Medication info
Dajibio New Jeong 50 mg (Sitagliptin Hydrochloride Monohydrate)

Dajibio New Jeong 50 mg (Sitagliptin Hydrochloride Monohydrate)

Prescription medicationTablet
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›56.7mg / 1 tablet
Manufacturer / importer
명문제약(주)
Appearance
A pale yellow-pink, round, biconvex film-coated tablet
Packaging
30 tablets/box [10 tablets/PTPX3]
Approval status
Active

MFDS item code 202004044 · Approved 2020.05.29 · Insurance code 649807910

Summary

Main use
Improvement in blood sugar control for type 2 diabetes
Who uses it
Adults
Adult dosage
The standard dosage is 100 mg once daily for use as monotherapy or in combination therapy, with a maximum daily dose of 100 mg. It can be taken regardless of meals. For patients with renal impairment, dosage adjustments are necessary based on kidney function. - No dosage adjustments are required for patients with mild renal impairment (eGFR 60-90 mL/min/1.73 m2) and moderate renal impairment (eGFR 45-60 mL/min/1.73 m2).

Ingredients

Manufacturer
명문제약(주)

Efficacy & effects

Improvement in blood sugar control for type 2 diabetes

  • Type 2 diabetes
  • difficulty in blood sugar control
View approved original text

This medication is used to improve blood sugar control in patients with type 2 diabetes as an adjunct to diet and exercise. It can be administered alone when initiating treatment. If monotherapy is insufficient, it may be used in combination with metformin. Additionally, it is added to treatment regimens when blood sugar control is difficult with single therapies or in combinations including sulfonylureas, metformin, thiazolidinediones, or insulin. These combination therapies may consist of various drug combinations. In summary, this drug effectively improves blood sugar control in patients with type 2 diabetes.

Dosage and Administration

Adult dosage

The standard dosage is 100 mg once daily for use as monotherapy or in combination therapy, with a maximum daily dose of 100 mg. It can be taken regardless of meals. For patients with renal impairment, dosage adjustments are necessary based on kidney function. - No dosage adjustments are required for patients with mild renal impairment (eGFR 60-90 mL/min/1.73 m2) and moderate renal impairment (eGFR 45-60 mL/min/1.73 m2).

Precautions

This medication may rarely cause severe allergic reactions, so if symptoms such as skin rash, difficulty breathing, or swelling of the face or neck occur after administration, it should be discontinued immediately and medical advice should be sought. While taking this medication, there can be serious side effects such as acute pancreatitis, which involves inflammation of the pancreas, so if abdominal pain, vomiting, or severe abdominal discomfort occurs, notify medical staff immediately. This medication should not be used in patients with type 1 diabetes or diabetic ketoacidosis, nor in cases of allergies to the drug or its ingredients. Patients with impaired renal function may require dosage adjustments; thus, those with kidney disease or issues regarding kidney function should consult with a physician to determine the appropriate dose. This medication may cause symptoms of hypoglycemia, particularly if taken with other blood-sugar-lowering agents such as insulin or sulfonylureas, necessitating careful monitoring of blood sugar levels. Severe joint pain or skin disorders such as blistering dermatosis similar to pemphigus may occur; thus, medical staff should be notified immediately if these symptoms arise. Pregnant or breastfeeding women are advised not to take this medication, and safety in pediatric patients under 18 years of age has not been established, so it is recommended not to use it. This medication may interact with other drugs; hence, it is essential to inform medical staff about other medications currently being taken and to consult for advice. In case of an overdose, standard treatment such as removal of the medication from the gastrointestinal tract is necessary, and some may be removed through dialysis, so appropriate actions should be taken following medical staff directions. The elderly may experience decreased kidney function, thus requiring regular assessment of renal function before and during treatment with this medication, and dosage adjustments may be necessary.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (angioedema), anaphylaxis, rash, exfoliative skin disorders (including Stevens-Johnson syndrome), acute pancreatitis, acute renal failure, severe and debilitating arthralgia, blistering dermatosis, jaundice, severe allergic reactions, severe skin adverse reactions, severe swelling or urination abnormalities

Mild side effects

  • Upper respiratory infection
  • nasopharyngitis
  • headache
  • diarrhea
  • nausea
  • abdominal pain
  • constipation
  • vomiting
  • thrombocytopenia
  • myalgia
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  • limb pain
  • back pain
  • pruritus
  • dyspepsia
  • dizziness
  • increased triglycerides
  • increased low-density lipoprotein
  • hyperglycemia
  • weight loss
  • hypernatremia
  • erectile dysfunction
  • hypertension

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 from entering, and it is best kept at room temperature between 1 to 30 degrees Celsius. This will maintain the medication's effectiveness and ensure safe usage.

Appearance and packaging

Appearance

A pale yellow-pink, round, biconvex film-coated tablet

Package unit

30 tablets/box [10 tablets/PTPX3]

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.