EmpaMet12.5 mg+1000 mg

EmpaMet is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, in patients who are:

• Not adequately controlled on metformin monotherapy alone
• Not adequately controlled on empagliflozin monotherapy alone
• Already being treated with the individual components of empagliflozin and metformin hydrochloride taken separately
• Requiring add-on therapy to other antidiabetic agents (e.g., insulin, sulfonylureas) under medical supervision

Some evidence for cardiovascular risk reduction (reduced cardiovascular death in patients with established cardiovascular disease) and renoprotective benefit (slower decline in kidney function/reduced progression of chronic kidney disease) has been demonstrated specifically for the empagliflozin component in dedicated outcome trials; this fixed-dose combination itself has not been separately studied for these outcomes, and any such benefit should be discussed with a physician on an individual basis.

EmpaMet is not indicated for type 1 diabetes mellitus or diabetic ketoacidosis.

Each film-coated tablet of Empagliflozin + Metformin Hydrochloride contains empagliflozin and metformin hydrochloride in fixed-dose combination. It is commercially available in multiple strength combinations (for example, empagliflozin 5 mg/12.5 mg with metformin hydrochloride 500 mg/1000 mg per tablet), allowing dose individualization. Refer to the specific product label for the exact strength dispensed.

EmpaMet is an oral fixed-dose combination antidiabetic medicine that brings together two complementary classes of glucose-lowering agents: empagliflozin, a sodium-glucose co-transporter-2 (SGLT2) inhibitor, and metformin hydrochloride, a biguanide. Together they are used to improve blood glucose control in adults with type 2 diabetes mellitus as an adjunct to diet and exercise, allowing lower pill burden compared with taking each component separately.

Oral antidiabetic combination: SGLT2 (sodium-glucose co-transporter-2) inhibitor plus Biguanide.

Empagliflozin + Metformin Hydrochloride combines two agents with complementary and independent mechanisms of action to lower blood glucose in type 2 diabetes:

• Empagliflozin inhibits SGLT2, the transporter responsible for the majority of glucose reabsorption in the renal proximal tubule. By blocking SGLT2, empagliflozin reduces renal glucose reabsorption and increases urinary glucose excretion, lowering plasma glucose in an insulin-independent manner. This action also produces a mild osmotic diuresis and caloric loss.
• Metformin hydrochloride is a biguanide that lowers both basal and postprandial plasma glucose. It works primarily by decreasing hepatic glucose production (reducing gluconeogenesis and glycogenolysis), by increasing peripheral insulin sensitivity (enhancing glucose uptake and utilization in muscle), and by modestly delaying intestinal glucose absorption. Metformin does not stimulate insulin secretion and therefore does not cause hypoglycemia when used alone.

Absorption, metabolism, and elimination of the two components proceed largely independently; empagliflozin is metabolized mainly by glucuronidation and eliminated renally and via feces, while metformin is not metabolized and is eliminated unchanged by the kidneys, so renal function is a key determinant of dosing and safety for both components.

EmpaMet immediate-release tablets are generally taken twice daily, with meals, to reduce gastrointestinal side effects and improve tolerability. Tablets should be swallowed whole with a glass of water and not crushed or chewed unless the specific product labeling states otherwise. Extended-release formulations, where available, are typically taken once daily with the morning meal and must be swallowed whole. Patients should take the medicine at consistent times each day and should not skip meals while on this medicine, given the metformin component's dependence on food intake for GI tolerability.

EmpaMet has several clinically significant drug interactions:

• Iodinated contrast media: Use of intravascular iodinated contrast agents can cause acute kidney injury, increasing the risk of metformin-associated lactic acidosis. EmpaMet should be temporarily withheld at the time of, or prior to, a contrast imaging procedure, and should only be restarted after renal function has been re-evaluated and found stable, per the treating physician's instructions.
• Alcohol: Alcohol potentiates the effect of metformin on lactate metabolism and increases the risk of lactic acidosis. Patients should avoid excessive alcohol intake while taking this medicine.
• Diuretics and other antihypertensives: Concomitant use with diuretics (especially loop diuretics) or other blood-pressure-lowering agents can increase the risk of volume depletion, hypotension, and dehydration due to the diuretic effect of the empagliflozin component.
• Insulin and insulin secretagogues (e.g., sulfonylureas): Combined use increases the risk of hypoglycemia; a lower dose of insulin or the secretagogue may be needed.
• Drugs that reduce metformin renal clearance (e.g., certain drugs that compete for renal tubular transport): may increase metformin exposure and lactic acidosis risk; use with caution and monitor.
• Carbonic anhydrase inhibitors (e.g., topiramate): may increase the risk of metabolic/lactic acidosis; monitor closely if co-administered.

