Medication info

Samsung Sitagliptin Plus Tablets 50/500 mg

Prescription medicationApproval withdrawn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Approval withdrawn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 201603428 · 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This product's status changed to Approval withdrawn on 2023.08.11.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 generally taken twice a day with food, and the dose should be gradually increased to minimize gastrointestinal side effects from metformin. The initial dose will be determined based on the patient's current treatment regimen. 1. For patients not currently treated with metformin: - Take this medication 50/500 mg, 1 tablet twice a day - If necessary, may increase to 50/1000 mg, 1 tablet twice a day.

Ingredients

Manufacturer
삼성제약(주)

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

  • Type 2 diabetes
  • difficulty controlling blood sugar
View approved original text

This medication is used in conjunction with dietary and exercise therapy to help patients control their blood sugar levels. It can be prescribed alone for patients who have not previously received antidiabetic drug therapy, and is also used as an alternative therapy in cases where blood sugar control is difficult with metformin or sitagliptin as monotherapy. Additionally, when the combined treatment of metformin with sulfonylurea, or metformin with thiazolidinedione, or insulin with metformin is insufficient, this drug can be combined to enhance blood sugar control. Its flexible use tailored to various situations effectively helps improve blood sugar control for patients.

Dosage and Administration

Adult dosage

This medication is generally taken twice a day with food, and the dose should be gradually increased to minimize gastrointestinal side effects from metformin. The initial dose will be determined based on the patient's current treatment regimen. 1. For patients not currently treated with metformin: - Take this medication 50/500 mg, 1 tablet twice a day - If necessary, may increase to 50/1000 mg, 1 tablet twice a day.

Precautions

This medication is used for the treatment of diabetes and helps especially in controlling blood sugar levels. While taking this medication, serious allergic reactions may occur, although it is rare, so if symptoms such as rashes, hives, or difficulty breathing occur, it should be stopped immediately and a doctor consulted. Acute pancreatitis can occur, so if abdominal pain, vomiting, or severe abdominal pain appears, it should be reported to medical professionals immediately. This medication should not be used in patients with decreased kidney function, heart failure, acute myocardial infarction, or serious infections that can affect the kidneys. This medication must be discontinued prior to and after diagnostic tests involving radiopaque iodine agents and should only be resumed when kidney function is confirmed to be normal afterward. It is safe not to administer to women during pregnancy or those who may become pregnant, as well as nursing mothers. During the course of treatment, patients should be vigilant for hypoglycemia, as the risk may increase when used in conjunction with other hypoglycemic agents like insulin or sulfonylureas. Elderly patients may have decreased kidney function, so regular kidney function tests and possible dose adjustments are necessary. Additionally, patients with liver dysfunction or severe infections and dehydration should be cautious. Alcohol consumption should be avoided during treatment, and if sudden vomiting, diarrhea, or signs of dehydration occur, discontinuation and consultation with healthcare professionals are advised. Patients undergoing surgery should temporarily stop this medication 48 hours prior to the surgery and only resume it after oral intake is normalized and kidney function is recovered post-surgery. This medication can lower vitamin B12 levels, so regular blood tests to monitor this are recommended. In case of overdose, inform medical personnel immediately, and treatment such as hemodialysis may be required if necessary. Common side effects during treatment can include diarrhea, nausea, vomiting, headache, and upper respiratory infections. If severe joint pain or a skin rash occurs, consult a doctor immediately. Finally, it is important to consistently perform regular blood sugar tests and kidney function tests while taking this medication, and to carefully observe the therapeutic effects and side effects.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, anaphylaxis, Stevens-Johnson syndrome, severe rash accompanied by high fever, blisters, skin peeling, pain in oral or ocular mucosa, jaundice (yellowing of skin or eyes), extreme lethargy, acute pancreatitis (including fatal/non-fatal hemorrhagic or necrotizing pancreatitis), severe lactic acidosis, shortness of breath or difficulty breathing, asthma attacks, cough and fever.

Mild side effects

  • Diarrhea
  • upper respiratory tract infection
  • headache
  • nausea
  • vomiting
  • abdominal pain
  • rhinitis
  • constipation
  • muscle pain
  • limb pain
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  • back pain
  • pruritus
  • thrombocytopenia
  • itching
  • dizziness
  • loss of appetite
  • weight loss
  • weakness
  • hypoglycemia
  • severe joint pain with disability
  • blistering similar to pemphigus.

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

Storage

This medication should be stored in a sealed container to prevent air from entering, and it is recommended to keep it at room temperature between 1 degree and 30 degrees Celsius. This way of storage helps to maintain the effectiveness of the medication and prevent deterioration.

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.