Sitagliptin

DRUG INFORMATION

  ADULT
    - The recommended dose of sitagliptin tablets is 100 mg once daily.
      Source: US FDA label for sitagliptin (Sitagliptin), section 'dosage and
      administration', retrieved 2026-08-29
    - The recommended dose of sitagliptin tablets is 100 mg once daily. Sitagliptin
      tablets can be taken with or without food. ( 2.1 ) Dosage adjustment is
      recommended for patients with eGFR less than 45 mL/min/1.73 m 2 .
      Source: US FDA label for sitagliptin (Sitagliptin), section 'dosage and
      administration', retrieved 2026-08-29

  CHILD
    - The safety and effectiveness of sitagliptin have not been established in pediatric
      patients. Three 20-week double-blind, placebo-controlled studies each with 34-week
      extensions were conducted to evaluate the efficacy and safety of sitagliptin in
      410 pediatric patients aged 10 to 17 years with inadequately controlled type 2
      diabetes, with or without insulin therapy (HbA1c 6.5 to 10% for patients not on
      insulin, HbA1c 7 to 10% for patients on insulin).
      Source: US FDA label for sitagliptin (Sitagliptin), section 'pediatric use',
      retrieved 2026-08-29

  RENAL IMPAIRMENT
    - ( 2.1 ) Dosage adjustment is recommended for patients with eGFR less than 45
      mL/min/1.73 m 2 .
      Source: US FDA label for sitagliptin (Sitagliptin), section 'dosage and
      administration', retrieved 2026-08-29
    - ( 2.2 ) Dosage Adjustment in Patients With Renal Impairment ( 2.2 ) eGFR greater
      than or equal to 30 mL/min/1.73 m 2 to less than 45 mL/min/1.73 m 2 eGFR less than
      30 mL/min/1.73 m 2 (including patients with end stage renal disease [ESRD] on
      dialysis) 50 mg once daily 25 mg once daily 2.1 Recommended Dosing The recommended
      dose of sitagliptin tablets is 100 mg once daily.
      Source: US FDA label for sitagliptin (Sitagliptin), section 'dosage and
      administration', retrieved 2026-08-29
    - Sitagliptin tablets can be taken with or without food. 2.2 Recommendations for Use
      in Renal Impairment Assess renal function prior to initiation of sitagliptin
      tablets and periodically thereafter.
      Source: US FDA label for sitagliptin (Sitagliptin), section 'dosage and
      administration', retrieved 2026-08-29

  HEPATIC IMPAIRMENT
    - No liver-impairment dose in this label. Not a statement that none is needed.
      Source: Read and found silent: the US FDA label for sitagliptin (Sitagliptin),
      retrieved 2026-08-29

  PREGNANCY
    - Risk Summary The limited available data with sitagliptin tablets in pregnant women
      are not sufficient to inform a drug- associated risk for major birth defects and
      miscarriage.
      Source: US FDA label for sitagliptin (Sitagliptin), section 'pregnancy', retrieved
      2026-08-29
    - There are risks to the mother and fetus associated with poorly controlled diabetes
      in pregnancy [see Clinical Considerations] .
      Source: US FDA label for sitagliptin (Sitagliptin), section 'pregnancy', retrieved
      2026-08-29
    - 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] .
      Source: US FDA label for sitagliptin (Sitagliptin), section 'pregnancy', retrieved
      2026-08-29

  BREASTFEEDING
    - Risk Summary There is no information regarding the presence of sitagliptin in
      human milk, the effects on the breastfed infant, or the effects on milk
      production.
      Source: US FDA label for sitagliptin (Sitagliptin), section 'nursing mothers',
      retrieved 2026-08-29
    - Sitagliptin is present in rat milk and therefore possibly present in human milk
      [see Data] .
      Source: US FDA label for sitagliptin (Sitagliptin), section 'nursing mothers',
      retrieved 2026-08-29
    - The developmental and health benefits of breastfeeding should be considered along
      with the mother’s clinical need for sitagliptin tablets and any potential adverse
      effects on the breastfed infant from sitagliptin tablets or from the underlying
      maternal condition.
      Source: US FDA label for sitagliptin (Sitagliptin), section 'nursing mothers',
      retrieved 2026-08-29