Empagrom 12.5/1000 milligram (Empagliflozin, Metformin Hydrochloride)

Adult dose

The recommended dosage of this medication is one tablet, twice a day. The dosage should be determined considering each patient's current treatment regimen, efficacy, and tolerability, without exceeding a maximum of 25 mg of empagliflozin and 2000 mg of metformin. If blood sugar control is insufficient, it is recommended to take 5 mg of empagliflozin twice daily (total daily dose of 10 mg) along with the existing metformin dosage. Good tolerability with empagliflozin 10 mg suggests that it can be increased to 25 mg (total daily dose) if additional blood sugar control is needed. For patients transitioning to this medication from combination therapy with empagliflozin (total daily dose of 10 mg or 25 mg) and metformin, the existing doses of empagliflozin and metformin should be administered. When this medication is used in conjunction with sulfonylureas or insulin, a reduction in the dose of sulfonylureas or insulin may be considered to reduce the risk of hypoglycemia (refer to precautions 4. Adverse Reactions and 6. Interactions). This medication should be taken with meals to minimize gastrointestinal side effects associated with metformin. If a dose is missed, take it as soon as you remember. However, do not take double the dose at once; in such cases, skip the missed dose. Special groups Patients with renal impairment Dose adjustment is not needed for patients with mild renal impairment. As this medication contains metformin, for patients with estimated glomerular filtration rate (eGFR) of 45-59 ml/min/1.73m2 or CrCl of 45-59 ml/min without other accompanying symptoms that increase the risk of lactic acidosis, it can be used with dose adjustment. The initial dose of metformin in such patients is 500 mg or 850 mg once daily, hence empagliflozin and metformin should be started as individual monotherapy. The maximum dose of metformin hydrochloride that can be given with this medication is 1000 mg, administered as 500 mg twice daily. Kidney function should be closely monitored every 3-6 months (refer to precautions 3. Caution in administration for reference 1). If CrCl <45 ml/min or eGFR <45 ml/min/1.73m2 indicates decreased kidney function, this medication should be immediately discontinued (refer to precautions 2. Do not administer to reference 2). Elderly patients Patients over 75 years should consider the risk of reduced kidney function and fluid volume loss.

This medication is used to help control blood sugar and is mainly used in diabetes treatment. Rare side effects can include severe lactic acidosis, so patients with poor kidney function or liver problems should be cautious when taking this medication. Additionally, there is a risk of hypoglycemia when taken with insulin or sulfonylurea medications, so dosages should be adjusted according to the doctor's instructions. Patients with moderate to severe kidney function impairment, acute infections, dehydration, heart failure, and those around the time of surgery should not take this medication. Use of iodine contrast agents should also lead to a temporary pause in this medication, which should only be resumed after kidney function returns to normal. This medication can increase the risk of urinary tract infections and genital infections, so consult a doctor immediately if infection symptoms occur. Long-term use may lower vitamin B12 levels, thus regular blood tests to monitor the condition are recommended. Pregnant or breastfeeding women are advised to avoid taking this medication, and it is not recommended for children or adolescents under 18. Older adults or patients at risk of fluid loss should be cautious for dehydration or low blood pressure, and kidney function tests should be performed regularly. Overdose can cause serious side effects such as lactic acidosis, so dosage must be strictly followed, and if unusual symptoms occur, a medical facility should be visited immediately. Avoid alcohol during this medication, and be careful of the risk of hypoglycemia during irregular meals or intense physical activity. The effects on driving or operating machinery are unclear, but caution is needed if dizziness or hypoglycemic symptoms occur. This medication may interact with other medications, so inform healthcare providers of any other medications being taken. Finally, store out of reach of children and keep in the original container to maintain quality.

Serious side effects

Hives, angioedema, necrosis of the perineum, ketoacidosis, lactic acidosis, acute kidney injury, significant urinary tract infections including pyelonephritis and urosepsis, severe allergic reactions, serious skin reactions, liver abnormalities (jaundice), serious neurological symptoms, severe edema or urination abnormalities, cerebral infarction, myocardial infarction, acute cholecystitis, autoimmune hepatitis, cholelithiasis, sepsis, pneumonia, appendiceal abscess, chronic otitis media, meningitis, acute

Mild side effects

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

This medication should be stored in a tightly closed container to avoid exposure to air or moisture. It is important to maintain a storage temperature between 1 degree to 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness and safety for a longer period.

Appearance

Biconvex oval film-coated tablet with a dark brownish purple color

Package unit

60 tablets/bottle, 60 tablets/box [10 tablets/PTP x 6]