Januvia

Januvia

sitagliptin

Manufacturer:

MSD

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Sitagliptin phosphate
Indications/Uses
Adjunct to diet & exercise to improve glycemic control in type 2 DM as monotherapy or in combination w/ insulin (w/ or w/o metformin). For type 2 DM to improve glycemic control in combination w/ metformin as initial therapy, sulfonylurea, PPARγ agonist as initial therapy, metformin & sulfonylurea or metformin & PPARγ agonist (eg, thiazolidinediones) when diet & exercise plus the single agent do not provide adequate glycemic control.
Dosage/Direction for Use
Monotherapy or in combination w/ metformin, sulfonylurea, insulin (w/ or w/o metformin), PPARγ agonist (eg, thiazolidinediones), metformin + sulfonylurea, or metformin + PPARγ agonist: 100 mg once daily. Moderate renal impairment (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) or ESRD (eGFR <15 mL/min/1.73 m2) requiring hemodialysis or peritoneal dialysis 25 mg once daily.
Administration
May be taken with or without food.
Contraindications
Special Precautions
Discontinue if hypersensitivity reaction including, anaphylaxis, angioedema & exfoliative skin conditions including SJS; pancreatitis; bullous pemphigoid is suspected. Not to be used in treating type 1 diabetes or diabetic ketoacidosis. Acute pancreatitis, including fatal & non-fatal hemorrhagic or necrotizing pancreatitis. Increased risk of severe joint pain. Hypoglycemia in combination w/ sulfonylurea or insulin. Not to be used concomitantly w/ alcohol. Not recommended during pregnancy. Not to be used during lactation. Childn <10 yr; <18 yr. Elderly w/ renal impairment.
Adverse Reactions
Hypoglycemia, abdominal pain, nausea, vomiting, diarrhea. Combination therapy: Headache, URTI, cough, fungal skin infection, peripheral edema, dyspepsia, flatulence, flu. Pancreatitis.
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.
Presentation/Packing
Form
Januvia FC tab 100 mg
Packing/Price
28's
Form
Januvia FC tab 50 mg
Packing/Price
28's
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