Empagliflozin/ Metformin Hydrochloride Tablet 12.5/850 mg

Adult dose

The recommended dosage of this medication is 1 tablet at a time, twice a day. Each patient's current treatment regimen, efficacy, and tolerability should be considered to decide the dosage within the maximum recommended daily doses of empagliflozin 25 mg and metformin 2000 mg. Patients who do not achieve adequate blood sugar control using metformin alone or in combination with other medications such as insulin may be prescribed empagliflozin 5 mg twice daily (total daily dose of 10 mg), along with their existing metformin dosage.

This medication helps control blood sugar levels. However, there is a risk of a rare side effect known as severe lactic acidosis, so caution is warranted. There may be a risk of hypoglycemia when used in conjunction with other diabetes medications. This medication should not be used in patients with moderate or severe renal impairment, acute kidney problems, or unstable cardiac function. It should be temporarily discontinued before and after undergoing tests that use iodine contrast agents, and restarted only after confirming normal kidney function. It is also prudent to suspend use temporarily during severe infections, trauma, or surgery. It is not recommended for use in pregnant or breastfeeding women. Since this medication can affect kidney function, regular monitoring of kidney function should be conducted before and during treatment. Care should be taken in cases of dehydration or fluid deficiency, and the medication may be discontinued if necessary. When used in conjunction with insulin or sulfonylureas, dosing adjustments may be required to reduce the risk of hypoglycemia. While taking this medication, there may be an increased risk of urinary infections or genital infections, so patients should consult their healthcare provider immediately if symptoms appear. Gastrointestinal disturbances may occur due to metformin, and regular blood tests may be necessary to monitor vitamin B12 levels. Excessive alcohol intake can increase the risk of lactic acidosis, so it should be avoided. This medication can cause serious infections such as perineal necrosis in some patients, so patients should inform their healthcare provider immediately if pain, redness, or swelling occurs in the genital area. Elderly patients or those with impaired renal function should take special care while using this medication and may require dosing adjustments. In the event of an overdose, immediate medical treatment should be sought, and dialysis may be necessary. It is recommended to avoid use in children, as safety and efficacy have not been established.

Serious side effects

Hives, angioedema, perineal necrosis, ketoacidosis, lactic acidosis, pyelonephritis, urosepsis, acute kidney injury, liver abnormalities (liver dysfunction, hepatitis, liver damage, jaundice), severe allergic reactions, severe edema, myocardial infarction, cerebral infarction, concussion, intracranial aneurysm, seizures, consciousness disturbances, visual disturbances, paralysis, asthma attacks, difficulty breathing, shortness of breath or respiratory distress, heart failure, shock, vascular stent thrombosis,

Mild side effects

• Hypoglycemia
• urinary infections
• genital infections
• increased urination
• nausea
• vomiting
• diarrhea
• abdominal pain
• loss of appetite
• constipation

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is recommended to maintain the storage temperature between 1°C and 30°C at room temperature to ensure the medication's effectiveness and safety.

Appearance

A film-coated tablet that is oval-shaped with a convex surface, white with a pink hue.

Package unit

Bottle packaging - 60 tablets/bottle, PTP packaging - 60 tablets/box [(10 tablets/PTP X 6)], PTP packaging - 10 tablets/box [(10 tablets/PTP X 1)]