Reditn: Side Effects & Dosing

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 Thai FDA Category Presentation/Packing

Concise Prescribing Info

Contents

Sitagliptin

Indications/Uses

Adjunct to diet & exercise to improve glycemic control in type 2 DM as monotherapy or in combination w/ insulin (w/ or w/o metformin). For type 2 DM to improve glycemic control in combination w/ metformin as initial therapy, sulfonylurea, PPARγ agonist as initial therapy, metformin & sulfonylurea or metformin & PPARγ agonist (eg, thiazolidinediones) when diet & exercise plus the single agent do not provide adequate glycemic control.

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Dosage/Direction for Use

100 mg once daily as monotherapy or combination therapy w/ metformin, sulfonylurea, insulin (w/ or w/o metformin), PPARγ agonist (eg, thiazolidinediones), metformin + sulfonylurea, or metformin + PPARγ agonist. 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, 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

Known serious hypersensitivity (eg, anaphylaxis, angioedema).

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Special Precautions

Discontinue use if hypersensitivity reactions, pancreatitis, bullous pemphigoid are suspected. Consider discontinuation if heart failure develops. Observe for signs & symptoms of pancreatitis; heart failure during therapy. History of angioedema w/ another dipeptidyl peptidase-4 inhibitor. Severe & disabling arthralgia. Hypoglycemia in combination w/ sulfonylurea or insulin. Possible loss of glycemic control during periods of stress (eg, fever, trauma, infection, surgery). Assess renal function prior to treatment initiation & periodically thereafter. Take into account dizziness & somnolence when driving or using machines. Moderate to severe renal impairment. 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

Nasopharyngitis, URTI, peripheral edema, headache, hypoglycemia, diarrhea.

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Drug Interactions

Slight increase in plasma conc & AUC of digoxin. Increased risk of hypoglycemia w/ insulin & sulfonylureas (eg, glimepiride). Potential additive effect on active glucagon-like peptide conc w/ metformin.

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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.

Thai FDA Category

Presentation/Packing

Form

Reditn FC tab 100 mg

Packing/Price

3 × 10's

Form

Reditn FC tab 50 mg

Packing/Price

3 × 10's

Reditn

sitagliptin

Manufacturer:

Dr. Reddy's

Distributor:

Zuellig Pharma

Marketer:

Dr. Reddy's