Medication info
Januglyptin Tablets 100 mg (Sitagliptin Phosphate)

Januglyptin Tablets 100 mg (Sitagliptin Phosphate)

Prescription medicationTablet경구
Ingredient · strength
Sitagliptin Phosphate›124.08mg / 1 tablet
Manufacturer / importer
(주)다산제약
Appearance
Beige, round, biconvex film-coated tablet
Packaging
30 tablets/box [10 tablets/PTP x 3]
Approval status
Active

MFDS item code 201503180 · Approved 2015.05.27 · Insurance code 678600520

Summary

Main use
Improvement in blood sugar control in type 2 diabetes
Who takes it
Adults
Adult dose
This medication is administered as a single dose of 100 mg once daily, with a maximum daily dose of 100 mg. Patients with renal impairment may require dose adjustments. - In mild renal impairment (eGFR 60-90 mL/min/1.73 m²), no dose adjustment is needed. - In moderate renal impairment (eGFR 45-60 mL/min/1.73 m²), no dose adjustment is needed. - In moderate renal impairment (eGFR 30-45 mL/min/1.73 m²), the dose is 50 mg once daily. - In severe renal impairment (eGFR < 30 mL/min/1.73 m²) or end-stage renal disease patients requiring dialysis (eGFR < 15 mL/min/1.73 m²), the dose is 25 mg once daily. This medication can be administered regardless of dialysis timing.

Ingredients

Manufacturer
(주)다산제약

Efficacy & effects

Improvement in blood sugar control in type 2 diabetes

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

This medication is used in conjunction with dietary and exercise therapy to help control blood sugar levels in patients with type 2 diabetes. It is initially administered as monotherapy, but in cases where the patient has not received previous diabetes treatment or has difficulty controlling blood sugar with monotherapy, it is used in combination with metformin. Additionally, if blood sugar control is inadequate with monotherapy using sulfonylureas, metformin, thiazolidinediones, or insulin, this medication is used as an adjunctive therapy. This medication is also added when blood sugar control is insufficient despite the use of multiple agents. It effectively assists in the management of the patient's blood sugar and improves blood sugar control.

How to take

Adult dose

This medication is administered as a single dose of 100 mg once daily, with a maximum daily dose of 100 mg. Patients with renal impairment may require dose adjustments. - In mild renal impairment (eGFR 60-90 mL/min/1.73 m²), no dose adjustment is needed. - In moderate renal impairment (eGFR 45-60 mL/min/1.73 m²), no dose adjustment is needed. - In moderate renal impairment (eGFR 30-45 mL/min/1.73 m²), the dose is 50 mg once daily. - In severe renal impairment (eGFR < 30 mL/min/1.73 m²) or end-stage renal disease patients requiring dialysis (eGFR < 15 mL/min/1.73 m²), the dose is 25 mg once daily. This medication can be administered regardless of dialysis timing.

Precautions

This medication may cause severe allergic reactions; if symptoms such as hives or skin rash, difficulty breathing occur, take it immediately and consult a doctor. While taking this medication, symptoms of acute pancreatitis, which is inflammation of the pancreas, may occur, so alert medical personnel immediately if there are symptoms such as abdominal pain or vomiting. This medication should not be used in patients with type 1 diabetes or diabetic ketoacidosis, nor in those allergic to this drug or its components. Patients with impaired renal function need dose adjustment; hence, regular kidney function tests should be conducted, and dosage should be followed according to the physician's instructions. During treatment, side effects such as cold symptoms, headache, indigestion, and diarrhea may occur, and caution should be exercised as the risk of hypoglycemia may increase, particularly in combination with insulin or sulfonylureas. This medication can cause hypoglycemic symptoms when used with other blood sugar-lowering agents, so dosage adjustment may be needed if necessary. If severe arthralgia or blistering skin symptoms occur, notify a doctor immediately and discontinue the medication if necessary. Pregnant or breastfeeding women are advised not to take this medication, and safety and efficacy in children or adolescents under 18 years have not been established. Elderly patients may have reduced kidney function, so kidney function should be monitored before and after administration, and dosage adjustments may be required. In case of overdose, the drug should be removed from the gastrointestinal tract, and the patient's condition must be closely monitored, including electrocardiogram tests, and blood dialysis may be performed if necessary. This medication has fewer interactions with other drugs, but caution is required when combined with specific medications, so all currently administered drugs should be disclosed to the medical personnel.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (angioedema)
  • anaphylaxis
  • severe allergic reactions
  • acute pancreatitis
  • severe rash
  • skin peeling
  • oral/ocular mucosal pain
  • Stevens-Johnson syndrome
  • difficulty breathing
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  • respiratory problems
  • liver abnormalities (jaundice)
  • acute renal failure
  • severe edema
  • severe hypoglycemia
  • severe and disabling joint pain
  • bullous pemphigoid
  • rhabdomyolysis
  • cardiac arrest

Mild side effects

  • Upper respiratory infection
  • nasopharyngitis
  • headache
  • diarrhea
  • nausea
  • constipation
  • indigestion
  • dizziness
  • increased triglycerides in the blood
  • gastritis
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  • muscle pain
  • limb pain
  • back pain
  • interstitial lung disease
  • pruritus
  • thrombocytopenia
  • 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 the ingress of air or moisture, and it should be kept at a temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

Beige, 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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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.