Gliptadin 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 phosphate monohydrate

Indications/Uses

Adjunct to diet & exercise or in combination w/ metformin, sulfonylurea, PPARγ agonist, metformin & sulfonylurea, metformin & PPARγ agonist, & insulin, to improve glycemic control in patients w/ type 2 DM.

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Dosage/Direction for Use

Monotherapy or combination therapy 100 mg once daily. Patient w/ mild renal impairment (eGFR ≥60 mL/min/1.73 m² to <90 mL/min/1.73 m²) 100 mg once daily. Patient w/ moderate renal impairment (eGFR ≥45 mL/min/1.73 m² to <60 mL/min/1.73 m²) 100 mg once daily, (eGFR ≥30 mL/min/1.73 m² to <45 mL/min/1.73 m²) 50 mg once daily. Patient w/ severe renal impairment (eGFR ≥15 mL/min/1.73 m² 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 & may be administered w/o regard to timing of dialysis.

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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 occurs; pancreatitis or bullous pemphigoid is suspected. Not to be used in patients w/ type 1 diabetes or for diabetic ketoacidosis. Reports of acute pancreatitis including fatal & non-fatal hemorrhagic or necrotizing pancreatitis. Hypoglycemia in combination w/ sulfonylurea or w/ insulin. Patients w/ renal impairment. Not recommended in pregnancy. Not to be used by nursing woman. Safety & effectiveness in ped patients <18 yr have not been established. Elderly.

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Use In Pregnancy & Lactation

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Adverse Reactions

Hypoglycemia; headache.

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Storage

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Description

View Gliptadin description for details of the chemical structure and excipients (inactive components).

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

Gliptadin FC tab 100 mg

Packing/Price

100's (P38.5/film-coated tab, P3,850/box)

Form

Gliptadin FC tab 50 mg

Packing/Price

100's (P37.5/film-coated tab, P3,750/box)

Gliptadin

sitagliptin

Manufacturer:

Sydenham

Distributor:

MedChoice Endocrine Group