Medication info
Sitagliptin M 50/500 mg Tablet (Sitagliptin Hydrochloride Monohydrate, Metformin Hydrochloride with Colloidal Silicon Dioxide)

Sitagliptin M 50/500 mg Tablet (Sitagliptin Hydrochloride Monohydrate, Metformin Hydrochloride with Colloidal Silicon Dioxide)

Prescription medicationTablet경구
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›56.7mg / 1 tabletMetformin Hydrochloride with Colloidal Anhydrous Silica›505mg / 1 tablet
Manufacturer / importer
(주)메디카코리아
Appearance
Bright pink oval film-coated tablet
Packaging
30 tablets/box [(10 tablets/PTP x 3)]
Approval status
Active

MFDS item code 202200314 · Approved 2022.01.19 · Insurance code 646005600

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who takes it
Adults
Adult dose
This medication is generally taken twice daily with food while gradually increasing the dosage to reduce gastrointestinal side effects associated with Metformin. 1. For patients who are not currently treated with Metformin: Take this medication 50/500 mg twice daily, 1 tablet at a time, and it can be escalated to 50/1000 mg twice daily, 1 tablet at a time. 2. For patients currently receiving Metformin treatment:

Ingredients

Manufacturer
(주)메디카코리아

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 alongside dietary and exercise therapy to help control blood sugar levels in patients with type 2 diabetes. It can be prescribed alone, particularly for patients who have not previously received diabetes medication, and is also used when blood sugar control is difficult with monotherapy using Metformin or Sitagliptin. Additionally, it can be added and used in combination therapy for patients who still struggle with blood sugar control on Metformin and sulfonylureas or thiazolidinediones. This medication is also used when insulin and Metformin therapy alone are insufficient to control blood sugar efficiently. It serves as an adjunctive therapy at various stages of treatment to improve blood sugar management for diabetic patients.

How to take

Adult dose

This medication is generally taken twice daily with food while gradually increasing the dosage to reduce gastrointestinal side effects associated with Metformin. 1. For patients who are not currently treated with Metformin: Take this medication 50/500 mg twice daily, 1 tablet at a time, and it can be escalated to 50/1000 mg twice daily, 1 tablet at a time. 2. For patients currently receiving Metformin treatment:

Precautions

This medication may cause severe allergic reactions after administration, so if any allergic symptoms are suspected, stop use immediately and consult a physician. Additionally, acute pancreatitis may occur, so if symptoms such as abdominal pain or vomiting appear, inform medical personnel promptly. Patients with severely reduced kidney function or in situations with a risk of acute renal failure should not use this medication, and kidney function tests should be performed regularly. Patients with acute cardiovascular diseases such as heart failure, myocardial infarction, or sepsis should also avoid use. Particularly, prior to and after examinations using iodinated contrast agents, the use of this medication should be temporarily suspended, and reinstitution should be based on kidney function checks. It is safe for women who are pregnant or breastfeeding to avoid using this medication. Patients with irregular meals or those engaging in intense physical activity should be cautious about the risk of hypoglycemia when used in conjunction with other hypoglycemic agents. This medication may cause side effects such as gastrointestinal disturbances, diarrhea, headache, upper respiratory tract infections, so consult a physician if symptoms are severe. Alcohol consumption can increase the risk of lactic acidosis, so excessive drinking should be avoided during treatment. Prior to and after surgery, administration should be stopped for a period of time and should only be restarted after the patient's condition is stabilized. Regular monitoring of kidney function and vitamin B12 levels through blood tests is important, and appropriate supplementation is required if vitamin B12 deficiency is suspected. If symptoms of hypoglycemia occur during treatment, immediate appropriate measures must be taken, especially for elderly patients or those in poor nutritional status. If severe joint pain or skin abnormalities occur, inform medical personnel immediately, and if necessary, drug discontinuation and specialist consultation are required.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (angioedema)
  • anaphylaxis
  • rash
  • Stevens-Johnson syndrome
  • exfoliative skin conditions
  • acute pancreatitis
  • acute renal failure
  • dyspnea
  • unstable angina
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  • severe joint pain
  • bullous pemphigoid
  • severe and debilitating joint pain
  • elevated liver enzymes
  • acute renal failure
  • severe hypoglycemia
  • severe lactic acidosis
  • thrombocytopenia
  • jaundice
  • extreme lethargy
  • severe headache
  • seizures
  • altered consciousness
  • visual disturbances

Mild side effects

  • Upper respiratory tract infections
  • nasopharyngitis
  • constipation
  • vomiting
  • headache
  • muscle pain
  • limb pain
  • back pain
  • pruritus
  • thrombocytopenia
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  • diarrhea
  • nausea
  • abdominal pain
  • hypoglycemia
  • appetite loss
  • itching
  • dizziness
  • dermatitis
  • weight loss

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

Storage

Store this medication in a tightly closed container to prevent air and moisture exposure. It is advisable to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature. This will ensure the efficacy is not altered and can be used safely.

Appearance and packaging

Appearance

Bright pink oval film-coated tablet

Package unit

30 tablets/box [(10 tablets/PTP x 3)]

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.