Uses of Sixtin 2.5: - Type 2 diabetes mellitus Type 2 diabetes Documented hypersensitivity (eg, anaphylaxis, angioedema, exfoliative skin conditions)

Dipeptidyl Peptidase-4 (DPP-4) inhibitor

Saxagliptin inhibits dipeptidyl peptidase IV (DPP-IV) enzyme resulting in prolonged active incretin levels. It elevates the circulating levels of glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) which stimulates insulin secretion in pancreatic β-cells in a glucose dependent manner. It improves glycaemic control by reducing fasting and postprandial plasma glucose concentration in patients w/ type 2 DM.

How to use Saxagliptin: Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Saxagliptin may be taken with or without food, but it is better to take it at a fixed time. Administration: May be taken with or without food. Adult Dose: Oral Type 2 diabetes mellitus Adult: 2.5 or 5 mg once daily. Combination therapy: May need to reduce dosage of sulfonylurea or other insulin secretagogues when administered in combination Coadministration with strong CYP450 3A4/5 inhibitors: Not to exceed 2.5 mg PO qDay Elderly: No dosage adjustment. Hepatic Impairment No dosage adjustment. Child Dose: <18 years: Safety and efficacy not established Renal Dose: Renal impairment CrCl >50 mL/min: No dose adjustment required CrCl <50 mL/min: Not to exceed 2.5 mg PO qDay ESRD requiring hemodialysis: Not to exceed 2.5 mg PO qDay administered postdialysis ESRD requiring peritoneal dialysis: Not studied

Strong CYP3A4/5 inhibitors (eg ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir & telithromycin).

Documented hypersensitivity (eg, anaphylaxis, angioedema, exfoliative skin conditions)

Common - Headache - Nasopharyngitis (inflammation of the throat and nasal passages) - Urinary tract infection - Hypoglycaemia (low blood sugar level) in combination with insulin or sulphonylurea - Upper respiratory tract infection 1-10% (selected) Urinary tract infection (7%),Headache (7%),Hypersensitivity-related events (<4%; eg, urticaria, facial edema),Peripheral edema (<4%; increased incidence when coadministered with thiazolidinediones),Upper respiratory tract infection (3%),Gastroenteritis (2%),Hypoglycemia (1.6%) Frequency Not Defined Increased creatinine phosphokinase,Increased creatinine,Idiopathic thrombocytopenic purpura rash

Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).

Precaution: Renal impairment Decrease dose with strong CYP450 3A4/5 inhibitors Coadministration with thiazolidinediones (eg, rosiglitazone, pioglitazone) increases risk for peripheral edema Pancreatitis reported with saxagliptin; monitor for signs and symptoms and discontinue if pancreatitis suspected Serious hypersensitivity reactions with saxagliptin reported (typically within the first 3 months of therapy) History of angioedema Coadministration with a sulfonylurea or with insulin may increase hypoglycemia; monitor closely and adjust sulfonylurea and/or insulin dose accordingly Congestive heart failure (CHF) risks. Observe patients for signs and symptoms of heart failure during therapy; Lactation: Not known whether distributed in breast milk; caution advised

Store between 20-25° C.

Dipeptidyl Peptidase-4 (DPP-4) inhibitor

Dipeptidyl peptidase IV (DPP-4) inhibition that results in increased incretin hormones and enhanced glycemic control.

Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).