Medication info
Danubia Tablet 50 mg (Sitagliptin Hydrochloride Monohydrate)

Danubia Tablet 50 mg (Sitagliptin Hydrochloride Monohydrate)

Prescription medicationTablet
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›56.69mg / 1 tablet
Manufacturer / importer
주식회사케이에스제약
Appearance
Bright yellow-orange round film-coated tablet
Packaging
100 tablets/bottle, 30 tablets/bottle
Approval status
Active

MFDS item code 202102660 · Approved 2021.03.26 · Insurance code 059001080

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who uses it
Adults
Adult dosage
This drug is administered once daily at a dose of 100 mg as monotherapy or in combination therapy, with a maximum daily dose of 100 mg. It can be taken regardless of meals. Dosage adjustment in patients with renal impairment: - Mild renal impairment (glomerular filtration rate [eGFR] ≥ 60 and < 90 mL/min/1.73 m2): No dosage adjustment required - Moderate renal impairment (glomerular filtration rate [eGFR] ≥ 45 and < 60 mL/min/1.73 m2):

Ingredients

Manufacturer
주식회사케이에스제약

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

  • Difficulty in blood sugar control in patients with type 2 diabetes
View approved original text

This drug is used to improve blood sugar control in patients with type 2 diabetes. Initially, it may be administered as monotherapy, and if blood sugar control is insufficient, it is used in combination with other antidiabetic agents including metformin. If blood sugar control remains difficult with monotherapy or combination therapy with sulfonylureas, metformin, thiazolidinediones, or insulin, this drug can be added for more effective blood sugar management. Thus, it is used beneficially in the treatment of type 2 diabetes in combination with various therapies.

Dosage and Administration

Adult dosage

This drug is administered once daily at a dose of 100 mg as monotherapy or in combination therapy, with a maximum daily dose of 100 mg. It can be taken regardless of meals. Dosage adjustment in patients with renal impairment: - Mild renal impairment (glomerular filtration rate [eGFR] ≥ 60 and < 90 mL/min/1.73 m2): No dosage adjustment required - Moderate renal impairment (glomerular filtration rate [eGFR] ≥ 45 and < 60 mL/min/1.73 m2):

Precautions

This drug may cause severe allergic reactions, so if symptoms such as skin rash or difficulty in breathing occur, use should be stopped immediately, and a doctor should be consulted. Severe inflammation of the pancreas, known as acute pancreatitis, may occur, so if symptoms such as abdominal pain or vomiting arise, this drug should be discontinued immediately, and medical personnel should be informed. It should not be used in patients with type 1 diabetes or diabetic ketoacidosis, and it should not be administered if there is an allergy to this drug or its components. Patients with impaired kidney function may experience delayed excretion of this drug, requiring dosage adjustment, and regular kidney function tests are important. The risk of hypoglycemia may increase when this drug is used in conjunction with other hypoglycemic agents; thus, caution should be exercised for hypoglycemic symptoms when used with insulin or sulfonylureas. Serious side effects such as arthralgia or vesicular skin rash may occur during treatment, and if such symptoms occur, a doctor should be notified immediately. Use in pregnant or breastfeeding women is not recommended, and the safety and efficacy in children under 18 years of age have not been established. In case of overdose, immediate medical attention should be sought for appropriate treatment, and this drug can be partially removed by hemodialysis. This drug has a low potential for interactions with other medications, but it is advisable to consult with healthcare personnel when taking specific medications. Elderly patients may have reduced kidney function and require dosage adjustments and monitoring of kidney function.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), anaphylaxis, rash, exfoliative skin diseases (including Stevens-Johnson syndrome), acute pancreatitis, difficulty breathing, severe hypoglycemia, vesicular pemphigoid, acute renal failure, severe arthralgia, elevated liver enzymes, liver dysfunction (jaundice), serious neurological symptoms (headache, seizures, etc.), severe edema or urinary abnormalities

Mild side effects

  • Upper respiratory infection
  • nasopharyngitis
  • constipation
  • vomiting
  • headache
  • arthralgia
  • myalgia
  • limb pain
  • back pain
  • pruritus
Show 12 more
  • thrombocytopenia
  • diarrhea
  • dyspepsia
  • dizziness
  • elevated triglycerides
  • gastritis
  • weight loss
  • hypertension
  • hypernatremia
  • erectile dysfunction
  • ALT elevation
  • AST elevation

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

Storage

This drug should be stored in a sealed container to prevent air ingress and should be kept at room temperature between 1 to 30 degrees Celsius. This helps maintain the drug's effectiveness and prevents deterioration.

Appearance and packaging

Appearance

Bright yellow-orange round film-coated tablet

Package unit

100 tablets/bottle, 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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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.