JARDIANCE FILM-COATED TABLET 25MG

BOEHRINGER INGELHEIM PHARMA GMBH & CO. KG - GERMANYROTTENDORF PHARMA GMBH (OSTENFELDER) - GERMANYBOEHRINGER INGELHEIM SEIYAKU CO. LTD. (JAPAN)🇸🇬 Health Sciences Authority

Approval Date: Dec 3, 2014
Approval ID: 8597969ed2dcd34b
Company: BOEHRINGER INGELHEIM PHARMA GMBH & CO. KG - GERMANYROTTENDORF PHARMA GMBH (OSTENFELDER) - GERMANYBOEHRINGER INGELHEIM SEIYAKU CO. LTD. (JAPAN)
Type: Therapeutic

Approval Details

Approval Id: 8597969ed2dcd34b
Drug Name: JARDIANCE FILM-COATED TABLET 25MG
Product Name: JARDIANCE FILM-COATED TABLET 25MG
Approval Number: SIN14687P
Approval Date: 2014-12-03
Registrant: BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.
Licence Holder: BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.
Drug Type: Therapeutic
Forensic Classification: PRESCRIPTION ONLY MEDICINES
Dosage Form: TABLET, FILM COATED
Dosage: 4.2 Posology and method of administration Posology Type 2 diabetes mellitus Monotherapy and add-on combination The recommended starting dose is 10 mg empagliflozin once daily for monotherapy and add-on combination therapy with other medicinal products including insulin. In patients tolerating empagliflozin 10 mg once daily and need tighter glycaemic control, the dose can be increased to 25 mg once daily. The maximum daily dose is 25 mg (see Renal impairment at section below and section 4.4 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). 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 (see sections 4.5 and 4.8 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Heart failure (HF) The recommended dose of JARDIANCE is 10 mg once daily (see clinical trial section – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Chronic kidney disease The recommended dose of JARDIANCE is 10 mg once daily (see clinical trial section – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Special populations Renal impairment Due to limited experience, it is not recommended to initiate treatment with JARDIANCE in patients on dialysis. Glycaemic efficacy of empagliflozin is dependent on renal function and reduced in patients with an eGFR <45 ml/min/1.73 m2 and likely absent in patients with an eGFR<30 ml/min/1.73 m2. If eGFR falls below 45 ml/min/1.73 m2 the recommended dose of empagliflozin is limited to 10 mg and additional glucose lowering treatment should be considered if needed (see Special warnings and precautions – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). 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 (see section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Elderly patients 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 (see sections 4.4 and 4.8 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Paediatric population Type 2 diabetes mellitus The recommended starting dose of JARDIANCE is 10 mg once daily. In patients tolerating empagliflozin 10 mg once daily and requiring additional glycaemic control, the dose can be increased to 25 mg once daily (see general information above in section 4.2 Dosage and Administration). No data are available for children with eGFR <60 ml/min/1.73 m2 and children below 10 years of age. Heart failure Safety and effectiveness of JARDIANCE for the treatment of heart failure in children under 18 years of age have not been established. Chronic kidney disease Safety and effectiveness of JARDIANCE for the treatment of CKD in children under 18 years of age have not been established. Method of administration 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.
Route Of Administration: ORAL
Indication Info: 4.1 Therapeutic indications Type 2 diabetes mellitus JARDIANCE is indicated in the treatment of type 2 diabetes mellitus to improve glycaemic control in adults and children aged 10 years and above as: Monotherapy When diet and exercise alone do not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate due to intolerance. Add-on combination therapy In combination with other glucose-lowering medicinal products including insulin, when these, together with diet and exercise, do not provide adequate glycaemic control (see sections 4.4, 4.5 and 5.1 for available data on different combinations – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Add-on combination in patients with established cardiovascular disease JARDIANCE is indicated as an adjunct to diet, exercise and standard care therapy to reduce the incidence of cardiovascular death in adult patients with type 2 diabetes mellitus and established cardiovascular disease who have inadequate glycemic control (see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Heart failure (HF) JARDIANCE is indicated in adult patients with heart failure (NYHA class II–IV), with or without type 2 diabetes mellitus to reduce the risk of cardiovascular death and hospitalisation for heart failure (see clinical trials – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information). Chronic kidney disease JARDIANCE is indicated to reduce the risk of sustained decline in eGFR, end-stage kidney disease, cardiovascular death, and hospitalisation in adults with chronic kidney disease at risk of progression.
Contraindications: 4.3 Contraindications Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.
Atc Code: A10BX12
Atc Item Name: xa 10 bx 12
Pharma Manufacturer Name: BOEHRINGER INGELHEIM SINGAPORE PTE. LTD.
Company Detail Path: /organization/boehringer-ingelheim-singapore-pte-ltd

Active Ingredients

Empagliflozin

25.00mg

Empagliflozin

25.00mg

Approved

Quick Info

Agency

HSA

Country

🇸🇬

Approval Date

Dec 3, 2014

Approval ID

8597969ed2dcd34b

Type

Therapeutic

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