Januvia健諾胰

Januvia

sitagliptin

Manufacturer:

MSD

Distributor:

Zuellig
/
Agencia Lei Va Hong
Concise Prescribing Info
Contents
Sitagliptin phosphate
Indications/Uses
Monotherapy or in combination w/ insulin (w/ or w/o metformin) in patients w/ type 2 DM as adjunct to diet & exercise to improve glycemic control. In combination w/ metformin or a PPARγ agonist (ie, thiazolidinediones) in patients w/ type 2 DM to improve glycemic control as initial therapy or when the single agent alone, w/ diet & exercise, provides inadequate glycemic control. In combination w/ a sulfonylurea in patients w/ type 2 DM to improve glycemic control when treatment w/ the maximal tolerated dose of a single agent alone, w/ diet & exercise, provides inadequate glycemic control & when metformin is inappropriate due to contraindications or intolerance. In combination w/ metformin & a sulfonylurea or a PPARγ agonist (ie, thiazolidinediones) in patients w/ type 2 DM to improve glycemic control when dual therapy w/ these agents, w/ diet & exercise, provides inadequate glycemic control.
Dosage/Direction for Use
100 mg once daily. Patient w/ moderate renal impairment (GFR ≥30 to <45 mL/min) 50 mg once daily. Patient w/ severe renal impairment (GFR ≥15 to <30 mL/min) or w/ end-stage renal disease (GFR <15 mL/min), including those requiring hemodialysis or peritoneal dialysis 25 mg once daily.
Administration
May be taken with or without food.
Contraindications
Special Precautions
Discontinue if hypersensitivity or bullous pemphigoid is suspected. Should not be used in patients w/ type 1 diabetes or for treatment of diabetic ketoacidosis. Reports of acute pancreatitis. Hypoglycemia in combination w/ insulin or a sulfonylurea. Assessment of renal function is recommended prior to treatment initiation & periodically thereafter. Patients w/ renal impairment. Patients w/ severe hepatic impairment (Child-Pugh score >9). Pregnancy. Should not be used by nursing mothers. Ped patients.
Adverse Reactions
Hypoglycemia. Add-on combination w/ metformin & a PPARγ agonist: Headache, diarrhea, nausea, vomiting, URTI, cough, fungal skin infection, peripheral edema. Initial combination therapy w/ metformin: Diarrhea, dyspepsia, flatulence, vomiting, headache. Add-on combination w/ insulin: Flu, headache.
Drug Interactions
Slightly increased AUC & Cmax of digoxin.
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 tab 100 mg
Packing/Price
28's
Form
Januvia tab 25 mg
Packing/Price
28's
Form
Januvia tab 50 mg
Packing/Price
28's
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