Fortesia 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 Side Effects Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Sitagliptin phosphate monohydrate

Indications/Uses

Monotherapy: Adjunct to diet & exercise to improve glycaemic control in patients w/ type 2 DM. Combination therapy: Type 2 DM to improve glycaemic 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 plus single agent do not provide adequate glycaemic control.

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Dosage/Direction for Use

100 mg 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: May be split into half if necessary.

Contraindications

Hypersensitivity.

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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. Severe & disabling arthralgia. Assess renal function prior to & periodically thereafter. Hypoglycaemia in combination w/ sulfonylurea or insulin. May affect ability to drive & use machines. Renal impairment. Not recommended during pregnancy. Not to be used during lactation. Not to be used in childn & adolescents <18 yr. Elderly w/ renal impairment.

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Use In Pregnancy & Lactation

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Adverse Reactions

Hypoglycaemia; headache.

Storage

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Description

View Fortesia 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

Fortesia FC tab 100 mg

Packing/Price

3 × 10's

Fortesia

sitagliptin

Manufacturer:

Duopharma Manufacturing (Bangi)

Distributor:

Duopharma Marketing