Medication info

Samsung Sitagliptin Plus Tablet 50/850mg

Prescription medicationApproval withdrawn
Ingredient · strength
Sitagliptin Phosphate Hydrate›Strength being verifiedMetformin Hydrochloride›Strength being verified
Manufacturer / importer
삼성제약(주)
Appearance
Pink oval film-coated tablet
Packaging
28 tablets/bottle, 30 tablets/bottle, 100 tablets/bottle, 300 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 201603429 · Approved 2016.06.14

This product's status changed to Approval withdrawn on 2023.08.11. 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 typically taken twice a day with food, with doses gradually increased to reduce gastrointestinal adverse reactions from Metformin. 1. For patients not currently treated with Metformin: Take this medication 50/500 mg twice a day, 1 tablet each time, and may increase to 50/1000 mg twice a day, 1 tablet each time. 2. For patients currently on Metformin treatment:

Ingredients

Manufacturer
삼성제약(주)

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

  • Difficulty in blood sugar control in patients with type 2 diabetes
View approved original text

This medication is used in conjunction with diet and exercise to assist in the control of blood sugar in patients with type 2 diabetes. It is effective for those who are starting diabetes medication for the first time or those who have difficulties controlling blood sugar with existing monotherapy. This medication can be used instead of combining Metformin or Sitagliptin monotherapy when those are insufficient. It can also be combined with Metformin and sulfonylurea therapy, thiazolidinedione therapy, and insulin therapy in patients who have difficulties controlling blood sugar as well. It is used to improve blood sugar control in conjunction with various treatment methods.

Dosage and Administration

Adult dosage

This medication is typically taken twice a day with food, with doses gradually increased to reduce gastrointestinal adverse reactions from Metformin. 1. For patients not currently treated with Metformin: Take this medication 50/500 mg twice a day, 1 tablet each time, and may increase to 50/1000 mg twice a day, 1 tablet each time. 2. For patients currently on Metformin treatment:

Precautions

This medication is used for the treatment of diabetes and contains two active ingredients, Sitagliptin and Metformin. While taking this medication, serious allergic reactions may occur, so discontinue use and consult a healthcare professional immediately if symptoms such as skin rash, difficulty breathing, or swelling of the face or neck occur. There is a risk of acute pancreatitis; if severe abdominal pain, nausea, vomiting, or fever occurs, one should go to a hospital immediately. The Metformin component can rarely cause lactic acidosis, a serious metabolic problem, so it’s important to inform medical personnel if symptoms like muscle pain, weakness, shortness of breath, or abdominal pain occur. Patients with poor kidney function or severe diseases such as serious infections, dehydration, heart failure, or acute myocardial infarction should not take this medication; its use should also be temporarily suspended before and after radiographic examinations that involve contrast agents. It is generally not recommended for use in pregnant or potentially pregnant women, nursing mothers, and children under 18 years of age. While on this medication, it's important to maintain a regular diet and exercise and to be aware of symptoms of hypoglycemia. When taken with insulin or other hypoglycemic agents, the risk of hypoglycemia may increase, so immediate measures should be taken if symptoms occur. This medication may affect liver and kidney function, so regular blood tests and kidney function tests are important. Additionally, alcohol consumption may increase the risk of side effects from this medication, so it is advisable to avoid alcohol while taking it. Patients scheduled for surgery or those with serious infections, trauma, or poor health should temporarily suspend use of this medication and resume once their condition improves. In the case of overdose, seek medical attention immediately, as this medication can be partially removed by hemodialysis. If blisters, severe joint pain, itching, or the like occur during treatment with this medication, inform your doctor immediately and seek treatment. Lastly, regular monitoring of blood sugar, kidney function, and hematological parameters is essential to safely continue treatment.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), anaphylaxis, angioedema, rash, exfoliative skin diseases (including Stevens-Johnson syndrome), severe skin adverse reactions, acute pancreatitis, acute renal failure, difficulty breathing, severe and disabling joint pain, bullous pemphigoid, hypoglycemia, lactic acidosis, liver abnormalities (elevated liver enzyme levels, jaundice, etc.), severe edema, acute renal function deterioration, unstable angina

Mild side effects

  • Headache
  • upper respiratory infection
  • nasopharyngitis
  • diarrhea
  • nausea
  • vomiting
  • abdominal pain
  • weakness
  • dyspepsia
  • constipation
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  • muscle pain
  • limb pain
  • back pain
  • itching
  • thrombocytopenia
  • reduced 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 to prevent air entry, at room temperature between 1 and 30 degrees Celsius. This will help maintain the effectiveness of the medication.

Appearance and packaging

Appearance

Pink oval film-coated tablet

Package unit

28 tablets/bottle, 30 tablets/bottle, 100 tablets/bottle, 300 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.