Januvia 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 Patient Counseling Information MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Sitagliptin phosphate

Indications/Uses

Monotherapy as an adjunct to diet & exercise to improve glycemic control in patients w/ type 2 DM. Combination therapy w/ metformin, sulfonylurea or PPARγ agonist (eg, thiazolidinediones) to improve glycemic control in patients w/ type 2 DM when monotherapy, w/ diet & exercise, does not provide adequate glycemic control. Combination therapy w/ metformin & sulfonylurea to improve glycemic control in patients w/ type 2 DM when dual therapy w/ these agents, w/ diet & exercise, does not provide adequate glycemic control. Add-on to insulin (w/ or w/o metformin) when diet, exercise & stable insulin dose do not provide adequate glycemic control.

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Dosage/Direction for Use

100 mg once daily. Moderate renal impairment (eGFR ≥30-<45 mL/min/1.73 m²) 50 mg once daily. Severe renal impairment (eGFR ≥15-<30 mL/min/1.73 m²) or ESRD (eGFR <15 mL/min/1.73 m²) including those requiring hemodialysis or peritoneal dialysis 25 mg once daily. Concomitant use w/ insulin secretagogue (eg, sulfonylurea) or insulin Lower dose of insulin secretagogue (eg, sulfonylurea) or insulin may be required to reduce risk of hypoglycemia.

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Overdosage

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

Administration

May be taken with or without food.

Contraindications

History of serious hypersensitivity reaction (eg, anaphylaxis or angioedema).

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Special Precautions

Discontinue use, assess for other potential causes for the event & institute alternative treatment for diabetes if hypersensitivity reaction is suspected. Not to be used in patients w/ type 1 diabetes or for diabetic ketoacidosis. Patients w/ history of pancreatitis. Promptly discontinue use & initiate appropriate management if pancreatitis is suspected. Possible hypoglycemia when used in combination w/ insulin or sulfonylurea. Discontinue use & consider referral to dermatologist for diagnosis & appropriate treatment if bullous pemphigoid is suspected. Possible severe & disabling arthralgia. Macrovascular outcomes. Pregnancy & lactation. Not to be used in childn & adolescents 10-17 yr. Childn <10 yr. Elderly.

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Use In Pregnancy & Lactation

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Adverse Reactions

Hypoglycemia; GI reactions (eg, abdominal pain, nausea & diarrhea). Nasopharyngitis; URTI & headache.

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Drug Interactions

Slightly increased AUC & C_maxof digoxin.

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Storage

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Description

View Januvia 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.

Regulatory Classification

POM

Patient Counseling Information

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Presentation/Packing

Form

Januvia FC tab 100 mg

Packing/Price

28's

Form

Januvia FC tab 25 mg

Packing/Price

28's

Form

Januvia FC tab 50 mg

Packing/Price

28's

Januvia

sitagliptin

Manufacturer:

MSD

Distributor:

Zuellig Pharma