Medication info

Sitavem Tablet 50/500 mg

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

MFDS item code 202200226 · Approved 2022.01.12

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who takes it
Adults
Adult dose
This medication is typically taken twice a day with meals, and to reduce gastrointestinal adverse reactions caused by metformin, the dosage should be increased gradually. 1. For patients not treated with metformin: The initial dose is one tablet of this medication 50/500 mg taken twice a day; if necessary, it can be increased to 50/1000 mg, taken twice a day. 2. For patients receiving treatment with metformin:

Ingredients

Manufacturer
(주)에이프로젠바이오로직스

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

  • Type 2 diabetes
  • difficulty in blood sugar control
View approved original text

This medication is used in conjunction with diet and exercise to help control blood sugar in patients with type 2 diabetes. It is particularly useful for those who have not previously been treated with diabetes medications and have difficulty achieving blood sugar control with monotherapy. Additionally, it is effective when sufficient blood sugar control cannot be achieved with monotherapy of metformin or sitagliptin, or when replacing the combination treatment of these medications. In cases where blood sugar control is insufficient with the combination therapy of metformin and sulfonylurea, or metformin and thiazolidinedione, this medication can be used in combination to improve treatment. It is also given to patients who are unable to control blood sugar in combination therapy with insulin and metformin, to enhance blood sugar levels. It is used at various stages of treatment to improve blood sugar control.

How to take

Adult dose

This medication is typically taken twice a day with meals, and to reduce gastrointestinal adverse reactions caused by metformin, the dosage should be increased gradually. 1. For patients not treated with metformin: The initial dose is one tablet of this medication 50/500 mg taken twice a day; if necessary, it can be increased to 50/1000 mg, taken twice a day. 2. For patients receiving treatment with metformin:

Precautions

This medication contains sitagliptin and metformin as diabetes therapeutics and has several important precautions during use. First, severe allergic reactions may occur during treatment with this medication; therefore, if symptoms such as rash, hives, difficulty breathing, or swelling of the face or neck appear, discontinue the medication immediately and consult a physician. Second, significant side effects such as acute pancreatitis have been reported, so if symptoms such as abdominal pain, vomiting, nausea, or fever occur, inform healthcare personnel immediately and discontinue the medication. Third, the metformin component can cause lactic acidosis, a rare but potentially fatal metabolic disturbance, so if sudden difficulty breathing, muscle pain, fatigue, or abdominal pain occurs, seek medical attention immediately. Fourth, this medication should not be used in patients with impaired kidney function, severe infections, dehydration, or acute cardiac conditions, and if such conditions occur, discontinue the medication and consult a physician. Fifth, it is safest for women who are pregnant or likely to become pregnant, as well as nursing mothers, to avoid using this medication. Sixth, during the use of this medication, regular kidney function and blood tests should be conducted to monitor health, and vitamin B12 levels should be checked periodically. Seventh, there is a risk of hypoglycemia, so especially when used together with other hypoglycemic agents or insulin, blood sugar levels should be carefully monitored and immediate action should be taken if symptoms arise. Finally, excessive alcohol consumption, intense exercise, and irregular meals should be avoided while taking this medication, and consultation with healthcare personnel is essential regarding the continuation or cessation of medication when undergoing surgery or contrast media tests.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (edema)
  • anaphylaxis
  • angioedema
  • severe allergic reactions
  • severe rash accompanied by high fever
  • blisters
  • skin peeling
  • pain in oral/ocular mucosa
  • Stevens-Johnson syndrome
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  • severe skin adverse reactions
  • difficulty breathing
  • respiratory distress
  • acute pancreatitis
  • acute kidney failure
  • liver abnormalities (jaundice)
  • elevated liver enzymes
  • acute kidney failure
  • jaundice
  • sudden and severe headache
  • seizures

Mild side effects

  • Diarrhea
  • upper respiratory infection
  • headache
  • nausea
  • vomiting
  • abdominal pain
  • nasopharyngitis
  • constipation
  • muscle pain
  • limb pain
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  • back pain
  • pruritus
  • thrombocytopenia
  • decreased appetite
  • itching
  • dizziness
  • hypoglycemia
  • severe and disabling joint pain
  • bullous pemphigoid
  • dermatitis
  • weight loss

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

Storage

This medication should be kept in a sealed container to protect it from air and moisture, and stored at room temperature between 1 degree and 30 degrees Celsius. Proper storage will help maintain the effectiveness of the medication for a long time.

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.