Country: Singapúr
Tungumál: enska
Heimild: HSA (Health Sciences Authority)
Metformin Hydrochloride + 0.5% Magnesium Stearate; Saxagliptin hydrochloride anhydrous 2.79mg eqv saxagliptin
ASTRAZENECA SINGAPORE PTE LTD
A10BD10
1000.0 mg
TABLET, FILM COATED, EXTENDED RELEASE
Metformin Hydrochloride + 0.5% Magnesium Stearate 1000.0 mg; Saxagliptin hydrochloride anhydrous 2.79mg eqv saxagliptin 2.5mg
ORAL
Prescription Only
AstraZeneca Pharmaceuticals LP
ACTIVE
2012-02-29
Page 1 of 47 KOMBIGLYZE XR TABLET PHARMACEUTICAL FORMS AND STRENGTHS KOMBIGLYZE XR (saxagliptin and metformin HCl extended-release) 5 mg/500 mg tablets are light brown to brown, biconvex, capsule-shaped, film-coated tablets with “5/500” printed on one side and “4221” printed on the reverse side, in blue ink. KOMBIGLYZE XR (saxagliptin and metformin HCl extended-release) 5 mg/1000 mg tablets are pink, biconvex, capsule-shaped, film-coated tablets with “5/1000” printed on one side and “4223” printed on the reverse side, in blue ink. KOMBIGLYZE XR (saxagliptin and metformin HCl extended-release) 2.5 mg/1000 mg tablets are pale yellow to light yellow, biconvex, capsule-shaped, film-coated tablets with “2.5/1000” printed on one side and “4222” printed on the reverse side, in blue ink. THERAPEUTIC INDICATIONS KOMBIGLYZE XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate. [See _Clinical Studies_] IMPORTANT LIMITATIONS OF USE KOMBIGLYZE XR should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. KOMBIGLYZE XR has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at an increased risk for the development of pancreatitis while using KOMBIGLYZE XR. [See _Special Warnings and Precautions for Use_] POSOLOGY AND METHOD OF ADMINISTRATION RECOMMENDED DOSAGE The dosage of KOMBIGLYZE XR should be individualized on the basis of the patient’s current regimen, effectiveness, and tole Lestu allt skjalið
Page 1 of 61 KOMBIGLYZE XR TABLET PHARMACEUTICAL FORMS AND STRENGTHS KOMBIGLYZE XR (saxagliptin and metformin HCl extended-release) 5 mg/500 mg tablets are light brown to brown, biconvex, capsule-shaped, film-coated tablets with “5/500” printed on one side and “4221” printed on the reverse side, in blue ink. KOMBIGLYZE XR (saxagliptin and metformin HCl extended-release) 5 mg/1000 mg tablets are pink, biconvex, capsule-shaped, film-coated tablets with “5/1000” printed on one side and “4223” printed on the reverse side, in blue ink. KOMBIGLYZE XR (saxagliptin and metformin HCl extended-release) 2.5 mg/1000 mg tablets are pale yellow to light yellow, biconvex, capsule-shaped, film-coated tablets with “2.5/1000” printed on one side and “4222” printed on the reverse side, in blue ink. THERAPEUTIC INDICATIONS KOMBIGLYZE XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate [See Clinical Studies]. IMPORTANT LIMITATIONS OF USE KOMBIGLYZE XR should not be used for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. POSOLOGY AND METHOD OF ADMINISTRATION RECOMMENDED DOSAGE The dosage of KOMBIGLYZE XR should be individualized on the basis of the patient’s current regimen, effectiveness, and tolerability. KOMBIGLYZE XR should generally be Page 2 of 61 administered once daily with the evening meal, with gradual dose titration to reduce the gastrointestinal side effects associated with metformin. The following dosage forms are available: KOMBIGLYZE XR (saxagliptin and metformin HCl extended-release) tablets 5 mg/500 mg KOMBIGLYZE XR (saxagliptin and metformin HCl extended-release) tablets 5 mg/1000 mg KOMBIGLYZE XR (saxagliptin and metformin HCl extended-release) tablets 2.5 mg/1000 mg The recommended starting dose of KOMBIGLYZE XR in patients who need 5 mg of saxagliptin and who are not currently treated with metformin is 5 mg saxagl Lestu allt skjalið