Sitaplus Use In Pregnancy & Lactation

There are no adequate and well-controlled studies in pregnant women with Sitagliptin phosphate + Metformin HCl or its individual components; therefore, the safety of Sitagliptin phosphate + Metformin HCl in pregnant women is not known. Sitagliptin phosphate + Metformin HCl, like other oral antihyperglycemic agents, is not recommended for use pregnancy.
No animal studies have been conducted with the combined products in Sitagliptin phosphate + Metformin HCl to evaluate effects on reproduction. The following data are based on findings in studies performed with Sitagliptin + Metformin individually.
Sitagliptin phosphate: Sitagliptin was not teratogenic in rats at oral doses up to 250 mg/kg or in rabbits up to 125 mg/kg during organogenesis (up to 32 and 22 times, respectively, the human exposure based on the recommended daily adult human dose of 100 mg/day). In rats, a slight increase in the incidence of fetal rib malformations (absent, hypoplastic and wavy ribs) was observed at oral doses of 1000 mg/kg/day (approximately 100 times the human exposure based on the recommended daily adult human dose of 100 mg/day). Slight decreases in mean preweaning body weights of both sexes and postweaning body weight gains of males were observed in the offspring of rats given oral dose of 1000 mg/kg/day. However, animal reproduction studies are not always predictive of the human response.
Metformin hydrochloride: Metformin was not teratogenic in rats and rabbits at doses up to 600 mg/kg/day. This represents of about 2 and 6 times the maximum recommended human daily dose of 2,000 mg based on body surface area comparisons for rats and rabbits, respectively. Determination of fetal concentrations demonstrated a partial placental barrier to metformin.
Nursing mothers: No studies in lactating animals have been conducted with the combined components of Sitagliptin phosphate + Metformin HCl.