Medication info
Sinubi Tablet 100 mg (Sitagliptin Hydrochloride Monohydrate)

Sinubi Tablet 100 mg (Sitagliptin Hydrochloride Monohydrate)

Prescription medicationTablet경구
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›113.4mg / 1 tablet
Manufacturer / importer
삼진제약(주)
Appearance
Light orange, round, biconvex film-coated tablet
Packaging
30 tablets/box [10 tablets/PTP x 3]
Approval status
Active

MFDS item code 202100091 · Approved 2021.01.06 · Insurance code 647805590

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who takes it
Adults
Adult dose
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 without regard to meals. Dosage adjustment for patients with renal impairment: 1. For patients with mild renal impairment (eGFR ≥ 60 and < 90 mL/min/1.73 m2), dosage adjustment is not required. 2. For patients with moderate renal impairment (eGFR ≥ 45 and < 60 mL/min/1.73 m2), dosage adjustment is not required.

Ingredients

Manufacturer
삼진제약(주)

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 in conjunction with diet and exercise to help control blood sugar levels in patients with type 2 diabetes. It is initially administered as monotherapy, but if blood sugar control is insufficient, it may be used in combination with metformin. Additionally, this drug can be used to control blood sugar when mono-therapy with sulfonylureas, metformin, thiazolidinediones, or insulin is ineffective. In cases where blood sugar control remains challenging with combination therapy, this drug may be added to sulfonylureas and metformin or other combination regimens to enhance therapeutic effects. This drug is used to improve blood sugar control in patients with type 2 diabetes.

How to take

Adult dose

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 without regard to meals. Dosage adjustment for patients with renal impairment: 1. For patients with mild renal impairment (eGFR ≥ 60 and < 90 mL/min/1.73 m2), dosage adjustment is not required. 2. For patients with moderate renal impairment (eGFR ≥ 45 and < 60 mL/min/1.73 m2), dosage adjustment is not required.

Precautions

This drug may cause severe allergic reactions in some patients. If symptoms such as skin rash, difficulty breathing, or swelling of the face or neck appear within the first 3 months of starting the medication, use should be discontinued immediately and a physician consulted. Additionally, this drug can cause severe side effects such as pancreatitis, which is an inflammation of the pancreas. If abdominal pain, vomiting, or severe abdominal pain occurs, immediate medical attention is required. Patients with type 1 diabetes, diabetic ketoacidosis, or known allergies to this drug or its components should not use it. Patients with impaired kidney function may require dosage adjustments, and regular kidney function tests are important. During treatment, symptoms similar to a cold, headache, indigestion, or diarrhea may occur. When used in conjunction with insulin or other glucose-lowering agents for diabetes treatment, there is a risk of hypoglycemia, so careful monitoring of blood sugar is essential. If severe joint pain or blistering on the skin occurs, immediate consultation with a doctor is necessary, and discontinuation of the drug may be required if these symptoms are suspected. It is not recommended for use during pregnancy or breastfeeding. In case of overdose, standard treatment should be rendered, and dialysis may be necessary as needed. Finally, regular medical checkups to monitor for side effects during the use of this drug are important.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, anaphylaxis, Stevens-Johnson syndrome, exfoliative skin disease, fatal hemorrhagic or necrotizing pancreatitis, acute pancreatitis, acute renal failure, severe joint pain with disabilities, bullous pemphigoid, pneumonia, diabetes complications, metabolic acidosis, falls, cardiac arrest

Mild side effects

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

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

Storage

This drug should be stored in an airtight container and kept at room temperature (between 1 to 30 degrees Celsius). Proper storage will help maintain the drug's effectiveness over time.

Appearance and packaging

Appearance

Light orange, 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.