Medication info
Januvex 50/500 mg (Sitagliptin Hydrochloride Monohydrate, Metformin Hydrochloride)

Januvex 50/500 mg (Sitagliptin Hydrochloride Monohydrate, Metformin Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Metformin Hydrochloride›500mg / 1 tabletSitagliptin Hydrochloride Hydrate›56.7mg / 1 tablet
Manufacturer / importer
(주)서울제약
Appearance
Bright pink oval film-coated tablet
Packaging
60 tablets/box [10 tablets/PTP x 6]
Approval status
Active

MFDS item code 202301950 · Approved 2023.06.26 · Insurance code 652904690

Summary

Main use
Improvement in blood sugar control for type 2 diabetes
Who takes it
Adults
Adult dose
This medication is taken twice a day with food, and the dosage is gradually increased to reduce gastrointestinal adverse effects of metformin. 1. For patients not previously treated with metformin: - Initial dose: 1 tablet (50/500 mg) twice a day - Possible increase: 1 tablet (50/1000 mg) twice a day 2. For patients currently on metformin treatment: - Initial dose: Total daily sitagliptin of 100 mg

Ingredients

Manufacturer
(주)서울제약

Efficacy & effects

Improvement in blood sugar control for type 2 diabetes

View approved original text

This medication is used to help patients with type 2 diabetes control their blood sugar levels. Taking it alongside meal and exercise therapies can more effectively manage blood sugar. Sitagliptin and metformin work together to help stabilize blood sugar levels. This also contributes to the prevention of diabetes complications. Therefore, this medication is used to improve blood sugar control.

How to take

Adult dose

This medication is taken twice a day with food, and the dosage is gradually increased to reduce gastrointestinal adverse effects of metformin. 1. For patients not previously treated with metformin: - Initial dose: 1 tablet (50/500 mg) twice a day - Possible increase: 1 tablet (50/1000 mg) twice a day 2. For patients currently on metformin treatment: - Initial dose: Total daily sitagliptin of 100 mg

Precautions

This medication contains sitagliptin and metformin, which are used in the treatment of diabetes. Firstly, severe allergic reactions may occur during the use of this medication, so if symptoms such as skin rash, hives, or difficulty breathing occur, discontinue use immediately and consult a doctor. Additionally, acute pancreatitis, an inflammation of the pancreas, may occur, so if symptoms such as abdominal pain, nausea, or vomiting arise, inform healthcare professionals immediately. This medication should not be administered to patients with poor kidney function or those with acute heart failure, myocardial infarction, or severe infections, especially as the risk of lactic acidosis, a serious side effect, increases in patients with impaired kidney function. Lactic acidosis is a rare complication that occurs when excess lactic acid accumulates in the body, which may present symptoms such as muscle pain, weakness, difficulty breathing, abdominal pain, or decreased consciousness; such symptoms require immediate hospital attention. During the use of this medication, regular kidney function and blood tests should be conducted to check for abnormalities, especially in the elderly or those with low kidney function. Furthermore, this medication may cause hypoglycemia, so caution should be exercised when skipping meals or engaging in vigorous exercise, and when combined with other hypoglycemic agents, the risk of hypoglycemia may increase. Patients scheduled for surgery should discontinue this medication 48 hours prior to the surgery and can resume after kidney function has normalized post-surgery. It is safer for pregnant women or those who may become pregnant, as well as breastfeeding mothers, to avoid this medication. Additionally, excessive alcohol consumption should be avoided while taking this medication as it may increase the risk of lactic acidosis. Other medications may interact with this medication, so be sure to inform healthcare professionals of any currently taken medications. Finally, it is important to consult with healthcare professionals immediately if you experience any abnormal symptoms or discomfort during the use of this medication to receive appropriate measures.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • angioedema
  • anaphylaxis
  • Stevens-Johnson syndrome
  • rash
  • cutaneous vasculitis
  • exfoliative skin diseases
  • hemorrhagic or necrotizing pancreatitis
  • acute pancreatitis
  • acute renal failure
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  • difficulty breathing
  • acute heart failure
  • severe and disabling arthralgia
  • vesicular bullous pemphigoid
  • rhabdomyolysis
  • severe lactic acidosis
  • hypoglycemia (severe)
  • acute renal failure
  • difficulty breathing
  • unstable angina
  • acute renal failure
  • cold sweats
  • pallor

Mild side effects

  • Diarrhea
  • nausea
  • vomiting
  • abdominal pain
  • upper respiratory infection
  • rhinitis
  • headache
  • hypoglycemia
  • myalgia
  • limb pain
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  • back pain
  • pruritus
  • thrombocytopenia
  • itching
  • dizziness
  • reduced appetite
  • gastrointestinal disturbances

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

Storage

This medication should be stored in a sealed container to prevent air exposure, ideally at room temperature between 1 and 30 degrees Celsius. This will help maintain its effectiveness and prevent deterioration.

Appearance and packaging

Appearance

Bright pink oval film-coated tablet

Package unit

60 tablets/box [10 tablets/PTP x 6]

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.