Medication info
Janudau Tablet 100 mg (Sitagliptin Hydrochloride Monohydrate)

Janudau Tablet 100 mg (Sitagliptin Hydrochloride Monohydrate)

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

MFDS item code 202004027 · Approved 2020.05.29 · Insurance code 694003160

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who takes it
Adults
Adult dose
Administer 100 mg once daily for monotherapy or combination therapy, with a maximum daily dose of 100 mg. Can be taken regardless of meals. For patients with renal impairment, no dosage adjustment is necessary for mild to moderate renal impairment (glomerular filtration rate [eGFR] 45 to less than 90). For eGFR 30 to less than 45, administer 50 mg once daily. For eGFR 15 to less than 30,

Ingredients

Manufacturer
대웅바이오(주)

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 to assist in blood sugar control in patients with type 2 diabetes in conjunction with diet and exercise. It can be administered alone, but in cases where there is no experience with diabetes drug treatment and blood sugar control is difficult with monotherapy, it may be combined with metformin. Additionally, if blood sugar control is insufficient with monotherapy of sulfonylureas, metformin, thiazolidinediones, or insulin, this medication is also used in combination to help improve blood sugar levels. Therefore, this medication is utilized for effective blood sugar control in patients with type 2 diabetes.

How to take

Adult dose

Administer 100 mg once daily for monotherapy or combination therapy, with a maximum daily dose of 100 mg. Can be taken regardless of meals. For patients with renal impairment, no dosage adjustment is necessary for mild to moderate renal impairment (glomerular filtration rate [eGFR] 45 to less than 90). For eGFR 30 to less than 45, administer 50 mg once daily. For eGFR 15 to less than 30,

Precautions

This medication may cause allergic reactions, so if symptoms such as skin rash, hives, or difficulty breathing occur during use, it should be discontinued immediately and consult a physician. Moreover, acute pancreatitis, a serious pancreatic inflammation, may occur, so it is important to carefully observe for abdominal pain, vomiting, or severe nausea and to discontinue use if symptoms are suspected. It should not be administered to patients with type 1 diabetes or diabetic ketoacidosis, and use should be avoided if there is hypersensitivity to this medication or its components. For patients with impaired kidney function, the dosage must be adjusted as the drug may not be adequately excreted from the body, especially in patients with end-stage renal disease undergoing dialysis, where low-dose usage is recommended. When used in combination with other hypoglycemic agents, there may be an increased risk of hypoglycemia, so caution should be exercised for hypoglycemic symptoms when taking insulin or sulfonylureas, and adjustments to the dosages of other medications may be necessary. Severe arthralgia or blistering skin diseases may occur, and if such symptoms arise, inform a physician immediately and consider discontinuing the medication. Use of this medication is not recommended during pregnancy or breastfeeding, and safety and efficacy have not been established for children and adolescents under 18 years of age. Elderly individuals may have impaired kidney function, so it is advisable to evaluate kidney function before administration and to periodically check kidney status after administration. In case of overdose, general symptomatic treatment should be initiated, and blood dialysis may be considered to remove some of the drug if necessary. This medication has no issues with cardiovascular safety; however, some adverse reactions such as upper respiratory infections, headaches, rhinitis, diarrhea, and nausea have been reported, so caution is advised if symptoms occur. Finally, there are no significant interactions with other medications, but there may be a slight increase in blood levels when taken with digoxin, so monitoring is necessary.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), anaphylaxis, angioedema, cutaneous vasculitis, Stevens-Johnson syndrome, exfoliative dermatitis, fatal/non-fatal hemorrhagic or necrotizing pancreatitis, acute pancreatitis, acute kidney failure, severe and disabling arthralgia, blistering dermatitis, pneumonia, diabetic complications, metabolic acidosis, cardiac arrest

Mild side effects

  • Rhinitis
  • upper respiratory infection
  • headache
  • diarrhea
  • nausea
  • constipation
  • myalgia
  • limb pain
  • back pain
  • pruritus
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  • thrombocytopenia
  • dyspepsia
  • dizziness
  • increased blood triglycerides
  • increased low-density lipoprotein
  • hyperglycemia
  • hypertension
  • weight loss
  • erectile dysfunction
  • increased liver enzyme levels

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

Storage

This medication should be stored in a tightly closed container to prevent air from entering, and it is recommended to store it at room temperature between 1 to 30 degrees Celsius. This will help maintain the effectiveness of the medication.

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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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.