Medication info
Januglutide 50 mg (Sitagliptin Hydrochloride Monohydrate)

Januglutide 50 mg (Sitagliptin Hydrochloride Monohydrate)

Prescription medicationTablet경구
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›56.69mg / 1 tablet
Manufacturer / importer
(주)시어스제약
Appearance
Bright yellow-orange round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202108142 · Approved 2021.12.29 · Insurance code 689001750

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who takes it
Adults
Adult dose
The dosage for this medication is 100 mg once daily in either monotherapy or combination therapy, with a maximum daily dose of 100 mg. It can be taken regardless of meals. For patients with moderate renal impairment (eGFR ≥ 30 and < 45 mL/min/1.73 m2), the dosage is 50 mg once daily. For patients with severe renal impairment (eGFR ≥ 15 and < 30 mL/min/1.73 m2

Ingredients

Manufacturer
(주)시어스제약

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

  • Difficulty in controlling blood sugar levels in patients with type 2 diabetes
View approved original text

This medication is an adjunct to diet and exercise to improve glycemic control in patients with type 2 diabetes. For patients who are new to treatment, this medication may be used alone. However, if glycemic control is insufficient with monotherapy, it can be used in combination with metformin. Additionally, when blood sugar levels are not sufficiently controlled by sulfonylurea, metformin, thiazolidinedione, or insulin alone, this medication is added to the regimen. Furthermore, it is used in cases where multiple medications do not adequately control blood sugar levels, assisting in glycemic control across various scenarios.

How to take

Adult dose

The dosage for this medication is 100 mg once daily in either monotherapy or combination therapy, with a maximum daily dose of 100 mg. It can be taken regardless of meals. For patients with moderate renal impairment (eGFR ≥ 30 and < 45 mL/min/1.73 m2), the dosage is 50 mg once daily. For patients with severe renal impairment (eGFR ≥ 15 and < 30 mL/min/1.73 m2

Precautions

This medication may cause serious allergic reactions during use; therefore, if symptoms such as skin rashes or breathing difficulties occur, it should be discontinued immediately and medical advice should be sought. During treatment with this medication, there is a risk of pancreatitis, so if symptoms such as abdominal pain or vomiting occur, medical personnel should be notified immediately. It should not be used in patients with type 1 diabetes or diabetic ketoacidosis, nor in those with a severe allergy to this medication or its components. Patients with impaired kidney function need to have their doses adjusted, hence regular kidney function tests are required. Symptoms of hypoglycemia may arise when this medication is used alone or in combination with other diabetes medications, so blood glucose levels should be monitored closely, and if necessary, consult with a physician to adjust the medication dosage. Severe joint pain or skin blistering may occur, and if these symptoms appear, the doctor should be informed immediately, and the medication should be stopped. There may be potential interactions with other medications; therefore, if any medications are currently being taken, it is imperative to inform medical professionals. Pregnant or breastfeeding women are advised not to take this medication, and safety and efficacy have not been established for children and adolescents under 18 years of age. Elderly patients may have reduced kidney function; hence, dose adjustment and kidney function tests are necessary, and in case of overdose, immediate medical treatment is required.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), anaphylaxis, angioedema, chest tightness, difficulty breathing, severe allergic reactions, severe rash, blisters, skin peeling, oral/ocular mucosal pain, Stevens-Johnson syndrome, shortness of breath or difficulty breathing, asthma attacks, cough accompanied by fever and respiratory abnormalities, yellowing of the skin or eyes (jaundice), extreme lethargy, acute pancreatitis, sudden and severe headaches, seizures

Mild side effects

  • Upper respiratory tract infections
  • nasopharyngitis
  • constipation
  • vomiting
  • headache
  • myalgia
  • limb pain
  • back pain
  • pruritus
  • diarrhea
Show 11 more
  • nausea
  • thrombocytopenia
  • dyspepsia
  • dizziness
  • increased blood 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 medication should be stored in a tightly sealed container to prevent exposure to air or moisture and should be kept at a temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Bright yellow-orange round film-coated tablet

Package unit

30 tablets/bottle, 100 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.

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.