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Image 0 of Kombiglyze XR 2.5-1000mg Tabs 60 By Astra Zeneca PharmaImage 1 of Kombiglyze XR 2.5-1000mg Tabs 60 By Astra Zeneca Pharma

Kombiglyze XR 2.5-1000mg Tabs 60 By Astra Zeneca Pharma

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Kombiglyze XR 2.5-1000mg Tabs 60 By Astra Zeneca Pharma This Item Requires A Valid Order From A Physician Licensed in USA. Item Number.:RXB10146493/RXD5043898/RXa612564/RXA323808
Size : 60
Selling UoM : EA
NDC: 00310-6125-60
UPC Barcode : 303106125609
Supplier: 0050000958 ASTRA ZENECA PHARM
Supplier Material : 612560
Generic Code : 066818 SAXAGLIPTIN HCL/METFORMIN HCL ORAL TBMP
Fine Line Class : 850085008510 All Rx Products
Product Category : RX Pharmaceuticals
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Product Description.:

2.5/1000, 4222
tablet , film-coated , yellow , oblong oblong
Blue inkPale to light yellowBiconvex

KOMBIGLYZE XR is a dipeptidyl peptidase-4 inhibitor and biguanide combination
product 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. (1, 14)
Important limitations of use:
? Not for treatment of type 1 diabetes or diabetic ketoacidosis. (1.1)
? Has not been studied in combination with insulin. (1.1)
------------------------- DOSAGE AND ADMINISTRATION --------------------------
? Administer once daily with the evening meal. (2.1)
? Individualize the starting dose based on the patient?s current regimen then adjust
the dose based on effectiveness and tolerability. (2.1)
? Do not exceed a daily dose of 5 mg saxagliptin/2000 mg metformin HCl
extended-release. (2.1)
? Swallow whole. Never crush, cut, or chew. (2.1)
? Limit the saxagliptin dose to 2.5 mg daily for patients also taking strong
cytochrome P450 3A4/5 inhibitors (e.g., ketoconazole). (2.2, 7.1)
------------------------ DOSAGE FORMS AND STRENGTHS ------------------------
Tablets:
? 5 mg saxagliptin/500 mg metformin HCl extended-release (3)
? 5 mg saxagliptin/1000 mg metformin HCl extended-release (3)
? 2.5 mg saxagliptin/1000 mg metformin HCl extended-release (3)
------------------------------- CONTRAINDICATIONS -------------------------------
? Renal impairment. (4)
? Hypersensitivity to metformin hydrochloride. (4)
? Metabolic acidosis, including diabetic ketoacidosis. (4, 5.1)
? Temporarily discontinue in patients undergoing radiologic studies with
intravascular administration of iodinated contrast materials. (4, 5.1, 5.10)
---------------------------WARNINGS AND PRECAUTIONS-------------------------
? Lactic acidosis: Warn patients against excessive alcohol intake. KOMBIGLYZE XR
(saxagliptin and metformin HCl extended-release) not recommended in hepatic
impairment and contraindicated in renal impairment. Ensure normal renal
function before initiating and at least annually thereafter. Temporarily discontinue
KOMBIGLYZE XR for surgical procedures necessitating restricted intake of food
and fluids. (4, 5.1, 5.2, 5.3, 5.6, 5.9)
? Vitamin B12 deficiency: Metformin may lower vitamin B12 levels. Measure
hematological parameters annually. (5.4, 6.1)
? Hypoglycemia: When used with an insulin secretagogue (e.g., sulfonylurea), a
lower dose of the insulin secretagogue may be required to reduce the risk of
hypoglycemia. (5.8)
? Macrovascular outcomes: No conclusive evidence of macrovascular risk
reduction with KOMBIGLYZE XR or any other antidiabetic drug. (5.12)
-------------------------------ADVERSE REACTIONS-------------------------------
? Adverse reactions reported in >5% of patients treated with metformin extendedrelease
and more commonly than in patients treated with placebo are: diarrhea
and nausea/vomiting. (6.1)
? Adverse reactions reported in ��% of patients treated with saxagliptin and more
commonly than in patients treated with placebo are: upper respiratory tract
infection, urinary tract infection, and headache. (6.1)
? Adverse reactions reported in ��% of treatment-naive patients treated with
coadministered saxagliptin and metformin and more commonly than in patients
treated with metformin alone are: headache and nasopharyngitis.
? Hypersensitivity-related events (e.g., urticaria, facial edema) were reported
more commonly in patients treated with saxagliptin than in patients treated with
placebo. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at
1-800-721-5072 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
-------------------------------- DRUG INTERACTIONS -----------------------------
? Coadministration with strong CYP3A4/5 inhibitors (e.g., ketoconazole)
significantly increases saxagliptin concentrations. Limit KOMBIGLYZE XR dose to
2.5 mg/1000 mg once daily. (2.2, 7.1)
? Cationic drugs eliminated by renal tubular secretion may reduce metformin
elimination: use with caution. (5.9, 7.2)
-------------------------- USE IN SPECIFIC POPULATIONS --------------------------
? No adequate and well-controlled studies in pregnant women. (8.1)
? Safety and effectiveness have not been established in children. (8.4)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient
labeling
Revised: 11/2010