Synjardy
Loading...Synjardy Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
SYNJARDY is a combination of empagliflozin and metformin HCl indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are not adequately controlled on a regimen containing empagliflozin or metformin, or in patients already being treated with both empagliflozin and metformin [see Clinical Studies (14)].
1.1 Limitation of UseSYNJARDY is not recommended for patients with type 1 diabetes or for the treatment of diabetic ketoacidosis.
History
There is currently no drug history available for this drug.
Other Information
SYNJARDY tablets contain two oral antihyperglycemic drugs used in the management of type 2 diabetes: empagliflozin and metformin hydrochloride.
Empagliflozin
Empagliflozin is an orally-active inhibitor of the sodium-glucose co-transporter 2 (SGLT2).
The chemical name of empagliflozin is D-Glucitol,1,5-anhydro-1-C-[4-chloro-3-[[4-[[(3S)-tetrahydro-3-furanyl]oxy]phenyl]methyl]phenyl]-, (1S).
Its molecular formula is C23H27ClO7 and the molecular weight is 450.91. The structural formula is:
Empagliflozin is a white to yellowish, non-hygroscopic powder. It is very slightly soluble in water, sparingly soluble in methanol, slightly soluble in ethanol and acetonitrile; soluble in 50% acetonitrile/water; and practically insoluble in toluene.
Metformin hydrochloride
Metformin hydrochloride is a white to off-white crystalline compound with a molecular formula of C4H11N5•HCl and a molecular weight of 165.63. Metformin hydrochloride is freely soluble in water and is practically insoluble in acetone, ether, and chloroform. The pKa of metformin is 12.4. The pH of a 1% aqueous solution of metformin hydrochloride is 6.68. The structural formula is:
SYNJARDY
SYNJARDY tablets for oral administration are available in four dosage strengths containing 5 mg empagliflozin and 500 mg metformin hydrochloride, 5 mg empagliflozin and 1000 mg metformin hydrochloride, 12.5 mg empagliflozin and 500 mg metformin hydrochloride, or 12.5 mg empagliflozin and 1000 mg metformin hydrochloride.
Each film-coated tablet of SYNJARDY contains the following inactive ingredients: copovidone, corn starch, colloidal silicon dioxide, magnesium stearate. Film-coating: hypromellose, titanium dioxide, talc, polyethylene glycol 400, and yellow ferric oxide (5 mg/500 mg, 5 mg/1000 mg) or red ferric oxide and black ferrosoferric oxide (12.5 mg/500 mg, 12.5 mg/1000 mg).
Sources
Synjardy Manufacturers
-
Boehringer Ingelheim Pharmaceuticals, Inc.
![Synjardy (Empagliflozin And Metformin Hydrochloride) Tablet [Boehringer Ingelheim Pharmaceuticals, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Synjardy | Boehringer Ingelheim Pharmaceuticals, Inc.
2.1 Recommended Dosage Individualize the starting dose of SYNJARDY based on the patient’s current regimen: – In patients on metformin, switch to SYNJARDY containing empagliflozin 5 mg with a similar total daily dose of metformin; – In patients on empagliflozin, switch to SYNJARDY containing metformin 500 mg with a similar total daily dose of empagliflozin; – In patients already treated with empagliflozin and metformin, switch to SYNJARDY containing the same total daily doses of each component. Take SYNJARDY twice daily with meals; with gradual dose escalation to reduce the gastrointestinal side effects due to metformin [see Dosage Forms and Strengths (3)]. In patients with volume depletion not previously treated with empagliflozin, correct this condition before initiating SYNJARDY [see Warnings and Precautions (5.2) and Patient Counseling Information (17)]. Adjust dosing based on effectiveness and tolerability while not exceeding the maximum recommended daily dose of metformin 2000 mg and empagliflozin 25 mg [see Dosage and Administration (2.2)]. 2.2 Recommended Dosage in Patients with Renal Impairment Assess renal function prior to initiation of SYNJARDY and periodically, thereafter. Do not initiate or continue SYNJARDY in patients with serum creatinine levels greater than or equal to 1.5 mg/dL for males or 1.4 mg/dL for females. In patients eligible for SYNJARDY based on creatinine cutoff criteria do not initiate or continue SYNJARDY if eGFR is persistently less than 45 mL/min/1.73 m2. In patients eligible for SYNJARDY based on creatinine cutoff criteria, no dose adjustment is needed if eGFR is greater than or equal to 45 mL/min/1.73 m2 [see Contraindications (4) and Warnings and Precautions (5.3)].
Login To Your Free Account