Medication info
Sitagliptin and Metformin Prolonged-Release Tablets 50/500 mg

Sitagliptin and Metformin Prolonged-Release Tablets 50/500 mg

Prescription medicationTablet경구
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›56.69mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
신풍제약(주)
Appearance
Pale blue, double convex, oval-shaped prolonged-release film-coated tablets
Packaging
Bottle - 100 tablets/bottle, Bottle - 30 tablets/bottle
Approval status
Active

MFDS item code 202300590 · Approved 2023.02.17 · Insurance code 648508160

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who takes it
Adults
Adult dose
This medication should be taken once daily with the evening meal, with a gradual increase in dosage. For the 100/1000 mg prolonged-release tablets, take one tablet once daily. For the 50/500 mg or 50/1000 mg prolonged-release tablets, take two tablets once daily. 1. For patients with no previous experience with diabetes medications or those who have difficulty controlling blood sugar with sitagliptin monotherapy, the initial dose is sitagliptin 100 mg.

Ingredients

Manufacturer
신풍제약(주)

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

View approved original text

This medication is used in conjunction with dietary and exercise therapy to help patients with type 2 diabetes control their blood sugar levels. The components sitagliptin and metformin work together to effectively improve blood sugar levels. This helps stabilize the condition of patients who have difficulty controlling their blood sugar levels, thereby supporting healthy blood sugar management.

How to take

Adult dose

This medication should be taken once daily with the evening meal, with a gradual increase in dosage. For the 100/1000 mg prolonged-release tablets, take one tablet once daily. For the 50/500 mg or 50/1000 mg prolonged-release tablets, take two tablets once daily. 1. For patients with no previous experience with diabetes medications or those who have difficulty controlling blood sugar with sitagliptin monotherapy, the initial dose is sitagliptin 100 mg.

Precautions

This medication contains sitagliptin and metformin. First, sitagliptin can cause rare but serious allergic reactions; therefore, if symptoms such as rash, difficulty breathing, or swelling of the face or neck occur, stop taking the medication immediately and consult a doctor. Also, acute pancreatitis, which is inflammation of the pancreas, may occur, so if symptoms such as abdominal pain, vomiting, or fever arise, inform medical personnel immediately. Metformin can lead to a rare but potentially fatal metabolic disorder known as lactic acidosis; therefore, it should not be administered to patients with severe dehydration, sudden renal function decline, severe infections, or heart disease. Additionally, excessive alcohol intake can increase the risk of lactic acidosis, so drinking should be avoided. This medication should not be administered to patients with moderate to severe renal impairment, acute heart failure, acute myocardial infarction, severe infections, or to women who are pregnant or breastfeeding. Before and during administration, regular kidney function and blood tests should be conducted to detect any abnormal signs early, and periodic checks of vitamin B12 levels are recommended. During treatment with this medication, blood sugar levels may drop due to irregular meals, intense exercise, or interactions with other medications, so caution should be exercised, and appropriate action should be taken immediately if symptoms of hypoglycemia (such as dizziness, cold sweat, or trembling) occur. When undergoing surgery or tests requiring contrast agents, take a break from this medication and restart only after confirming normal kidney function. Finally, safety and efficacy have not been established for patients under the age of 18, and elderly patients may have decreased kidney function, necessitating dose adjustments and careful monitoring.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, anaphylaxis, exfoliative skin diseases (including Stevens-Johnson syndrome), acute pancreatitis, acute renal failure, severe joint pain with disability, bullous pemphigoid, elevated liver enzymes, liver abnormalities (jaundice), acute pancreatitis, severe hypoglycemia, lactic acidosis, severe edema or urinary abnormalities, serious skin adverse reactions, severe allergic reactions, severe swelling (edema), difficulty breathing, cold sweat, paleness

Mild side effects

  • Diarrhea
  • upper respiratory tract infection
  • headache
  • nausea
  • vomiting
  • abdominal pain
  • nasopharyngitis
  • muscle pain
  • limb pain
  • back pain
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  • pruritus
  • thrombocytopenia
  • rhabdomyolysis
  • hypoglycemia
  • constipation

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

Storage

This medication is sensitive to air and moisture, so it should be stored in a tightly sealed container. Additionally, it is best to avoid extremely hot or cold environments and to store it at room temperature, between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

Pale blue, double convex, oval-shaped prolonged-release film-coated tablets

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.