Sitazuca 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 Caution For Usage Storage MIMS Class ATC Classification Thai FDA Category Presentation/Packing

Concise Prescribing Info

Contents

Sitagliptin

Indications/Uses

Adults w/ type 2 DM to improve glycaemic control as monotherapy in patients inadequately controlled by diet & exercise alone & for whom metformin is inappropriate due to contraindications or intolerance; in combination w/ metformin, sulphonylurea (when metformin is inappropriate due to contraindications or intolerance), or PPARγ agonist (ie, thiazolidinedione), & combination w/ sulphonylurea & metformin, or PPARγ agonist & metformin, when diet & exercise + single agent alone or dual therapy do not provide adequate glycaemic control. Add-on to insulin (w/ or w/o metformin) when diet & exercise + stable dose of insulin do not provide adequate glycaemic control.

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Dosage/Direction for Use

100 mg once daily. Moderate renal impairment (GFR ≥30 to <45 mL/min) 50 mg once daily. Severe renal impairment (GFR ≥15 to <30 mL/min) or ESRD (GFR <15 mL/min) including those requiring haemodialysis or peritoneal dialysis 25 mg once daily. May be administered w/o regard to timing of dialysis.

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Overdosage

View Sitazuca 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

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Special Precautions

Serious hypersensitivity reactions including anaphylaxis, angioedema & exfoliative skin conditions including SJS. Not to be used in patients w/ type 1 diabetes or for treatment of diabetic ketoacidosis; severe infection, or serious accident. Discontinue treatment if pancreatitis, hypersensitivity reaction, bullous pemphigoid are suspected; acute pancreatitis is confirmed. Hypoglycaemia. May increase risk of severe joint pain. Patients w/ history of pancreatitis. Not to be used concomitantly w/ alcohol. Take into account dizziness & somnolence when driving or using machines. Renal & severe hepatic impairment. Not to be used during pregnancy & breast-feeding. Not to be used in childn & adolescents 10-17 yr. Ped patients <10 yr.

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Use In Pregnancy & Lactation

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Adverse Reactions

Hypoglycaemia; headache. Exfoliative skin conditions including SJS.

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Drug Interactions

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

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Caution For Usage

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Storage

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Description

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

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

Sitazuca FC tab 100 mg

Packing/Price

2 × 14's

Form

Sitazuca FC tab 50 mg

Packing/Price

2 × 14's

Sitazuca

sitagliptin

Manufacturer:

Viatris

Distributor:

Zuellig Pharma