药品信息: 英文药名:Xigduo(dapagliflozin+metformin)Tablet
中文药名:达格列净/盐酸二甲双胍复方片
生产厂家:阿斯利康和百时美施贵宝
药品介绍:
名称:达格列净+二甲双胍片
英文名:dapagliflozin/metformin
商品名:Xigduo
规格:5mg/850mg 5mg/1000 mg
厂家:施贵宝-阿斯利康
Xigduo (dapagliflozin + metformin): first SGLT2 inhibitor combination tablet
Xigduo (dapagliflozin + metformin) has been launched for the treatment of type II diabetes.
The twice-daily combination tablet, launched by Bristol-Myers Squibb and AstraZeneca, contains the sodium-glucose cotransporter 2 (SGLT2) inhibitor, dapagliflozin, and the biguanide, metformin.
Xigduo is licensed for use alongside diet and exercise to treat type II diabetes in adults who are inadequately controlled on metformin alone, inadequately controlled on other hypoglycaemic agents (including insulin) plus metformin, or currently taking the combination as separate tablets.
Xigduo is given as a single tablet twice daily and is available in two strengths: dapagliflozin 5mg/metformin 850mg and dapagliflozin 5mg/metformin 1g. Prescribers should select the initial dose of Xigduo based on the patient's current metformin dose. Both strengths cost £36.59 for 56 tablets.
If Xigduo is to be added to a regimen containing insulin or a sulfonylurea, prescribers should consider reducing the dose of insulin and/or sulfonylurea to reduce the risk of hypoglycaemia.
Xigduo 5 mg/850 mg & 5 mg/1,000 mg film coated tablets
1. Name of the medicinal product
Xigduo 5 mg/850 mg film-coated tablets
Xigduo 5 mg/1,000 mg film-coated tablets
2. Qualitative and quantitative composition
5 mg/850 mg:
Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin and 850 mg of metformin hydrochloride.
For the full list of excipients, see section 6.1.
5 mg/1,000 mg:
Each tablet contains dapagliflozin propanediol monohydrate equivalent to 5 mg dapagliflozin and 1,000 mg of metformin hydrochloride.
For the full list of excipients, see section 6.1.
3. Pharmaceutical form
Film-coated tablet (tablet).
5 mg/850 mg:
Brown, biconvex, 9.5 x 20 mm oval, film-coated tablets engraved with “5/850” on one side and “1067” engraved on the other side.
5 mg/1,000 mg:
Yellow, biconvex, 10.5 x 21.5 mm oval, film-coated tablets engraved with “5/1000” on one side and “1069” engraved on the other side.
4. Clinical particulars
4.1 Therapeutic indications
Xigduo is indicated in adults aged 18 years and older with type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycaemic control
• in patients inadequately controlled on their maximally tolerated dose of metformin alone
• in combination with other glucose-lowering medicinal products, including insulin, in patients inadequately controlled with metformin and these medicinal products (see sections 4.4, 4.5 and 5.1 for available data on different combinations)
• in patients already being treated with the combination of dapagliflozin and metformin as separate tablets.
4.2 Posology and method of administration
Posology
For patients inadequately controlled on metformin monotherapy or metformin in combination with other glucose-lowering medicinal products including insulin
The recommended dose is one tablet twice daily. Each tablet contains a fixed dose of dapagliflozin and metformin (see section 2). Patients not adequately controlled on metformin alone or in combination with other glucose-lowering medicinal products, including insulin, should receive a total daily dose of Xigduo equivalent to dapagliflozin 10 mg, plus the total daily dose of metformin, or the nearest therapeutically appropriate dose, already being taken. When Xigduo is used in combination with insulin or an insulin secretagogue such as sulphonylurea, a lower dose of insulin or sulphonylurea may be considered to reduce the risk of hypoglycaemia (see sections 4.5 and 4.8).
For patients switching from separate tablets of dapagliflozin and metformin
Patients switching from separate tablets of dapagliflozin (10 mg total daily dose) and metformin to Xigduo should receive the same daily dose of dapagliflozin and metformin already being taken or the nearest therapeutically appropriate dose of metformin.
Special populations
Renal impairment
No dose adjustment is recommended for patients with mild renal impairment. This medicinal product must not be used in patients with moderate to severe renal impairment (patients with creatinine clearance [CrCl] < 60 ml/min or estimated glomerular filtration rate [eGFR] < 60 ml/min/1.73 m2, see sections 4.3, 4.4, 4.8, 5.1 and 5.2).
Hepatic impairment
This medicinal product must not be used in patients with hepatic impairment (see sections 4.3, 4.4 and 5.2).
Elderly patients (≥ 65 years)
Because metformin is eliminated in part by the kidney, and because elderly patients are more likely to have decreased renal function, this medicinal product should be used with caution as age increases. Monitoring of renal function is necessary to aid in prevention of metformin-associated lactic acidosis, particularly in elderly patients (see sections 4.3 and 4.4). Risk of volume depletion with dapagliflozin should also be taken into account (see sections 4.4 and 5.2). Due to the limited therapeutic experience with dapagliflozin in patients 75 years and older, initiation of therapy in this population is not recommended.
Paediatric population
The safety and efficacy of Xigduo in children and adolescents aged 0 to < 18 years have not yet been established. No data are available.
Method of administration
Xigduo should be given twice daily with meals to redu |