Medication info
Danubia Tablet 100 mg (Sitagliptin Hydrochloride Hydrate)

Danubia Tablet 100 mg (Sitagliptin Hydrochloride Hydrate)

Prescription medicationTablet
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›113.37mg / 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 202102661 · Approved 2021.03.26 · Insurance code 059001090

Summary

Main use
Improves blood sugar control in type 2 diabetes
Who uses it
Adults
Adult dosage
This medication is administered once daily at a dose of 100 mg either as monotherapy or in combination, with a maximum daily dose of 100 mg. It can be taken regardless of meals. In patients with renal impairment, - For mild to moderate renal impairment (eGFR 45 to less than 90), dose adjustment is not necessary. - In moderate renal impairment with a glomerular filtration rate (GFR) of 30 to less than 45, the dose is 50 mg once daily. -

Ingredients

Manufacturer
주식회사케이에스제약

Efficacy & effects

Improves blood sugar control in type 2 diabetes

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

This medication is used alongside dietary and exercise regimens to assist patients with type 2 diabetes in controlling their blood sugar levels. It can be administered alone for patients who are receiving treatment for the first time and can be combined with metformin if sufficient blood sugar control is not achieved with monotherapy. Additionally, if blood sugar control is difficult with other diabetes medications like sulfonylureas, metformin, thiazolidinediones, or insulin, this medication can be added for combined use. This medication effectively improves blood sugar control when used with various other drugs.

Dosage and Administration

Adult dosage

This medication is administered once daily at a dose of 100 mg either as monotherapy or in combination, with a maximum daily dose of 100 mg. It can be taken regardless of meals. In patients with renal impairment, - For mild to moderate renal impairment (eGFR 45 to less than 90), dose adjustment is not necessary. - In moderate renal impairment with a glomerular filtration rate (GFR) of 30 to less than 45, the dose is 50 mg once daily. -

Precautions

This medication can rarely cause serious allergic reactions; hence, if symptoms such as skin rash or difficulty breathing occur, immediate discontinuation and consultation with a physician is required. During treatment with this medication, serious pancreatic inflammation known as pancreatitis may occur, so if symptoms like abdominal pain, vomiting, or loss of appetite arise, you should notify medical personnel immediately. This medication should not be used by patients with type 1 diabetes or those suffering from diabetic ketoacidosis, and it should also be avoided if there is an allergy to this medication or its components. Patients with impaired renal function should have their dosage adjusted, making it important to determine the appropriate dose through kidney function tests. When used in combination with other diabetes medications, this medication may increase the risk of hypoglycemia; therefore, blood sugar levels should be carefully monitored when taken with insulin or sulfonylureas. If severe joint pain or blistering skin symptoms appear, the medication should be discontinued immediately, and consultation with a specialist is advised. The use of this medication is not recommended for pregnant or breastfeeding women, and its safety and efficacy have not been established in children under 18 years of age. Elderly patients may have decreased kidney function, so evaluating and monitoring kidney function before starting this medication is necessary. In case of overdose, immediate medical attention should be sought, and this medication can be partially removed through hemodialysis. If any adverse reactions or discomfort occur while taking this medication, it is crucial to consult medical personnel to receive appropriate measures.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • angioedema
  • chest tightness
  • difficulty breathing
  • cold sweat
  • pallor
  • anaphylaxis
  • severe hypersensitivity reactions
  • Stevens-Johnson syndrome
  • exfoliative skin disease
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  • severe rashes accompanied by high fever
  • blisters
  • skin peeling
  • pain in oral/ocular mucosa
  • acute pancreatitis
  • elevated liver enzymes
  • liver dysfunction (jaundice)
  • acute renal failure
  • severe edema
  • severe joint pain
  • bullous pemphigoid
  • rhabdomyolysis
  • cardiac arrest
  • sudden and severe reactions

Mild side effects

  • Upper respiratory infection
  • nasopharyngitis
  • constipation
  • vomiting
  • headache
  • myalgia
  • limb pain
  • back pain
  • pruritus
  • thrombocytopenia
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  • hypoglycemia
  • dyspepsia
  • dizziness
  • diarrhea
  • nausea
  • weight loss
  • hypertension
  • hypernatremia
  • erectile dysfunction

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

Storage

This medication should be stored in a sealed container to prevent air or moisture ingress. It is advisable to maintain the storage temperature between 1 to 30 degrees Celsius to ensure the medication's efficacy and safety.

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.