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November 28, 2015


Company: Bristol-Myers Squibb Pharmaceuticals / AstraZeneca Pharmaceuticals (Ireland) Ltd.
Legal category: Prescription. GMS. Sport permitted.
Active ingredient: Saxagliptin (HCl) 5mg.
Description: Pink, biconvex, round, film-coated tablet, with 5 printed on one side and 4215 on the other side.
Presentation: 28, €38.47.
Indications: Add-on therapy to improve glycaemic control in adults with type 2 diabetes mellitus. With metformin, when metformin alone, with diet and exercise, does not provide adequate glycaemic control. With a sulphonylurea, when the sulphonylurea alone, with diet and exercise, does not provide adequate glycaemic control in patients for whom use of metformin is considered inappropriate. With a thiazolidinedione, when the thiazolidinedione alone with diet and exercise, does not provide adequate glycaemic control in patients for whom use of a thiazolidinedione is considered appropriate.

Pharmacology: Saxagliptin is a highly potent, selective, reversible, competitive, DPP-4 inhibitor. In patients with type 2 diabetes, administration of saxagliptin led to inhibition of DPP-4 enzyme activity for a 24-hour period.
Dosage: Adult: 5 mg once daily as add-on therapy. Safety and efficacy not established as part of triple therapy. Elderly: As per adults; caution. Children: Not recommended.
Contraindications: Hypersensitivity to the active substance or to any of the excipients. Pregnancy (unless necessary), lactation.
Special precautions: Not indicated for type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. Not recommended: Moderate to severe renal impairment, severe hepatic impairment. Safety not established: Cardiac failure (NYHA class III-IV), immunocompromised. Caution: Moderate hepatic impairment, elderly, NYHA class I-II. Monitoring for skin disorders (blistering, ulceration or rash) recommended. Contains lactose.
Drug interactions: Potent CYP3A4/5 inducers and inhibitors.
Adverse drug reactions: Infections, hypoglycaemia (with sulphonylurea), headache, vomiting, peripheral oedema (with thiazolidinedione).
Full prescribing information and references available from Bristol-Myers Squibb Pharmaceuticals. Telephone: 1800 749749.