Medication info
Januum Tablet 100 mg (Sitagliptin Hydrochloride Hydrate)

Januum Tablet 100 mg (Sitagliptin Hydrochloride Hydrate)

Prescription medicationTablet
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›113.4mg / 1 tablet
Manufacturer / importer
에이치엘비제약(주)
Appearance
Bright brown, round, bilaterally convex film-coated tablets
Packaging
28 tablets/box [14 tablets/PTP×2]
Approval status
Active

MFDS item code 202101228 · Approved 2021.02.10 · Insurance code 647304380

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who uses it
Adults
Adult dosage
This medication is administered at a dose of 100 mg once daily for monotherapy or combination therapy, with a maximum daily dosage of 100 mg. It can be taken regardless of meals. In patients with renal impairment: - Mild renal impairment (estimated glomerular filtration rate [eGFR] ≥ 60 and < 90 mL/min/1.73 m2) does not require dose adjustment. - Moderate renal impairment (estimated glomerular filtration rate [eGFR] ≥ 45 and < 60 mL/min/1.73 m2) does not require dose adjustment.

Ingredients

Manufacturer
에이치엘비제약(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 medication is used to help control blood sugar levels in patients with type 2 diabetes. It can be administered alone during the initial treatment, and if blood glucose control is insufficient with monotherapy, it can be used in combination with metformin or other diabetes medications. If blood sugar control is still inadequate with any one of sulfonylureas, metformin, thiazolidinediones, or insulin, this drug can be added as an adjunct treatment to improve blood glucose control. Therefore, this medication is effectively used in conjunction with diet and exercise therapy to improve blood sugar control.

Dosage and Administration

Adult dosage

This medication is administered at a dose of 100 mg once daily for monotherapy or combination therapy, with a maximum daily dosage of 100 mg. It can be taken regardless of meals. In patients with renal impairment: - Mild renal impairment (estimated glomerular filtration rate [eGFR] ≥ 60 and < 90 mL/min/1.73 m2) does not require dose adjustment. - Moderate renal impairment (estimated glomerular filtration rate [eGFR] ≥ 45 and < 60 mL/min/1.73 m2) does not require dose adjustment.

Precautions

This medication may cause serious allergic reactions; therefore, if symptoms such as skin rash, difficulty in breathing, or swelling of the face or neck occur within 3 months of use, discontinue use immediately and consult a doctor. This medication may cause pancreatitis, an inflammation of the pancreas; if symptoms such as abdominal pain, vomiting, or loss of appetite occur, notify healthcare personnel immediately. It should not be used in patients with type 1 diabetes or diabetic ketoacidosis, and it should not be administered to individuals with an allergy to this medication or its components. In patients with impaired renal function, the dosage of this medication should be adjusted, and regular kidney function tests should be performed according to the physician's instructions. Hypoglycemia may occur when this drug is used alone or in combination with other diabetes drugs, especially when taken with insulin or sulfonylureas, so it is important to carefully monitor blood glucose levels. If severe joint pain or skin blistering occurs, notify the physician immediately and discontinue use of this medication to receive appropriate treatment. Women who are pregnant or breastfeeding should avoid using this medication, and safety and efficacy have not been established in children under 18 years of age. Elderly patients may have reduced renal function, so renal function should be assessed before and during treatment, and dosage adjustments may be necessary. In case of overdose, seek medical treatment immediately, and this medication can be partially removed by hemodialysis. Drug interactions are generally minimal when taken with other medications; however, inform healthcare personnel and monitor if taken with cyclosporine or digoxin.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), anaphylaxis, exfoliative skin disorders (including Stevens-Johnson syndrome), acute pancreatitis, difficulty breathing, bullous pemphigoid, elevated liver enzymes (signs of liver dysfunction), acute renal failure, severe and disabling joint pain, cardiac arrest

Mild side effects

  • Upper respiratory tract infection
  • nasopharyngitis
  • headache
  • diarrhea
  • nausea
  • dyspepsia
  • dizziness
  • constipation
  • vomiting
  • muscle pain
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  • limb pain
  • back pain
  • pruritus
  • thrombocytopenia
  • peripheral edema

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 a temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the efficacy of the medication.

Appearance and packaging

Appearance

Bright brown, round, bilaterally convex film-coated tablets

Package unit

28 tablets/box [14 tablets/PTP×2]

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.