Medication info
Janudim Extended-release Tablet 50/1000 mg

Janudim Extended-release Tablet 50/1000 mg

Prescription medicationTablet경구
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›56.69mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
국제약품(주)
Appearance
Bright green oval-shaped extended-release film-coated tablet
Packaging
Bottle - 100 tablets/bottle, Bottle - 30 tablets/bottle
Approval status
Active

MFDS item code 202300600 · Approved 2023.02.17 · Insurance code 643705440

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who takes it
Adults
Adult dose
This medication 100/1000 mg extended-release tablet is taken once daily at a dose of 1 tablet. Patients who are taking the 50/500 mg extended-release tablets or the 50/1000 mg extended-release tablets should take 2 tablets simultaneously once daily. 1. For patients who are not currently being treated with Metformin: The initial dose is a total daily dose of 100 mg Sitagliptin and 1000 mg Metformin. If the initial dose is insufficient for adequate blood sugar control, the dosage can be gradually increased to the maximum recommended daily dose of 2000 mg for Metformin while monitoring for gastrointestinal side effects. 2. For patients currently being treated with Metformin: The recommended initial dose of this medication is a total daily dose of Sitagliptin 100 mg and the existing Metformin dosage for those unable to control blood sugar adequately on Metformin monotherapy.

Ingredients

Manufacturer
국제약품(주)

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

View approved original text

This medication is used to enhance blood sugar control in patients with type 2 diabetes in conjunction with diet and exercise. Specifically, Sitagliptin and Metformin work together to effectively lower blood sugar levels, serving as an important therapeutic agent to assist patients in managing their blood sugar better.

How to take

Adult dose

This medication 100/1000 mg extended-release tablet is taken once daily at a dose of 1 tablet. Patients who are taking the 50/500 mg extended-release tablets or the 50/1000 mg extended-release tablets should take 2 tablets simultaneously once daily. 1. For patients who are not currently being treated with Metformin: The initial dose is a total daily dose of 100 mg Sitagliptin and 1000 mg Metformin. If the initial dose is insufficient for adequate blood sugar control, the dosage can be gradually increased to the maximum recommended daily dose of 2000 mg for Metformin while monitoring for gastrointestinal side effects. 2. For patients currently being treated with Metformin: The recommended initial dose of this medication is a total daily dose of Sitagliptin 100 mg and the existing Metformin dosage for those unable to control blood sugar adequately on Metformin monotherapy.

Precautions

This medication contains both Sitagliptin and Metformin, helping to control blood sugar. Firstly, it may cause serious allergic reactions in some patients, so if symptoms such as rash, hives, or difficulty breathing occur, the medication should be discontinued immediately, and a doctor should be consulted. Also, acute pancreatitis, an inflammation of the pancreas may occur, so symptoms such as abdominal pain, nausea, and vomiting should be closely monitored and reported to a doctor. The Metformin component included in this medication can rarely lead to a serious metabolic disorder known as lactic acidosis, which may present with symptoms such as muscle pain, weakness, difficulty breathing, and abdominal pain; these symptoms should prompt immediate notification to healthcare staff. Patients with poor kidney function, severe infections, or dehydration, and those with acute myocardial infarction or heart failure should not use this medication as it may pose risks. In addition, the use of iodine contrast agents before and after scans may worsen kidney function and pose a risk of lactic acidosis, so use of this drug should be temporarily halted, resuming only after confirming normal kidney function post-scan. Women who are pregnant or breastfeeding are advised against using this medication, and safety has not been established for children under the age of 18. This medication may increase the risk of hypoglycemia due to irregular meals, intense exercise, or interactions with other medications, thus careful monitoring of blood sugar changes is necessary. Furthermore, long-term use may lower vitamin B12 levels, so regular blood tests are recommended, and alcohol intake should be avoided due to the risk of lactic acidosis. Patients scheduled for surgery should discontinue this medication 48 hours before surgery and resume only after normal oral intake and confirmation of kidney function. Finally, regular monitoring of blood sugar, kidney function, and hematological tests should be conducted while taking this medication, and any unusual symptoms should be promptly discussed with healthcare staff.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, chest discomfort, difficulty breathing, cold sweats, pallor, anaphylaxis, severe skin adverse reactions (including Stevens-Johnson syndrome, exfoliative skin disease), acute pancreatitis (including fatal/non-fatal hemorrhagic or necrotizing pancreatitis), acute renal failure, jaundice (yellowing of skin or eyes), generalized fatigue, severe headache, seizures, confusion, visual disturbances, paralysis, severe swelling, significant reduction in urine output

Mild side effects

Diarrhea, nausea, vomiting, abdominal pain, upper respiratory tract infection, nasopharyngitis, headache, arthralgia, myalgia, limb pain, back pain, interstitial lung disease, pruritus, thrombocytopenia, rhabdomyolysis, hypoglycemia, decreased vitamin B12, joint pain without severe or disabling symptoms

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. It is essential to maintain a storage temperature between 1 and 30 degrees Celsius. This helps to preserve the effectiveness and safety of the medication for an extended period.

Appearance and packaging

Appearance

Bright green oval-shaped extended-release film-coated tablet

Package unit

Bottle - 100 tablets/bottle, Bottle - 30 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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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.