Sitagliptin Sandoz 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 Adverse Reactions Drug Interactions Caution For Usage 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, sulphonylurea, or PPARγ agonist (ie, thiazolidinedione) as initial therapy, or combination w/ metformin & sulphonylurea, or metformin & PPARγ agonist (ie, thiazolidinedione), 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 (GFR ≥30 to <45 mL/min/1.73 m²) 50 mg once daily. Severe renal impairment (GFR ≥15 to <30 mL/min/1.73 m²) or ESRD (GFR <15 mL/min/1.73 m²) including those requiring hemodialysis or peritoneal dialysis 25 mg once daily. May be administered w/o regards 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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Special Precautions

Discontinue use if hypersensitivity reactions, pancreatitis or bullous pemphigoid is suspected. Not to restart treatment if acute pancreatitis is confirmed. Not to be used in patients w/ type 1 diabetes or for treatment of diabetic ketoacidosis. Anaphylaxis, angioedema, & exfoliative skin conditions including SJS. Acute pancreatitis, persistent, severe abdominal pain; necrotising or haemorrhagic pancreatitis. Hypoglycaemia in combination w/ insulin or sulphonylurea. Dizziness & somnolence. Patients w/ history of pancreatitis. Assess renal function prior to initiation of therapy & periodically thereafter. May affect ability to drive & use machines. Severe hepatic impairment (Child-Pugh score >9). Not to be used during pregnancy & lactation. Not to be used in childn & adolescents 10-17 yr. Childn <10 yr.

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Use In Pregnancy & Lactation

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Adverse Reactions

Hypoglycemia. Monotherapy: Headache. Combination therapy: Flu, nausea & vomiting, flatulence, constipation, peripheral oedema.

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Drug Interactions

Altered pharmacokinetics w/ potent CYP3A4 inhibitors (ie, ketoconazole, itraconazole, ritonavir, clarithromycin) in patients w/ severe renal impairment or ESRD. Increased AUC & C_max of digoxin.

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Caution For Usage

For caution against possible variation of physical aspect of medicine... Click to view Sitagliptin Sandoz detailed prescribing information

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

Sitagliptin Sandoz FC tab 100 mg

Packing/Price

4 × 7's

Form

Sitagliptin Sandoz FC tab 50 mg

Packing/Price

4 × 7's

Sitagliptin Sandoz

sitagliptin

Manufacturer:

Sandoz

Distributor:

Zuellig Pharma

Marketer:

Sandoz