Medication info
Empagliflozin 10 mg

Empagliflozin 10 mg

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

MFDS item code 202102110 · Approved 2021.03.05 · Insurance code 647805160

Summary

Main use
Improvement of blood sugar control in type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The recommended dose of this medication is 10 mg once daily for monotherapy and as an add-on therapy with insulin or other hypoglycemic agents. If tolerance is good and additional blood glucose control is needed, the dose may be increased to 25 mg once daily. It can be taken regardless of meals, and the tablet should be swallowed whole. If a dose is missed, take it as soon as remembered, but do not take a double dose within a single day.

Ingredients

Manufacturer
삼진제약(주)

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes and prevention of cardiovascular events

  • Difficulty in blood sugar control in adults with type 2 diabetes
  • inability to control blood sugar
  • cardiovascular disease
View approved original text

This medication is an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes. If initial blood sugar control is difficult, it can be used as monotherapy, and when self-control is insufficient, it may be administered in combination with other diabetes medications such as metformin. If blood sugar control is inadequate with only metformin or in combination with other drugs, this medication can be added to enhance effectiveness. It can also be used when blood sugar control is insufficient during insulin therapy. Caution is recommended for patients with cardiovascular disease or high risk for type 2 diabetes, so consultation with a professional is advised. This medication effectively improves blood sugar control in patients with type 2 diabetes requiring complex treatment.

How to take

Adult dose

The recommended dose of this medication is 10 mg once daily for monotherapy and as an add-on therapy with insulin or other hypoglycemic agents. If tolerance is good and additional blood glucose control is needed, the dose may be increased to 25 mg once daily. It can be taken regardless of meals, and the tablet should be swallowed whole. If a dose is missed, take it as soon as remembered, but do not take a double dose within a single day.

Precautions

This medication should not be administered to certain patients. Firstly, patients with allergic reactions to the active substance or any component of this medication should not use it. Secondly, it is unsuitable for patients with type 1 diabetes or diabetic ketoacidosis. Thirdly, patients with severely impaired renal function, specifically a glomerular filtration rate below 30 mL/min/1.73m2, those with end-stage kidney disease, or those undergoing dialysis should not use this medication. Fourthly, it contains lactose, thus it should not be administered to patients with lactose intolerance, galactose intolerance, or genetic lactase deficiency. This medication should be used with caution in patients with mildly impaired renal function. If the glomerular filtration rate is below 60 mL/min/1.73m2, do not initiate treatment, and if already being treated, dosage adjustment may be necessary. If the glomerular filtration rate falls below 45 mL/min/1.73m2, the medication should be discontinued. This medication is not used in end-stage renal disease or during dialysis, as its efficacy cannot be expected. Patients with heart failure also require caution. It is especially not recommended for patients classified as NYHA class III-IV, and it should be administered with caution to those with mild to moderate heart failure. This medication may increase the risk of hypoglycemia when used with other medications that can cause hypoglycemia, such as insulin or sulfonylureas. Therefore, when used in conjunction with these medications, it may be necessary to reduce the dose of insulin or sulfonylureas. Various adverse reactions can occur while using this medication. The most common side effect is hypoglycemia, particularly increased incidence when used with insulin or sulfonylureas. Also reported are genital infections, urinary tract infections, increased urination, decreased fluid volume, increased serum creatinine, and decreased glomerular filtration rate, decreased blood pressure, dehydration, decreased blood volume, orthostatic hypotension, increased urination, difficulty urinating, interstitial nephritis, thirst, headache, dizziness, anxiety, fatigue, edema, facial swelling, back pain, and glaucoma. Serious side effects include urticaria, angioedema, ketoacidosis, urosepsis, pyelonephritis, perineal necrosis, severe swelling, deep vein thrombosis, acute cholecystitis, autoimmune hepatitis, gallstones, liver abnormalities (jaundice), sudden and severe headaches, cerebrovascular accidents, intracranial aneurysms, seizures, altered consciousness, visual disturbances, paralysis, a significant decrease in urine output, general severe edema, increased blood pressure, severe allergic reactions, severe skin adverse reactions, and severe.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • angioedema
  • ketoacidosis
  • urosepsis
  • pyelonephritis
  • perineal necrosis
  • severe swelling
  • deep vein thrombosis
  • acute cholecystitis
  • autoimmune hepatitis
Show 15 more
  • gallstones
  • liver abnormalities (jaundice)
  • sudden and severe headaches
  • cerebrovascular accidents
  • intracranial aneurysms
  • seizures
  • altered consciousness
  • visual disturbances
  • paralysis
  • significant decrease in urine output
  • general severe edema
  • increased blood pressure
  • severe allergic reactions
  • severe skin adverse reactions
  • severe

Mild side effects

  • Hypoglycemia
  • vulvovaginitis
  • balanitis
  • and other genital infections
  • increased urination
  • rash
  • itching
  • angioedema
  • decreased fluid volume
  • increased serum lipids
Show 18 more
  • increased serum creatinine
  • reduced glomerular filtration rate
  • decreased blood pressure
  • dehydration
  • decreased blood volume
  • orthostatic hypotension
  • increased urination
  • difficulty urinating
  • interstitial nephritis
  • thirst
  • headache
  • dizziness
  • anxiety
  • fatigue
  • edema
  • facial swelling
  • back pain
  • glaucoma

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air and moisture. It is important to keep the storage temperature between 1 and 30 degrees Celsius. Proper storage ensures the medication's effectiveness is maintained safely.

Appearance and packaging

Appearance

Light yellow, double-sided, convex, film-coated tablet

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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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.