Synjardy XR

SYNJARDY XR- empagliflozin and metformin hydrochloride tablet, extended release
Boehringer Ingelheim Pharmaceuticals, Inc.

WARNING: LACTIC ACIDOSIS

Postmarketing cases of metformin-associated lactic acidosis have resulted in death, hypothermia, hypotension, and resistant bradyarrhythmias. The onset of metformin-associated lactic acidosis is often subtle, accompanied only by nonspecific symptoms such as malaise, myalgias, respiratory distress, somnolence, and abdominal pain. Metformin-associated lactic acidosis was characterized by elevated blood lactate levels (>5 mmol/Liter), anion gap acidosis (without evidence of ketonuria or ketonemia), an increased lactate/pyruvate ratio; and metformin plasma levels generally >5 mcg/mL [see Warnings and Precautions (5.1)].

Risk factors for metformin-associated lactic acidosis include renal impairment, concomitant use of certain drugs (e.g., carbonic anhydrase inhibitors such as topiramate), age 65 years old or greater, having a radiological study with contrast, surgery and other procedures, hypoxic states (e.g., acute congestive heart failure), 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 [see Dosage and Administration (2.1), Contraindications (4), Warnings and Precautions (5.1), Drug Interactions (7), and Use in Specific Populations (8.6, 8.7)].

If metformin-associated lactic acidosis is suspected, immediately discontinue SYNJARDY XR and institute general supportive measures in a hospital setting. Prompt hemodialysis is recommended [see Warnings and Precautions (5.1)].

1 INDICATIONS AND USAGE

SYNJARDY XR is a combination of empagliflozin and metformin hydrochloride (HCl) indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

Empagliflozin is indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease [see Clinical Studies (14)].

Limitation of Use

SYNJARDY XR is not recommended in patients with type 1 diabetes mellitus. It may increase the risk of diabetic ketoacidosis in these patients [see Warnings and Precautions (5.2)].

2 DOSAGE AND ADMINISTRATION

2.1 Prior to Initiation of SYNJARDY XR

2.2 Recommended Dosage and Administration

  • Individualize the starting dose of SYNJARDY XR based on the patient’s current regimen:
    • In patients on metformin HCl, switch to SYNJARDY XR containing a similar total daily dose of metformin HCl and a total daily dose of empagliflozin 10 mg;
    • In patients on empagliflozin, switch to SYNJARDY XR containing the same total daily dose of empagliflozin and a total daily dose of metformin HCl extended-release 1000 mg;
    • In patients already treated with empagliflozin and metformin HCl, switch to SYNJARDY XR containing the same total daily doses of empagliflozin and a similar total daily dose of metformin HCl.
  • Monitor effectiveness and tolerability, and adjust dosing as appropriate, not to exceed the maximum recommended daily dose of empagliflozin 25 mg and metformin HCl 2000 mg.
  • The dose of metformin HCl should be gradually escalated to reduce the gastrointestinal side effects due to metformin.
  • Take SYNJARDY XR orally once daily with a meal in the morning
  • Swallow SYNJARDY XR tablets whole. Do not split, crush, dissolve, or chew.
  • SYNJARDY XR 10 mg/1000 mg and 25 mg/1000 mg tablets should be taken as a single tablet once daily. SYNJARDY XR 5 mg/1000 mg and 12.5 mg/1000 mg tablets should be taken as two tablets together once daily.

2.3 Dosage Recommendations in Patients with Renal Impairment

2.4 Discontinuation for Iodinated Contrast Imaging Procedures

Discontinue SYNJARDY XR at the time of, or prior to, an iodinated contrast imaging procedure in patients with an eGFR less than 60 mL/min/1.73 m2 ; in patients with a history of liver disease, alcoholism or heart failure; or in patients who will be administered intra-arterial iodinated contrast. Re-evaluate eGFR 48 hours after the imaging procedure; restart SYNJARDY XR if renal function is stable [see Warnings and Precautions (5.1)].

3 DOSAGE FORMS AND STRENGTHS

SYNJARDY XR Tablets:

Empagliflozin Strength Metformin HCl Strength Color/Shape Tablet Markings
5 mg 1000 mg olive green, oval, biconvex, film-coated tablet 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.
10 mg 1000 mg orange, oval, biconvex, film-coated tablet 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.
12.5 mg 1000 mg blue, oval, biconvex, film-coated tablet 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.
25 mg 1000 mg light green, oval, biconvex, film-coated tablet 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.

4 CONTRAINDICATIONS

SYNJARDY XR is contraindicated in patients with:

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.