Xelevia: 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 Side Effects Drug Interactions Storage MIMS Class ATC Classification Thai FDA Category Presentation/Packing Local Product Insert

Concise Prescribing Info

Contents

Sitagliptin phosphate

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, sulfonylurea, insulin (w/ or w/o metformin), PPARγ agonist (eg, 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) or w/ 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

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

Administration

May be taken with or without food.

Contraindications

Hypersensitivity.

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Warnings

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

Special Precautions

Discontinue treatment if hypersensitivity reaction including, anaphylaxis, angioedema & exfoliative skin conditions including SJS; pancreatitis; bullous pemphigoid is suspected. Not to be used in type I diabetes, diabetic ketoacidosis, severe infection or serious accident. Acute pancreatitis including fatal & non-fatal hemorrhagic or necrotizing pancreatitis. Increased risk of severe joint pain. Hypoglycemia in combination w/ sulfonylurea or insulin. Not to be used concomitantly w/ alcohol. Not recommended for use in pregnancy. Not to be used in nursing woman. Childn <10 yr. Elderly w/ renal impairment.

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Use In Pregnancy & Lactation

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Adverse Reactions

Hypoglycemia, abdominal pain, nausea, vomiting, diarrhea. Hypersensitivity reactions including anaphylaxis, angioedema, rash, urticaria, cutaneous vasculitis & exfoliative skin conditions including SJS; acute pancreatitis including fatal & non-fatal hemorrhagic & necrotizing pancreatitis; worsening renal function including acute renal failure (sometimes requiring dialysis); bullous pemphigoid; nasopharyngitis; constipation; arthralgia; myalgia; pain in extremity; back pain; pruritus. Combination therapy: Headache, URTI, cough, fungal skin infection, peripheral edema, dyspepsia, flatulence, flu.

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

Xelevia FC tab 100 mg

Packing/Price

4 × 7's

Xelevia

sitagliptin

Manufacturer:

Organon Pharma

Distributor:

Zuellig Pharma

Marketer:

Zuellig Pharma