Coadministration with sitagliptin may require lower doses of insulin to reduce the risk of hypoglycemia.
Source: NLP:sitagliptin phosphate
Brand names: Sitagliptin Phosphate
Route: Oral
Contraindications
4 CONTRAINDICATIONS History of a serious hypersensitivity reaction to sitagliptin, such as anaphylaxis or angioedema. [See Warnings and Precautions ( 5.5 ); Adverse Reactions ( 6.2 ).] History of a serious hypersensitivity reaction to sitagliptin, such as anaphylaxis or angioedema ( 5.5 , 6.2 )
Pregnancy & Breastfeeding
8.1 Pregnancy Risk Summary The limited available data with sitagliptin in pregnant women are not sufficient to inform a drug-associated risk for major birth defects and miscarriage. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy [see Clinical Considerations]. No adverse developmental effects were observed when sitagliptin was administered to pregnant rats and rabbits during organogenesis at oral doses up to 30-times and 20-times, respectively, the 100 mg clinical dose, based on AUC [see Data] . The estimated background risk of major birth defects is 6 to 10% in women with pre-gestational diabetes with a Hemoglobin A1c >7% and has been reported to be as high as 20 to 25% in women with a Hemoglobin A1c >10%. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, and delivery complications. Poorly controlled diabetes increases the fetal risk for major birth defects, still birth, and macrosomia related morbidity. Data Animal Data In embryo-fetal development studies, sitagliptin administered to pregnant rats and rabbits during organogenesis (gestation day 6 to 20) did not adversely affect developmental outcomes at oral doses up to 250 mg/kg (30-times the 100 mg clinical dose) and 125 mg/kg (20-times the 100 mg clinical dose), respectively, based on AUC. Higher doses in rats associated with maternal toxicity increased the incidence of rib malformations in offspring at 1000 mg/kg, or approximately 100-times the clinical dose, based on AUC. Placental transfer of sitagliptin was observed in pregnant rats and rabbits. Sitagliptin administered to female rats from gestation day 6 to lac
2 interactions on record
Coadministration with sitagliptin may require lower doses of insulin to reduce the risk of hypoglycemia.
Source: NLP:sitagliptin phosphate
Coadministration with sitagliptin may require lower doses of sulfonylurea to reduce the risk of hypoglycemia.
Source: NLP:sitagliptin phosphate