Medication info

Sitamero Tablet 50/500 mg

Prescription medicationApproval withdrawn
Ingredient · strength
Sitagliptin Phosphate Hydrate›Strength being verifiedMetformin Hydrochloride›Strength being verified
Manufacturer / importer
동국제약(주)
Appearance
Pink oval film-coated tablet
Packaging
PTP - 28 tablets/box[(14 tablets/PTP*2)], PTP - 56 tablets/box[(14 tablets/PTP*4)]
Approval status
Approval withdrawn

MFDS item code 201505844 · Approved 2015.08.20

This product's status changed to Approval withdrawn on 2023.08.30. 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 uses it
Adults
Adult dosage
This medication is usually taken twice a day with food, and the dosage should be gradually increased to minimize gastrointestinal adverse reactions from metformin. 1. For patients currently not receiving metformin therapy: The initial dose is 50/500 mg taken twice a day, 1 tablet each time, and it can be increased to 50/1000 mg taken twice a day, 1 tablet each time. 2. For patients receiving metformin therapy,

Ingredients

Manufacturer
동국제약(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 as an adjunct to diet and exercise to help control blood sugar levels in patients with type 2 diabetes. It can be administered to patients who have never received diabetes medication treatment before or when adequate blood sugar control cannot be achieved with monotherapy. Additionally, it may be used when effects from monotherapy with metformin or sitagliptin are insufficient, or as a replacement for a combination therapy with these two medications. Even when combined with other medications, if blood sugar control is not sufficient, this medication can be added to enhance treatment efficacy. For example, it helps improve blood sugar control when used in combination with sulfonylureas, thiazolidinediones, and insulin. Overall, this medication is used to enhance blood sugar control in various treatment situations.

Dosage and Administration

Adult dosage

This medication is usually taken twice a day with food, and the dosage should be gradually increased to minimize gastrointestinal adverse reactions from metformin. 1. For patients currently not receiving metformin therapy: The initial dose is 50/500 mg taken twice a day, 1 tablet each time, and it can be increased to 50/1000 mg taken twice a day, 1 tablet each time. 2. For patients receiving metformin therapy,

Precautions

This medication is used for the treatment of diabetes and helps in controlling blood sugar levels. While taking this medication, there is a risk of severe allergic reactions; therefore, if symptoms such as skin rash, difficulty breathing, or swelling of the face or neck occur, discontinue use immediately and consult a physician. There is a risk of pancreatitis, which is inflammation of the pancreas; therefore, immediate medical attention is required if symptoms such as sudden abdominal pain, vomiting, or fever occur. This medication should not be administered to patients with severely impaired renal function, severe infections, congestive heart failure, or acute myocardial infarction. If these conditions are suspected, it is essential to inform the physician. It is advisable for women who are pregnant or may become pregnant, as well as those who are breastfeeding, to avoid taking this medication. During treatment, it is important to be vigilant for symptoms of hypoglycemia, as the risk of hypoglycemia increases, especially when taken with insulin or other antidiabetic agents, necessitating immediate appropriate action if symptoms occur. This medication may affect liver and kidney function; therefore, regular blood tests to monitor liver and kidney status are necessary. Gastrointestinal adverse effects such as severe diarrhea, nausea, vomiting, and abdominal pain may occur; if symptoms are severe, consult a physician. Alcohol consumption may increase the risk of side effects of this medication; therefore, excessive drinking should be avoided during treatment. If surgery is imminent or the patient is in a poor condition due to severe infections or traumatic injuries, it is advisable to temporarily discontinue the medication and to resume it when the condition improves. There may be drug interactions with specific medications; thus, inform the physician or pharmacist about any other medications being taken. Elderly patients may have decreased renal function; therefore, dosage adjustments and regular kidney function tests are necessary. In case of overdose, immediate medical attention should be sought, as this medication can be partially removed through hemodialysis. During this medication, it is important to regularly monitor blood sugar, kidney function, liver function, and hematological values to check for any abnormalities.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (angioedema)
  • chest tightness
  • difficulty breathing
  • anaphylaxis
  • Stevens-Johnson syndrome
  • severe skin reactions
  • acute pancreatitis
  • elevation of liver enzymes
  • acute renal failure
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  • severe joint pain
  • bullous pemphigoid
  • thrombocytopenia
  • dyspnea
  • unstable angina pectoris
  • acute renal failure
  • hypoglycemia
  • lactic acidosis
  • severe edema or urination abnormalities
  • jaundice
  • severe liver abnormalities
  • severe neurological symptoms

Mild side effects

  • Diarrhea
  • nausea
  • vomiting
  • abdominal pain
  • upper respiratory tract infection
  • nasopharyngitis
  • headache
  • joint pain
  • muscle pain
  • limb pain
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  • back pain
  • pruritus
  • thrombocytopenia
  • dermatitis
  • decreased appetite
  • weight loss
  • constipation
  • dizziness

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

Storage

This medication should be stored in an airtight, closed container at room temperature between 1°C to 30°C. Storing it this way will help maintain its efficacy and prevent deterioration.

Appearance and packaging

Appearance

Pink oval film-coated tablet

Package unit

PTP - 28 tablets/box[(14 tablets/PTP*2)], PTP - 56 tablets/box[(14 tablets/PTP*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.

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.