Si2norm 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 MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Sitagliptin

Indications/Uses

Type 2 DM in adults to improve glycaemic control: as monotherapy; as dual oral therapy in combination w/ metformin, sulphonylurea, or peroxisome proliferator-activated receptor γ (PPARγ) agonist; or as triple oral therapy in combination w/ sulphonylurea + metformin, or a PPARγ agonist + metformin. Add-on to insulin (w/ or w/o metformin) when diet & exercise + stable dose of insulin do not provide adequate glycaemic control.

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Dosage/Direction for Use

Recommended dose: 100 mg once daily as monotherapy or as combination therapy w/ metformin, sulfonylurea, insulin (w/ or w/o metformin), PPARγ agonist (eg, thiazolidinediones), metformin + sulfonylurea, or metformin + PPARγ agonist. Patient w/ moderate renal impairment (eGFR ≥30 to <45 mL/min/1.73 m²) 50 mg once daily. Patient w/ severe renal impairment (eGFR ≥15 to <30 mL/min/1.73 m²) or ESRD (eGFR <15 mL/min/1.73 m²) including those requiring hemodialysis or peritoneal dialysis 25 mg once daily.

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Overdosage

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Administration

May be taken with or without food.

Contraindications

Hypersensitivity.

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Special Precautions

Discontinue use if hypersensitivity reaction or bullous pemphigoid is suspected. Not to be used in patients w/ type 1 diabetes or for the treatment of diabetic ketoacidosis. Risk of developing acute pancreatitis; caution in patients w/ history of pancreatitis. Risk of hypoglycaemia when used in combination w/ insulin or sulphonylurea. Patients w/ renal impairment. Do not use during pregnancy & breast-feeding.

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Use In Pregnancy & Lactation

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Adverse Reactions

Hypoglycaemia; headache. Pancreatitis, hypersensitivity reactions.

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Drug Interactions

Possible alteration in pharmacokinetics w/ potent CYP3A4 inhibitors (ie, ketoconazole, itraconazole, ritonavir, clarithromycin) in patients w/ severe renal impairment or ESRD. Increased plasma AUC of digoxin; monitor patients at risk of digoxin toxicity.

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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

A10BH01 - sitagliptin ; Belongs to the class of dipeptidyl peptidase 4 (DPP-4) inhibitors. Used in the treatment of diabetes.

Regulatory Classification

Presentation/Packing

Form

Si2norm FC tab 100 mg

Packing/Price

30's

Form

Si2norm FC tab 50 mg

Packing/Price

30's

Si2norm

sitagliptin

Manufacturer:

National Healthcare

Distributor:

Orange Biotec