Medication info

Gliduocure Tablet 10/100 mg

Prescription medicationTablet
Ingredient · strength
Dapagliflozin Propanediol Hydrate›12.3mg / 1 tabletSitagliptin Phosphate Hydrate›128.5mg / 1 tablet
Manufacturer / importer
성이바이오제약주식회사
Appearance
Bright yellow, rectangular film-coated tablet
Packaging
Box - 28 tablets/box [(7 tablets/PTP (Alu-Alu) x 4)]
Approval status
Active

MFDS item code 202200215 · Approved 2022.01.12

Summary

Main use
Improvement of blood glucose control in type 2 diabetes
Who uses it
Adults
Adult dosage
This medication can be administered as one tablet once daily to patients receiving sitagliptin 100 mg and dapagliflozin 10 mg, regardless of meal times. The tablet should be swallowed whole.

Ingredients

Manufacturer
성이바이오제약주식회사

Efficacy & effects

Improvement of blood glucose control in type 2 diabetes

View approved original text

This medication is prescribed in conjunction with dietary changes and exercise programs to assist in blood glucose control for patients with type 2 diabetes using sitagliptin and dapagliflozin together. It is used to effectively manage blood glucose levels and improve symptoms of diabetes.

Dosage and Administration

Adult dosage

This medication can be administered as one tablet once daily to patients receiving sitagliptin 100 mg and dapagliflozin 10 mg, regardless of meal times. The tablet should be swallowed whole.

Precautions

This medication contains sitagliptin and dapagliflozin and is used for the treatment of diabetes. Firstly, sitagliptin may rarely cause serious allergic reactions such as anaphylaxis, angioedema, or skin exfoliative diseases, so if any abnormal symptoms occur within 3 months after administration, it should be discontinued immediately. Additionally, sitagliptin may induce acute pancreatitis, thus if symptoms like abdominal pain or vomiting occur during treatment, it is essential to consult medical personnel immediately. This medication should not be administered to patients with type 1 diabetes, diabetic ketoacidosis, or those undergoing dialysis. Dapagliflozin poses a risk of volume depletion and renal dysfunction, thus patients with impaired kidney function, elderly patients, or those on diuretics should evaluate their fluid status and renal function adequately before administration and be monitored regularly during treatment. This medication may lead to metabolic abnormalities, including severe pancreatitis and diabetic ketoacidosis, so if such symptoms are suspected, immediate discontinuation and treatment should be sought. Furthermore, dapagliflozin may increase the risk of genital and urinary tract infections, so appropriate treatment is necessary if infection symptoms develop. Elderly patients are at higher risk of decreased kidney function, so dose adjustment and renal function tests are recommended. Pregnant or breastfeeding women are advised to avoid using this medication, and it should be discontinued immediately if pregnancy is confirmed. While taking this medication, there is a risk of hypoglycemia, especially when used in conjunction with insulin or sulfonylureas, thus caution is necessary for hypoglycemic symptoms, and dosage adjustments may be required. In cases of overdose, appropriate treatment should be sought according to the symptoms, and while some drug components may be removed by dialysis, specific treatment methods should be discussed with medical personnel. Lastly, this medication has not established safety and efficacy in children, so it should not be used in patients under 18 years of age. There is a risk of hypoglycemia when driving or operating machinery during the use of this medication, so caution is warranted.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin shedding, pain in mucous membranes of the mouth/eyes, difficulty breathing or shortness of breath, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urination

Mild side effects

  • Hypoglycemia
  • headache
  • upper respiratory tract infection
  • nasopharyngitis
  • nausea
  • diarrhea
  • constipation
  • dry mouth
  • back pain
  • dysuria
Show 25 more
  • polyuria
  • nocturia
  • vulvar pruritus
  • genital pruritus
  • elevated hematocrit
  • increased serum creatinine
  • dyslipidemia
  • weight loss
  • indigestion
  • nausea
  • diarrhea
  • vomiting
  • abdominal pain
  • urinary abnormalities
  • urgency
  • taste alterations
  • drowsiness
  • sleep disturbances
  • insomnia
  • pruritus
  • hives
  • cold sweat
  • chest pain
  • fatigue
  • pain

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

Storage

This medication should be stored in a tightly closed container to protect against air and moisture and should be kept at room temperature, ideally between 1 to 30 degrees Celsius. Avoid storing in warm or excessively cold places and keep it in a cool place away from direct sunlight.

Appearance and packaging

Appearance

Bright yellow, rectangular film-coated tablet

Package unit

Box - 28 tablets/box [(7 tablets/PTP (Alu-Alu) x 4)]

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.