SYNJARDYXR(empagliflozin and metformin hydrochloride extended-release) tablets(三十一)
bsp; Estimated Cumulative Incidence of Cardiovascular Death
Figure 5
The efficacy of empagliflozin on cardiovascular death was generally consistent across major demographic and disease subgroups.
Vital status was obtained for 99.2% of subjects in the trial. A total of 463 deaths were recorded during the EMPA-REG OUTCOME trial. Most of these deaths were categorized as cardiovascular deaths. The non-cardiovascular deaths were only a small proportion of deaths, and were balanced between the treatment groups (2.1% in patients treated with empagliflozin, and 2.4% of patients treated with placebo).
16 HOW SUPPLIED/STORAGE AND HANDLING
SYNJARDY XR (empagliflozin and metformin hydrochloride extended-release) tablets are available in the following strengths and packages:
Tablet Strength Film-Coated Tablet,
Color/Shape Tablet Markings Package Size NDC Number
5 mg/1000 mg olive green, oval, biconvex Printed on one side in
black ink with the
Boehringer Ingelheim
company logo and “S5”
on the top line and
“1000 M” on the bottom
line. Bottles of 60
Bottles of 180 0597-0290-74
0597-0290-59
10 mg/1000 mg orange, oval, biconvex Printed on one side in
black ink with the
Boehringer Ingelheim
company logo and
“S10” on the top line and
“1000 M” on the bottom
line. Bottles of 30
Bottles of 90 0597-0280-73
0597-0280-90
12.5 mg/1000 mg blue, oval, biconvex Printed on one side in
black ink with the
Boehringer Ingelheim
company logo and “S12”
on the top line and
“1000 M” on the bottom
line. Bottles of 60
Bottles of 180 0597-0300-45
0597-0300-93
25 mg/1000 mg light green, oval, biconvex Printed on one side in
black ink with the
Boehringer Ingelheim
company logo and “S25”
on the top line and
“1000 M” on the bottom
line. Bottles of 30
Bottles of 90 0597-0295-88
0597-0295-78
Storage
Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled Room Temperature]. Store in a safe place out of reach of children.
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Medication Guide
Instruct patients to read the Medication Guide before starting SYNJARDY XR therapy and to reread it each time the prescription is renewed. Instruct patients to inform their doctor or pharmacist if they develop any unusual symptom, or if any known symptom persists or worsens.
Inform patients of the potential risks and benefits of SYNJARDY XR and of alternative modes of therapy. Also inform patients about the importance of adherence to dietary instructions, regular physical activity, periodic blood glucose monitoring and HbA1c testing, recognition and management of hypoglycemia and hyperglycemia, and assessment for diabetes complications. Advise patients to seek medical advice promptly during periods of stress such as fever, trauma, infection, or surgery, as medication requirement |
