If you are:
Possibly Safe: INSUFFICIENT HUMAN DATA AVAILABLE
FDB Only When Necessary: INSUFF HUMAN DATA; POORLY CONTROLLED DIABETES MAY INCREASE MATERNAL/FETAL RISK
Precaution: NO KNOWN INFANT ADVERSE OUTCOMES; MFR ADVISES CAUTION
Precaution: INSUFFICIENT DATA AVAILABLE; ALTERNATIVE AGENTS MAY BE PREFERRED
An adult over 60:
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.
management or monitoring precaution: Cardiovascular-Box warning states the drug may cause or exacerbate CHF. Contraindicated in patients with NYHA Class III or IV heart failure. Monitor for weight gain, peripheral edema and new onset dyspnea. Hepatic-Monitor for elevations of serum transaminases. Musculoskeletal-Consider increased fracture risk.
Giving pioglitazone-metformin Tablet, Extended Release Multiphase 24 hr (Tablet, ER hr) to a child under 12:
Severe Precaution: Possible risks include fracture, fluid retention and heart failure, bladder tumor. Not recommended.
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.