Indications: Synjardy (empagliflozin and metformin hydrochloride) is 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 regimen containing empagliflozin or metformin, or in patients already being treated with both empagliflozin and metformin.

Dosing: Individualize the starting dose based on patient’s current regimen. Maximum recommended dose is 12.5 mg empagliflozin/1000 mg metformin twice daily. Take twice daily with meals, with gradual dose escalation to reduce the gastrointestinal side effects due to metformin.

Pharmacokinetics: The results of a bioequivalence study in healthy subjects demonstrated that Synjardy (empagliflozin/metformin hydrochloride) 5 mg/500 mg, 5 mg/1000 mg, 12.5 mg/500 mg, and 12.5 mg/1000 mg combination tablets are bioequivalent to co-administration of corresponding doses of empagliflozin and metformin as individual tablets.

Side Effects/Risks: Assess renal function before initiating. Most common adverse reactions associated with empagliflozin are urinary tract infection and female genital mycotic infections. Adverse reactions with metformin include diarrhea, nausea/vomiting, flatulence, abdominal discomfort, indigestion, asthenia, and headache.

Citation: Highlights of prescribing information: Synjardy (empagliflozin and metformin hydrochloride). Prescribing Information, including Medication Guide. Revised August 2015. Accessed August 31, 2015.