Medication info

Samsung Sitagliptin Plus Tablet 50/1000 mg

Prescription medicationApproval withdrawn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Approval withdrawn

MFDS item code 201604235 · Approved 2016.07.08

This product's status changed to Approval withdrawn on 2023.08.11.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
The usual dosage of this medication is taken twice daily with food, and the dose is gradually increased to reduce gastrointestinal side effects caused by Metformin. 1. For patients not currently receiving treatment with Metformin: Take this medication 50/500 mg twice daily, 1 tablet per dose, and if dose escalation is required, take 50/1000 mg twice daily, 1 tablet per dose. 2. For patients currently receiving Metformin: The recommended initial dosage of this medication for patients who cannot achieve sufficient blood sugar control with Metformin monotherapy is Sitagliptin 50 mg twice daily (total daily dose of 100 mg) together with the existing dose of Metformin.

Ingredients

Manufacturer
삼성제약(주)

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

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

This medication is used as an adjunct to diet and exercise to help control blood sugar in patients with type 2 diabetes. It may be used alone in patients who have not previously been treated with diabetes medications, and it can be prescribed as an alternative when blood sugar control is difficult with monotherapy of Metformin or Sitagliptin. Additionally, it can be used in combination with Metformin and sulfonylureas or thiazolidinediones when blood sugar control is insufficient. For patients who have difficulty controlling blood sugar with insulin and Metformin combination therapy, insulin can be administered along with this drug. It is used in various treatment situations to improve blood sugar control in type 2 diabetes.

Dosage and Administration

Adult dosage

The usual dosage of this medication is taken twice daily with food, and the dose is gradually increased to reduce gastrointestinal side effects caused by Metformin. 1. For patients not currently receiving treatment with Metformin: Take this medication 50/500 mg twice daily, 1 tablet per dose, and if dose escalation is required, take 50/1000 mg twice daily, 1 tablet per dose. 2. For patients currently receiving Metformin: The recommended initial dosage of this medication for patients who cannot achieve sufficient blood sugar control with Metformin monotherapy is Sitagliptin 50 mg twice daily (total daily dose of 100 mg) together with the existing dose of Metformin.

Precautions

This medication is used for the treatment of diabetes and contains two active ingredients: Sitagliptin and Metformin. Firstly, Sitagliptin can cause severe allergic reactions in some patients, so if symptoms such as rash or difficulty breathing occur, use should be discontinued immediately. Additionally, acute pancreatitis may occur, so if severe abdominal pain or vomiting occurs, consulting a doctor is necessary. Metformin can rarely cause a serious metabolic disorder called lactic acidosis, which requires prompt treatment. Patients with poor kidney function, heart failure, severe infections, or dehydration should not use this medication. Before and after undergoing tests with iodinated contrast agents, medication should be temporarily discontinued due to the risk of kidney damage and lactic acidosis. It is safest for pregnant or breastfeeding women to avoid taking this medication. Furthermore, irregular meals, intense exercise, or interactions with other medications can increase the risk of hypoglycemia or lactic acidosis, so caution is advised. While taking this medication, regular blood and kidney function tests should be conducted, and monitoring vitamin B12 levels is also recommended. Symptoms such as diarrhea, nausea, headache, and cold-like symptoms may occur, so if symptoms are severe, consulting a doctor is advised. In particular, when taking this medication with other diabetes medications such as insulin or sulfonylureas, hypoglycemic symptoms may occur more frequently, so blood sugar should be closely monitored. In case of surgery, medication should be stopped 48 hours prior to the procedure and resumed only after confirming that kidney function is normal post-recovery. Finally, this drug can also be used for the elderly, but dose adjustment and periodic testing are necessary due to declining kidney function. If symptoms such as sudden muscle pain, skin rash, or difficulty breathing occur while taking this medication, notify healthcare professionals immediately.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • angioedema
  • anaphylaxis
  • Stevens-Johnson syndrome
  • rash
  • severe allergic reactions
  • acute pancreatitis
  • severe lactic acidosis
  • hypoglycemia
  • difficulty breathing
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  • acute renal failure
  • jaundice
  • elevated liver enzymes
  • severe and disabling arthralgia
  • blistering similar to pemphigus
  • thrombocytopenia
  • severe hypoglycemia
  • acute renal failure
  • difficulty breathing
  • unstable angina
  • serious neurological symptoms

Mild side effects

  • Diarrhea
  • upper respiratory infections
  • headache
  • nausea
  • vomiting
  • abdominal pain
  • constipation
  • nasopharyngitis
  • muscle pain
  • limb pain
Show 7 more
  • back pain
  • pruritus
  • thrombocytopenia
  • decreased appetite
  • itching
  • dizziness
  • weight loss

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 from entering and kept at room temperature between 1°C and 30°C. This helps maintain the drug's effectiveness and ensures safe use.

Appearance and packaging

Appearance

Dark red 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.