Empaa-M XR (empagliflozin + metformin hci): Uses, Dosage & Side Effects

What it's for (Indications)

Empagliflozin + Metformin HCl is used in combination with a proper exercise and diet regimen to help patients with type 2 diabetes mellitus lower their blood glucose levels.
It is also used to reduce the risk of cardiovascular death in adults with type 2 diabetes and established cardiovascular disease.

Dosage Information

Type	Guideline
Standard	Assess renal function and volume status before initiating therapy. 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. Take this medicine by mouth with a glass of water. Immediate-release formulations (SYNJARDY) should be taken orally twice daily with meals. Extended-release formulations (SYNJARDY XR) should be taken orally once daily with a meal in the morning. Swallow the tablet whole; do not split, crush, dissolve, or chew. Gradual dosage escalation is recommended to minimize gastrointestinal adverse reactions related to metformin HCl. Take at the same time every day to aid adherence. Discontinue use for 48 hours before and after surgery or prior to imaging procedures with iodinated contrast media. Store at room temperature, away from sunlight and water, and out of the reach of children and pets.

Type

Guideline

Standard

Assess renal function and volume status before initiating therapy. 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. Take this medicine by mouth with a glass of water. Immediate-release formulations (SYNJARDY) should be taken orally twice daily with meals. Extended-release formulations (SYNJARDY XR) should be taken orally once daily with a meal in the morning. Swallow the tablet whole; do not split, crush, dissolve, or chew. Gradual dosage escalation is recommended to minimize gastrointestinal adverse reactions related to metformin HCl. Take at the same time every day to aid adherence. Discontinue use for 48 hours before and after surgery or prior to imaging procedures with iodinated contrast media. Store at room temperature, away from sunlight and water, and out of the reach of children and pets.

Safety & Warnings

Common Side Effects

Common side effects include: Bladder discomfort, cloudy or bloody urine, painful or difficult urination, pain in the lower back, blurred vision, rapid heartbeat, confusion, headache, unusual exhaustion or weakness, sweating, vomiting and nausea, gastrointestinal and taste disturbances (e.
g.
, metallic taste), flatulence, upper respiratory tract infections, urinary tract infections, and female genital mycotic infections.
Less common or severe side effects include: Abnormal liver function, skin reactions, hepatitis (liver infection), reduced Vitamin B-12 absorption, Stevens Johnson Syndrome (a severe allergic reaction), hypoglycemia (low blood sugar levels), facial swelling, volume depletion, diabetic ketoacidosis, lactic acidosis, lower limb amputation, urosepsis, pyelonephritis, necrotizing fasciitis of the perineum (Fournier's Gangrene), and other hypersensitivity reactions.

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 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, and an increased lactate/pyruvate ratio; plasma metformin levels >5 mcg/mL are generally found. Risk factors include renal impairment, concomitant use of certain drugs, advanced age, dehydration, hepatic impairment, excessive alcohol intake, and conditions associated with hypoxemia.
Assess renal function and volume status before initiating therapy and as clinically indicated; initiation is not recommended in patients with an eGFR less than 45 mL/min/1.
73 m2 due to the metformin HCl component.
This medication can cause Lactic Acidosis (see Black Box Warning), Diabetic Ketoacidosis (including in patients with Type 1 Diabetes Mellitus), severe Genitourinary Infections (e.
g.
, Urosepsis, Pyelonephritis, Necrotizing Fasciitis of the Perineum (Fournier's Gangrene), and Genital Mycotic Infections), Hypoglycemia, Lower Limb Amputation, and Hypersensitivity Reactions.
Monitor for signs of Volume Depletion.
Reduced Vitamin B-12 absorption may occur.
Alcohol consumption is contraindicated due to increased risk of both high and low blood sugar levels, as well as lactic acidosis.
Discontinue use for 48 hours before and after surgery or prior to imaging procedures with iodinated contrast media.
Do not discontinue this medicine without informing your doctor.
Inform your doctor about your complete medical history, especially heart disease, kidney problems (including dialysis), liver disorders, alcohol use/abuse, dehydration, low blood pressure, high blood cholesterol, or a history of vaginal or penile yeast infections.
Inform your doctor about all your current medicines (prescription, nonprescription, and herbal) and significant past medical history.
Blood sugar control may be difficult under stress (e.
g.
, infection, injury, fever, surgery), or if not eating adequately, potentially leading to increased ketone levels; treatment adjustments may be necessary.
Use with caution in patients with kidney or liver disease, and monitor function closely.
Empagliflozin + Metformin HCl is not recommended for children.
Due to potential dizziness and sleepiness, avoid driving or operating machinery until you know how the medicine affects you.
Negative effects such as dehydration, kidney issues, and lightheadedness (especially while standing) may be more severe in older persons.
Use during pregnancy and lactation only if absolutely necessary, after consulting a doctor regarding benefits and risks; for lactating females, a doctor may advise to stop breastfeeding or stop taking the medicine.
Store at room temperature, away from sunlight and water, and out of the reach of children and pets.

How it Works (Mechanism of Action)

SYNJARDY and SYNJARDY XR contain empagliflozin, a SGLT2 inhibitor, and metformin HCl, a biguanide. Empagliflozin inhibits SGLT2, the predominant transporter responsible for reabsorption of glucose from the glomerular filtrate back into the circulation. By inhibiting SGLT2, empagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose, thereby increasing urinary glucose excretion. Empagliflozin also reduces sodium reabsorption, increasing sodium delivery to the distal tubule, which may influence physiological functions such as increasing tubuloglomerular feedback, reducing intraglomerular pressure, lowering cardiac pre- and afterload, and downregulating sympathetic activity. Metformin HCl is an antihyperglycemic agent that improves glucose tolerance in patients with type 2 diabetes mellitus, primarily by decreasing hepatic glucose production, decreasing intestinal absorption of glucose, and improving insulin sensitivity by increasing peripheral glucose uptake and utilization.