What should I Know Regarding Pregnancy, Nursing and Administering Canagliflozin-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: INSUFF HUMAN DATA AVAIL; ANIMAL DATA SHOW DEVELOPMENTAL TOXICITY IN 2ND/3RD TRIM
If you are NURSING
- Precaution: NO KNOWN INFANT ADVERSE OUTCOMES; MFR ADVISES CAUTION
- Precaution: INSUFF HUMAN DATA; EXCRETED IN RATS, DATA SUGGEST RISK TO KIDNEY DEVELOPMENT
If you are an adult over 60
- management or monitoring precaution: Cardiovascular-Reduced intravascular volume increased risk of hypotension, dizziness, dehydration. Renal-Renal toxicity increases with hypovolemia, CHF. Evaluate renal function prior to initiation and monitor periodically. Dosage adjustment recommended with eGFR<60 mL/min/1.73 m2. Not recommended with persistent eGFR <45 mL/min/1.73 m2 and is contraindicated with eGFR<30 mL/min/1.73 m2. Musculoskeletal-Monitor bone mineral density in osteopenia/osteoporosis. Bone fractures have occurred.
- 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 Canagliflozin-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: Safety and efficacy in pediatrics age < 10 years not established.
- management or monitoring precaution: Rare reports of cholestatic and hepatocellular injury. No pediatric safety/efficacy of extended release dose form.
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.