 years of age.

Dosing in elderly

There is no dose adjustment required based on age. There may be an increased risk of side effects (volume depletion, urinary tract infection) in the elderly taking empagliflozin. Empagliflozin may not be as effective in elderly individuals (>75 years) with renal impairment.

Dosing in renal impairment

Assess renal function before starting empagliflozin and periodically thereafter. Do not start empagliflozin in patients with estimated glomerular filtration rate (eGFR) < 45 mL/min/1.73m2. Discontinue empagliflozin if eGFR drops below this level. No dose adjustment is needed if eGFR is ≥ 45 mL/min/1.73m2.

Dosing in hepatic impairment

There are no restrictions for use in hepatic impairment.

Drug interactions

Diuretics: Coadministration of empagliflozin with diuretics resulted in increased urine volume and frequency of voids, which might increase the potential for volume depletion.

Insulin or sulfonylureas: Coadministration of empagliflozin with insulin or sulfonylureas increases the risk for hypoglycemia.

Positive urine glucose test: Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors because these drugs increase urinary glucose excretion and lead to positive urine glucose tests. Use alternative methods to monitor glycemic control.

Adverse drug reactions

Empagliflozin may cause volume depletion, hypotension, genital mycotic infections, increased urination, impaired renal function, dyslipidemia, arthralgias, and increased low-density lipoprotein cholesterol.

Monitoring parameters

In the event of an overdose with empagliflozin, contact a poison control center. Employ the usual supportive measures (e.g., remove unabsorbed material from the gastrointestinal tract, employ clinical monitoring, and institute supportive treatment) as dictated by the patient’s clinical status. Removal of empagliflozin by hemodialysis has not been studied.

Pregnancy risk factor

Pregnancy category C: There are no adequate and well-controlled studies of empagliflozin in pregnant women. Empagliflozin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Preparation of suspension

N/A

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