JANUMET XR

brand

JANUMET XR Warnings

Rarely, too much metformin can build up in the body and cause a serious (sometimes fatal) condition called lactic acidosis. Lactic acidosis is more likely if you are an older adult, if you have kidney or liver disease, dehydration, heart failure, heavy alcohol use, if you have surgery, if you have X-ray or scanning procedures that use iodinated contrast, or if you are using certain drugs. For some conditions, your doctor may tell you to stop taking this medication for a short time. Ask your doctor or pharmacist for more details.

Stop taking this medication and get medical help right away if you have any symptoms of lactic acidosis, such as unusual tiredness, dizziness, severe drowsiness, chills, blue/cold skin, muscle pain, fast/difficult breathing, slow/irregular heartbeat, or stomach pain with nausea/vomiting/diarrhea.
  • Swallow whole. Do not chew or crush.
  • If you drink alcohol, discuss the safe use of alcohol while using this medication with your healthcare professional.
  • Take with food.
  • It is very important that you take or use this exactly as directed. Do not skip doses or discontinue unless directed by your doctor.
  • Read the boxed warning information for this medication.

Lactation Warnings

  • NO KNOWN INFANT ADVERSE OUTCOMES; MFR ADVISES CAUTION
  • INSUFFICIENT HUMAN DATA; POTENTIAL FOR EXCRETION BASED ON DRUG PROPERTIES

Pregnancy Warnings

  • Insufficient human data available. Insufficient animal data available. Consider maternal treatment benefits versus potential fetal/neonatal adverse outcomes. Poorly controlled maternal diabetes can lead to increased maternal and fetal/neonatal morbidity and mortality.
  • Insufficient human data available. Poorly controlled maternal diabetes can lead to increased maternal and fetal/neonatal morbidity and mortality. Animal data suggest no developmental toxicity at doses less than 10 times the maximum recommended human dose. Consider maternal treatment benefits versus potential fetal/neonatal adverse outcomes.