Medication info
Danalya MR Tablet 10/500 mg

Danalya MR Tablet 10/500 mg

Prescription medicationTablet경구
Ingredient · strength
Teneligliptin Hydrochloride Hydrate›13mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
한국휴텍스제약(주)
Appearance
Orange oval extended-release film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202201308 · Approved 2022.04.04 · Insurance code 649105470

Summary

Main use
Improved blood sugar control in type 2 diabetes
Who takes it
Adults
Adult dose
This medication is generally administered once daily with the evening meal. The 20/1000 mg extended-release tablet is taken once daily, at a dose of one tablet. Patients taking the 10/750 mg or 10/500 mg extended-release tablets should take two tablets simultaneously, once daily. The initial dosage is 20 mg of teneligliptin once daily, together with the existing dosage of metformin. The maximum recommended dosage is 20 mg of teneligliptin.

Ingredients

Manufacturer
한국휴텍스제약(주)

Efficacy & effects

Improved blood sugar control in type 2 diabetes

View approved original text

This medication is used to improve blood sugar control in patients with type 2 diabetes in conjunction with dietary and exercise therapy.

How to take

Adult dose

This medication is generally administered once daily with the evening meal. The 20/1000 mg extended-release tablet is taken once daily, at a dose of one tablet. Patients taking the 10/750 mg or 10/500 mg extended-release tablets should take two tablets simultaneously, once daily. The initial dosage is 20 mg of teneligliptin once daily, together with the existing dosage of metformin. The maximum recommended dosage is 20 mg of teneligliptin.

Precautions

This medication is used for the treatment of diabetes and should not be administered to patients with impaired renal function. In particular, it should not be used in patients with moderate to severe renal impairment, heart failure, liver dysfunction, or in pregnant women. This medication can rarely cause a condition known as lactic acidosis, which can be life-threatening due to increased levels of lactate in the blood. The risk of lactic acidosis is higher in patients with decreased kidney function, liver dysfunction, severe infections, dehydration, or severe hypoxemia. Additionally, this medication may cause hypoglycemia when used in combination with other diabetes medications, so it is important to be aware of the symptoms of hypoglycemia and how to respond. The medication should be discontinued for a period before surgery or tests using contrast agents, and should only be resumed after confirming normal kidney function post-examination. Regular monitoring of liver and kidney function is required while on this medication, and if unusual symptoms such as gastrointestinal disturbances, abdominal pain, difficulty breathing, or skin rash occur, immediate consultation with a physician is necessary. Taking this medication with alcohol may increase the risk of lactic acidosis, so it is advised to avoid alcohol consumption. It is recommended that pregnant or potentially pregnant women and nursing mothers do not use this medication. Elderly patients may have an increased risk of impaired kidney function, so dosage adjustments and regular kidney function tests are necessary. While taking this medication, careful observation for symptoms of hypoglycemia or lactic acidosis is needed, and immediate notification to healthcare personnel should occur if symptoms arise.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe allergic reactions, severe rash with high fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, severe skin reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme fatigue, liver abnormalities (jaundice), sudden and severe headache.

Mild side effects

  • Hypoglycemia
  • constipation
  • dizziness
  • headache
  • abdominal bloating
  • abdominal discomfort
  • nausea
  • abdominal pain
  • flatulence
  • stomatitis
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  • gastric polyp
  • colonic polyp
  • duodenal ulcer
  • gastroesophageal reflux
  • diarrhea
  • decreased appetite
  • increased amylase
  • increased lipase
  • proteinuria
  • ketonuria
  • potential hematuria
  • eczema
  • rash
  • itching
  • allergic dermatitis
  • arthralgia
  • increased CK (CPK)
  • elevated serum potassium levels
  • fatigue
  • allergic rhinitis
  • elevated serum uric acid.

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 is best kept at room temperature, between 1 and 30 degrees Celsius. This helps maintain the effectiveness and safety of the medication.

Appearance and packaging

Appearance

Orange oval extended-release film-coated tablet

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.