What it's for (Indications)
- Empagliflozin + Metformin Hydrochloride is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
- Empagliflozin, specifically, is also indicated to reduce the risk of cardiovascular death in adults with type 2 diabetes mellitus and established cardiovascular disease.
Dosage Information
| Type | Guideline |
|---|---|
| Standard | Assess renal function and volume status before initiating therapy, correcting any volume depletion as needed. Individualize the starting dosage based on the patient's current regimen and renal function. Initiation is not recommended in patients with an eGFR less than 45 mL/min/1.73 m². The maximum recommended dosage is 25 mg/day of empagliflozin and 2,000 mg/day of metformin HCl. For immediate-release formulations (e.g., SYNJARDY): Take orally twice daily with meals. Gradual dosage escalation is recommended to reduce gastrointestinal adverse reactions associated with metformin HCl. For extended-release formulations (e.g., SYNJARDY XR): Take orally once daily with a meal in the morning. Swallow tablets whole; do not split, crush, dissolve, or chew. Gradual dosage escalation is recommended. Discontinuation of therapy may be necessary under certain clinical conditions. |
Safety & Warnings
Common Side Effects
- Common side effects include urinary tract infections, female genital mycotic infections, bladder discomfort, cloudy or bloody urine, painful or difficult urination, lower back pain, blurred vision, rapid heartbeat, confusion, headache, unusual exhaustion or weakness, sweating, vomiting, and nausea.
- More serious adverse reactions can include lactic acidosis, diabetic ketoacidosis, volume depletion, severe genitourinary infections (including urosepsis, pyelonephritis, and Necrotizing Fasciitis of the Perineum (Fournier's Gangrene)), hypoglycemia, lower limb amputation, and hypersensitivity reactions.
- Vitamin B12 deficiency may also occur.
Serious Warnings
- Black Box Warning: 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 is characterized by elevated blood lactate levels (>5 mmol/Liter), anion gap acidosis (without evidence of ketoacidosis).
- Renal Impairment: Assess renal function before initiating treatment and as clinically indicated.
- Not recommended for initiation if eGFR is less than 45 mL/min/1.
- 73 m².
- Use with caution in patients with kidney disease; close monitoring of kidney function, potential dose modifications, or substitution may be necessary.
- Volume Depletion: Assess volume status and correct any volume depletion prior to initiation.
- Empagliflozin may cause dehydration and lightheadedness, especially in older persons.
- Lactic Acidosis: Metformin-associated lactic acidosis is a rare but serious complication (refer to Boxed Warning).
- Diabetic Ketoacidosis: Cases of diabetic ketoacidosis have been reported, including in patients with type 1 diabetes mellitus and other forms of ketoacidosis.
- Genitourinary Infections: Increased risk of genitourinary infections, including serious ones like urosepsis, pyelonephritis, Necrotizing Fasciitis of the Perineum (Fournier's Gangrene), and genital mycotic infections.
- Hypoglycemia: Increased risk of hypoglycemia, particularly when used in combination with insulin or insulin secretagogues.
- Hypersensitivity Reactions: Hypersensitivity reactions (e.
- g.
- , angioedema) have been reported.
- Inform your doctor about any known allergies to empagliflozin, metformin HCl, or other medications.
- Pregnancy: Should only be used if absolutely necessary; pregnant females should consult their doctors regarding benefits and risks.
- Lactation: Should only be used if absolutely necessary; lactating females should consult their doctors regarding benefits and risks.
- A doctor may advise stopping breastfeeding or discontinuing the medicine.
- Driving: May cause dizziness and sleepiness; avoid driving or operating machinery until you have a clear idea of how the medication affects you.
- Liver Impairment: Patients with liver diseases should consult their doctor before use.
- Alcohol Consumption: Alcohol consumption is contraindicated during treatment as it increases the risk of both high and low blood sugar levels.
- Medical History: Inform your doctor about your medical history, especially if you have kidney problems (e.
- g.
- , dialysis), liver disorders, alcohol use/abuse, dehydration, low blood pressure, high blood cholesterol, or a history of vaginal or penile yeast infections.
- Stress and Illness: During periods of stress (e.
- g.
- , infection, injury, fever, surgery) or when not eating enough, blood sugar control may be difficult, and increased ketone levels may occur.
- Adjustments to treatment, medications, or blood glucose/ketone monitoring may be necessary.
- Surgery: Inform your doctor or dentist about all medications (prescription, nonprescription, herbal) you are taking before any surgery.
- Elderly Patients: Older persons may be more susceptible to adverse effects such as dehydration, kidney issues, and lightheadedness.
How it Works (Mechanism of Action)
Empagliflozin is a sodium-glucose co-transporter 2 (SGLT2) inhibitor, which reduces renal reabsorption of filtered glucose, lowers the renal threshold for glucose, and increases urinary glucose excretion. It also reduces sodium reabsorption and increases sodium delivery to the distal tubule, which may influence tubuloglomerular feedback, intraglomerular pressure, cardiac pre- and afterload, and sympathetic activity. Metformin HCl is an antihyperglycemic biguanide that improves glucose tolerance in patients with type 2 diabetes mellitus.
Commercial Brands (Alternatives)
No other brands found for this formula.