Jimvia: Side Effects & Dosing

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 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/ insulin, sulfonylurea, metformin or PPARγ agonist (ie, thiazolidinediones) as initial therapy, or combination w/ metformin & sulfonylurea, or metformin & PPARγ agonist (ie, thiazolidinediones), when single agent alone or dual therapy, w/ diet & exercise, does not provide adequate glycemic control.

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Dosage/Direction for Use

Monotherapy or combination therapy 100 mg once daily. Moderate renal impairment [estimated GFR (eGFR) ≥30 to <45 mL/min/1.73 m²] 50 mg once daily. Severe renal impairment (eGFR ≥15 to <30 mL/min/1.73 m²), ESRD (eGFR <15 mL/min/1.73 m²), patients requiring hemodialysis or peritoneal dialysis 25 mg once daily. May be administered w/o regard to timing of dialysis.

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Overdosage

View Jimvia overdosage for action to be taken in the event of an overdose.

Administration

May be taken with or without food.

Contraindications

Serious hypersensitivity.

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Warnings

For additional cautionary notes to warn of the potential risk of using the medicine... Click to view Jimvia detailed prescribing information

Special Precautions

Not to be used in type I DM, diabetic ketoacidosis, severe infection or serious accident. Discontinue treatment if signs/symptoms of hypersensitivity reaction occur; if pancreatitis is suspected. Anaphylaxis, angioedema & exfoliative skin reactions eg, SJS. Severe & disabling arthralgia; hemorrhagic & necrotizing acute pancreatitis. May increase risk of severe joint pain. Monitor for signs/symptoms of pancreatitis (severe & prolonged stomach pain). Assess renal function prior to treatment initiation & periodically thereafter. Consider lowering dose of sulfonylurea or insulin to reduce risk of sulfonylurea- or insulin-induced hypoglycemia. Not to be used concomitantly w/ alcohol. Worsening renal function including acute renal failure requiring dialysis. Severe hepatic impairment (Child-Pugh class C). Not recommended during pregnancy. Lactation. Ped patients <18 yr. Elderly w/ renal impairment.

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Use In Pregnancy & Lactation

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Adverse Reactions

Monotherapy: Peripheral edema; hypoglycemia; constipation, diarrhea, nausea; OA; nasopharyngitis, pharyngitis, viral URTI. Acne rosacea, acute pancreatitis (including hemorrhagic & necrotizing w/ some fatalities), acute renal failure (possibly requiring dialysis), anaphylaxis, anemia, bundle branch block, depression, erectile dysfunction, exfoliative dermatitis, gastritis (Helicobacter), GERD, HTN, hypersensitivity, hypersensitivity vasculitis, hypotension, increased liver enzymes, liver steatosis, migraine, orthostatic hypotension, pemphigoid, peripheral neuropathy, renal insufficiency, severe arthralgia, SJS.

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Drug Interactions

Increased risk of hypoglycemia w/ insulin secretagogues; thioctic acid; insulin or pramlintide; ACE inhibitors. Increased exposure & plasma conc of digoxin. May impair glucose regulation w/ somatostatin analogues. Blood glucose changes & increased risk of hypo-/hyperglycemia w/ fluoroquinolones. Decreased symptoms of hypoglycemia, or hypo-/hyperglycemia w/ β-blockers. Increased risk of hyperglycemia & insulin requirement w/ selected diuretics.

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Storage

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Description

View Jimvia 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

Jimvia FC tab 100 mg

Packing/Price

3 × 10's

Form

Jimvia FC tab 50 mg

Packing/Price

3 × 10's

Jimvia

sitagliptin

Manufacturer:

Unison

Distributor:

Medline

Marketer:

B.Grimm Pharma