PHARMACOLOGY
SiglimetTM combines two antihyperglycemic agents with complementary mechanisms of action to improve
glycemic control in patients with type 2 diabetes: Sitagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, and
Metformin hydrochloride, a member of the biguanide class.
Sitagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor, which is believed to exert its actions in patients with type
2 diabetes by slowing the inactivation of incretin hormones. Incretin hormones, including glucagon-like
peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), are released by the intestine
throughout the day, and levels are increased in response to a meal. These hormones are rapidly inactivated by
the enzyme, DPP-4. The incretins are part of an endogenous system involved in the physiologic regulation of
glucose homeostasis. When blood glucose concentrations are normal or elevated, GLP-1 and GIP increase insulin
synthesis and release from pancreatic beta cells by intracellular signaling pathways involving cyclic AMP. GLP-1
also lowers glucagon secretion from pancreatic alpha cells, leading to reduced hepatic glucose production. By
increasing and prolonging active incretin levels, Sitagliptin increases insulin release and decreases glucagon
levels in the circulation in a glucose-dependent manner.
The pharmacologic mechanism of action of Metformin is different from other classes of oral antihyperglycemic
agents. Metformin decreases hepatic glucose production, decreases intestinal absorption of glucose, and
increases peripheral glucose uptake and utilization.
INDICATION AND USAGE
SiglimetTM is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2
diabetes mellitus when treatment with both Sitagliptin and Metformin is appropriate.
DOSAGE AND ADMINISTRATION
Dose of this combination should be individualized on the basis of the patient’s current regimen, effectiveness,
and tolerability while not exceeding the maximum recommended daily dose of 100 mg Sitagliptin and 2000 mg
Metformin.
Sitagliptin/Metformin combination should generally be given twice daily with meals, with gradual dose
escalation, to reduce the gastrointestinal (GI) side effects due to Metformin.
The recommended starting dose in patients not currently treated with Metformin is 50 mg Sitagliptin/500 mg
Metformin hydrochloride twice daily, with gradual dose escalation recommended to reduce gastrointestinal side
effects associated with Metformin.
The starting dose in patients already treated with Metformin should provide sitagliptin dosed as 50 mg twice
daily (100 mg total daily dose) and the dose of Metformin already being taken. For patients taking Metformin 850
mg twice daily, the recommended starting dose of this combination is 50 mg Sitagliptin/1000 mg Metformin
hydrochloride twice daily.
Patients treated with an insulin secretagogue or insulin
Co-administration of the combination with an insulin secretagogue (e.g., sulfonylurea) or insulin may require
lower doses of the insulin secretagogue or insulin to reduce the risk of hypoglycemia.
PRECAUTIONS
Do not use the combination of Sitagliptin & Metformin in patients with hepatic disease.
Before initiating the combination and at least annually thereafter, assess renal function and verify as normal. May need to discontinue the combination and temporarily use insulin during periods of stress and decreased
intake of fluids and food as may occur with fever, trauma, infection or surgery.
CONTRAINDICATIONS
Combination (Sitagliptin/Metformin HCl) is contraindicated in patients with:
Renal disease or renal dysfunction, e.g., as suggested by serum creatinine levels 1.5 mg/dL [males], 1.4 mg/dL
[females] Acute or chronic metabolic acidosis, including diabetic ketoacidosis, with or without coma.
History of a serious hypersensitivity reaction to the combination or sitagliptin, such as anaphylaxis or
angioedema.
ADVERSE EFFECTS
The most common (>5%) adverse reactions due to initiation of Metformin therapy are diarrhea, nausea/vomiting,
flatulence, abdominal discomfort, indigestion, asthenia, and headache.
Siglimet XR 100/1000 6pcs
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