Bergliptin: Dosing, Side Effect & Interaction

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

Adjunct to diet & exercise to improve glycemic control as monotherapy in patients w/ type 2 DM & for whom metformin is contraindicated or not tolerated; or in combination w/ metformin, sulfonylurea, or PPARγ agonist (ie, thiazolidinedione) as initial therapy, or combination w/ metformin & sulfonylurea, or metformin & PPARγ agonist (ie, thiazolidinedione), when single agent alone or dual therapy, w/ maximal tolerated dose of sulfonylurea, 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

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 w/ ESRD (GFR <15 mL/min) 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

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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 use if hypersensitivity reactions (including anaphylaxis, angioedema & exfoliative skin conditions eg, SJS), pancreatitis or bullous pemphigoid is suspected. Do not restart treatment if acute pancreatitis is confirmed. Not to be used in patients w/ type 1 diabetes or for treatment of diabetic ketoacidosis. Severe infection or serious accident. May increase risk of severe joint pain. Acute pancreatitis, persistent, severe abdominal pain; necrotising or haemorrhagic pancreatitis. Hypoglycaemia in combination w/ insulin or sulfonylurea. Patients w/ history of pancreatitis. Not to be used concomitantly w/ alcohol. Assess renal function prior to initiation of therapy & periodically thereafter. Take into account dizziness & somnolence when driving or using machines. Severe hepatic impairment. Not to be used during pregnancy & breast-feeding. 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

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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

Bergliptin FC tab 100 mg

Packing/Price

3 × 10's

Form

Bergliptin FC tab 50 mg

Packing/Price

3 × 10's

Bergliptin

sitagliptin

Manufacturer:

Berlin Pharm

Marketer:

Berlin Pharm