Maglitin Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Warnings 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 patients w/ type 2 DM as monotherapy, or in combination w/ metformin, sulfonylurea, or PPARγ agonist (ie, thiazolidinediones) as initial therapy, or combination w/ metformin & sulfonylurea, or metformin & PPARγ agonist (ie, thiazolidinediones), when single agent alone or dual therapy, w/ diet & exercise, does not provide adequate glycemic control. Adjunct to diet & exercise to improve glycemic control in combination w/ insulin (w/ or w/o metformin).

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Dosage/Direction for Use

Monotherapy or combination therapy w/ metformin, insulin (w/ or w/o metformin), PPARγ agonist (ie, thiazolidinediones), metformin + sulfonylurea, or metformin + PPARγ agonist 100 mg once daily. Moderate renal impairment [estimated GFR (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), ESRD (eGFR <15 mL/min/1.73 m²) & patients 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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Warnings

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Special Precautions

Discontinue treatment if pancreatitis; hypersensitivity reaction; bullous pemphigoid is suspected. Not to be used in patients w/ type 1 diabetes, severe infection or serious accident; for treatment of diabetic ketoacidosis. Anaphylaxis, angioedema, & exfoliative skin conditions including SJS. Acute pancreatitis including fatal & non-fatal hemorrhagic or necrotizing pancreatitis. Risk of sulfonylurea- or insulin-induced hypoglycemia. May increase risk of severe joint pain. Not to be used concomitantly w/ alcohol. Not recommended during pregnancy. Not to be used during lactation.

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Use In Pregnancy & Lactation

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Adverse Reactions

Hypoglycemia; diarrhea, nausea; increased serum creatinine; nasopharyngitis, URTI.

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Drug Interactions

Concomitant use w/ 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.

Thai FDA Category

Presentation/Packing

Form

Maglitin FC tab 100 mg

Packing/Price

3 × 10's

Maglitin

sitagliptin

Manufacturer:

M & H Manufacturing

Distributor:

B L H Trading

Marketer:

M & H Manufacturing