Film coated, Oral, Tablets: 50 mg, and 25 mg
Indication & Usage
Sanoptin is indicated as an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus (type 2 diabetes). Sanoptin is indicated for:
- Combination therapy with metformin or a peroxisome proliferator- activated receptor gamma (PPARγ) agonist (e.g., thiazolidinediones) when the single agent does not provide adequate glycemic control.
Important Limitations of Use: Sanoptin should not be used in patients with type 1 diabetes mellitus (type 1 diabetes) or for the treatment of diabetic ketoacidosis.
Dosage & Administration
- Recommended Dosing
The recommended dose of Sanoptin is 100 mg once daily as monotherapy or as combination therapy with metformin or a PPARγ agonist (e.g., thiazolidinediones). Sanoptin can be taken with or without food.
- Patients with Renal Insufficiency
- For patients with mild renal insufficiency (creatinine clearance [CrCl] ≥ 50 mL/min, approximately corresponding to serum creatinine levels of ≤ 1.7 mg/dL in men and ≤1.5 mg/dL in women), no dosage adjustment for Sanoptin is required.
- For patients with moderate renal insufficiency (CrCl ≥30 to <50 mL/min, approximately corresponding to serum creatinine levels of >1.7 to ≤3.0 mg/dL in men and >1.5 to ≤2.5 mg/dL in women), the dose of Sanoptin is 50 mg once daily.
- For patients with severe renal insufficiency (CrCl <30 mL/min, approximately corresponding to serum creatinine levels of >3.0 mg/dL in men and >2.5 mg/dL in women) or with end-stage renal disease (ESRD) requiring hemodialysis or peritoneal dialysis, the dose of Sanoptin is 25 mg once daily. Sitagliptin may be administered without regard to the timing of
Because there is a need for dosage adjustment based upon renal function, assessment of renal function is recommended prior to initiation of Sanoptin and periodically thereafter. Creatinine clearance can be estimated from serum creatinine using the Cockcroft-Gault formula.
The most common adverse reactions, reported in ≥5% of patients treated with Sanoptin and more commonly than in patients treated with placebo are: upper respiratory tract infection, nasopharyngitis, and headache.
There was a slight increase in the area under the curve (AUC, 11%) and mean peak drug concentration (Cmax, 18%) of digoxin with the co-administration of 100 mg sitagliptin for 10 days. Patients receiving digoxin should be monitored appropriately. No dosage adjustment of digoxin or Sanoptin is recommended.
Warning & Precaution
A dosage adjustment is recommended in patients with moderate renal insufficiency and in patients with severe renal insufficiency or with ESRD requiring hemodialysis or peritoneal dialysis. Assessment of renal function is recommended prior to initiation of Sanoptin and periodically thereafter. Creatinine clearance can be estimated from serum creatinine using the Cockcroft-Gault formula.
Pregnancy & Lactation
Pregnancy Category B
Reproduction studies have been performed in rats and rabbits. Doses of sitagliptin up to 125 mg/kg (approximately 12 times the human exposure at the maximum recommended human dose) did not impair fertility or harm the fetus. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Sitagliptin administered to pregnant female rats and rabbits from gestation day 6 to 20 (organogenesis) was not teratogenic at oral doses up to 250 mg/kg (rats) and 125 mg/kg (rabbits), or approximately 30- and 20-times human exposure at the maximum recommended human dose (MRHD) of 100 mg/day based on AUC comparisons. Higher doses increased the incidence of rib malformations in offspring at 1000 mg/kg, or approximately 100 times human exposure at the MRHD.
Sitagliptin administered to female rats from gestation day 6 to lactation day 21 decreased body weight in male and female offspring at 1000 mg/kg. No functional or behavioral toxicity was observed in offspring of rats.
Placental transfer of sitagliptin administered to pregnant rats was approximately 45% at 2 hours and 80% at 24 hours postdose. Placental transfer of sitagliptin administered to pregnant rabbits was approximately 66% at 2 hours and 30% at 24 hours.
Sitagliptin is secreted in the milk of lactating rats at a milk to plasma ratio of 4:1. It is not known whether sitagliptin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Sanoptin is administered to a nursing woman.
Keep out of the reach of children.
Store below 30°C and protect from light and moisture.
Carton containing 3 Blister strips of 10 tablets each.
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