Medication info
Empaloh Tablet 10 mg (Empagliflozin)

Empaloh Tablet 10 mg (Empagliflozin)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin Amorphous›10mg / 1 tablet
Manufacturer / importer
동광제약(주)
Appearance
Light yellow, double-convex, round film-coated tablets
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202102079 · Approved 2021.03.05 · Insurance code 645907220

Summary

Main use
Blood sugar control and prevention of cardiovascular events in type 2 diabetes
Who takes it
Adults
Adult dose
The recommended dose of this medication is 10 mg once daily for monotherapy and in combination therapy with other antihyperglycemic agents such as insulin. If excellent tolerance is observed and additional blood sugar control is needed, the dose can be increased to 25 mg once daily. It can be administered without regard to meals, and the tablets should be swallowed whole. If a dose is forgotten, take it as soon as you remember, but do not take double doses in a day.

Ingredients

Manufacturer
동광제약(주)

Efficacy & effects

Blood sugar control and prevention of cardiovascular events in type 2 diabetes

  • Type 2 diabetes
  • difficulty in blood sugar control
  • cardiovascular disease
  • inability to control blood sugar
View approved original text

This medication is used in conjunction with dietary and exercise therapy to help control blood sugar levels in adults with type 2 diabetes. It can be administered as monotherapy and, in cases of poor blood sugar control, can be combined with other medications such as metformin, pioglitazone, sulfonylureas, insulin, and DPP-4 inhibitors. Caution is advised for type 2 diabetes patients with cardiovascular disease, and usage should be closely monitored according to a professional's guidance. This medication effectively improves blood sugar levels and is used for diabetes treatment.

How to take

Adult dose

The recommended dose of this medication is 10 mg once daily for monotherapy and in combination therapy with other antihyperglycemic agents such as insulin. If excellent tolerance is observed and additional blood sugar control is needed, the dose can be increased to 25 mg once daily. It can be administered without regard to meals, and the tablets should be swallowed whole. If a dose is forgotten, take it as soon as you remember, but do not take double doses in a day.

Precautions

This medication should not be used by individuals who are allergic to the active ingredient or any component of this medication. This medication is not suitable for patients with type 1 diabetes or diabetic ketoacidosis. Patients with severely impaired kidney function, particularly those with a glomerular filtration rate below 30 mL/min/1.73m2 or with end-stage kidney disease or on dialysis should not take this medication. This medication contains lactose, so individuals with issues breaking down lactose or genetic disorders such as galactose intolerance, Lapp lactose deficiency, and glucose-galactose malabsorption should not use it. This medication should be used cautiously in patients with slightly impaired kidney function, and kidney function should be regularly monitored, with dosage adjustments or discontinuation as necessary. In patients with heart failure, particularly those with mild to moderate severity, caution is required, and it is not recommended for those with severe heart failure. When this medication is used with drugs that can cause hypoglycemia, such as insulins or sulfonylureas, dosage adjustments may be necessary to reduce the risk of hypoglycemia. While taking this medication, keep a close watch for symptoms such as hypoglycemia, urinary tract infections, genital infections, increased urination, and decreased fluid volume since these side effects may occur. Severe metabolic abnormalities such as ketoacidosis may occur, and if symptoms like vomiting, abdominal pain, or respiratory distress are observed, consult healthcare professionals immediately. Elderly patients, especially those over 75 years of age, are at higher risk of fluid loss and should be monitored closely, while use is not recommended for those over 85 years. This medication may increase the risk of serious urinary tract infections such as urosepsis or pyelonephritis, so prompt treatment is necessary if infection symptoms occur. Pregnant women or those planning to become pregnant should avoid using this medication, and breastfeeding mothers should also discontinue breastfeeding. It is not used in children and adolescents due to lack of safety and efficacy data. No specific toxicity has been reported in cases of overdose, but appropriate treatment may be required according to clinical conditions. This medication may have a minor impact on driving or operating machinery, so caution is advised especially in cases of risk of hypoglycemia. Regularly check kidney function and blood sugar levels while taking this medication, and inform healthcare professionals if abnormalities are observed.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), ketoacidosis, urosepsis, pyelonephritis, perineal necrosis, severe skin reactions (severe rash, blisters, skin peeling, pain in the mouth/eyes), liver abnormalities (jaundice of the skin or eyes, general malaise), severe edema (widespread swelling, markedly decreased urine output), severe neurological symptoms (intense headache, seizures, confusion, visual disturbances, paralysis), respiratory issues (shortness of breath or difficulty breathing

Mild side effects

  • Hypoglycemia
  • itching
  • rash
  • increased urination
  • urinary tract infection
  • vulvovaginitis
  • balanitis
  • increased serum creatinine
  • decreased glomerular filtration rate
  • thirst
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  • fatigue
  • peripheral edema
  • facial swelling
  • pain
  • headache
  • dizziness
  • cough
  • indigestion
  • abdominal pain
  • vomiting
  • diarrhea
  • weight gain
  • weight loss
  • constipation
  • dry mouth
  • blood in stool
  • hemorrhoids
  • toothache
  • back pain
  • musculoskeletal chest pain
  • joint pain
  • drowsiness

Not everyone experiences these, and they can vary from person to person.

Storage

This medication should be stored in a tightly closed container that protects it from air and moisture, and it is best stored at room temperature between 1 degree and 30 degrees Celsius. This will help maintain the effectiveness of the medication.

Appearance and packaging

Appearance

Light yellow, double-convex, round film-coated tablets

Package unit

30 tablets/bottle

Same-ingredient medicines

Even with the same ingredient, strength, dosage form and how it is taken can differ.

Even with the same ingredient, the dose and directions can differ by strength and dosage form. Talk to a doctor or pharmacist before switching from a medication you are already taking.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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This drug information is based on data provided by the Korea Ministry of Food and Drug Safety.
Consult a doctor or pharmacist for accurate dosage, administration, and usage instructions.