Always inform the prescribing physician or pharmacist of all other medicines, supplements, and herbal products being used before starting EmpaMet.

Side effects of EmpaMet reflect both component drugs:

• Very common/common: Gastrointestinal disturbances (diarrhea, nausea, vomiting, flatulence, abdominal discomfort, indigestion), urinary tract infection, female genital mycotic (yeast) infection, increased urination
• Common: Male genital mycotic infection, thirst, taste disturbance
• Uncommon: Volume depletion, hypotension, increased blood creatinine/decreased eGFR, hematocrit elevation
• Rare/serious (see precautions_and_warnings for detail): Lactic acidosis, diabetic ketoacidosis (including euglycemic DKA), necrotizing fasciitis of the perineum (Fournier's gangrene), acute kidney injury, vitamin B12 deficiency with long-term use, hypersensitivity reactions (including angioedema), hypoglycemia when combined with insulin or sulfonylureas

Patients should seek prompt medical attention for any serious or persistent side effect. See precautions_and_warnings for detailed guidance on warning signs.

Pregnancy: EmpaMet is generally not recommended for the management of type 2 diabetes during pregnancy, particularly during the second and third trimesters, based on animal data suggesting potential effects on fetal kidney development with the empagliflozin component. Insulin is generally the preferred agent for glycemic control during pregnancy. Poorly controlled diabetes in pregnancy carries risks of diabetic ketoacidosis, preeclampsia, macrosomia, and other adverse outcomes, so any change in therapy must be made only in consultation with a physician. Women of reproductive potential should discuss pregnancy planning and contraception with their doctor, as metformin may improve ovulation in some women with anovulatory infertility.

Lactation: Use of EmpaMet is generally not recommended while breastfeeding, as effects on the nursing infant (particularly from the empagliflozin component, based on animal data) are not fully established, although metformin itself is present in breast milk in low amounts. Consult a physician before use while breastfeeding.

Lactic acidosis: The metformin component carries a rare but serious risk of lactic acidosis, which can be fatal. Risk is increased by renal impairment, hepatic impairment, alcohol use, dehydration, sepsis, acute heart failure, hypoxic conditions, and advanced age. Symptoms may be subtle and include malaise, muscle pain, respiratory distress, unusual sleepiness, and abdominal pain. Seek immediate medical attention if these symptoms occur, and discontinue the medicine.

Iodinated contrast procedures: Hold EmpaMet before or at the time of an iodinated contrast imaging procedure, as directed by the physician, and resume only after renal function has been re-checked and confirmed stable.

Diabetic ketoacidosis (including euglycemic DKA): The empagliflozin component can rarely cause ketoacidosis even when blood glucose levels are only mildly elevated or near normal ("euglycemic DKA"). Seek medical attention immediately for nausea, vomiting, abdominal pain, unusual fatigue, or difficulty breathing, even if blood glucose appears normal. Temporary discontinuation may be advised before scheduled surgery or during acute serious illness.

Volume depletion and hypotension: The empagliflozin component can cause a mild diuretic effect. Elderly patients, patients with renal impairment, and those taking diuretics or other blood-pressure-lowering medicines are at increased risk of volume depletion, dehydration, dizziness, and hypotension.

Genital mycotic infections and urinary tract infections: Increased urinary glucose can increase the risk of genital yeast infections and urinary tract infections; maintain good genital hygiene and report symptoms such as itching, discharge, burning, or urinary symptoms promptly.

