Medication info

Sitagliptin 50/850 mg Tablets

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Sitagliptin Phosphate Hydrate›64.25mg / 1 tabletMetformin Hydrochloride›850mg / 1 tablet
Manufacturer / importer
한림제약(주)
Appearance
Pink oval film-coated tablet
Packaging
56 tablets (14 tablets/PTP packaging x 4)
Approval status
Approval withdrawn

MFDS item code 201505753 · 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This product's status changed to Approval withdrawn on 2025.02.12.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 glucose control in type 2 diabetes
Who takes it
Adults
Adult dose
This medication is generally taken twice daily with food, and the dosage is gradually increased to reduce gastrointestinal adverse reactions caused by metformin. 1. Patients not previously treated with metformin: The initial dose is 50/500 mg taken twice daily, one tablet at a time, and can be increased to 50/1000 mg, taken twice daily as one tablet. 2. Patients treated with metformin: The recommended initial dose is

Ingredients

Manufacturer
한림제약(주)

Efficacy & effects

Improvement of blood glucose control in type 2 diabetes

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

This medicine is used in conjunction with dietary and exercise therapy to help control blood sugar in patients with type 2 diabetes. It can be used in patients who have not previously received pharmacological treatment for diabetes or are having difficulty controlling blood sugar on monotherapy. Additionally, it can be used instead of combination therapy with metformin or sitagliptin alone when blood glucose control is inadequate with either agent. If blood glucose control remains poor, this medication may be used in conjunction with other agents such as sulfonylureas, thiazolidinediones, or insulin. It effectively assists in managing patients' blood sugar in various scenarios.

How to take

Adult dose

This medication is generally taken twice daily with food, and the dosage is gradually increased to reduce gastrointestinal adverse reactions caused by metformin. 1. Patients not previously treated with metformin: The initial dose is 50/500 mg taken twice daily, one tablet at a time, and can be increased to 50/1000 mg, taken twice daily as one tablet. 2. Patients treated with metformin: The recommended initial dose is

Precautions

This medication helps control blood sugar levels. However, rare but serious allergic reactions may occur while taking this medication, so caution is advised. If symptoms such as skin rash, swelling, or difficulty breathing appear within three months of starting this medication, it should be stopped immediately and a doctor consulted. Additionally, this medication may cause serious side effects, including inflammation of the pancreas (pancreatitis); if abdominal pain, vomiting, or nausea occur, seek medical attention immediately. One of the components of this medication may be harmful to patients with impaired kidney function, so it should not be taken if kidney function is poor. Patients with weakened heart function or severe infections, or dehydration should also avoid this medication. This medication should not be taken by women who are pregnant or may become pregnant, or who are breastfeeding. During treatment, hypoglycemic symptoms may occur due to excessively low blood sugar, so special care should be taken with irregular meals or intense exercise. When used in conjunction with other diabetes medications or insulin, the risk of hypoglycemia may increase, so the dosage should be adjusted according to a doctor's instructions. This medication may affect liver and kidney function, thus regular liver and kidney function tests are necessary. Alcohol consumption can increase the risk of side effects from this medication; therefore, it is advisable to avoid alcohol during treatment. Patients undergoing surgery should discontinue this medication 48 hours prior to surgery and can restart it only after kidney function has returned to normal post-surgery. It is important to consistently practice dietary therapy, regular exercise, and to regularly monitor blood sugar and kidney function during the course of this medication. If blisters or severe pain develop on the skin during treatment, notify a physician immediately and discontinue the medication. In case of overdose, seek medical care promptly for appropriate treatment, and if necessary, the medication can be removed through dialysis.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (angioedema)
  • chest tightness
  • difficulty breathing
  • anaphylaxis
  • severe allergic reactions
  • high fever accompanied by severe rash
  • blisters
  • skin peeling
  • pain in mouth/eye mucous membranes
Show 12 more
  • Stevens-Johnson syndrome
  • acute pancreatitis
  • liver abnormalities (jaundice)
  • sudden and very severe headache
  • thunderclap headache
  • seizures
  • confusion of consciousness
  • vision abnormalities
  • paralysis
  • significantly decreased urine output
  • widespread severe swelling
  • accompanied by increased blood pressure

Mild side effects

  • Diarrhea
  • upper respiratory tract infection
  • headache
  • nausea
  • vomiting
  • abdominal pain
  • nasopharyngitis
  • constipation
  • myalgia
  • extremity pain
Show 13 more
  • back pain
  • pruritus
  • thrombocytopenia
  • dermatitis
  • loss of appetite
  • weight loss
  • itching
  • dizziness
  • hypoglycemia
  • severe and disabling arthralgia
  • bullous pemphigoid
  • unstable angina
  • dizziness

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

Storage

Store this medication in a tightly closed container to prevent air from entering, and it is recommended to keep it at room temperature between 1 and 30 degrees Celsius. Proper storage helps maintain the medication's effectiveness.

Appearance and packaging

Appearance

Pink oval film-coated tablet

Package unit

56 tablets (14 tablets/PTP packaging x 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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.