Medication info
Janumax M Tablet 50/500 mg (Sitagliptin Phosphate Hydrate, Metformin Hydrochloride)

Janumax M Tablet 50/500 mg (Sitagliptin Phosphate Hydrate, Metformin Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Sitagliptin Phosphate Hydrate›64.25mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
삼익제약(주)
Appearance
Light pink oval film-coated tablets
Packaging
30 tablets/bottle, 120 tablets/bottle
Approval status
Active

MFDS item code 202400318 · Approved 2024.02.14 · Insurance code 644004800

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who takes it
Adults
Adult dose
This medication is typically taken twice a day with food, gradually increasing the dosage to minimize gastrointestinal side effects caused by metformin. 1. Patients not currently being treated with metformin: Starting dosage is 50/500 mg, taking 1 tablet twice a day, with an option to increase to 50/1000 mg twice a day. 2. Patients currently being treated with metformin: Sitagliptin 50 mg twice a day.

Ingredients

Manufacturer
삼익제약(주)

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

View approved original text

This medication helps patients with type 2 diabetes to achieve better blood sugar control. Sitagliptin and metformin work together to complement the effects of diet and exercise, improving blood sugar levels. This aids in diabetes management.

How to take

Adult dose

This medication is typically taken twice a day with food, gradually increasing the dosage to minimize gastrointestinal side effects caused by metformin. 1. Patients not currently being treated with metformin: Starting dosage is 50/500 mg, taking 1 tablet twice a day, with an option to increase to 50/1000 mg twice a day. 2. Patients currently being treated with metformin: Sitagliptin 50 mg twice a day.

Precautions

This medication consists of two components, each with specific precautions. Firstly, one of the components may cause hypersensitivity reactions. Such reactions can range from severe allergic responses to severe skin rashes or inflammation, so if symptoms such as skin rash, difficulty breathing, or swelling of the face or neck occur after taking the medication, discontinue use immediately and consult a doctor. Secondly, this medication may cause pancreatitis, which is an inflammation of the pancreas. Symptoms such as abdominal pain, nausea, or vomiting should prompt immediate medical attention. Thirdly, the other component may cause severe lactic acidosis, a rare but life-threatening metabolic complication. Lactic acidosis occurs when lactate accumulates excessively in the body, presenting symptoms like muscle pain, weakness, difficulty breathing, and abdominal pain. If these symptoms arise, discontinue the medication and inform healthcare professionals immediately. Additionally, this medication should not be administered to patients with impaired kidney function, severe heart or liver issues, pregnant or breastfeeding women, and those with certain acute conditions. While taking this medication, be cautious of irregular or insufficient food intake, intense exercise, or concurrent use of other medications, as this may increase the risk of hypoglycemia or lactic acidosis. Regular checks of blood sugar, kidney function, liver function, and vitamin B12 levels should be conducted to ensure no abnormalities arise during treatment. Symptoms of hypoglycemia include dizziness, sweating, and severe hunger, and the risk of low blood sugar may increase when this medication is taken with other hypoglycemic agents, requiring possible dosage adjustments depending on the medications being used. Furthermore, this medication should be temporarily stopped before surgeries, and it should also be interrupted for a period before and after tests using iodinated contrast agents. Excessive alcohol consumption should be avoided during treatment as alcohol may increase the risk of side effects from this medication. Lastly, in case of an overdose, seek immediate medical assistance, as some components can be removed through dialysis. This medication should not be administered to children, particularly those under 18 years of age, as its safety and efficacy have not been established in this age group. In elderly patients, reduced kidney function may occur, necessitating more cautious management and regular monitoring during treatment.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • angioedema
  • chest tightness
  • difficulty breathing
  • anaphylaxis
  • severe swelling (edema)
  • severe rash
  • blisters
  • skin peeling
  • oral/ocular mucosal pain
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  • Stevens-Johnson syndrome
  • acute pancreatitis
  • severe allergic reactions
  • breathing issues
  • liver dysfunction (jaundice)
  • acute renal failure
  • severe edema or urinary issues
  • serious neurological symptoms
  • severe hypoglycemia
  • acute renal failure
  • dyspnea
  • unstable angina
  • vesicular pemphigoid.

Mild side effects

  • Diarrhea
  • nausea
  • vomiting
  • abdominal pain
  • upper respiratory infection
  • nasopharyngitis
  • headache
  • hypoglycemia
  • constipation
  • muscle pain
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  • limb pain
  • back pain
  • pruritus
  • itching
  • thrombocytopenia
  • dizziness
  • decreased appetite
  • weight loss
  • weakness
  • decreased serum vitamin B12
  • severe and disabling joint pain.

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 and moisture. The optimal storage temperature is between 1 degree and 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

Light pink oval film-coated tablets

Package unit

30 tablets/bottle, 120 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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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.