Medication info
Danubia Tablet 25 mg (Sitagliptin Hydrochloride Hydrate)

Danubia Tablet 25 mg (Sitagliptin Hydrochloride Hydrate)

Prescription medicationTablet
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›28.34mg / 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 202102662 · Approved 2021.03.26 · Insurance code 059001100

Summary

Main use
Improvement of blood glucose control in type 2 diabetes
Who uses it
Adults
Adult dosage
The recommended dosage for this medication is 100 mg once daily for monotherapy or combination therapy, with a maximum daily dose of 100 mg. Patients with renal impairment need dosage adjustments based on renal function. - Mild and moderate renal impairment do not require dosage adjustments. - Patients with moderate renal impairment (glomerular filtration rate 30-45 mL/min/1.73 m2) should take 50 mg once daily. - Patients with a glomerular filtration rate of 15-30 mL/min/...

Ingredients

Manufacturer
주식회사케이에스제약

Efficacy & effects

Improvement of blood glucose control in type 2 diabetes

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

This medication is used to improve blood glucose control in patients with type 2 diabetes. It can be administered alone or in combination with dietary and exercise therapy, and it may be used with metformin when blood glucose control is difficult in patients who have not received previous diabetes drug treatment. Additionally, if blood glucose control is inadequate with monotherapy using sulfonylureas, metformin, thiazolidinediones, or insulin, this drug can be added to the regimen. When blood glucose control is difficult with combination therapy, this medication helps to effectively manage blood glucose levels when used with multiple drugs.

Dosage and Administration

Adult dosage

The recommended dosage for this medication is 100 mg once daily for monotherapy or combination therapy, with a maximum daily dose of 100 mg. Patients with renal impairment need dosage adjustments based on renal function. - Mild and moderate renal impairment do not require dosage adjustments. - Patients with moderate renal impairment (glomerular filtration rate 30-45 mL/min/1.73 m2) should take 50 mg once daily. - Patients with a glomerular filtration rate of 15-30 mL/min/...

Precautions

This medication may cause severe allergic reactions after administration; therefore, if symptoms such as rash or difficulty breathing occur, discontinue use immediately and seek medical attention. There is a risk of pancreatitis (inflammation of the pancreas); therefore, if symptoms such as abdominal pain or vomiting occur, inform medical personnel immediately. Patients with type 1 diabetes or diabetic ketoacidosis should not take this medication, and those with severe allergies to this medication or its ingredients should also avoid it. Patients with decreased renal function need dosage adjustments for this medication, so renal function tests should be conducted and usage should follow the physician's guidance. Common side effects noted in clinical trials include cold symptoms, headache, upper respiratory infections, and some patients may experience hypoglycemic symptoms, so caution is necessary. The risk of hypoglycemia may increase when used in conjunction with other hypoglycemic agents or insulin, so blood glucose levels should be monitored regularly while taking this medication, and dosage adjustments may be necessary. If severe arthralgia or skin blisters occur during treatment, notify the physician immediately and discontinue medication. Pregnant or breastfeeding women are advised not to take this medication, and it is not recommended for children under 18 as safety and efficacy have not been established. Elderly patients may experience decreased renal function, so renal function evaluation is needed before administration, and regular monitoring is also required during treatment. In cases of overdose, gastrointestinal decontamination or monitoring, including electrocardiograms, should be performed, and some drugs may be removed via hemodialysis. This medication has relatively few interactions with other drugs, but it is important to consult a physician or pharmacist when taking certain medications.

Side effects and when to seek care immediately

Serious side effects

  • Hives, angioedema, chest tightness, difficulty breathing, cold sweats, pallor, and other severe allergic reactions.
  • Severe skin reactions (including Stevens-Johnson syndrome with rash, blisters, skin peeling, etc.)
  • Acute pancreatitis (including potentially fatal/non-fatal hemorrhagic or necrotizing pancreatitis)
  • Acute renal failure (sometimes requiring dialysis)
  • Severe and disabling arthralgia
  • Bullous pemphigoid
  • Elevated liver enzymes and liver abnormalities such as jaundice of the skin/eyes.

Mild side effects

  • Headache
  • upper respiratory infection
  • nasopharyngitis
  • constipation
  • vomiting
  • myalgia
  • limb pain
  • back pain
  • pruritus
  • thrombocytopenia
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  • diarrhea
  • nausea
  • dyspepsia
  • dizziness
  • increased blood triglycerides
  • increased low-density lipoprotein
  • elevated blood glucose
  • weight loss
  • hypertension
  • hypernatremia
  • erectile dysfunction

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

Storage

Store this medication in a tightly sealed container to prevent air or moisture from entering and keep it at a temperature between 1 and 30 degrees Celsius. This storage will help maintain the medication's effectiveness over time.

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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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.