Medication info

Januren 100 mg (Sitagliptin Phosphate hydrate)

Prescription medicationTablet
Ingredient · strength
Sitagliptin Phosphate Hydrate›128.5mg / 1 tablet
Manufacturer / importer
(주)서흥
Appearance
Beige, round, biconvex film-coated tablet
Packaging
30 tablets/bottle, 90 tablets/bottle
Approval status
Active

MFDS item code 202107871 · Approved 2021.12.09

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who uses it
Adults
Adult dosage
This medication is administered as a single daily dose of 100 mg, and the maximum daily dose is 100 mg. It can be taken with or without food. Patients with renal impairment may require dosage adjustments based on their kidney function. For mild to moderate renal impairment (eGFR 45 or greater and less than 90), dosage adjustments are not necessary. For moderate renal impairment (eGFR 30 or greater and less than 45), 50 mg is administered once daily.

Ingredients

Manufacturer
(주)서흥

Efficacy & effects

Improvement of 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 together with diet and exercise to help control blood sugar levels in patients with type 2 diabetes. It can initially be administered alone, and in cases where blood sugar control is challenging with monotherapy despite not having previously used diabetes medications, it can be taken in combination with Metformin. Additionally, when sufficient blood sugar control is not achieved with monotherapy of Sulfonylureas, Metformin, Thiazolidinediones, or Insulin, this medication is used to enhance the treatment effect. If blood sugar control is difficult even with multiple drug combinations, this medication can be added to improve blood sugar management. Therefore, this medication is effectively used in various cases to enhance blood sugar control.

Dosage and Administration

Adult dosage

This medication is administered as a single daily dose of 100 mg, and the maximum daily dose is 100 mg. It can be taken with or without food. Patients with renal impairment may require dosage adjustments based on their kidney function. For mild to moderate renal impairment (eGFR 45 or greater and less than 90), dosage adjustments are not necessary. For moderate renal impairment (eGFR 30 or greater and less than 45), 50 mg is administered once daily.

Precautions

This medication may cause severe allergic reactions after administration, so if symptoms such as skin rash or difficulty breathing occur, discontinue use immediately and consult a physician. This medication has been reported to cause serious side effects such as pancreatitis, and if symptoms like abdominal pain or vomiting appear during use, immediate medical attention is required. This medication should not be used in patients with type 1 diabetes or diabetic ketoacidosis, and should be avoided if there is an allergy to this medication or its components. Patients with impaired kidney function may have reduced excretion of this medication, so dosage should be adjusted or taken cautiously under a doctor's guidance. Possible side effects when used alone or in combination with other diabetes treatments include upper respiratory infections, headaches, nasopharyngitis, diarrhea, and hypoglycemic symptoms, so blood sugar levels should be carefully monitored. Particularly when taken with insulin or Sulfonylureas, the risk of hypoglycemia may increase, so dosage adjustments of these medications may be necessary. Rare side effects such as severe arthralgia or the development of blistering pemphigoid may occur, and if symptoms appear, patients should inform their doctor and receive treatment immediately. The safety of this medication during pregnancy or lactation has not been established, so its use is not recommended, and it is also not recommended for children under 18 years of age. Elderly patients may experience reduced kidney function, and regular kidney function tests should be performed before and after taking this medication, with dosage adjustments as necessary. In case of overdose, gastrointestinal removal of the medication and monitoring of conditions such as electrocardiograms should be undertaken, and some removal may be possible through hemodialysis. Interactions with other medications are relatively low, but monitoring and dosage adjustments may be needed in consultation with a doctor or pharmacist when certain medications are taken.

Side effects and when to seek care immediately

Serious side effects

  • Hives, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, pallor → severe allergic reaction
  • Severe rash with high fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes → severe skin adverse reaction
  • Acute pancreatitis (including fatal/non-fatal hemorrhagic or necrotizing pancreatitis)
  • Difficulty breathing or shortness of breath, asthma attack, respiratory abnormalities accompanied by cough and fever
  • Yellowing of skin or eyes (jaundice)

Mild side effects

  • Upper respiratory infection
  • nasopharyngitis
  • headache
  • abdominal pain
  • nausea
  • diarrhea
  • constipation
  • vomiting
  • muscle pain
  • limb pain
Show 12 more
  • back pain
  • pruritus
  • thrombocytopenia
  • dyspepsia
  • dizziness
  • increased blood triglycerides
  • increased low-density lipoproteins
  • hyperglycemia
  • hypernatremia
  • erectile dysfunction
  • weight loss
  • 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 or moisture from entering, and it is safe to store at room temperature between 1 degree and 30 degrees. Therefore, always ensure the lid is tightly closed when using the medication, and avoid storing it in excessively hot or cold places.

Appearance and packaging

Appearance

Beige, round, biconvex film-coated tablet

Package unit

30 tablets/bottle, 90 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.

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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.