Sixtin Tablet

Monotherapy And Combination Therapy: Sixtin tablet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus

Limitation Of Use: Sixtin tablet is not indicated for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis, as it would not be effective in these settings.

Saxagliptin is an orally-active inhibitor of the DPP4 enzyme. Saxagliptin is a competitive DPP4 inhibitor that slows the inactivation of the incretin hormones, thereby increasing their bloodstream concentrations and reducing fasting and postprandial glucose concentrations in a glucose-dependent manner in patients with type 2 diabetes mellitus.

The recommended dose: 2.5 mg or 5 mg once daily taken regardless of meals.

Patients with Renal Impairment: No dosage adjustment is recommended for patients with mild renal impairment (creatinine clearance >50 mL/min). The dose is 2.5 mg once daily for patients with moderate or severe renal impairment, or with end-stage renal disease (ESRD) requiring hemodialysis (creatinine clearance < 50 mL/min). Saxagliptin should be administered following hemodialysis. Saxagliptin has not been studied in patients undergoing peritoneal dialysis. Because the dose of Saxagliptin should be limited to 2.5 mg based upon renal function, assessment of renal function is recommended prior to initiation of Saxagliptin and periodically thereafter. Renal function can be estimated from serum creatinine using the Cockcroft-Gault formula or Modification of Diet in Renal Disease formula.

Increased risk of hypoglycaemia with concomitant sulfonylureas, dose reduction may be necessary. Increased serum levels with CYP3A4/5 inhibitors (e.g. atazanavir, ketoconazole, nefazodone, ritonavir). Concomitant CYP3A4 inducers (e.g. carbamazepine, phenobarbital) may reduce the glycaemic lowering effect of Sixtin.

Saxagliptin is contraindicated in patients with known hypersensitivity to this drug.

Adverse reactions reported in >5% of patients treated with Sixtin and more commonly than in patients treated with placebo are: upper respiratory tract infection, urinary tract infection, and headache. Peripheral edema was reported more commonly in patients treated with the combination of Sixtin and a thiazolidinedione (TZD) than in patients treated with the combination of placebo and TZD. Hypoglycemia was reported more commonly in patients treated with the combination of Sixtin and sulfonylurea than in patients treated with the combination of placebo and sulfonylurea. Hypersensitivity-related events (e.g.,
urticaria, facial edema) were reported more commonly in patients treated with Sixtin than in patients treated with placebo.

Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. Saxagliptin, like other antidiabetic medications, should be used during pregnancy only if clearly needed. It is not known whether Saxagliptin is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when Saxagliptin is administered to a nursing woman.

Dosage adjustment of Sixtin is not recommended in case of rifampin, diltiazem, amprenavir, aprepitant, erythromycin, fluconazole, fosamprenavir, grapefruit juice, and verapamil. The dose of Sixtin should be limited to 2.5 mg when coadministered with ketoconazole, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, and telithromycin.

In a controlled clinical trial, once-daily, orally-administered Sixtin in healthy subjects at doses up to 400 mg daily for 2 weeks (80 times the MRHD) had no dose-related clinical adverse reactions and no clinically meaningful effect on QTc interval or heart rate. In the event of an overdose, appropriate supportive treatment should be initiated as dictated by the patient's clinical status. Sixtin and its active metabolite are removed by hemodialysis (23% of dose over 4 hours).

Dipeptidyl Peptidase-4 (DPP-4) inhibitor

Store at (at 20-25°C). Protect from light and moisture. Keep out of the reach of the children.