Jardiance

Posology Type 2 diabetes mellitus 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. 73 m2 and need tighter glycaemic control, the dose can be increased to 25 mg once daily.

4). Heart failure The recommended dose is 10 mg empagliflozin once daily. Chronic kidney disease The recommended dose is 10 mg empagliflozin once daily. 8). If a dose is missed, it should be taken as soon as the patient remembers; however, a double dose should not be taken on the same day.

73 m2. 73 m2 the daily dose of empagliflozin is 10 mg. 73 m2. 2). Hepatic impairment No dose adjustment is required for patients with hepatic impairment. Empagliflozin exposure is increased in patients with severe hepatic impairment. 2).

Elderly No dose adjustment is recommended based on age. 8). Paediatric population The recommended starting dose is 10 mg empagliflozin once daily. 2). 73 m2 and children below 10 years of age. 4 The safety and efficacy of empagliflozin for the treatment of heart failure or for the treatment of chronic kidney disease in children under 18 years of age have not been established.

No data are available. Method of administration The tablets can be taken with or without food, swallowed whole with water.

Summary of the safety profile Type 2 diabetes mellitus A total of 15 582 patients with type 2 diabetes were included in clinical studies to evaluate the safety of empagliflozin, of which 10 004 patients received empagliflozin, either alone or in combination with metformin, a sulphonylurea, pioglitazone, DPP-4 inhibitors, or insulin.

In 6 placebo-controlled trials of 18 to 24 weeks duration, 3 534 patients were included of which 1 183 9 were treated with placebo and 2 351 with empagliflozin. The overall incidence of adverse events in patients treated with empagliflozin was similar to placebo.

The most frequently reported adverse reaction was hypoglycaemia when used with sulphonylurea or insulin (see description of selected adverse reactions). Heart failure The EMPEROR studies included patients with heart failure and either reduced ejection fraction (N = 3 726) or preserved ejection fraction (N = 5 985) treated with empagliflozin 10 mg or placebo.

Approximately half of the patients had type 2 diabetes mellitus. 4%. 7%). Chronic kidney disease The EMPA-KIDNEY study included patients with chronic kidney disease (N = 6 609) treated with 10 mg empagliflozin or placebo. About 44% of the patients had type 2 diabetes mellitus.

5%) which were more frequently reported in patients on placebo. The overall safety profile of empagliflozin was generally consistent across the studied indications. Tabulated list of adverse reactions Adverse reactions classified by system organ class and MedDRA preferred terms reported in patients who received empagliflozin in placebo-controlled studies are presented in the table below (Table 1).

The adverse reactions are listed by absolute frequency. Frequencies are defined as very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), or very rare (< 1/10 000), and not known (cannot be estimated from the available data).

4). Ketoacidosis Cases of ketoacidosis, including life-threatening and fatal cases, have been reported in patients with diabetes mellitus treated with SGLT2 inhibitors, including empagliflozin. In a number of cases, the presentation of the condition was atypical with only moderately increased blood glucose values, below 14 mmol/L (250 mg/dL).

It is not known if ketoacidosis is more likely to occur with higher doses of empagliflozin. Although ketoacidosis is less likely to occur in patients without diabetes mellitus, cases have also been reported in these patients. The risk of 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 ketoacidosis 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. Monitoring of ketones is recommended in these patients. Measurement of blood ketone levels is preferred to urine.

Treatment with empagliflozin may be restarted when the ketone values are normal and the patient’s condition has stabilised. Before initiating empagliflozin, factors in the patient history that may predispose to ketoacidosis should be considered.

Prolonged ketoacidosis and prolonged glucosuria have been observed with empagliflozin. 2). Empagliflozin-independent factors, such as insulin deficiency, might be involved in prolonged periods of ketoacidosis. g. type 2 diabetes patients with low C-peptide or latent autoimmune diabetes in adults (LADA) or patients with a history of pancreatitis), patients with conditions that lead to restricted food intake or severe dehydration, patients for whom insulin doses are reduced and patients with increased insulin requirements due to acute medical illness, surgery or alcohol abuse.

1.