JARDIANCE- empagliflozin tablet, film coated

Država: Sjedinjene Američke Države

Jezik: engleski

Izvor: NLM (National Library of Medicine)

Aktivni sastojci:

EMPAGLIFLOZIN (UNII: HDC1R2M35U) (EMPAGLIFLOZIN - UNII:HDC1R2M35U)

Dostupno od:

A-S Medication Solutions

Administracija rute:

ORAL

Tip recepta:

PRESCRIPTION DRUG

Terapijske indikacije:

JARDIANCE is indicated: - to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure. - to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease. - as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus. Limitations of Use JARDIANCE is not recommended in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients [see Warnings and Precautions (5.1)] . JARDIANCE is not recommended for use to improve glycemic control in patients with type 2 diabetes mellitus with an eGFR less than 30 mL/min/1.73 m2 . JARDIANCE is likely to be ineffective in this setting based upon its mechanism of action. JARDIANCE is contraindicated in patients: - with a hypersensitivity to empagliflozin or any of the excipients in JARDIANCE, reactions such as angioedema have occurred [se

Proizvod sažetak:

Product: 50090-4384 NDC: 50090-4384-0 90 TABLET, FILM COATED in a BOTTLE NDC: 50090-4384-1 30 TABLET, FILM COATED in a BOTTLE

Status autorizacije:

New Drug Application

Uputa o lijeku

A-S Medication Solutions
----------
This MEDICATION GUIDE has been approved by the U.S. Food and Drug
Administration.
Revised: June 2023
MEDICATION GUIDE
JARDIANCE® (jar DEE ans)
(empagliflozin tablets)
for oral use
What is the most important information I should know about JARDIANCE?
JARDIANCE can cause serious side effects, including:
•
Ketoacidosis (increased ketones in your blood or urine). Ketoacidosis
has happened in people who
have type 1 diabetes or type 2 diabetes, during treatment with
JARDIANCE. Ketoacidosis has also
happened in people with diabetes who were sick or who had surgery
during treatment with
JARDIANCE. Ketoacidosis is a serious condition, which needs to be
treated in a hospital.
Ketoacidosis may lead to death. Ketoacidosis can happen with JARDIANCE
even if your blood
sugar is less than 250 mg/dL. Stop taking JARDIANCE and call your
healthcare provider right away
or go to the nearest hospital emergency room if you get any of the
following symptoms:
•
nausea
•
vomiting
•
stomach-area (abdominal) pain
•
tiredness
•
trouble breathing
If you get any of these symptoms during treatment with JARDIANCE, if
possible, check for ketones in
your urine, even if your blood sugar is less than 250 mg/dL.
•
Dehydration. JARDIANCE can cause some people to become dehydrated (the
loss of body water and
salt). Dehydration may cause you to feel dizzy, faint, light-headed,
or weak, especially when you
stand up (orthostatic hypotension). There have been reports of sudden
worsening of kidney function
in people who are taking JARDIANCE.
You may be at higher risk of dehydration if you:
•
take medicines to lower your blood pressure, including diuretics
(water pills)
•
are on low sodium (salt) diet
•
have kidney problems
•
are 65 years of age or older
Talk to your healthcare provider about what you can do to prevent
dehydration including how much fluid
you should drink on a daily basis.
Talk to your healthcare provider right away if you reduce the amount
of food or liquid you drink, for
example if

Svojstava lijeka

JARDIANCE- EMPAGLIFLOZIN TABLET, FILM COATED
A-S MEDICATION SOLUTIONS
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
JARDIANCE SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR JARDIANCE.
JARDIANCE (EMPAGLIFLOZIN TABLETS), FOR ORAL USE
INITIAL U.S. APPROVAL: 2014
RECENT MAJOR CHANGES
Indications and Usage (1)
6/2023
Dosage and Administration (2.2, 2.3)
6/2023
Warnings and Precautions (5.4)
6/2023
INDICATIONS AND USAGE
JARDIANCE is a sodium-glucose co-transporter 2 (SGLT2) inhibitor
indicated:
To reduce the risk of cardiovascular death and hospitalization for
heart failure in adults with heart
failure. (1)
To reduce the risk of cardiovascular death in adults with type 2
diabetes mellitus and established
cardiovascular disease. (1)
As an adjunct to diet and exercise to improve glycemic control in
adults and pediatric patients aged 10
years and older with type 2 diabetes mellitus. (1)
Limitations of Use:
Not recommended in patients with type 1 diabetes mellitus. It may
increase the risk of diabetic
ketoacidosis in these patients. (1)
Not recommended for use to improve glycemic control in patients with
type 2 diabetes mellitus with an
eGFR less than 30 mL/min/1.73 m (1)
DOSAGE AND ADMINISTRATION
Assess renal function before initiating and as clinically indicated.
Correct volume depletion before
initiating (2.1)
Recommended dosage is 10 mg once daily in the morning, taken with or
without food (2.2)
For additional glycemic control, dosage may be increased to 25 mg in
patients tolerating JARDIANCE
(2.2)
DOSAGE FORMS AND STRENGTHS
Tablets: 10 mg, 25 mg (3)
CONTRAINDICATIONS
Hypersensitivity to empagliflozin or any of the excipients in
JARDIANCE (4)
Patients on dialysis (4)
WARNINGS AND PRECAUTIONS
_Ketoacidosis:_ Assess patients who present with signs and symptoms of
metabolic acidosis for
ketoacidosis, regardless of blood glucose level. If suspected,
discontinue JARDIANCE, evaluate and treat
promptly. Before initiating JARDIANCE, consider ris