Medication info

Janusitin M Tablet 50/1000 mg

Prescription medicationTablet경구
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›56.7mg / 1 tabletMetformin Hydrochloride with Colloidal Anhydrous Silica›1010mg / 1 tablet
Manufacturer / importer
(주)한국파비스제약
Appearance
Pink oval film-coated tablet
Packaging
30 tablets/box[(10 tablets/PTP x 3)]
Approval status
Active

MFDS item code 202200114 · Approved 2022.01.06

Summary

Main use
Improvement of blood glucose control in type 2 diabetes
Who takes it
Adults
Adult dose
This medication is generally taken twice a day with food. The dosage is gradually increased to reduce gastrointestinal adverse reactions caused by metformin. 1. For patients not currently being treated with metformin: The initial dosage is 1 tablet (50/500 mg) taken twice daily, and it can be titrated to 1 tablet (50/1000 mg) taken twice daily. 2. For patients currently being treated with metformin: Recommendation for initial dosage is sitagliptin at 50 mg, taken twice daily (total 100 mg) along with the patient's existing metformin dosage.

Ingredients

Manufacturer
(주)한국파비스제약

Efficacy & effects

Improvement of blood glucose control in type 2 diabetes

  • Difficulty in blood glucose control in patients with type 2 diabetes
View approved original text

This medication is used in conjunction with dietary and exercise therapy to help control blood sugar levels in patients with type 2 diabetes. It can be used in cases where previous diabetes medication therapy has not been experienced and blood sugar control is difficult with monotherapy. Additionally, it may be used as an alternative if treatment with metformin or sitagliptin alone is insufficient or if the two medications cannot be combined. This medication helps improve blood glucose control when used in combination with metformin and sulfonylurea, or metformin and thiazolidinedione when those therapies are ineffective. It is also used to enhance treatment effectiveness when blood glucose control remains difficult even after combination therapy with insulin and metformin. Thus, this medication aids in improving blood glucose control at various stages of treatment.

How to take

Adult dose

This medication is generally taken twice a day with food. The dosage is gradually increased to reduce gastrointestinal adverse reactions caused by metformin. 1. For patients not currently being treated with metformin: The initial dosage is 1 tablet (50/500 mg) taken twice daily, and it can be titrated to 1 tablet (50/1000 mg) taken twice daily. 2. For patients currently being treated with metformin: Recommendation for initial dosage is sitagliptin at 50 mg, taken twice daily (total 100 mg) along with the patient's existing metformin dosage.

Precautions

This medication contains both sitagliptin and metformin and is used for diabetes treatment. When taking this medication, serious allergic reactions may occur, so if symptoms such as skin rash, difficulty breathing, or swelling of the face or neck appear, discontinue use immediately and consult a physician. There is also a risk of acute pancreatitis, which is inflammation of the pancreas; therefore, if abdominal pain, vomiting, or nausea occur after taking this medication, immediately inform healthcare professionals. Patients with significantly reduced kidney function or conditions that may affect kidney function, such as heart failure, acute myocardial infarction, or severe infections, should not use this medication. It is also unsafe for women who are pregnant or may become pregnant, as well as for breastfeeding women. This medication may lead to a rare but serious side effect called lactic acidosis, so it is important to undergo regular kidney function tests and blood tests. If dehydration, severe vomiting, or diarrhea occurs, stop taking the medication. Care should be taken as hypoglycemia may occur in individuals with high levels of physical activity, irregular eating patterns, or those taking other blood sugar lowering agents. Alcohol consumption should be avoided while taking this medication, and it should be temporarily discontinued prior to any scheduled surgeries, confirming that kidney function is normal before resuming. Additionally, because this medication may interact with other drugs, inform healthcare professionals of any other medications being taken. Elderly patients should exercise more caution as kidney function may decline, and regular kidney function tests should be conducted. It is important to immediately consult a physician if any unusual symptoms or suspected side effects occur.

Side effects and when to seek care immediately

Serious side effects

Hives, severe hypersensitivity reactions (anaphylaxis, angioedema, Stevens-Johnson syndrome), severe rash with high fever, blisters, skin peeling, oral/ocular mucosal pain, acute pancreatitis, acute renal failure, difficulty breathing, respiratory problems, jaundice of the skin or eyes, liver abnormalities, sudden and severe headaches, confusion, vision changes, paralysis, severe swelling, acute renal failure, high blood pressure, abdominal pain, dizziness, unstable angina.

Mild side effects

Diarrhea, upper respiratory tract infection, headache, nausea, vomiting, abdominal pain, rhinitis, constipation, muscle pain, limb pain, back pain, pruritus, thrombocytopenia, decreased appetite, itching, dizziness, hypoglycemia, and joint pain with severity and disability.

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 exposure, at room temperature between 1°C and 30°C. Proper storage will maintain the drug's effectiveness and allow for safe use.

Appearance and packaging

Appearance

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.

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.