Adempa Tablet 10mg
10 tabletsProduct Information
ADEMPA
Presentation
Adempa 10 : Pale yellow, round shaped film coated tablet; each tablet contains Empagliflozin INN10 mg.
Adempa 25 : Pale yellow, oval shaped film coated tablet; each tablet contains Empagliflozin INN 25 mg.
Indications
Empagliflozin is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to
diet and exercise.
– as monotherapy when metformin is considered inappropriate due to intolerance and
– in addition to other medicinal products for the treatment of diabetes.
Dose and administration
The recommended starting dose is 10 mg Empagliflozin once daily for monotherapy and add-on combination therapy with other
medicinal products for the treatment of diabetes. In patients tolerating Empagliflozin 10 mg once daily who have an eGFR =60
ml/min/1.73 m2 and need tighter glycaemic control, the dose can be increased to 25 mg once daily. The maximum daily dose is 25 mg
. When Empagliflozin is used in combination with a sulphonylurea or with insulin, a lower dose of the sulphonylurea or insulin may
be considered to reduce the risk of hypoglycaemia.
Renal impairment: Due to the mechanism of action, the glycaemic efficacy of Empagliflozin is dependent on renal function. No dose
adjustment is required for patients with an eGFR =60 ml/min/1.73 m2 or CrCl =60 ml/min. Empagliflozin should not be initiated in
patients with an eGFR <60 ml/min/1.73 m2 or CrCl <60 ml/min. In patients tolerating Empagliflozin whose eGFR falls persistently
below 60 ml/min/1.73 m2 or CrCl below 60 ml/min, the dose of Empagliflozin should be adjusted to or maintained at 10 mg once
daily. Empagliflozin should be discontinued when eGFR is persistently below 45 ml/min/1.73 m2 or CrCl persistently below 45
ml/min. Empagliflozin should not be used in patients with end stage renal disease (ESRD) or in patients on dialysis as it is not
expected to be effective in these patients. Hepatic impairment: No dose adjustment is required for patients with hepatic
impairment. Empagliflozin exposure is increased in patients with severe hepatic impairment. Therapeutic experience in patients
with severe hepatic impairment is limited and therefore not recommended for use in this population . Elderly: No dose adjustment
is recommended based on age. In patients 75 years and older, an increased risk for volume depletion should be taken into account.
In patients aged 85 years and older, initiation of Empagliflozin therapy is not recommended due to the limited therapeutic
experience. Paediatric population: The safety and efficacy of Empagliflozin in children and adolescents has not yet been
established. No data are available. The tablets can be taken with or without food, swallowed whole with water. If a dose is
missed, it should be taken as soon as the patient remembers. A double dose should not be taken on the same day.
Contra-indications, Warning etc. Hypersensitivity to the active substance or to any of the excipients. Diabetic ketoacidosis: Rare
cases of diabetic ketoacidosis (DKA), including life-threatening and fatal cases, have been reported in patients treated with
SGLT2 inhibitors, including empagliflozin. The risk of diabetic ketoacidosis must be considered in the event of non-specific
symptoms such as nausea, vomiting, anorexia, abdominal pain, excessive thirst, difficulty breathing, confusion, unusual fatigue or
sleepiness. Patients should be assessed for ketoacidosis immediately if these symptoms occur, regardless of blood glucose level.
In patients where DKA is suspected or diagnosed, treatment with empagliflozin should be discontinued immediately. Treatment should
be interrupted in patients who are hospitalised for major surgical procedures or acute serious medical illnesses. In both cases,
treatment with empagliflozin may be restarted once the patient's condition has stabilised. Before initiating empagliflozin,
factors in the patient history that may predispose to ketoacidosis should be considered. The safety and efficacy of empagliflozin
in patients with type 1 diabetes have not been established and empagliflozin should not be used for treatment of patients with
type 1 diabetes. Limited data from clinical trials suggest that DKA occurs with common frequency when patients with type 1
diabetes are treated with SGLT2 inhibitors. Renal impairment: In patients tolerating Empagliflozin whose eGFR falls persistently
below 60 ml/min/1.73 m2 or CrCl below 60 ml/min, the dose of Empagliflozin should be adjusted to or maintained at 10 mg once
daily. Empagliflozin should be discontinued when eGFR is persistently below 45 ml/min/1.73 m2 or CrCl persistently below 45
ml/min. Empagliflozin should not be used in patients with end stage renal disease (ESRD) or in patients on dialysis as it is not
expected to be effective in these patients. Monitoring of renal function: Due to the mechanism of action, the glycaemic efficacy
of empagliflozin is dependent on renal function. Therefore assessment of renal function is recommended as follows: - Prior to
empagliflozin initiation and periodically during treatment, i.e. at least yearly. - Prior to initiation of any concomitant
medicinal product that may have a negative impact on renal function. Hepatic Injury: Cases of hepatic injury have been reported
with empagliflozin in clinical trials. A causal relationship between empagliflozin and hepatic injury has not been established.
Elevated haematocrit: Haematocrit increase was observed with empagliflozin treatment. Elderly: No dose adjustment is recommended
based on age. In patients 75 years and older, an increased risk for volume depletion should be taken into account. In patients
aged 85 years and older, initiation of Empagliflozin therapy is not recommended due to the limited therapeutic experience.
Therefore, special attention should be given to their volume intake in case of co-administered medicinal products which may lead
to volume depletion (e.g. diuretics, ACE-inhibitors). Risk for volume depletion: Based on the mode of action of SGLT-2 inhibitors,
osmotic diuresis accompanying therapeutic glucosuria may lead to a modest decrease in blood pressure. Therefore, caution should be
exercised in patients for whom an empagliflozin-induced drop in blood pressure could pose a risk, such as patients with known
cardiovascular disease, patients on anti-hypertensive therapy with a history of hypotension or patients aged 75 years and older.
Urinary tract infections: Post-marketing cases of complicated urinary tract infections including pyelonephritis and urosepsis have
been reported in patients treated with empagliflozin. Temporary interruption of empagliflozin should be considered in patients
with complicated urinary tract infections. Drug Interaction: Diuretics. Empagliflozin may add to the diuretic effect of thiazide
and loop diuretics and may increase the risk of dehydration and hypotension. Insulin and insulin secretagogues: Insulin and
insulin secretagogues, such as sulphonylureas, may increase the risk of hypoglycaemia. Therefore, a lower dose of insulin or an
insulin secretagogue may be required to reduce the risk of hypoglycaemia when used in combination with empagliflozin. Effects of
Empagliflozin on other medicinal products: Interaction studies conducted in healthy volunteers suggest that Empagliflozin had no
clinically relevant effect on the pharmacokinetics of metformin, glimepiride, pioglitazone, sitagliptin, linagliptin, simvastatin,
warfarin, ramipril, digoxin, diuretics and oral contraceptives. Use in Pregnancy and lactation: As a precautionary measure, it is
preferable to avoid the use of Empagliflozin during pregnancy.No data in humans are available on excretion of Empagliflozin into
milk. Empagliflozin should not be used during breast-feeding. Empagliflozin has minor influence on the ability to drive and use
machines. Patients should be advised to take precautions to avoid hypoglycaemia while driving and using machines. Pharmaceutical
Precaution Store in a cool and dry place, protected from light. Packaging quantities Adempa 10 : Carton containing 10 tablets in
Alu-Alu blister. Adempa 25 : Carton containing 10 tablets in Alu-Alu blister. Manufactured by UniMed UniHealth Pharmaceuticals
Limited B K Bari, Gazipur, Bangladesh ® Registered Trademark