SYNJARDYXR(empagliflozin and metformin hydrochloride extended-release) tablets(三十二)
s may change.
Lactic Acidosis
Inform patients of the risks of lactic acidosis due to the metformin component, its symptoms, and conditions that predispose to its development [see WARNINGS AND PRECAUTIONS (5.1)]. Advise patients to discontinue SYNJARDY XR immediately and to notify their doctor promptly if unexplained hyperventilation, malaise, myalgia, unusual somnolence, slow or irregular heart beat, sensation of feeling cold (especially in the extremities), or other nonspecific symptoms occur. GI symptoms are common during initiation of metformin treatment and may occur during initiation of SYNJARDY XR therapy; however, advise patients to consult their doctor if they develop unexplained symptoms. Although GI symptoms that occur after stabilization are unlikely to be drug related, such an occurrence of symptoms should be eva luated to determine if it may be due to metformin-induced lactic acidosis or other serious disease.
Hypotension
Inform patients that hypotension may occur with SYNJARDY XR and advise them to contact their healthcare provider if they experience such symptoms [see WARNINGS AND PRECAUTIONS (5.2)]. Inform patients that dehydration may increase the risk for hypotension, and to have adequate fluid intake.
Ketoacidosis
Inform patients that ketoacidosis is a serious life-threatening condition. Cases of ketoacidosis have been reported during use of empagliflozin. Instruct patients to check ketones (when possible) if symptoms consistent with ketoacidosis occur even if blood glucose is not elevated. If symptoms of ketoacidosis (including nausea, vomiting, abdominal pain, tiredness, and labored breathing) occur, instruct patients to discontinue SYNJARDY XR and seek medical advice immediately [see WARNINGS AND PRECAUTIONS (5.3)].
Acute Kidney Injury
Inform patients that acute kidney injury has been reported during use of empagliflozin. Advise patients to seek medical advice immediately if they have reduced oral intake (such as due to acute illness or fasting) or increased fluid losses (such as due to vomiting, diarrhea, or excessive heat exposure), as it may be appropriate to temporarily discontinue SYNJARDY XR use in those settings [see WARNINGS AND PRECAUTIONS (5.4)].
Serious Urinary Tract Infections
Inform patients of the potential for urinary tract infections, which may be serious. Provide them with information on the symptoms of urinary tract infections. Advise them to seek medical advice if such symptoms occur [see WARNINGS AND PRECAUTIONS (5.5)].
Genital Mycotic Infections in Females (e.g., Vulvovaginitis)
Inform female patients that vaginal yeast infections may occur and provide them with information on the signs and symptoms of vaginal yeast infections. Advise them of treatment options and when to seek medical advice [see WARNINGS AND PRECAUTIONS (5.7)].
Genital Mycotic Infections in Ma |
