Medication info
Janubex Tablet 50/1000 Milligrams (Sitagliptin Hydrochloride Monohydrate, Metformin Hydrochloride)

Janubex Tablet 50/1000 Milligrams (Sitagliptin Hydrochloride Monohydrate, Metformin Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Metformin Hydrochloride›1000mg / 1 tabletSitagliptin Hydrochloride Hydrate›56.7mg / 1 tablet
Manufacturer / importer
(주)서울제약
Appearance
Brown oval film-coated tablet
Packaging
60 tablets/box [10 tablets/PTP x 6]
Approval status
Active

MFDS item code 202301949 · Approved 2023.06.26 · Insurance code 652904670

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who takes it
Adults
Adult dose
The dosage of this medication should not exceed the maximum recommended daily dosage for each component, which is 100 mg for sitagliptin and 2000 mg for metformin, and should be determined based on the patient's current treatment regimen, efficacy, and tolerability. Generally, it is taken twice daily with meals, and the dosage should be gradually increased to reduce gastrointestinal side effects caused by metformin. 1. For patients not currently being treated with metformin

Ingredients

Manufacturer
(주)서울제약

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

View approved original text

This medication is used to assist patients with type 2 diabetes in controlling their blood sugar when combined with dietary and exercise regimens. Sitagliptin and metformin work together to effectively regulate blood sugar and help the patient's health management.

How to take

Adult dose

The dosage of this medication should not exceed the maximum recommended daily dosage for each component, which is 100 mg for sitagliptin and 2000 mg for metformin, and should be determined based on the patient's current treatment regimen, efficacy, and tolerability. Generally, it is taken twice daily with meals, and the dosage should be gradually increased to reduce gastrointestinal side effects caused by metformin. 1. For patients not currently being treated with metformin

Precautions

This medication consists of two components, each with different precautions. First, the sitagliptin component can cause serious allergic reactions, although they are rare. Such reactions can include skin rashes, angioedema, and severe skin disorders, and may occur within the first three months of taking the medication, so careful monitoring is necessary. If such symptoms are suspected, immediately discontinue the medication and consult a physician. Additionally, sitagliptin can trigger acute pancreatitis, so if abdominal pain or vomiting occurs during treatment, inform healthcare providers immediately. The metformin component can cause lactic acidosis, a rare but fatal metabolic disorder, so patients with impaired kidney function or liver problems should not use this medication. Moreover, patients in conditions that can affect kidney function, such as dehydration, severe infections, heart failure, or acute myocardial infarction, should also avoid this medication. This medication should be used with regular monitoring of kidney function, especially for the elderly or patients with impaired renal function, who need to be checked more frequently. If kidney function is severely impaired, the medication should be discontinued. Furthermore, if undergoing acute surgery or radiological testing during the use of this medication, the medication should be temporarily paused before and after tests, and resumed only after confirming normal kidney function. There is also a risk of hypoglycemia, so particular caution is needed for those taking this medication alongside other hypoglycemic agents such as insulin or sulfonylureas. If symptoms arise, appropriate measures should be taken immediately. Pregnant or potentially pregnant women and nursing mothers should not take this medication, and safety for children under 18 has not been established. It is advisable to avoid alcohol consumption during treatment, as excessive drinking may elevate the risk of lactic acidosis. Finally, if any abnormal symptoms or side effects occur while taking this medication, promptly consult a doctor, and ensure regular blood tests and kidney function checks to manage health status.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (angioedema), chest tightness, difficulty breathing, anaphylaxis, severe hypersensitivity reactions, Stevens-Johnson syndrome, severe skin reactions (severe rash, blisters, skin peeling, pain in mouth/eyes), pancreatitis, acute pancreatitis, liver abnormalities (jaundice), acute renal failure, lactic acidosis, severe edema, severe and disabling joint pain, bullous pemphigoid, rhabdomyolysis, thrombocytopenia, acute kidney failure

Mild side effects

  • Diarrhea
  • nausea
  • vomiting
  • abdominal pain
  • upper respiratory infection
  • nasopharyngitis
  • headache
  • hypoglycemia
  • constipation
  • indigestion
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  • weakness
  • myalgia
  • limb pain
  • back pain
  • pruritus
  • thrombocytopenia
  • rhabdomyolysis
  • itching
  • dizziness
  • decreased appetite
  • weight loss
  • dermatitis

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 degree and 30 degrees. Storing it this way helps maintain its efficacy and prevent degradation.

Appearance and packaging

Appearance

Brown 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.