Medication info
Sitagliptin and Metformin XR Tablet 50/1000mg (Sitagliptin, Metformin)

Sitagliptin and Metformin XR Tablet 50/1000mg (Sitagliptin, Metformin)

Prescription medicationTablet경구
Ingredient · strength
Metformin Hydrochloride›1000mg / 1 tabletSitagliptin Phosphate Hydrate›64.25mg / 1 tablet
Manufacturer / importer
한미약품(주)
Appearance
Green, biconvex, oval-shaped extended-release film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201505032 · Approved 2015.07.23 · Insurance code 643507380

Summary

Main use
(Blood sugar control) Improvement therapy
Who takes it
Adults
Adult dose
Take one 100/1000 mg extended-release tablet once daily. Patients taking the 50/500 mg or 50/1000 mg extended-release tablets should take two tablets simultaneously, once daily. 1. Patients not currently treated with metformin: The initial dose should total 100 mg of sitagliptin and 1000 mg of metformin per day. If adequate blood sugar control is not achievable.

Ingredients

Manufacturer
한미약품(주)

Efficacy & effects

(Blood sugar control) Improvement therapy

  • Type 2 diabetes
View approved original text

This medication helps improve blood sugar control in patients with type 2 diabetes. It is used as an adjunct to diet and exercise and works effectively to manage blood sugar levels by the combined actions of sitagliptin and metformin. This contributes to reducing blood sugar fluctuations and improving diabetes symptoms.

How to take

Adult dose

Take one 100/1000 mg extended-release tablet once daily. Patients taking the 50/500 mg or 50/1000 mg extended-release tablets should take two tablets simultaneously, once daily. 1. Patients not currently treated with metformin: The initial dose should total 100 mg of sitagliptin and 1000 mg of metformin per day. If adequate blood sugar control is not achievable.

Precautions

This medication contains both sitagliptin and metformin and is primarily used for blood sugar control in patients with type 2 diabetes. Firstly, the sitagliptin component can cause rare but serious allergic reactions. If symptoms such as skin rash, hives, or difficulty breathing occur, the medication should be discontinued immediately, and a doctor should be consulted. Additionally, sitagliptin can cause acute pancreatitis, which is inflammation of the pancreas, so if there are symptoms like abdominal pain or vomiting, medical personnel should be notified immediately. The metformin component can cause a rare complication called lactic acidosis, which is a condition where lactic acid builds up excessively in the blood and can be life-threatening if severe. This condition can start with nonspecific symptoms such as vomiting, abdominal pain, difficulty breathing, muscle pain, and fatigue, so caution is needed. Patients with impaired kidney function, severe infections, dehydration, heart failure, or liver disease may be at risk when using this medication, and it should not be administered. The use of iodine-containing contrast agents should require a temporary discontinuation of this medication before and after tests, and it should be resumed only after confirming normal kidney function post-examination. It is advisable not to use this medication during pregnancy or lactation due to the lack of established safety, and it is also not recommended for children under 18 years of age. Regular kidney function tests and blood tests should be conducted during the use of this medication, and vitamin B12 levels should also be checked periodically. Furthermore, caution should be taken as the risk of hypoglycemia may increase when used with other blood sugar-lowering agents or insulin. Dosage adjustments should be made according to a doctor's guidance when needed. Excessive alcohol consumption should be avoided while taking this medication as it can increase the risk of lactic acidosis. In the event of surgery, severe infections, or dehydration symptoms, it is safer to temporarily discontinue the medication and resume after recovery. Lastly, it is important to consult medical personnel immediately if any unusual symptoms occur during the use of this medication to receive appropriate care.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • angioedema
  • chest tightness
  • breathing difficulty
  • anaphylaxis
  • Stevens-Johnson syndrome
  • severe edema
  • severe allergic reactions
  • severe skin reactions
  • acute pancreatitis
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  • acute renal failure
  • severe hypoglycemia
  • lactic acidosis
  • acute or chronic metabolic acidosis
  • jaundice
  • severe edema or urination abnormalities
  • joint pain with severe and disability
  • blistering dermatitis
  • liver abnormalities (jaundice)
  • severe neurological symptoms

Mild side effects

  • Diarrhea
  • upper respiratory tract infection
  • headache
  • nausea
  • vomiting
  • abdominal pain
  • constipation
  • nasopharyngitis
  • muscle pain
  • limb pain
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  • back pain
  • itching
  • thrombocytopenia
  • rhabdomyolysis

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is best to store it at room temperature between 1°C and 30°C. This way, the medication's efficacy can be maintained for a long time.

Appearance and packaging

Appearance

Green, biconvex, oval-shaped extended-release film-coated tablet

Package unit

30 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.