Medication info
Ectosiga 10/15 mg (Dapagliflozin, Pioglitazone)

Ectosiga 10/15 mg (Dapagliflozin, Pioglitazone)

Prescription medicationTablet
Ingredient · strength
Pioglitazone Hydrochloride›16.53mg / 1 tabletDapagliflozin Propanediol Hydrate›12.3mg / 1 tablet
Manufacturer / importer
한국휴텍스제약(주)
Appearance
Yellow round film-coated tablet
Packaging
30 tablets/box [10 tablets/PPT x 3], 30 tablets/bottle
Approval status
Active

MFDS item code 202400241 · Approved 2024.02.01

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who uses it
Adults
Adult dosage
For patients taking 10 mg of dapagliflozin and 15 mg of pioglitazone, take one tablet once daily regardless of meals. Do not split the tablet. For patients unable to achieve adequate blood sugar control with metformin and dapagliflozin, the recommended dose of this medication is dapagliflozin 10 mg/pioglitazone 15 mg once daily.

Ingredients

Manufacturer
한국휴텍스제약(주)

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

View approved original text

This drug is used to help patients with type 2 diabetes more effectively control their blood sugar when combined with dietary management and exercise.

Dosage and Administration

Adult dosage

For patients taking 10 mg of dapagliflozin and 15 mg of pioglitazone, take one tablet once daily regardless of meals. Do not split the tablet. For patients unable to achieve adequate blood sugar control with metformin and dapagliflozin, the recommended dose of this medication is dapagliflozin 10 mg/pioglitazone 15 mg once daily.

Precautions

This drug should not be used in patients with heart failure. In particular, patients with symptoms of heart failure or a past history of heart failure should not be administered this drug. This drug may worsen symptoms of heart failure; therefore, after starting treatment or increasing the dose, symptoms such as weight changes, shortness of breath, and edema should be carefully monitored. If such symptoms of heart failure occur, the healthcare provider should be informed immediately, and the dosage may be reduced or discontinued as necessary. This drug should not be used in patients with active bladder cancer or a history of bladder cancer. Patients with severely impaired liver function or severe kidney dysfunction should also avoid taking this drug. Pregnant women or women who may become pregnant are advised not to use this drug. Patients at risk of fluid volume depletion or low blood pressure, particularly the elderly or those with decreased kidney function, should have their fluid status and kidney function evaluated before taking this drug. This drug helps in blood sugar control but may cause symptoms of hypoglycemia (e.g., dizziness, headache), so caution is required. Additionally, genital infections or urinary tract infections may occur, so any symptoms of infection should be reported immediately. Weight gain or edema may occur, hence it is important to regularly monitor weight and edema status. If symptoms of liver dysfunction (such as fatigue, loss of appetite, jaundice) appear, the healthcare provider should be informed immediately, and treatment can be adjusted based on liver function test results. If symptoms such as hematuria, urination disorders, or urgency occur during the course of medication, consultation with a physician is necessary to rule out the possibility of bladder cancer. Regular check-ups and consultations with the healthcare provider are essential to monitor for adverse reactions and to safely take the medication.

Side effects and when to seek care immediately

Serious side effects

Congestive heart failure, signs and symptoms of heart failure (excessive and rapid weight changes, shortness of breath, edema), severe edema, bladder cancer, hematuria, urination disorders, cold sweats, urticaria, liver dysfunction (including jaundice), fatigue, loss of appetite, discomfort in the right upper abdomen, dark urine, jaundice, acute pancreatitis, chronic pancreatitis, ketoacidosis (including diabetic ketoacidosis), urosepsis, pyelonephritis, acute kidney injury, renal dysfunction, perineal necrosis,

Mild side effects

Headache, dizziness, abdominal pain, diarrhea, dyspepsia, facial edema, visual disturbances, cystitis, increased creatine phosphokinase in the blood, urinary retention, abdominal discomfort, upper abdominal pain, rectal polyps, edema, cervicitis, laryngitis, hematuria, urination disorders, increased urine albumin/creatinine ratio, vulvar pruritus, urticaria, hypoglycemia when used with sulfonylureas or insulin, thirst, dry mouth, dizziness,

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 closed container. The recommended storage temperature is between 1 and 30 degrees Celsius at room temperature. Proper storage will help maintain the efficacy and safety of the medication for a longer period.

Appearance and packaging

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/box [10 tablets/PPT x 3], 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.