Onglyza 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

Saxagliptin HCl

Indications/Uses

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

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Dosage/Direction for Use

5 mg once daily.

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Overdosage

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Administration

May be taken with or without food: Do not split/cut tab.

Contraindications

History of serious hypersensitivity reactions eg, anaphylaxis, angioedema or exfoliative skin conditions.

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Special Precautions

Discontinue use if serious hypersensitivity reaction, pancreatitis, severe & disabling arthralgia or bullous pemphigoid is suspected. Not to be used in type 1 DM or diabetic ketoacidosis. History of angioedema to another dipeptidyl peptidase-4 inhibitor; heart failure. Assess renal function prior to & periodically thereafter. Concomitant use of sulfonylurea or insulin. Not recommended in moderate or severe renal impairment, ESRD requiring hemodialysis. Pregnancy & lactation. Ped patients <18 yr. Elderly.

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Use In Pregnancy & Lactation

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Adverse Reactions

URTI, UTI, headache.

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Drug Interactions

Increased exposure by ketoconazole. Increased plasma conc w/ strong CYP3A4/5 inhibitors eg, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin.

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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

A10BH03 - saxagliptin ; Belongs to the class of dipeptidyl peptidase 4 (DPP-4) inhibitors. Used in the treatment of diabetes.

Regulatory Classification

Patient Counseling Information

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Presentation/Packing

Form

Onglyza FC tab 2.5 mg

Packing/Price

28's

Form

Onglyza FC tab 5 mg

Packing/Price

28's

Onglyza

Manufacturer:

AstraZeneca

Distributor:

Zuellig Pharma

Marketer:

Zuellig Pharma