Medication info
Sitadual Tablet 50/850 mg (Sitagliptin Hydrochloride Monohydrate, Metformin Hydrochloride)

Sitadual Tablet 50/850 mg (Sitagliptin Hydrochloride Monohydrate, Metformin Hydrochloride)

Prescription medicationTablet경구
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›56.69mg / 1 tabletMetformin Hydrochloride›850mg / 1 tablet
Manufacturer / importer
현대약품(주)
Appearance
Pink oval film-coated tablet
Packaging
Bottle - 100 tablets/bottle, Bottle - 30 tablets/bottle
Approval status
Active

MFDS item code 202300860 · Approved 2023.03.13 · Insurance code 642005020

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 food. The dosage may be gradually increased to reduce gastrointestinal side effects caused by metformin. 1. Patients not currently being treated with metformin: - The initial dose is this medication 50/500 mg taken twice a day, with a possible increase to 50/1000 mg. 2. Patients receiving treatment with metformin: - Recommended initial amount for patients unable to achieve adequate blood sugar control using metformin alone is this medication 50 mg taken twice a day (total daily dose of 100 mg) and the usual metformin dosage.

Ingredients

Manufacturer
현대약품(주)

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

View approved original text

This medication is used effectively in conjunction with diet and exercise to assist patients with type 2 diabetes in controlling their blood sugar.

How to take

Adult dose

This medication is typically taken twice a day with food. The dosage may be gradually increased to reduce gastrointestinal side effects caused by metformin. 1. Patients not currently being treated with metformin: - The initial dose is this medication 50/500 mg taken twice a day, with a possible increase to 50/1000 mg. 2. Patients receiving treatment with metformin: - Recommended initial amount for patients unable to achieve adequate blood sugar control using metformin alone is this medication 50 mg taken twice a day (total daily dose of 100 mg) and the usual metformin dosage.

Precautions

This medication contains both sitagliptin and metformin, and is used in the treatment of type 2 diabetes. Firstly, the sitagliptin component can rarely cause serious allergic reactions; therefore, if symptoms such as skin rash or difficulty breathing occur, the use of this medication should be discontinued immediately and a doctor should be consulted. Additionally, sitagliptin has the potential to induce acute pancreatitis, so if symptoms such as abdominal pain, vomiting, or nausea arise, one should go to the hospital right away. The metformin component can rarely cause a serious side effect called lactic acidosis, which occurs when there is an excessive accumulation of lactic acid in the body, posing a risk. Lactic acidosis is especially dangerous for patients with impaired kidney function, liver disease, severe infection, or dehydration, and those conditions should avoid this medication. This medication should not be administered to patients with moderate to severe renal impairment, acute heart failure, acute myocardial infarction, severe infection, or to women who are pregnant or breastfeeding. Moreover, this medication should be temporarily discontinued before and after examinations using iodinated radiocontrast agents, and can only be resumed once normal kidney function is confirmed. During treatment, there may be symptoms of hypoglycemia, particularly when using this medication in conjunction with insulin or sulfonylurea medications; thus, vigilance for hypoglycemic symptoms is necessary. Hypoglycemic symptoms include dizziness, headache, severe fatigue, and cold sweat, and immediate sugar intake is recommended when such symptoms appear. This medication can frequently cause side effects such as gastrointestinal disturbances, diarrhea, nausea, and vomiting; if these symptoms are severe, consulting a doctor is advised. Patients with impaired liver function or those who consume excessive alcohol are at an increased risk of lactic acidosis while taking this medication; therefore, it is advised to avoid alcohol. Patients scheduled for surgery should discontinue this medication 48 hours before the procedure and should not resume it until oral intake is restored post-surgery and renal function is confirmed to be normal. Regular blood tests and kidney function tests should be performed during treatment, and it is advisable to periodically check vitamin B12 levels. Additionally, this medication contains certain colorants, so patients with allergies to them should exercise caution. Finally, this medication is not recommended for use in pediatric patients under 18 years of age due to the lack of established safety and efficacy. It is important to consult healthcare providers regarding any unusual symptoms or discomfort experienced during the course of this medication.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria, severe swelling (angioedema), chest tightness, difficulty breathing, anaphylaxis, Stevens-Johnson syndrome, severe allergic reaction
  • Severe rash with fever, blisters, skin peeling, pain in the mucous membranes of the mouth/eyes, severe skin adverse reactions
  • Respiratory issues (difficulty breathing, difficulty in breathing, asthma attacks, abnormal breathing accompanied by cough and fever)
  • Liver abnormalities (yellowing of skin or eyes, jaundice, extreme fatigue throughout the body)
  • Severe

Mild side effects

  • Diarrhea
  • nausea
  • vomiting
  • abdominal pain
  • headache
  • upper respiratory infection
  • nasopharyngitis
  • constipation
  • muscle pain
  • limb pain
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  • back pain
  • pruritus
  • thrombocytopenia
  • rhabdomyolysis
  • itching
  • dizziness
  • decreased appetite
  • weight loss

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

Storage

This medication should be stored in a tightly closed container to prevent air ingress, and it is best kept at room temperature between 1 to 30 degrees Celsius. By storing it this way, the medication's effectiveness can be maintained over a long period.

Appearance and packaging

Appearance

Pink oval film-coated tablet

Package unit

Bottle - 100 tablets/bottle, Bottle - 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.