Medication info
Emplazine 25 mg (Empagliflozin)

Emplazine 25 mg (Empagliflozin)

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

MFDS item code 202102601 · Approved 2021.03.25 · Insurance code 653405980

Summary

Main use
Improvement of blood glucose control in Type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The recommended dosage of this medication is 10 mg once a day for both monotherapy and additional combination therapy with other glucose-lowering agents like insulin. If well-tolerated and further blood glucose control is needed, the dose can be increased to 25 mg once a day. This medication can be administered regardless of 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 in one day.

Ingredients

Manufacturer
동국제약(주)

Efficacy & effects

Improvement of blood glucose control in Type 2 diabetes and prevention of cardiovascular events

  • Difficulty controlling blood glucose in patients with Type 2 diabetes
  • failure to control blood glucose
  • cardiovascular disease
View approved original text

This medication is used in adult patients with Type 2 diabetes to assist along with dietary and exercise therapy to improve blood glucose control. It can be administered as monotherapy, but if blood glucose control is insufficient, it should be used in combination with metformin or other antidiabetic agents. Specifically, it can be combined with metformin, pioglitazone, sulfonylureas, insulin, DPP-4 inhibitors, etc., to increase efficacy. It must be used cautiously in Type 2 diabetes patients with cardiovascular disease, and it is recommended to refer to relevant clinical trial information. It effectively improves blood glucose control tailored for various circumstances.

How to take

Adult dose

The recommended dosage of this medication is 10 mg once a day for both monotherapy and additional combination therapy with other glucose-lowering agents like insulin. If well-tolerated and further blood glucose control is needed, the dose can be increased to 25 mg once a day. This medication can be administered regardless of 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 in one day.

Precautions

This medication should not be administered to certain patients. First, patients who are allergic to the main component or any ingredients of this medication should not take it. Also, it should not be used in patients with Type 1 diabetes or diabetic ketoacidosis. Patients with severely decreased kidney function with a glomerular filtration rate (GFR) less than 30 mL/min/1.73m2, those with end-stage kidney disease, or those on dialysis should not take this medication. This drug contains lactose, so it should not be administered to patients with lactose intolerance, galactose intolerance, or congenital lactase deficiency. Caution should be taken when administering to patients with slightly reduced kidney function. It is advisable not to initiate this medication in patients with a GFR less than 60 mL/min/1.73m2, and if administered, the dose should be adjusted. If GFR continues to drop below 45 mL/min/1.73m2, the medication should be discontinued. In patients with end-stage kidney disease or those undergoing dialysis, the effectiveness of this drug is not expected, and it should not be used. In patients with mild to moderate heart failure, this medication should be used with caution; it is not recommended in patients with severe heart failure. If using glucose-lowering agents like insulin or sulfonylureas together, the risk of hypoglycemia may increase, so the dose of those agents may need to be reduced when used in conjunction with this medication. During treatment with this medication, symptoms of hypoglycemia may occur, so blood glucose should be monitored regularly, and if any abnormal symptoms arise, immediate consultation with healthcare professionals is advised. There may be an increased risk of genital infections or urinary tract infections, so early treatment should be sought if infection symptoms develop. Due to possible fluid loss in the body, dehydration, and hypotension may occur; thus, caution is needed especially for elderly patients or those with low blood pressure. Rarely, severe metabolic disorders known as ketoacidosis may occur, so if symptoms such as vomiting, abdominal pain, or difficulty breathing arise, immediate medical attention should be sought. Women who are pregnant or planning to become pregnant should avoid taking this medication, and it should also not be used while breastfeeding. This medication has not been confirmed for safety and efficacy in children under 18 years of age. No specific toxicity has been reported in case of overdose, but if suspected, appropriate treatment should be obtained immediately from a medical institution. This medication should be kept out of the reach of children, and transferring it to another container should be avoided as it may affect its quality. Caution is required when driving or operating machinery due to the risk of hypoglycemia, especially if taking this medication with insulin or sulfonylureas. Diabetic patients should prioritize regular foot care, and care should be taken to prevent wounds or infections on the feet while using this medication. If pain, swelling, or redness occurs around the perineum, it could be a serious infection known as perineal necrotizing fasciitis, and immediate medical attention should be sought. This medication can interact with other medications, so it is important to inform healthcare professionals of all medications being taken and undergo regular evaluations.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • angioedema
  • ketoacidosis
  • urosepsis
  • pyelonephritis
  • perineal necrosis
  • acute cholecystitis
  • autoimmune hepatitis
  • gallstones
  • acute kidney injury
Show 18 more
  • fever
  • asthma
  • respiratory distress
  • dyspnea
  • deep vein thrombosis
  • angina
  • Prinzmetal angina
  • coronary artery disease
  • unstable angina
  • headache
  • cerebral infarction
  • intracranial aneurysm
  • seizures
  • confusion
  • visual disturbances
  • paralysis
  • jaundice
  • sudden very severe

Mild side effects

  • Vulvovaginal candidiasis
  • vulvitis
  • balanitis
  • and other genital infections
  • hypoglycemia
  • itching
  • rash
  • increased urination
  • dehydration
  • hypotension
Show 23 more
  • elevated blood creatinine
  • reduced GFR
  • fatigue
  • peripheral edema
  • facial edema
  • stent thrombosis
  • headache
  • dizziness
  • drowsiness
  • diarrhea
  • nausea
  • gastritis
  • vomiting
  • abdominal pain
  • constipation
  • cough
  • allergic rhinitis
  • anxiety
  • insomnia
  • weight loss
  • myalgia
  • arthralgia
  • back pain

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is best to maintain storage temperatures between 1 and 30 degrees Celsius to preserve the medication's efficacy.

Appearance and packaging

Appearance

Light yellow, biconvex oval 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.