Synjardy FDA Approval History
Last updated by Judith Stewart, BPharm on July 2, 2023.
FDA Approved: Yes (First approved August 26, 2015)
Brand name: Synjardy
Generic name: empagliflozin and metformin
Dosage form: Tablets
Company: Eli Lilly and Company and Boehringer Ingelheim
Treatment for: Diabetes, Type 2
Synjardy (empagliflozin and metformin hydrochloride) is a sodium glucose co-transporter-2 (SGLT2) inhibitor and biguanide combination for the treatment of type 2 diabetes.
- Synjardy is indicated as an adjunct to diet and exercise to improve glycemic control in adults and pediatric patients aged 10 years and older with type 2 diabetes mellitus.
- Synjardy contains a combination of two medicines well established in the treatment of type 2 diabetes. Empagliflozin is an SGLT2 inhibitor which reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, thereby increasing urinary glucose excretion. Metformin hydrochloride is a biguanide antihyperglycemic agent which improves glucose tolerance in patients with type 2 diabetes mellitus, lowering both basal and postprandial plasma glucose, decreasing hepatic glucose production, decreasing intestinal absorption of glucose, and improving insulin sensitivity by increasing peripheral glucose uptake and utilization.
- Synjardy tablets are taken orally twice daily with meals, with gradual dosage escalation to reduce the gastrointestinal side effects due to metformin.
- The Synjardy product label carries a Boxed Warning for lactic acidosis, which can be fatal.
- Warnings and precautions associated with Synjardy include lactic acidosis, ketoacidosis, volume depletion, urosepsis and pyelonephritis, hypoglycemia, necrotizing fasciitis of the perineum (Fournier’s Gangrene), genital mycotic infections, and vitamin B12 deficiency.
- Common adverse reactions associated with empagliflozin include urinary tract infection and female genital mycotic infections.
Common adverse reactions associated with metformin include diarrhea, nausea/vomiting, flatulence, abdominal discomfort, indigestion, asthenia, and headache.
Development timeline for Synjardy
Further information
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