What should I Know Regarding Pregnancy, Nursing and Administering Qtern to Children or the Elderly?
If you are PREGNANT
- Requires a Risk/Benefit Assessment:
- Known or Theoretical Risk:
If you are NURSING
- Precaution: INSUFFICIENT HUMAN DATA AVAILABLE
- Precaution: INSUFFICIENT HUMAN DATA AVAILABLE; EXCRETED IN RATS
If you are an adult over 60
- management or monitoring precaution: Renal-Begin at the low end of the dosing range for CrCL<51 mL/min. Cardiovascular-As of 02/11/14, the FDA is investigating a possible association with use of saxagliptin and heart failure. "Preliminary" data is presented in NEJM 2013;369:1317-1326. Monitor patients for new onset or worsening heart failure.
- management or monitoring precaution: Renal-Risk for increased creatinine. Risk is highest in pre-existing renal impairment. Poor efficacy shown with CrCL<60 mL/min. Monitor closely and discontinue if CrCL<60mL/min. Urosepsis and pyelonephritis reported in post-marketing studies. Cardiovascular-Dapagliflozin causes an osmotic diuresis which can lead to low intravascular volume, orthostatic blood pressure changes and falls in the elderly. Endocrine-Ketoacidosis reported with glucose levels lower than expected (<250mg/dL).
Giving Qtern to a child under 12
- management or monitoring precaution: Safety and efficacy not established.
- management or monitoring precaution: No safety and efficacy established in pediatrics.
CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.