Siglivia: Side Effects & Dosing

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 phosphate monohydrate

Indications/Uses

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

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Dosage/Direction for Use

Monotherapy or combination therapy 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

View Siglivia overdosage for action to be taken in the event of an overdose.

Administration

May be taken with or without food.

Contraindications

Patients w/ known serious hypersensitivity.

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Warnings

For additional cautionary notes to warn of the potential risk of using the medicine... Click to view Siglivia detailed prescribing information

Special Precautions

Not to be used in type I diabetes, diabetic ketoacidosis, severe infection or serious accident. Discontinue treatment & other potential medicinal products if pancreatitis, hypersensitivity reaction, or bullous pemphigoid is suspected. Anaphylaxis, angioedema, & exfoliative skin conditions including SJS. Patients should be advised to report development of blisters or erosions while on therapy. May increase risk of severe joint pain. Acute pancreatitis including fatal & non-fatal hemorrhagic or necrotizing pancreatitis. Consider lowering dose of sulfonylurea or insulin to reduce risk of sulfonylurea- or insulin-induced hypoglycemia. Not to be used concomitantly w/ alcohol. May affect ability to drive & use machines. 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; headache; URTI, nasopharyngitis; peripheral edema. SJS.

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Drug Interactions

Monitor appropriately patients receiving digoxin.

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Storage

View Siglivia storage conditions for details to ensure optimal shelf-life.

Description

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

Action

View Siglivia mechanism of action for pharmacodynamics and pharmacokinetics details.

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

Siglivia FC tab 100 mg

Packing/Price

3 × 10's

Form

Siglivia FC tab 50 mg

Packing/Price

3 × 10's

Siglivia

sitagliptin

Manufacturer:

Siam Bheasach

Distributor:

Siam Pharmaceutical

Marketer:

Siam Pharmaceutical