Medication info

Sinubi Tablet 25 mg (Sitagliptin Hydrochloride Monohydrate)

Prescription medicationTablet경구Expired
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›28.35mg / 1 tablet
Manufacturer / importer
삼진제약(주)
Appearance
Pink, round, biconvex film-coated tablet
Packaging
30 tablets/box [10 tablets/PTP x 3]
Approval status
Expired

MFDS item code 202100093 · Approved 2021.01.06

This product's status changed to Expired on 2026.01.06. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement in blood sugar control for type 2 diabetes
Who takes it
Adults
Adult dose
This medication is administered at a dose of 100 mg once daily for monotherapy or combination therapy, with a maximum daily dose of 100 mg. It can be taken regardless of meals. Patients with renal impairment require dosage adjustments based on their kidney function. - Mild renal impairment (eGFR 60 to < 90): No dosage adjustment required - Moderate renal impairment (eGFR 45 to < 60): No dosage adjustment required - Moderate renal impairment (eGFR 30 to < 45): 50 mg once daily - Severe renal impairment (eGFR 15 to < 30) or end-stage renal disease (ESRD) requiring dialysis (eGFR < 15): 25 mg once daily. This medication can be administered regardless of the timing of dialysis.

Ingredients

Manufacturer
삼진제약(주)

Efficacy & effects

Improvement in blood sugar control for type 2 diabetes

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

This medication is used to assist with dietary and exercise therapy to improve blood sugar control in patients with type 2 diabetes. Initially, it may be administered alone, and patients who have not previously used other diabetes medications may benefit from monotherapy. However, if blood sugar control is difficult with monotherapy, it is co-administered with metformin. Additionally, if blood sugar is not adequately controlled with monotherapy using sulfonylureas, metformin, thiazolidinediones, or insulin, this medication may be used in combination. In cases of insufficient blood sugar control with combination therapy, this medication may be added to enhance blood sugar control. Therefore, this medication is effectively used for blood sugar control in type 2 diabetes.

How to take

Adult dose

This medication is administered at a dose of 100 mg once daily for monotherapy or combination therapy, with a maximum daily dose of 100 mg. It can be taken regardless of meals. Patients with renal impairment require dosage adjustments based on their kidney function. - Mild renal impairment (eGFR 60 to < 90): No dosage adjustment required - Moderate renal impairment (eGFR 45 to < 60): No dosage adjustment required - Moderate renal impairment (eGFR 30 to < 45): 50 mg once daily - Severe renal impairment (eGFR 15 to < 30) or end-stage renal disease (ESRD) requiring dialysis (eGFR < 15): 25 mg once daily. This medication can be administered regardless of the timing of dialysis.

Precautions

This medication can rarely cause serious allergic reactions. Such reactions may occur within the first 3 months of taking the medication, so caution is necessary. During the use of this medication, symptoms of acute pancreatitis, which is inflammation of the pancreas, may occur. Therefore, if symptoms such as abdominal pain or vomiting arise, consult a physician immediately. This medication should not be used in patients with type 1 diabetes or diabetic ketoacidosis, nor in individuals who are allergic to this medication or its components. Patients with impaired kidney function may need dosage adjustments, so renal function should be monitored regularly. This medication may cause hypoglycemia, so blood sugar levels should be closely monitored, especially when taken together with other antidiabetic agents like insulin or sulfonylureas. Patients may experience headaches, upper respiratory infections, nasopharyngitis, dyspepsia, diarrhea, and other symptoms during treatment. Report any persistent symptoms to a physician. This medication is not recommended for use in pregnant or nursing women, and its safety and efficacy have not been established in children or adolescents under 18 years of age. When administering to elderly patients, adjust the dosage considering the potential decline in kidney function, and regular kidney function tests are advised. In case of overdose, gastrointestinal decontamination and monitoring of conditions such as ECG may be required, and some removal can occur through hemodialysis. This medication has low interaction potential with other drugs, but caution is advised when used with digoxin or cyclosporine, and consultation with a physician is necessary. If symptoms such as joint pain or skin blisters occur during treatment, inform medical personnel immediately, and discontinue medication when necessary.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • angioedema
  • anaphylaxis
  • Stevens-Johnson syndrome
  • exfoliative skin disease
  • acute pancreatitis
  • acute renal failure
  • severe joint pain with disability
  • bullous pemphigoid
  • pneumonia
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  • diabetic complications
  • metabolic acidosis
  • cardiac arrest

Mild side effects

  • Upper respiratory infection
  • nasopharyngitis
  • headache
  • diarrhea
  • abdominal pain
  • nausea
  • constipation
  • vomiting
  • muscle pain
  • limb pain
Show 12 more
  • back pain
  • pruritus
  • thrombocytopenia
  • joint pain without severity or disabling
  • dyspepsia
  • dizziness
  • increased serum triglycerides
  • elevated low-density lipoprotein
  • hyperglycemia
  • hypertension
  • hypernatremia
  • erectile dysfunction

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

Storage

This medication should be stored in a tight container that is not exposed to air, and it is best kept at a temperature between 1 and 30 degrees Celsius. Proper storage helps maintain the medication's efficacy and prevent degradation.

Appearance and packaging

Appearance

Pink, round, biconvex film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP x 3]

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.