Medication info

Janusitin M Tablet 50/500 mg

Prescription medicationTablet경구
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›56.7mg / 1 tabletMetformin Hydrochloride with Colloidal Anhydrous Silica›505mg / 1 tablet
Manufacturer / importer
(주)한국파비스제약
Appearance
Bright pink oval film-coated tablet
Packaging
30 tablets/box [(10 tablets/PTP x 3)]
Approval status
Active

MFDS item code 202200116 · Approved 2022.01.06

Summary

Main use
Improvement in blood sugar control for type 2 diabetes
Who takes it
Adults
Adult dose
This medication is generally taken twice daily with meals, with a gradual increase in dosage to minimize gastrointestinal side effects associated with metformin. 1. Patients not previously treated with metformin: Take this medication 50/500 mg, 1 tablet twice daily, and may increase to 50/1000 mg, 1 tablet twice daily. 2. Patients currently treated with metformin: The recommended initial dosage of this drug in patients who are inadequately controlled by metformin monotherapy is sitagliptin 50 mg, twice daily (total daily dose 100 mg) along with the current dose of metformin.

Ingredients

Manufacturer
(주)한국파비스제약

Efficacy & effects

Improvement in blood sugar control for type 2 diabetes

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

This medication is a combination treatment primarily used to help control blood sugar levels in patients with type 2 diabetes, administered alongside dietary and exercise therapies. It is indicated for use when initial treatment as monotherapy is insufficient, when blood glucose control is inadequate with monotherapy of metformin or sitagliptin, or when replacing the combination therapy of the two drugs. Furthermore, it can be used in conjunction with metformin and sulfonylureas, metformin and thiazolidinediones, or in cases where blood glucose control is challenging with insulin and metformin, to effectively manage blood sugar levels. These various combination therapies provide optimal blood sugar control tailored to individual patients. Thus, this drug improves blood sugar control in patients with type 2 diabetes.

How to take

Adult dose

This medication is generally taken twice daily with meals, with a gradual increase in dosage to minimize gastrointestinal side effects associated with metformin. 1. Patients not previously treated with metformin: Take this medication 50/500 mg, 1 tablet twice daily, and may increase to 50/1000 mg, 1 tablet twice daily. 2. Patients currently treated with metformin: The recommended initial dosage of this drug in patients who are inadequately controlled by metformin monotherapy is sitagliptin 50 mg, twice daily (total daily dose 100 mg) along with the current dose of metformin.

Precautions

This medication is a diabetes treatment that contains both sitagliptin and metformin. Firstly, there is a possibility of allergic reactions occurring while taking this medication, so if symptoms such as rash, hives, shortness of breath, or swelling of the face, lips, tongue, or throat appear, immediately stop taking the drug and consult a physician. Additionally, acute pancreatitis may occur, so if you experience abdominal pain, nausea, vomiting, or severe abdominal pain, seek medical attention immediately. This drug should not be given to patients with severely impaired kidney function, dehydration, severe infections, heart failure, or acute conditions that can affect kidney function, such as acute myocardial infarction. If iodine contrast agents are to be used during tests, this medication should be withheld for a certain period before and after the test, and only restarted after confirming normal kidney function. Women who are pregnant or may become pregnant, and nursing mothers should not take this medication. There is a risk of lactic acidosis, a serious metabolic disturbance, so if you experience symptoms like shortness of breath, muscle pain, weakness, abdominal pain, or changes in consciousness, you should go to the hospital immediately. Also, hypoglycemia may occur, so extra caution must be taken if meals are skipped or irregular, with excessive exercise, or when used in combination with other antidiabetic medications. This drug should be used cautiously or avoided in patients with liver impairment, severe infections, malnutrition, dehydration, severe diarrhea, or vomiting. Regular monitoring of blood glucose, kidney function, and vitamin B12 levels should be performed to ensure safety. Before surgery, this medication should be stopped for more than 48 hours, and can be resumed only after kidney function has recovered post-surgery. Finally, it is advisable to avoid alcohol consumption during this treatment, and consult a doctor or pharmacist if you are taking other medications, as drug interactions may occur.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, anaphylaxis (severe allergic reaction), severe rash with high fever, blisters, skin peeling, oral/ocular mucosal pain (severe skin adverse reactions), acute pancreatitis, liver abnormalities (jaundice), sudden and severe headache, seizures, confusion, vision changes, paralysis (serious neurological symptoms), significantly reduced urine output, severe swelling throughout the body

Mild side effects

  • Diarrhea
  • nausea
  • vomiting
  • abdominal pain
  • upper respiratory infection
  • nasopharyngitis
  • headache
  • weakness
  • constipation
  • muscle pain
Show 12 more
  • limb pain
  • back pain
  • itching
  • thrombocytopenia
  • decreased appetite
  • pruritus
  • dizziness
  • weight loss
  • hypoglycemia
  • severe and disabling joint pain
  • bullous pemphigoid
  • anemia

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

Storage

Store this medication in a tightly sealed container to prevent exposure to air or moisture, and it is safe to store at room temperature between 1 to 30 degrees Celsius. Therefore, to maintain the effectiveness of the medicine, avoid storing it in direct sunlight or in extremely hot or cold locations.

Appearance and packaging

Appearance

Bright pink oval 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.

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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.