Adempa Tablet 10mg

Product 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