Regulatory Class: ℞

Content: Sitagliptin phosphate

Formulations: Each film-coated 50 mg tablet contains 64.25 mg sitagliptin, which is equivalent to 50 mg of free base; Each film-coated 100 mg tablet contains 128.5 mg sitagliptin, which is equivalent to 100 mg of free base

Indications or Uses: Adjunct to diet & exercise to improve glycemic control in patients w/ type 2 DM. In combination w/ PPAR-γ agonist (eg, thiazolidinediones) or metformin as initial therapy or when the single agent alone, w/ diet & exercise do not improve adequate glycemic control. Combination therapy w/ a sulfonylurea in patients w/ type 2 DM to improve glycemic control when treatment w/ single agent alone, w/ diet & exercise do not provide adequate glycemic control. In combination w/ metformin & sulfonylurea, metformin & PPAR-γ agonists (eg, thiazolidinediones) when dual therapy w/ these agents does not provide adequate glycemic control. Adjunct to diet & exercise to improve glycemic control in combination w/ insulin (w/ or w/o metformin).

Dosage and Directions for Use: 100 mg once daily as monotherapy or combination therapy w/ metformin, sulfonylurea, insulin (w/ or w/o metformin), PPAR-γ agonist, metformin + sulfonylurea or metformin + PPAR-γ agonist. Patients with moderate renal impairment, 50 mg once daily. Severe renal impairment with end-stage renal disease ,including those requiring hemodialysis or peritoneal dialysis, 25 mg once daily, maybe administered without regard to the timing of dialysis.

Administration: Taken with or without food

Contraindication: Hypersensitivity

Special Precaution: Not to be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis .Acute pancreatitis ,including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. Lower dosages are recommended in patients with eGFR <45 mL/min/1.73 m2, as well as in ESRD patient requiring hemodialysis or peritoneal dialysis. Hypoglycemia in combination with sulfonylurea or with insulin. Renal impairment. Pregnancy & lactation.Childre (10-17 yr.)

Adverse Reaction: Allergic Reactions. Headache, diarrhea; vomiting. In combination with metformin: Indigestion, flatulence. In combination with pioglitazone; Decreased blood sugar with out symptoms of hypoglymcemia. In combination with metformin and rosiglitazone: Hypoglycemia, upper respiratory infection, nausea, cough, fungal skin infection, swelling of the hands or legs. Hypersensitivity reactions including anaphylaxis, angioedema,rash, uticaria, cutaneous vasculitis & exfoliative skin conditions including Stevens-Johnson syndrome.

Presentation/Packaging: Film coated tab 50 mg x 28's. 100 mg x 28's .

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