WARNING: LACTIC ACIDOSIS See full prescribing information for complete boxed warning. Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. Symptoms included malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Laboratory abnormalities included elevated blood lactate levels, anion gap acidosis, increased lactate/pyruvate ratio; and metformin plasma levels generally greater than 5 mcg/mL. Risk factors include renal impairment, concomitant use of certain drugs, age greater than 65 years old, radiological studies with contrast, surgery and other procedures, hypoxic states, excessive alcohol intake, and hepatic impairment. Steps to reduce the risk of and manage metformin-associated lactic acidosis in these high risk groups are provided in the Full Prescribing Information. If lactic acidosis is suspected, discontinue TRIJARDY XR and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended. Before you start taking Trijardy XR, tell your doctor:, About all the medications you take, including prescription, over-the-counter, vitamins, and herbal supplements, About your allergies, About your health conditions, If you are pregnant or have plans to become pregnant, If you are breastfeeding or have plans to breastfeed, Before you undergo iodinated contrast imaging procedures, talk to your doctor. Your doctor may decide to discontinue Trijardy XR before or at the time of your procedure., Trijardy XR can cause inflammation of the pancreas. Contact your doctor right away if you experience severe and persistent stomach pain or pain in your abdomen to your back, with or without vomiting., Trijardy XR can cause ketoacidosis, a condition in which ketones are elevated in your blood or urine. Seek emergency care right away if you experience nausea, vomiting, stomach pain, trouble breathing, and fatigue., Trijardy XR can cause dehydration. Your risk may be higher if you have kidney problems, are 65 years old or older, are on a low sodium diet, or take blood pressure medications such as diuretics., Trijardy XR can cause urinary tract infections. Contact your doctor right away if you experience burning when urinating, frequent urination, urge to urinate, lower stomach or pelvic pain, fever, nausea, vomiting, back pain, or blood in your urine., Trijardy XR can cause a serious bacterial infection that can damage the tissue under the skin around your anus and genitals. Seek emergency care right away if you experience a fever, weakness, fatigue, general discomfort, and pain, tenderness, swelling, and redness of the skin around your anus and genitals., Trijardy XR can cause a vaginal yeast infection. Contact your doctor if you experience odor from your vagina, vaginal discharge that is white or yellowish, and/or itching of your vagina., Trijardy XR can cause a penile yeast infection. Contact your doctor if you experience redness, itching, or swelling of the penis, odorous discharge from the penis, or rash or pain of the penile skin., Trijardy XR can cause a decrease in your vitamin B12 levels., Trijardy XR can cause joint pain that may become severe., Trijardy XR can cause a skin reaction. Contact your doctor right away if you develop blisters., Trijardy XR can cause heart failure. Call your doctor right away if you experience breathing problems, swelling in the feet, ankles, or legs, rapid weight gain, and abnormal fatigue. About all the medications you take, including prescription, over-the-counter, vitamins, and herbal supplements, About your allergies, About your health conditions, If you are pregnant or have plans to become pregnant, If you are breastfeeding or have plans to breastfeed, Before you undergo iodinated contrast imaging procedures, talk to your doctor. Your doctor may decide to discontinue Trijardy XR before or at the time of your procedure.
