Kombiglyze XR Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage Patient Counseling Information MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Per 2.5 mg/1,000 mg XR-FC tab Saxagliptin 2.5 mg, metformin HCl extended-release 1,000 mg. Per 5 mg/500 mg XR-FC tab Saxagliptin 5 mg, metformin HCl extended-release 500 mg. Per 5 mg/1,000 mg XR-FC tab Saxagliptin 5 mg, metformin HCl extended-release 1,000 mg

Indications/Uses

Adjunct to diet & exercise to improve glycemic control in adults w/ type 2 DM.

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Dosage/Direction for Use

Individualized dosage. Recommended initial dose: Saxagliptin 5 mg/metformin HCl extended-release 500 mg once daily. Max daily dose: Saxagliptin 5 mg & metformin HCl extended-release 2,000 mg.

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Overdosage

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Administration

Should be taken with food: Take w/ evening meal. Swallow whole, do not chew/crush/cut tab.

Contraindications

Hypersensitivity to metformin or saxagliptin. Acute or chronic metabolic acidosis including diabetic ketoacidosis. Severe renal impairment (eGFR <30 mL/min/1.73 m²).

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Special Precautions

Discontinue use if hypersensitivity occurs or metformin-associated lactic acidosis, pancreatitis, severe & disabling arthralgia or bullous pemphigoid is suspected. Not to be used in type 1 DM or diabetic ketoacidosis. Heart failure; CV collapse (shock), acute CHF & MI & other conditions associated w/ hypoxemia. Assess renal function prior to & at least annually after treatment. Perform routine serum vit B₁₂ measurement at 2- to 3-yr intervals. Temporarily discontinue treatment prior to, during or 48 hr after iodinated contrast agent administration & surgery. Avoid excessive alcohol intake. Concomitant use of sulfonylurea or insulin. Not recommended in hepatic impairment & patients w/ eGFR 30-45 mL/min/1.73 m². Pregnancy & lactation. Childn <18 yr. Elderly >65 yr.

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Use In Pregnancy & Lactation

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Adverse Reactions

Diarrhea, nausea & vomiting, URTI, UTI, headache, nasopharyngitis. Heart failure, bullous pemphigoid, hypoglycemia, hypersensitivity reactions, acute pancreatitis, severe & disabling arthralgia.

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Drug Interactions

Increased risk of lactic acidosis w/ topiramate or other carbonic anhydrase inhibitors eg, zonisamide, acetazolamide or dichlorphenamide. Hyperglycemia & loss of glycemic control w/ thiazides, other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, OCs, phenytoin, nicotinic acid, sympathomimetics, Ca-channel blockers & INH. Saxagliptin: Increased plasma conc w/ strong CYP3A4/5 inhibitors eg, ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin. Hypoglycemia w/ insulin secretagogues or insulin. Metformin: Increased systemic exposure w/ organic cationic transporter-2 or multidrug & toxin extrusion inhibitors eg, ranolazine, vandetanib, dolutegravir, cimetidine. Potentiated effect w/ alcohol.

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Storage

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Description

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Action

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MIMS Class

Antidiabetic Agents

ATC Classification

A10BD10 - metformin and saxagliptin ; Belongs to the class of combinations of oral blood glucose lowering drugs. Used in the treatment of diabetes.

Regulatory Classification

Patient Counseling Information

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Presentation/Packing

Form

Kombiglyze XR 2.5 mg/1,000 mg XR-FC tab

Packing/Price

56's

Form

Kombiglyze XR 5 mg/1,000 mg XR-FC tab

Packing/Price

28's

Form

Kombiglyze XR 5 mg/500 mg XR-FC tab

Packing/Price

28's

Kombiglyze XR

Manufacturer:

AstraZeneca

Distributor:

Zuellig Pharma

Marketer:

Zuellig Pharma