Synjardy Generic Name & Formulations
Mechanism of Action
Limitations of Use
Not recommended in those with type 1 diabetes; may increase risk of diabetic ketoacidosis. Not recommended in those with heart failure without T2DM due to the metformin component.
Synjardy Dosage and Administration
Synjardy Boxed Warnings
Increased risk of metformin-associated lactic acidosis in renal or hepatic impairment, concomitant use of certain drugs (eg, cationic drugs), ≥65yrs of age, undergoing radiological contrast study, surgery and other procedures, hypoxic states, and excessive alcohol intake; discontinue if lactic acidosis is suspected. Discontinue at time of, or prior to intravascular iodinated contrast imaging in patients with eGFR <60mL/min/1.73m2, history of hepatic impairment, alcoholism, heart failure, or will be given intra-arterial contrast; reevaluate eGFR 48hrs after procedure and restart therapy if renally stable. Correct volume depletion before initiating. Increased risk for volume depletion or hypotension in those with renal impairment (eGFR <60mL/min/1.73m2), elderly, or on loop diuretics. Assess volume status and renal function prior to initiation; monitor during therapy; more frequently in elderly. Assess for ketoacidosis in presence of signs/symptoms of metabolic acidosis, regardless of blood glucose levels; discontinue if suspected, evaluate and treat; consider risk factors before initiation (eg, pancreatic insulin deficiency, caloric restriction, alcohol abuse). Consider temporarily discontinuing prior to scheduled surgery (for ≥3 days) or other clinical situations (eg, prolonged fasting due to illness or post-surgery). Necrotizing fasciitis of the perineum (Fournier's gangrene); discontinue and treat immediately if suspected; use alternative antidiabetic. Increased risk of genital mycotic infections, UTIs (including urosepsis, pyelonephritis); monitor and treat as appropriate. Discontinue if hypersensitivity reaction occurs; treat promptly and monitor until resolve. Measure hematologic parameters annually and Vit. B12 levels at 2–3 year intervals. Hepatic impairment, pregnancy (during 2nd & 3rd trimesters), nursing mothers: not recommended.
- Peak plasma concentrations were reached at 1.5 hours post-dose.
- Steady-state mean plasma AUC and Cmax were 1,870 nmol∙h/L and 259 nmol/L, respectively, with 10 mg empagliflozin once daily treatment, and 4,740 nmol∙h/L and 687 nmol/L, respectively, with 25 mg empagliflozin once daily treatment.
- Absolute bioavailability of immediate-release metformin HCl 500 mg tablet under fasting conditions is ~50 to 60%.
- Apparent steady-state volume of distribution: estimated 73.8 L.
- Plasma protein binding: 86.2%.
- Apparent volume of distribution of immediate-release metformin HCl 850 mg tablet: 654 ± 358 L.
- Renal (54.4%), fecal (41.2%). Half-life: 12.4 hours.
- Apparent oral clearance: 10.6 L/h.
- Renal (~90%). Half-life: ~6.2 hours (plasma); ~17.6 hours (blood).
Increased risk of lactic acidosis with topiramate, other carbonic anhydrase inhibitors (eg, zonisamide, acetazolamide, dichlorphenamide); monitor. Concomitant cationic drugs that interfere with renal tubular transport systems (eg, ranolazine, vandetanib, dolutegravir, cimetidine) may increase metformin levels; monitor. Avoid excessive alcohol. Diuretics, steroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, sympathomimetics, nicotinic acid, CCBs, and isoniazid may cause hyperglycemia. Greater potential for volume depletion with concomitant diuretics. β-blockers may mask hypoglycemia. May need a lower dose of concomitant insulin or insulin secretagogue (eg, sulfonylurea) to reduce risk of hypoglycemia. Empagliflozin may antagonize serum lithium concentrations; monitor levels more frequently. Empagliflozin will lead to false (+) urine glucose tests or unreliable measurements of 1, 5-AG assay; use alternative methods to monitor glycemic control.
Synjardy Adverse Reactions
UTIs, female genital mycotic infections, diarrhea, nausea/vomiting, flatulence, abdominal discomfort, indigestion, asthenia, headache; hypotension, ketoacidosis, renal impairment, angioedema; rare: Fournier's gangrene.
Synjardy Clinical Trials
Synjardy Patient Counseling