Xiglip M 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 Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Per 50 mg/500 mg FC tab Sitagliptin phosphate monohydrate 50 mg, metformin HCl 500 mg. Per 50 mg/1,000 mg FC tab Sitagliptin phosphate monohydrate 50 mg, metformin HCl 1,000 mg

Indications/Uses

As an adjunct to diet & exercise to improve glycemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those treated w/ the combination of sitagliptin & metformin. In combination w/ sulphonylurea (eg, triple combination therapy) as an adjunct to diet & exercise in patients inadequately controlled on their maximal tolerated dose of metformin & sulphonylurea; as triple combination therapy w/ peroxisome proliferator-activated receptor γ (PPARγ) agonist (eg, a thiazolidinedione) as an adjunct to diet & exercise in patients inadequately controlled on their maximal tolerated dose of metformin & PPARγ agonist. As add-on to insulin (eg, triple combination therapy) as an adjunct to diet & exercise to improve glycemic control in patients when stable dose of insulin & metformin alone do not provide adequate glycemic control.

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Dosage/Direction for Use

Individualized dosage. Max daily dose: Sitagliptin 100 mg & metformin 2,000 mg. Patient not currently treated w/ metformin Recommended starting dose: Sitagliptin 50 mg & metformin 500 mg bid. Patient already treated w/ metformin Initially sitagliptin 50 mg bid & the dose of metformin already being taken. Patient taking metformin HCl 850 mg bid Initially sitagliptin 50 mg & metformin 1 g bid.

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Overdosage

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Administration

Should be taken with food.

Contraindications

Hypersensitivity. Severe renal impairment (eGFR <30 mL/min/1.73 m²); metabolic acidosis, including diabetic ketoacidosis.

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Special Precautions

Serious allergic & hypersensitivity reactions may occur eg, anaphylaxis, angioedema, & exfoliative skin conditions including SJS. Discontinue if pancreatitis, bullous pemphigoid is suspected. Discontinued at time of, or prior to, iodinated contrast imaging procedures. Lactic acidosis. Patients w/ known risk factors for heart failure. Severe & disabling arthralgia. Concomitant use w/ insulin &/or an insulin secretagogue. Acute renal failure. Not recommended in patients w/ eGFR 30-<45 mL/min/1.73 m². Not to be used in patients w/ eGFR <30 mL/min/1.73 m². Not recommended in pregnancy & lactation. Metformin: May lower vit B levels. Measure hematologic parameters annually & vit B at 2-3 yr intervals & manage any abnormalities.

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Use In Pregnancy & Lactation

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Adverse Reactions

Diarrhea, URTI, & headache.

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Drug Interactions

Increased risk of lactic acidosis w/ carbonic anhydrase inhibitors. Metformin: Decreased clearance w/ ranolazine, vandetanib, dolutegravir, & cimetidine. Potentiated effect w/ alcohol.

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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

A10BD07 - metformin and sitagliptin ; Belongs to the class of combinations of oral blood glucose lowering drugs. Used in the treatment of diabetes.

Regulatory Classification

Presentation/Packing

Form

Xiglip M 50 mg/1 g FC tab

Packing/Price

30's

Form

Xiglip M 50 mg/500 mg FC tab

Packing/Price

30's

Xiglip M

metformin + sitagliptin

Manufacturer:

Fredun Pharmaceuticals

Distributor:

Cathay YSS