Necrotizing fasciitis of the perineum (Fournier's gangrene): A rare but serious and life-threatening infection of the tissue surrounding the genitals and perineum has been reported with SGLT2 inhibitors. Seek urgent medical attention for severe pain, tenderness, redness, or swelling in the genital or perineal area accompanied by fever or general malaise.

Lower limb amputation: An increased risk of lower-limb amputation (usually toe) has been observed with some SGLT2 inhibitors in clinical trials, particularly in patients with peripheral vascular disease, prior amputation, neuropathy, or diabetic foot ulcers. Monitor feet regularly for infection, ulceration, or pain, and seek prompt care for any foot problems.

Vitamin B12 deficiency: Long-term metformin use may reduce vitamin B12 absorption; periodic monitoring of hematological parameters and B12 levels is advisable, especially with anemia or peripheral neuropathy.

General advice: Take with meals to reduce gastrointestinal side effects. Avoid excessive alcohol intake. Use caution in elderly patients and those with hepatic impairment. Do not use in patients with acute or unstable medical conditions predisposing to hypoxia or dehydration without physician guidance.

Overdose of EmpaMet carries a risk of hypoglycemia (particularly if combined with insulin or sulfonylureas) and, more seriously, lactic acidosis from the metformin component, which is a medical emergency. Symptoms of lactic acidosis include marked weakness, muscle pain, difficulty breathing, abdominal discomfort, and lowered blood pressure. Excessive doses of the empagliflozin component may also increase the risk of diabetic ketoacidosis and dehydration. In case of suspected overdose, seek immediate medical attention or contact a poison control center; hospital management may include supportive care, monitoring of renal function and acid-base status, and hemodialysis in confirmed lactic acidosis or severe renal impairment.

Store at room temperature (below 30°C), away from light and moisture. Keep out of reach of children.

Renal impairment: Dose and eligibility depend on eGFR; contraindicated below eGFR 30 mL/min/1.73 m², not recommended for initiation at eGFR 30-44 mL/min/1.73 m², and requires periodic renal monitoring at eGFR ≥45 mL/min/1.73 m² (see dosage).

Hepatic impairment: Use with caution; hepatic impairment increases the risk of metformin-associated lactic acidosis, so this medicine should generally be avoided in patients with significant hepatic dysfunction unless directed by a physician.

Elderly: Older patients are at higher risk of renal impairment, volume depletion, and lactic acidosis; renal function should be monitored more frequently and dosing individualized.

Pediatric use: See pediatric_uses.

Pregnancy and lactation: See pregnancy_and_lactation.

EmpaMet is generally used as a long-term, ongoing treatment for type 2 diabetes mellitus, as diabetes is a chronic condition requiring sustained glycemic control. The duration of treatment should be determined by the treating physician based on regular monitoring of blood glucose (including HbA1c), renal function, and overall response to therapy. Treatment should not be stopped or altered without medical advice, as doing so may lead to loss of glycemic control.

SGLT2 (sodium-glucose co-transporter-2) inhibitor combined with a Biguanide; oral antidiabetic fixed-dose combination.

Empagliflozin + Metformin Hydrochloride lowers blood glucose through two complementary and independent mechanisms. The empagliflozin component inhibits SGLT2 in the renal proximal tubule, reducing glucose reabsorption and promoting urinary glucose excretion in an insulin-independent manner. The metformin component reduces hepatic glucose production and improves peripheral insulin sensitivity without stimulating insulin secretion. Together, this dual mechanism provides complementary glycemic control while minimizing the risk of hypoglycemia when used without insulin or sulfonylureas.

The safety and efficacy of the immediate-release formulation of EmpaMet have been established for some pediatric patients aged 10 years and older with type 2 diabetes mellitus, based on clinical trial data, and may be used as an adjunct to diet and exercise in this age group under specialist supervision. Notably, pediatric patients showed a higher rate of hypoglycemia compared with adults, regardless of concomitant insulin use, so closer monitoring is warranted. Extended-release formulations of this combination have not been established as safe and effective in pediatric patients. Use in children below 10 years of age is not recommended. Any pediatric use should be initiated and supervised by a pediatric endocrinologist or specialist physician.