What should I Know Regarding Pregnancy, Nursing and Administering Dapagliflozin-Metformin Tablet, Immediate Release And Extended Release, Biphasic 24Hr (Tablet,Immed & Ext Release,Biphasic 24Hr) to Children or the Elderly?

If you are PREGNANT

  • FDB Only When Necessary: INSUFFICIENT HUMAN DATA AVAILABLE
  • Not Recommended: BASED ON ANIMAL DATA SHOWING ADV RENAL EFFECTS, NOT RECOMMENDED IN 2ND/3RD TRIM

If you are NURSING

  • Precaution: NO KNOWN INFANT ADVERSE OUTCOMES; MFR ADVISES CAUTION
  • Precaution: INSUFFICIENT HUMAN DATA AVAILABLE; EXCRETED IN RATS

If you are an adult over 60

  • 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. Endocrine-Ketoacidosis reported with glucose levels lower than expected (<250mg/dL).
  • management or monitoring precaution: Renal-Increased risk for drug induced metabolic acidosis with increasing age and declining renal function. Metformin is contraindicated in patients with an eGFR below 30 mL/min. Cardiovascular-Heart failure patients may have a higher risk for metabolic acidosis.

Giving Dapagliflozin-Metformin Tablet, Immediate Release And Extended Release, Biphasic 24Hr (Tablet,Immed & Ext Release,Biphasic 24Hr) to a child under 12

  • management or monitoring precaution: No safety and efficacy established in pediatrics.
  • management or monitoring precaution: Rare reports of cholestatic and hepatocellular injury. No pediatric safety/efficacy of extended release dose form.

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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.