Medication info

Steglujan Tablet 5/100 mg

Prescription medicationTablet경구Approval revoked
Ingredient · strength
Ertugliflozin L-Pyroglutamic Acid›6.477mg / 1 tabletSitagliptin Phosphate Hydrate›128.5mg / 1 tablet
Manufacturer / importer
한국엠에스디(주)
Appearance
Beige almond-shaped film-coated tablet engraved with 554 on one side
Packaging
28 tablets
Approval status
Approval revoked

MFDS item code 201803606 · Approved 2018.09.05

This product's status changed to Approval revoked on 2025.10.13. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Effectiveness in blood sugar control for type 2 diabetes and prevention of cardiovascular events
Who takes it
Adults
Adult dose
The recommended starting dose of this medication is 1 time daily of ertugliflozin 5 mg/sitagliptin 100 mg. This medication should be taken orally once daily in the morning, irrespective of meals. If the 5/100 mg dose is well tolerated but additional blood sugar control is needed, the dose can be increased to ertugliflozin 15 mg/sitagliptin 100 mg once daily.

Ingredients

Importer
한국엠에스디(주)

Efficacy & effects

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

  • Type 2 diabetes
  • abnormal blood sugar control
  • cardiovascular disease
View approved original text

This medication is used as an adjunct to diet and exercise to help control blood sugar in patients with type 2 diabetes. It is particularly effective in patients whose blood sugar is not adequately controlled and should be used with caution in patients with cardiovascular diseases. Overall, it aids in the treatment of type 2 diabetes and improves blood sugar control.

How to take

Adult dose

The recommended starting dose of this medication is 1 time daily of ertugliflozin 5 mg/sitagliptin 100 mg. This medication should be taken orally once daily in the morning, irrespective of meals. If the 5/100 mg dose is well tolerated but additional blood sugar control is needed, the dose can be increased to ertugliflozin 15 mg/sitagliptin 100 mg once daily.

Precautions

This medication contains sitagliptin and ertugliflozin. First, caution is needed as serious allergic reactions may occur when taking this medication. Allergic reactions can include anaphylaxis, angioedema, and skin diseases, and if any of these symptoms occur, the medication should be discontinued immediately and healthcare professionals should be consulted. Also, this medication can cause a serious side effect known as acute pancreatitis, which involves inflammation of the pancreas, so if symptoms such as abdominal pain or vomiting occur after taking the medication, healthcare professionals must be informed immediately. This medication is contraindicated in certain patients. For example, those who are allergic to any ingredient in this medication, patients with type 1 diabetes, and those with severely impaired kidney function should not take it. Patients with low blood pressure, weak kidney function, elderly patients, and those taking diuretics should check their blood volume status before taking this medication and should closely monitor blood pressure and kidney function while on it. Patients with heart failure or at high risk for heart failure should carefully observe symptoms before and after taking this medication, and if symptoms worsen, they should inform healthcare professionals immediately. This medication can induce a severe metabolic acidosis known as ketoacidosis, so if symptoms such as vomiting, abdominal pain, or difficulty breathing develop while taking this medication, it must be discontinued immediately and the patient should go to the hospital. There is an increased risk of fungal infections in the genital area, so appropriate treatment is needed if signs of infection appear. This medication carries a risk of hypoglycemia, particularly when used in conjunction with insulin or sulfonylureas, hence hypoglycemic symptoms should be closely monitored, and immediate action should be taken when symptoms occur. Additionally, while taking this medication, symptoms such as urinary tract infections, headaches, thirst, and increased urination may occur, and if abnormal symptoms persist, consultation with healthcare professionals is necessary. Women who are pregnant or breastfeeding should avoid taking this medication, and if pregnancy is confirmed, they should stop taking it immediately. The safety and efficacy of this medication have not been established in children or adolescents under 18 years of age, so it is not used in these populations. Elderly patients should be assessed regularly for kidney function before and after taking this medication as they may be more susceptible to side effects such as low blood pressure. Patients with severely impaired kidney function, end-stage renal disease, and those undergoing dialysis should not take this medication. Patients with severely impaired liver function are also advised against taking this medication. In the case of overdose, appropriate medical treatment should be sought immediately, and while dialysis may remove some components, it is not always complete. This medication should be kept out of reach of children and should not be transferred to another container; it is best to keep it in its original packaging.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash accompanied by high fever, blisters, skin peeling, mucosal pain in the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with cough and fever, yellowing of the skin or eyes (jaundice), extreme fatigue, sudden and severe headaches, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

Headache, nasopharyngitis, back pain, weight loss, thirst, vulvar pruritus, increased urination, upper respiratory infection, abdominal pain, nausea, diarrhea, constipation, vomiting, muscle pain, limb pain, indigestion, dizziness, increased blood triglycerides, gastritis, hypertension, hypernatremia, erectile dysfunction, increased low-density lipoprotein cholesterol (LDL-C), increased hemoglobin, elevated serum phosphate, increased serum creatinine, urinary tract infections, female and

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 air or moisture from entering, and it is best kept at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the medication’s efficacy and prevent deterioration.

Appearance and packaging

Appearance

Beige almond-shaped film-coated tablet engraved with 554 on one side

Package unit

28 tablets

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.

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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.