Torsit 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 Side Effects Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Sitagliptin 50 mg, metformin HCl 1 g

Indications/Uses

Adjunct to diet & exercise to improve glycaemic control in patients inadequately controlled on their maximal tolerated dose of metformin alone or those already being treated w/ combination of sitagliptin & metformin, metformin & sulphonylurea or insulin, or metformin & PPARγ agonist.

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Dosage/Direction for Use

Adult w/ normal renal function (GFR ≥90 mL/min) Sitagliptin 50 mg bid (100 mg total daily dose) + dose of metformin already being taken. Patient switching from co-administration of sitagliptin & metformin Initiate at the dose of sitagliptin & metformin already being taken.

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Overdosage

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Administration

Should be taken with food.

Contraindications

Hypersensitivity. Lactic acidosis, diabetic ketoacidosis; diabetic pre-coma; severe renal failure (GFR <30 mL/min); acute conditions eg, dehydration, severe infection, shock, intravascular administration of iodinated contrast agents, acute or chronic disease which may cause tissue hypoxia eg, cardiac or resp failure, recent MI, shock, hepatic impairment, acute alcohol intoxication, alcoholism. Breastfeeding.

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Special Precautions

Hypersensitivity. Not to be used in patients w/ type I diabetes & for the treatment of diabetic ketoacidosis. Discontinue if acute pancreatitis occurs. Lactic acidosis. Temporarily discontinue in conditions w/ the potential to alter renal function. Risk for hypoglycemia. Discontinue if bullous pemphigoid is suspected. Discontinue at the time of surgery under general, spinal or epidural anaesth & may restarted no earlier than 48 hr following surgery or resumption of oral nutrition. Discontinue prior to or at the time of the imaging procedure & not restarted until at least 48 hr after re-evaluation of renal function & found to be stable. Assess GFR before initiation of treatment & at least annually thereafter. Not to be used during pregnancy. Elderly.

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Use In Pregnancy & Lactation

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Adverse Reactions

Hypoglycaemia. Nausea, flatulence, vomiting.

Drug Interactions

Not recommended w/ alcohol. Intravascular administration of iodinated contrast agents may lead to contrast-induced nephropathy, resulting in metformin accumulation & increased risk of lactic acidosis. May increase risk of lactic acidosis w/ NSAIDs, COX-II inhibitors, ACE inhibitors, AIIAs & loop diuretics; ranolazine, vandetanib, dolutegravir, & cimetidine. Intrinsic hyperglycemic activity w/ systemic & local glucocorticosteroids, β2 -agonists & diuretics. May decrease blood glucose levels w/ ACE inhibitors. Small effect on plasma digoxin conc.

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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

Torsit M FC tab

Packing/Price

30's (P585/box)

Torsit M

metformin + sitagliptin

Manufacturer:

Torrent

Distributor:

Torrent