Jardian 10 Tablet

Nazione: Bangladesh

Lingua: inglese

Fonte: DGDA (Directorate General of Drug Administration)

Scarica Foglio illustrativo (PIL)
08-06-2024

Principio attivo:

Empagliflozin

Commercializzato da:

Beximco Pharmaceuticals Ltd.

INN (Nome Internazionale):

Empagliflozin

Dosaggio:

10 mg

Forma farmaceutica:

Tablet

Composizione:

Each film coated tablet contains Empagliflozin INN 10 mg.

Confezione:

Box containing 20 tablets in blister strips.

Indicazioni terapeutiche:

Jardian is indicated as an adjunct to diet and exercise for the treatment of type-2 diabetes. It can be given alone or in combination with other oral antidiabetic agents. It is also indicated for reduction in cardiovascular risk in type-2 diabetic patients.

Dettagli prodotto:

Jardian® is a preparation of Empagliflozin. Empagliflozin is a drug of the gliflozin class, approved for the treatment of type 2 diabetes in adults. It is an inhibitor of the sodium glucose co-transporter-2 (SGLT-2), and causes sugar in the blood to be excreted by the kidneys and eliminated in urine.

Foglio illustrativo

                                Jardian
®
Empagliflozin
Tablet
DESCRIPTION
Empagliflozin is an orally active SGLT-2 (sodium-glucose
co-transporter 2) receptor antagonist,
which targets the kidney for the excretion of excess glucose.
INDICATIONS
Empagliflozin is indicated as an adjunct to diet and exercise for the
treatment of type-2 diabetes.
It can be given alone or in combination with other oral antidiabetic
agents. It is also indicated for
reduction in cardiovascular risk in type-2 diabetic patients.
DOSAGE AND ADMINISTRATION
The usual recommended starting dose of Empagliflozin is 10 mg once
daily in the morning. The
dosage
of
Empagliflozin
can
be
increased
to
25
mg
once
daily.
Empagliflozin
may
be
administered with or without food.
CONTRAINDICATIONS
Empagliflozin
is
contraindicated
in
patients
with
a
history
of
serious
hypersensitivity
to
Empagliflozin or any of its components, severe renal impairment, end
stage renal disease, or
dialysis.
PRECAUTIONS
Empagliflozin should not be used in patients with type 1 diabetes or
for the treatment of diabetic
ketoacidosis.
For renal impaired patients, assessment of renal function is
recommended prior to initiation of
Empagliflozin and periodically thereafter. Empagliflozin should not be
initiated in patients with
an eGFR less than 45 ml/min/1.73 m2. No dose adjustment is needed in
patients with an eGFR
greater than or equal to 45 ml/min/1.73 m2. Empagliflozin should be
discontinued if eGFR is
persistently less than 45 ml/min/1.73m2.
Cases of hepatic injury have been reported with Empagliflozin in
clinical trials.
Osmotic diuresis accompanying therapeutic glucosuria may lead to a
modest decrease in blood
pressure. Therefore, caution should be exercised in patients with
known cardiovascular disease,
patients on anti-hypertensive therapy with a history of hypotension.
In case of conditions that may lead to fluid loss (e.g.
gastrointestinal illness), careful monitoring
of volume status and electrolytes is recommended. Temporary
interruption of treatment with
Empagliflozin should be considered until the f
                                
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