Medication info
Traciga 10/5 Milligrams (Dapagliflozin Propanediol Monohydrate, Linagliptin)

Traciga 10/5 Milligrams (Dapagliflozin Propanediol Monohydrate, Linagliptin)

Prescription medicationTablet
Ingredient · strength
Dapagliflozin Propanediol Hydrate›12.3mg / 1 tabletLinagliptin Micronized›5mg / 1 tablet
Manufacturer / importer
한국휴텍스제약(주)
Appearance
Yellow round film-coated tablet
Packaging
28 tablets/box [7 tablets/PTP × 4], 30 tablets/bottle
Approval status
Active

MFDS item code 202400934 · Approved 2024.04.22

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who uses it
Adults
Adult dosage
This medication is administered at a dose of 1 tablet containing 10 mg of dapagliflozin and 5 mg of linagliptin once daily, regardless of meals.

Ingredients

Manufacturer
한국휴텍스제약(주)

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

View approved original text

This medication helps patients with Type 2 diabetes achieve more effective blood sugar control when combined with dietary and exercise therapies. It is a drug that improves blood sugar levels with the combination of dapagliflozin and linagliptin, thus assisting in the management of diabetes. Therefore, this medication is used for the blood sugar control in Type 2 diabetes.

Dosage and Administration

Adult dosage

This medication is administered at a dose of 1 tablet containing 10 mg of dapagliflozin and 5 mg of linagliptin once daily, regardless of meals.

Precautions

This medication should not be used in patients who have had allergic reactions to the active ingredients or excipients. It should not be administered to patients with Type 1 diabetes, diabetic ketoacidosis, those undergoing dialysis, or those with a history of myocardial infarction. Caution is necessary in patients with reduced fluid volume or impaired kidney function due to the risk of hypotension or kidney damage. When used with blood sugar-lowering medications, the risk of hypoglycemia may increase, so dose adjustments may be necessary. It should be used with caution in patients with heart failure and is not recommended for severe heart failure patients. If acute pancreatitis symptoms develop, the medication should be discontinued immediately and a physician consulted. If vesicular skin diseases occur, discontinue the medication and seek specialist care. This medication may increase the risk of genital infections and urinary tract infections, requiring prompt treatment if symptoms arise. Elderly patients or those taking diuretics have a higher risk of fluid volume depletion and hypotension, so blood pressure and kidney function should be monitored regularly. Use is not recommended during pregnancy or breastfeeding, and it should be discontinued immediately if pregnancy is confirmed. Safety in children has not been established, so it is advisable not to use this medication in that population. There is no specific antidote for overdose; appropriate treatment should be carried out based on symptoms. It is important to regularly check blood sugar control, kidney function, and blood pressure during the use of this medication. If discomfort or adverse reactions occur during medication use, immediate consultation with healthcare professionals is necessary.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with high fever, blisters, peeling skin, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory issues with cough + fever, jaundice (yellowing of skin or eyes), profound lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

  • Constipation
  • diarrhea
  • dizziness
  • palpitations
  • weight loss
  • vulvar pruritus
  • sweating
  • cystitis
  • urinary tract infections
  • thirst
Show 27 more
  • dry mouth
  • low back pain
  • pain during urination
  • polyuria
  • nocturia
  • increased hematocrit
  • dyslipidemia
  • hypoglycemia
  • headache
  • sensory impairment
  • paresthesia
  • drowsiness
  • insomnia
  • depression
  • pruritus
  • cold sweats
  • edema
  • facial swelling
  • peripheral edema
  • fatigue
  • fever
  • pain
  • tinnitus
  • vertigo
  • chest pain
  • nosebleeds
  • vomiting

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 exposure to air and light, at a temperature between 1 to 30 degrees Celsius. Proper storage will maintain the efficacy of the medication and prevent deterioration.

Appearance and packaging

Appearance

Yellow round film-coated tablet

Package unit

28 tablets/box [7 tablets/PTP × 4], 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.