Medication info
Sitaro M Tablets 50/850 mg (Sitagliptin Hydrochloride Monohydrate, Metformin Hydrochloride Colloidal Silicon Dioxide)

Sitaro M Tablets 50/850 mg (Sitagliptin Hydrochloride Monohydrate, Metformin Hydrochloride Colloidal Silicon Dioxide)

Prescription medicationTablet경구
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›56.7mg / 1 tabletMetformin Hydrochloride with Colloidal Anhydrous Silica›858.5mg / 1 tablet
Manufacturer / importer
한림제약(주)
Appearance
Pink oval film-coated tablet
Packaging
30 tablets/box [(10 tablets/PTP x 3)]
Approval status
Active

MFDS item code 202200311 · Approved 2022.01.19 · Insurance code 645306910

Summary

Main use
Improvement in blood sugar control in type 2 diabetes
Who takes it
Adults
Adult dose
This medication is generally taken twice daily with meals, and to reduce gastrointestinal side effects caused by metformin, the dosage is gradually increased. 1. Patients currently not receiving treatment with metformin: The initial dosage is 50/500 mg of this medication to be taken twice a day, 1 tablet at a time, which may be increased to 50/1000 mg taken twice a day, 1 tablet at a time. 2. Patients treated with metformin:

Ingredients

Manufacturer
한림제약(주)

Efficacy & effects

Improvement in blood sugar control in type 2 diabetes

  • Difficulty in blood sugar control in patients with type 2 diabetes
  • difficulty in maintaining adequate blood sugar control
View approved original text

This medication is used to assist in blood sugar control in patients with type 2 diabetes along with dietary and exercise therapies. It can be administered as monotherapy to patients who are not currently receiving antidiabetic medication. It is also used when blood sugar control is difficult with either metformin or sitagliptin alone, or to replace the combined use of both medications. It is administered in conjunction with this medication when blood sugar control is insufficient with a combination of metformin and sulfonylurea or between metformin and thiazolidinedione. This medication is also used when the combination therapy of insulin and metformin is ineffective. In this way, it helps improve blood sugar control in various situations, thereby enhancing diabetes management for the patient.

How to take

Adult dose

This medication is generally taken twice daily with meals, and to reduce gastrointestinal side effects caused by metformin, the dosage is gradually increased. 1. Patients currently not receiving treatment with metformin: The initial dosage is 50/500 mg of this medication to be taken twice a day, 1 tablet at a time, which may be increased to 50/1000 mg taken twice a day, 1 tablet at a time. 2. Patients treated with metformin:

Precautions

This medication may cause allergic reactions; therefore, if symptoms such as skin rash, hives, or difficulty breathing appear, you must immediately discontinue use and consult a physician. Additionally, there are rare reports of severe side effects such as pancreatitis, which is inflammation of the pancreas; if abdominal pain or vomiting occurs while taking this medicine, notify healthcare providers immediately. This medication should not be taken by patients with impaired kidney function or severe infections, heart failure, acute myocardial infarction, etc., and kidney function should be checked regularly. When undergoing imaging tests using radiographic contrast agents, this medication should be temporarily discontinued before and after the test, and it should be resumed only after confirming that kidney function is normal. Pregnant women or those who may become pregnant, as well as nursing mothers, should not take this medication for safety. While on this medication, it is necessary to be cautious as irregular eating, excessive exercise, and concomitant use of other blood sugar-lowering agents may lead to hypoglycemia. Due to the metformin component, rare but serious metabolic abnormalities such as lactic acidosis may occur, so if symptoms like fatigue, muscle pain, difficulty breathing, or abdominal pain occur, notify healthcare providers immediately. Alcohol consumption may increase the risk of side effects from this medication, so it is advisable to avoid drinking while on it. If surgery is to be performed, this medication should be stopped 48 hours before surgery, and it can be resumed only after confirming the patient's condition is stable and kidney function is normal post-surgery. This medication may cause side effects such as gastrointestinal disturbances, headaches, and upper respiratory infections, and hypoglycemic symptoms may also occur; therefore, it is essential to consult a healthcare provider immediately if symptoms occur. Regular blood tests and kidney function tests are required, and especially in the elderly, careful monitoring is vital due to the higher risk of side effects related to decreased kidney function. In case of overdose of this medication, one must immediately visit a hospital for appropriate treatment, and some components may be removed through dialysis. If severe joint pain or blistering skin symptoms appear during treatment, you must immediately discontinue the medication and consult a specialist.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • angioedema
  • anaphylaxis
  • Stevens-Johnson syndrome
  • exfoliative skin disease
  • acute pancreatitis
  • acute renal failure
  • severe hypersensitivity reactions
  • difficulty breathing
  • acute renal failure
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  • severe and disabling joint pain
  • blistering-like pemphigoid
  • severe hypoglycemia
  • lactic acidosis
  • increased serum creatinine
  • acute myocardial infarction
  • heart failure
  • unstable angina

Mild side effects

  • Diarrhea
  • nausea
  • vomiting
  • abdominal pain
  • upper respiratory infection
  • nasopharyngitis
  • headache
  • myalgia
  • limb pain
  • back pain
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  • pruritus
  • thrombocytopenia
  • anemia
  • decreased appetite
  • itching
  • dizziness
  • weight loss
  • decrease in vitamin B12
  • hypoglycemia
  • arthralgia

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 exposure to air or moisture and should be kept at room temperature between 1 and 30 degrees Celsius for safety. Storing this way can help maintain the efficacy of the medication for a longer period.

Appearance and packaging

Appearance

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.

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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.