Medication info

PARIEM 25 mg (Empagliflozin) Tablets

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin›25mg / 1 tablet
Manufacturer / importer
안국약품(주)
Appearance
Light yellow, oval, biconvex, film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202102096 · Approved 2021.03.05

Summary

Main use
Blood glucose control for 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 monotherapy and as an additional combination therapy with insulin and other hypoglycemic agents. If tolerance is good and additional blood glucose control is needed, the dosage can be increased to 25 mg once daily. It can be administered regardless of meals, and the tablet should be swallowed whole. If a dose is missed, take it as soon as you remember and do not take double the dose on the same day.

Ingredients

Manufacturer
안국약품(주)

Efficacy & effects

Blood glucose control for type 2 diabetes and prevention of cardiovascular events

  • Type 2 diabetes
  • difficulty controlling blood glucose
  • cardiovascular disease
  • occurrence of cardiovascular events
View approved original text

This medication primarily helps adult patients with type 2 diabetes control their blood glucose levels. It can be administered alone or in conjunction with dietary and exercise therapies, and if blood glucose control is difficult, it may be used in combination with other diabetes medications such as metformin, pioglitazone, sulfonylureas, or insulin. Particularly, it is often prescribed as a combination therapy for patients who have not had prior treatment experiences or have not achieved sufficient effects through monotherapy. Additionally, patients with type 2 diabetes who have cardiovascular disease should carefully check precautions when using this medication. This medication improves blood glucose control in various situations, effectively assisting in diabetes management.

How to take

Adult dose

The recommended dosage for this medication is 10 mg once daily for monotherapy and as an additional combination therapy with insulin and other hypoglycemic agents. If tolerance is good and additional blood glucose control is needed, the dosage can be increased to 25 mg once daily. It can be administered regardless of meals, and the tablet should be swallowed whole. If a dose is missed, take it as soon as you remember and do not take double the dose on the same day.

Precautions

This medication should not be used by patients with allergies to the active ingredient or any excipients. It should not be administered to patients with type 1 diabetes or diabetic ketoacidosis. Patients with severely impaired kidney function, end-stage kidney disease, or those undergoing dialysis should also avoid using this medication. Additionally, this medication contains lactose and should not be administered to patients with lactose intolerance or specific genetic metabolic disorders. Patients with mildly impaired kidney function should use this medication cautiously, and if kidney function continues to deteriorate, dosage adjustments or discontinuation of treatment may be necessary. Patients with heart failure should be cautious when using this medication and it is not recommended for those with severe heart failure. When this medication is used in combination with insulin or sulfonylureas, there may be a risk of hypoglycemia, so dosage adjustments may be needed. During the use of this medication, adverse reactions such as hypoglycemia, genital infections, urinary tract infections, increased urination, decreased fluid volume, and increased serum creatinine may occur, and you should consult a healthcare professional immediately if symptoms appear. Metabolic anomalies such as ketoacidosis can occur rarely; therefore, if symptoms such as vomiting, abdominal pain, or difficulty breathing appear, immediate medical attention is necessary. Elderly patients or those at risk of fluid loss should be careful of dehydration and low blood pressure, and it is important to regularly monitor fluid status. This medication can cause serious infections such as urosepsis, pyelonephritis, and perineal necrosis, so immediate treatment is crucial if related symptoms appear. It is advisable for pregnant or breastfeeding women to avoid using this medication, and treatment should be discontinued upon confirmation of pregnancy. The safety and efficacy in children under 18 years have not been established, so it should not be used in this population. No specific toxic reactions have been reported in cases of overdose, but appropriate treatment may be required based on the patient's condition. While using this medication, one should be careful of the risk of hypoglycemia during driving or operating machinery, especially when combined with insulin or sulfonylureas. This medication may affect the results of some tests during blood glucose monitoring, so it is recommended to use alternative methods for monitoring blood glucose. Patients taking this medication should pay attention to routine foot care and infection prevention, and should consult a specialist immediately if any unusual symptoms arise.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • angioedema
  • ketoacidosis
  • rash
  • urosepsis
  • pyelonephritis
  • severe allergic reactions
  • severe skin reactions
  • serious neurological symptoms
  • liver abnormalities (jaundice)
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  • severe swelling or urination problems
  • perineal necrosis
  • nausea
  • vomiting
  • abdominal pain
  • fatigue
  • difficulty breathing
  • acute cholecystitis
  • acute pyelonephritis
  • sepsis
  • kidney injury
  • deep vein thrombosis
  • heart failure
  • major hypoglycemia due to hypoglycemia

Mild side effects

  • Hypoglycemia
  • malodorous vaginitis
  • vulvitis
  • balanitis
  • and other genital infections
  • increased urination
  • urinary tract infection
  • decreased fluid volume
  • urinary difficulty
  • interstitial nephritis
Show 18 more
  • thirst
  • increased serum lipids
  • increased serum creatinine
  • decreased glomerular filtration rate
  • increased hematocrit
  • fever
  • diarrhea
  • nausea
  • gastric ulcers
  • colitis
  • vomiting
  • ischemic colitis
  • intestinal bleeding
  • soft tissue infections
  • appendiceal abscess
  • appendicitis
  • meningitis
  • chronic otitis media

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 or moisture. The recommended storage temperature is between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

Light yellow, oval, biconvex, 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.