Xelevia

Xelevia

sitagliptin

Manufacturer:

Merck Sharp & Dohme

Distributor:

Natrapharm
Concise Prescribing Info
Contents
Sitagliptin phosphate monohydrate
Indications/Uses
Adjunct to diet & exercise to improve glycemic control in patients w/ type 2 DM as monotherapy. 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 do not provide adequate glycemic control. Adjunct to diet & exercise to improve glycemic control in combination w/ insulin (w/ or w/o metformin).
Dosage/Direction for Use
Monotherapy or combination therapy w/ metformin, sulfonylurea, insulin (w/ or w/o metformin), PPAR-γ agonist, metformin + sulfonylurea or metformin + PPAR-γ agonist 100 mg once daily. Patients w/ moderate renal impairment 50 mg once daily. Severe renal impairment or w/ ESRD, including those requiring hemodialysis or peritoneal dialysis 25 mg once daily, may be administered w/o regard to the timing of dialysis.
Administration
May be taken with or without food.
Contraindications
Special Precautions
Hypersensitivity. Not to be used in patients w/ type 1 diabetes or for the treatment of diabetic ketoacidosis. Acute pancreatitis, including fatal & non-fatal hemorrhagic or necrotizing pancreatitis. Lower dosage are recommended in patients w/ eGFR <45 mL/min/1.73 m2, as well as in ESRD patient requiring hemodialysis or peritoneal dialysis. Hypoglycemia in combination w/ sulfonylurea or w/ insulin. Renal impairment. Pregnancy & lactation. Childn (10-17 yr).
Adverse Reactions
Allergic reactions. Headache; diarrhea; vomiting. In combination w/ insulin: Flu. In combination w/ metformin: Indigestion, flatulence. In combination w/ pioglitazone: Decreased blood sugar w/o symptoms of hypoglycemia. In combination w/ metformin & rosiglitazone: Hypoglycemia, upper resp infection, nausea, cough, fungal skin infection, swelling of the hands or legs. Hypersensitivity reactions including anaphylaxis, angioedema, rash, urticaria, cutaneous vasculitis & exfoliative skin conditions including SJS.
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
Xelevia FC tab 100 mg
Packing/Price
28's (P993.7/box)
Form
Xelevia FC tab 50 mg
Packing/Price
28's (P971.2/box)
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