Medication info

Sitam 50/500 mg Tablets

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Sitagliptin Phosphate Hydrate›64.25mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
한림제약(주)
Appearance
Pink oval film-coated tablet
Packaging
56 tablets (14 tablets/PTP packaging × 4)
Approval status
Approval withdrawn

MFDS item code 201505752 · Approved 2015.08.18

This product's status changed to Approval withdrawn on 2025.02.12. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who takes it
Adults
Adult dose
In antidiabetic therapy, the dosage of this medication is determined based on each component's daily maximum recommended dosage of sitagliptin 100 mg and metformin 2000 mg, considering each patient's current therapeutic regimen, efficacy, and tolerability. This medication is generally taken twice a day with meals, with gradual dosage escalation to reduce gastrointestinal adverse effects caused by metformin. 1. Metformin

Ingredients

Manufacturer
한림제약(주)

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

  • Type 2 diabetes
  • difficulty in blood sugar control
View approved original text

This medication is used in conjunction with diet and exercise therapy to help manage blood sugar levels in patients with type 2 diabetes. It can be used in cases where there is no prior experience with diabetes treatment or if blood sugar control is difficult with monotherapy. Additionally, this medication can be used as a substitute or in combination when metformin or sitagliptin alone is insufficient. It is used in conjunction with metformin when blood sugar control is difficult, even when combining with sulfonylureas or thiazolidinediones. In cases where blood sugar control remains inadequate while on insulin and metformin therapy, this medication can be added to improve treatment. Thus, this medication is used effectively to improve blood sugar control at various stages of treatment.

How to take

Adult dose

In antidiabetic therapy, the dosage of this medication is determined based on each component's daily maximum recommended dosage of sitagliptin 100 mg and metformin 2000 mg, considering each patient's current therapeutic regimen, efficacy, and tolerability. This medication is generally taken twice a day with meals, with gradual dosage escalation to reduce gastrointestinal adverse effects caused by metformin. 1. Metformin

Precautions

This medication is used to treat diabetes, and patients should be cautious as serious allergic reactions may occur during use. If skin rash, shortness of breath, or swelling of the face or lips occurs, discontinue use immediately and consult a doctor. Acute pancreatitis, an inflammation of the pancreas, may develop, so if abdominal pain, vomiting, or severe indigestion symptoms occur after taking this medication, seek medical attention immediately. This medication should not be used in patients with impaired kidney function, severe heart disease, liver dysfunction, or in pregnant or nursing women. Use of this medication should be temporarily discontinued before and after procedures involving iodine contrast agents and should only be resumed once normal kidney function is confirmed. This medication can cause hypoglycemia, especially when taken with other blood sugar-lowering agents, so blood sugar levels should be checked frequently, and symptoms of hypoglycemia should be monitored. Regular meals and exercise should be maintained, and this medication should be temporarily stopped in cases of sudden dehydration, severe infection, or pre/post-surgery. Alcohol intake can increase the risk of serious side effects such as lactic acidosis, so it is advisable to avoid drinking alcohol while on this medication. Regular blood tests should be conducted to monitor kidney function and vitamin B12 levels, and any abnormal symptoms should be discussed with healthcare providers. This medication carries a risk of reduced kidney function in the elderly, so dose adjustments and periodic function tests are necessary. In cases of overdose, immediate medical care should be sought as some drugs may be removed through dialysis. Irregular meals or intense exercise should be avoided during the course of this medication, and potential interactions with other medications should be discussed with healthcare providers.

Side effects and when to seek care immediately

Serious side effects

Hives, hypersensitivity reactions (anaphylaxis, angioedema), rash, exfoliative skin conditions (Stevens-Johnson syndrome), severe allergic reactions; acute pancreatitis (fatal/non-fatal hemorrhagic or necrotizing pancreatitis), pancreatitis; acute kidney failure, deterioration of kidney function; shortness of breath, respiratory abnormalities; liver abnormalities (including possible elevation of liver enzymes and symptoms related to jaundice); severe headaches, confusion of consciousness, neurological symptoms such as seizures; severe arthralgia associated with disability.

Mild side effects

  • Headache
  • diarrhea
  • nausea
  • vomiting
  • abdominal pain
  • upper respiratory infection
  • nasopharyngitis
  • constipation
  • muscle pain
  • limb pain
Show 6 more
  • back pain
  • itching
  • thrombocytopenia
  • decreased appetite
  • pruritus
  • dizziness

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

Storage

This medication should be stored in a tightly sealed container that allows for proper air circulation, kept at room temperature between 1°C and 30°C. This helps maintain the medication's effectiveness and safety.

Appearance and packaging

Appearance

Pink oval film-coated tablet

Package unit

56 tablets (14 tablets/PTP packaging × 4)

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.

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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.