Medication info
Empagliflozin 10 mg (Empagliflozin)

Empagliflozin 10 mg (Empagliflozin)

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

MFDS item code 202102045 · Approved 2021.03.05 · Insurance code 670105210

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 dosage for this medication is 10 mg once daily for both monotherapy and additional combination therapy with insulin and other hypoglycemic agents. If excellent tolerance and additional blood glucose control are needed, the dose may be increased to 25 mg once daily. It can be taken without regard to meals, and the tablet should be swallowed whole. If a dose is missed, it should be taken as soon as remembered, but do not take two doses on the same day.

Ingredients

Manufacturer
(주)팜젠사이언스

Efficacy & effects

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

  • Type 2 diabetes
  • difficulty in blood sugar control
  • uncontrolled blood sugar
  • cardiovascular disease
  • occurrence of cardiovascular events
View approved original text

This medication is used to help control blood sugar levels in adult patients with type 2 diabetes, in conjunction with dietary and exercise therapy. It can also be used as monotherapy, but if blood sugar control is insufficient, it can be administered in combination with other drugs such as metformin, pioglitazone, sulfonylureas, insulin, or DPP-4 inhibitors. Careful attention is required for patients with type 2 diabetes and cardiovascular disease concerning the occurrence of cardiovascular events when using this medication. This medication is used to improve optimal blood sugar control tailored to the individual patient.

How to take

Adult dose

The recommended dosage for this medication is 10 mg once daily for both monotherapy and additional combination therapy with insulin and other hypoglycemic agents. If excellent tolerance and additional blood glucose control are needed, the dose may be increased to 25 mg once daily. It can be taken without regard to meals, and the tablet should be swallowed whole. If a dose is missed, it should be taken as soon as remembered, but do not take two doses on the same day.

Precautions

This medication should not be used in patients with a history of allergic reactions to the active ingredient or any components. It should not be administered to patients with type 1 diabetes or diabetic ketoacidosis. Use of this medication is not recommended in patients with severely impaired kidney function, end-stage kidney disease, or those undergoing dialysis. This medication contains lactose and should not be given to patients with hereditary metabolic disorders such as lactose intolerance or galactose intolerance. Caution is required when administering this medication to patients with impaired kidney function, and dosage should be discontinued if kidney function falls below a certain level. Use is not recommended in patients with severe heart failure, and it should be administered with caution in mild cases. When used in conjunction with insulin or insulin secretagogues, there may be an increased risk of hypoglycemia, requiring possible dosage adjustments. During the course of treatment, adverse reactions such as hypoglycemia, urinary tract infections, genital infections, increased urination, and decreased fluid volume may occur, so caution is advised. Especially, serious metabolic abnormalities such as ketoacidosis may arise, and immediate medical attention should be sought if related symptoms appear. Elderly patients or those at risk of fluid loss should be cautious of dehydration and hypotension, and temporary discontinuation of medication may be necessary. This medication may have a mild effect on driving or operating machinery, so caution is needed in combination therapy with hypoglycemia risk. Use of this medication during pregnancy is not recommended, and breastfeeding should be discontinued if breastfeeding is ongoing. Safety and efficacy have not been established in pediatric patients under 18 years of age, and its use is not recommended. In the event of overdose, appropriate clinical measures are required, and there is no information on whether it can be removed by blood dialysis. This medication may interact with other medications, so consultation with a specialist is advised, especially when used in conjunction with diuretics or insulin secretagogues. Store in a tightly closed container to avoid exposure to air or moisture, keeping it out of reach of children and not transferring to other containers.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • angioedema
  • ketoacidosis
  • rash
  • urosepsis
  • pyelonephritis
  • perineal necrosis
  • severe allergic reactions
  • severe skin manifestations
  • breathing difficulties
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  • hepatic abnormalities (jaundice)
  • severe neurological symptoms
  • severe edema or urination abnormalities

Mild side effects

  • Hypoglycemia
  • vulvovaginal candidiasis
  • balanitis
  • other genital infections
  • increased urination
  • urination difficulties
  • itching
  • rash
  • increased serum lipids
  • increased serum creatinine
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  • decreased glomerular filtration rate
  • increased hematocrit
  • thirst
  • diarrhea
  • nausea
  • gastric ulcer
  • colitis
  • vomiting
  • ischemic colitis
  • gastrointestinal bleeding
  • soft tissue infection
  • appendiceal abscess
  • appendicitis
  • meningitis
  • chronic otitis media
  • peritonsillar abscess
  • pneumonia
  • pulmonary tuberculosis
  • acute

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

Storage

This medication should be stored in a tightly closed container to avoid exposure to air or moisture. It is recommended to maintain a storage temperature between 1 and 30 degrees Celsius (33.8 - 86 degrees Fahrenheit).

Appearance and packaging

Appearance

Light yellow, double convex, round 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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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.