Medication info
Sitaglutinem 50/500 mg Tablets (Sitagliptin Hydrochloride Hydrate, Metformin Hydrochloride)

Sitaglutinem 50/500 mg Tablets (Sitagliptin Hydrochloride Hydrate, Metformin Hydrochloride)

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

MFDS item code 202301963 · Approved 2023.06.27 · Insurance code 640904540

Summary

Main use
Improvement of blood glucose control in type 2 diabetes
Who takes it
Adults
Adult dose
The dosage of this medication is determined considering the patient's current treatment regimens, efficacy, and tolerance, without exceeding a maximum total daily dosage of sitagliptin 100 mg and metformin 2000 mg. Generally taken twice daily with food, this dosage is gradually increased to reduce gastrointestinal adverse effects attributed to metformin. 1. For patients not currently treated with metformin: Starting dosage is this medication 50/500 mg.

Ingredients

Manufacturer
(주)일화

Efficacy & effects

Improvement of blood glucose control in type 2 diabetes

View approved original text

This medication helps control blood glucose levels in patients with type 2 diabetes when used alongside dietary and exercise therapy. Sitagliptin and Metformin work together to effectively improve blood glucose levels. This can facilitate easier blood sugar management and help in preventing complications. Continuing to take this medication may assist in maintaining a healthy blood glucose state.

How to take

Adult dose

The dosage of this medication is determined considering the patient's current treatment regimens, efficacy, and tolerance, without exceeding a maximum total daily dosage of sitagliptin 100 mg and metformin 2000 mg. Generally taken twice daily with food, this dosage is gradually increased to reduce gastrointestinal adverse effects attributed to metformin. 1. For patients not currently treated with metformin: Starting dosage is this medication 50/500 mg.

Precautions

This medication is used for the treatment of diabetes and contains two components. The first component helps regulate blood glucose levels, but in some patients, serious allergic reactions may occur, and caution should be exercised. Such allergic reactions are most likely to occur within the first 3 months after taking the medication, and if symptoms are suspected, the medication should be stopped immediately, and a doctor should be consulted. Additionally, this medication can induce pancreatitis, a serious inflammation of the pancreas, so if symptoms such as abdominal pain or vomiting occur during treatment, it should be reported to healthcare professionals immediately. The second component carries a risk of lactic acidosis, a rare but potentially fatal metabolic disorder, and should not be administered to patients with impaired kidney function, severe infections, or dehydration. This medication should not be used in patients with moderately impaired kidney function or higher, those with acute heart failure or myocardial infarction, pregnant or breastfeeding women, and patients with certain acute conditions. Regular monitoring of kidney function and blood tests should be conducted during treatment for adverse symptoms. During treatment, symptoms of hypoglycemia may occur if blood sugar levels drop too low, so particular care should be taken with irregular eating or vigorous exercise. The risk of hypoglycemia may increase when used with other blood sugar-lowering agents; hence, medication doses should be adjusted according to a doctor’s directions. Taking this medication with alcohol may increase risks, so excessive drinking should be avoided. In the case of scheduled surgeries or tests using iodinated contrast agents, this medication should be temporarily discontinued for a period, and it should be readministered only after confirming normal kidney function. If symptoms such as skin rash, hives, difficulty breathing, severe joint pain, or bullous skin disorders occur after taking the medication, inform a doctor immediately and stop the medication. Elderly patients may have a higher likelihood of decreased renal function, so doses should be adjusted with greater caution and their condition should be monitored regularly. Finally, this medication is not recommended for use in children under 18 as safety and efficacy have not been sufficiently confirmed.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • angioedema
  • anaphylaxis
  • Stevens-Johnson syndrome
  • acute pancreatitis
  • acute renal failure
  • difficulty breathing
  • acute renal failure
  • severe hypoglycemia
  • acute pancreatitis
Show 5 more
  • acute pancreatitis
  • acute renal failure
  • difficulty breathing
  • acute pancreatitis
  • acute renal failure.

Mild side effects

Diarrhea, upper respiratory infection, headache, nausea, vomiting, abdominal pain, nasopharyngitis, constipation, muscle pain, limb pain, back pain, pruritus, thrombocytopenia, dizziness, decreased appetite, itching, weight loss, hypoglycemia, significant joint pain and joint pain with disability, bullous pemphigoid.

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, and it is best kept at room temperature between 1 and 30 degrees Celsius. Storing it this way can help maintain the drug's effectiveness for a longer period.

Appearance and packaging

Appearance

Light 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.