Xigatin 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

Monotherapy: Adjunct to diet & exercise to improve glycemic control in patients w/ type 2 DM. Combination therapy: Type 2 DM to improve glycemic control in combination w/ metformin, sulphonylurea, metformin + sulphonylurea, PPARγ agonist (eg, thiazolidinediones), metformin + PPARγ agonist or insulin (w/ or w/o metformin) when diet & exercise + single agent do not provide adequate glycaemic control.

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Dosage/Direction for Use

100 mg once daily. Moderate renal impairment (eGFR ≥30 to 45 mL/min/1.73 m²) 50 mg once daily, severe renal impairment (eGFR ≥15 to <30 mL/min/1.73 m²) or ESRD (eGFR <15 mL/min/1.73 m²) 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: Swallow whole w/ sufficient liqd.

Contraindications

Hypersensitivity. Pregnancy & lactation.

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Special Precautions

Discontinue use if hypersensitivity reactions, pancreatitis, bullous pemphigoid are suspected. Not to be used in type 1 DM or diabetic ketoacidosis. Assess renal function prior to & periodically thereafter. Hypoglycaemia in combination w/ insulin or sulphonylurea. May affect ability to drive & use machines. Renal impairment. Not to be used during pregnancy & lactation. Not to be used in childn & adolescents 10-17 yr.

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Use In Pregnancy & Lactation

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Adverse Reactions

Hypoglycaemia; headache.

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Drug Interactions

Increased plasma conc of digoxin.

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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

Xigatin FC tab 100 mg

Packing/Price

3 × 10's

Xigatin

sitagliptin

Manufacturer:

Y.S.P. Industries

Distributor:

Y.S.P. Industries