Medication info

Zadilirina Tablets 10/5 mg (Empagliflozin 2L-Proline, Linagliptin)

Prescription medicationTablet경구
Ingredient · strength
Empagliflozin 2L-Proline›15.107mg / 1 tabletLinagliptin Micronized›5mg / 1 tablet
Manufacturer / importer
주식회사제뉴원사이언스
Appearance
Pale yellow triangular film-coated tablets
Packaging
30 tablets / bottle
Approval status
Active

MFDS item code 202502428 · Approved 2025.09.12

Summary

Main use
Improvement in blood sugar control for type 2 diabetes
Who takes it
Adults
Adult dose
The recommended starting dose of this medication is once daily with empagliflozin 10 mg (equivalent to 15.107 mg of empagliflozin 2L-proline) and linagliptin 5 mg. If further blood glucose control is needed and tolerance is good, the dose may be increased to empagliflozin 25 mg/linagliptin 5 mg once daily (equivalent to 37.766 mg of empagliflozin 2L-proline). This medication can be taken irrespective of meals.

Ingredients

Manufacturer
주식회사제뉴원사이언스

Efficacy & effects

Improvement in blood sugar control for type 2 diabetes

View approved original text

This medication is used to assist patients with type 2 diabetes in controlling their blood sugar levels. It is particularly effective when taken in conjunction with dietary and exercise therapy. The combination of empagliflozin and linagliptin helps to maintain stable blood sugar levels. Therefore, this medication is used as an important adjunct in diabetes treatment.

How to take

Adult dose

The recommended starting dose of this medication is once daily with empagliflozin 10 mg (equivalent to 15.107 mg of empagliflozin 2L-proline) and linagliptin 5 mg. If further blood glucose control is needed and tolerance is good, the dose may be increased to empagliflozin 25 mg/linagliptin 5 mg once daily (equivalent to 37.766 mg of empagliflozin 2L-proline). This medication can be taken irrespective of meals.

Precautions

This medication contains empagliflozin and linagliptin as active ingredients and should not be administered to certain patients. For example, it should not be used in patients who are allergic to its components, those with type 1 diabetes, diabetic ketoacidosis, and patients undergoing dialysis. Additionally, patients with impaired kidney function or congestive heart failure should use this medication cautiously, and if skin conditions such as acute pancreatitis or bullous pemphigoid are suspected, treatment should be discontinued immediately. The most common side effect when taking this medication is urinary tract infection. Rarely, ketoacidosis, pancreatitis, hypersensitivity reactions, and hypoglycemia may occur. Special care is needed when taken in conjunction with insulin or sulfonylureas due to an increased risk of hypoglycemia. Ketoacidosis can occur regardless of blood sugar levels, and symptoms such as nausea, vomiting, abdominal pain, lethargy, and dyspnea should prompt immediate consultation with medical personnel. Patients at risk of dehydration or hypotension should carefully monitor their fluid status while taking this medication. This medication may increase the risk of genital fungal infections, so appropriate treatment is necessary if related symptoms occur. Elderly patients aged 75 or older should pay special attention to potential fluid volume loss. Caution is also advised while driving or operating machinery due to the risk of hypoglycemia, and the risk of limb amputation has been reported, necessitating thorough foot care. It is recommended that women who are pregnant or breastfeeding not use this medication, and it is also not indicated for children under 18 years of age. In case of an overdose, medical attention should be sought immediately, and this medication should be stored out of reach of children. It is also safe to store in the original packaging.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • angioedema
  • ketoacidosis
  • pancreatitis
  • bullous pemphigoid
  • Fournier's gangrene (perineal necrosis)
  • vascular stent thrombosis
  • vascular stent stenosis
  • cerebrovascular accident
  • acute renal impairment
Show 17 more
  • acute pyelonephritis
  • acute cholangitis
  • acute cholecystitis
  • cholecystitis
  • acute cholecystitis
  • acute cholangitis
  • kidney transplant failure
  • heart failure
  • angina pectoris
  • acute myocardial infarction
  • cardiac arrest
  • palpitations
  • hypertension
  • severe edema
  • dyspnea
  • asthma attack
  • chest

Mild side effects

  • Urinary tract infection
  • vulvovaginal candidiasis
  • vulvitis
  • balanitis and other genital infections
  • rhinitis
  • cough
  • constipation
  • oral ulcer formation
  • itching
  • rash
Show 17 more
  • hypoglycemia
  • thirst
  • increased urination
  • urination difficulties
  • increased amylase
  • increased lipase
  • increased hematocrit
  • increased serum lipids
  • increased blood creatinine
  • increased triglycerides
  • decreased blood pressure
  • dehydration
  • hypotension
  • decreased blood volume
  • orthostatic hypotension
  • syncope
  • blood

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

Storage

This medication can be sensitive to air and moisture, so it must be stored in a tightly sealed container. It is important to maintain a storage temperature between 1 and 30 degrees Celsius. This helps to preserve the efficacy and safety of the medication.

Appearance and packaging

Appearance

Pale yellow triangular 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.