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

Sinubiem Tablet 50/1000 mg (Sitagliptin, Metformin)

Prescription medicationTablet경구
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›56.7mg / 1 tabletMetformin Hydrochloride with Colloidal Anhydrous Silica›1010mg / 1 tablet
Manufacturer / importer
삼진제약(주)
Appearance
Pink oval film-coated tablet
Packaging
30 tablets/box [(10 tablets/PTP x 3)]
Approval status
Active

MFDS item code 202200505 · Approved 2022.01.28 · Insurance code 647805620

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who takes it
Adults
Adult dose
In diabetes treatment, the dosage of this medication is determined considering the patient's treatment regimen, efficacy, and tolerability, without exceeding a maximum daily dose of 100 mg of sitagliptin and 2000 mg of metformin. Generally, it is taken twice daily with food, and the dose should be gradually increased to reduce gastrointestinal side effects caused by metformin. 1. For patients not treated with metformin: The initial dosage is 50/500 mg.

Ingredients

Manufacturer
삼진제약(주)

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 alongside dietary and exercise therapy to assist with blood sugar control in patients with type 2 diabetes. It is used when patients starting drug therapy cannot achieve sufficient blood sugar control with monotherapy, and if blood sugar control is inadequate with either metformin or sitagliptin alone, it can be substituted or used in combination. Additionally, it can be administered together if there is insufficient efficacy with combination therapy of metformin and sulfonylureas or metformin and thiazolidinediones. If there is inadequate effect in the combined therapy of insulin and metformin, this drug may also be added to help improve blood sugar control. It is used in various treatment scenarios to enhance and improve blood sugar control.

How to take

Adult dose

In diabetes treatment, the dosage of this medication is determined considering the patient's treatment regimen, efficacy, and tolerability, without exceeding a maximum daily dose of 100 mg of sitagliptin and 2000 mg of metformin. Generally, it is taken twice daily with food, and the dose should be gradually increased to reduce gastrointestinal side effects caused by metformin. 1. For patients not treated with metformin: The initial dosage is 50/500 mg.

Precautions

This medication contains the active ingredients sitagliptin and metformin, and is used for diabetes treatment. First, this medication may cause rare but serious allergic reactions, so if symptoms such as rash, urticaria, or swelling of the face or neck appear, it is important to stop taking it immediately and consult a doctor. Second, acute pancreatitis may occur; thus, if sudden abdominal pain, vomiting, or nausea occurs, one should visit a hospital immediately. Third, lactic acidosis, a serious metabolic disorder, may occur due to the metformin component, so it is contraindicated for individuals with poor kidney function, dehydration, severe infections, or heart issues. If any symptoms are suspected, it is crucial to inform a healthcare professional immediately. Fourth, patients with moderate to severe impairment of kidney function, severe heart disease, those in acute infection states, and women who are pregnant or breastfeeding should not use this medication. Fifth, while taking this medication, regular monitoring of kidney function, blood tests, and vitamin B12 levels is necessary, especially for the elderly, as they are more prone to kidney function decline. Sixth, there is a risk of hypoglycemia, so meals should be regular, and vigorous exercise or alcohol consumption should be avoided, particularly if taken with other hypoglycemic agents where symptoms of hypoglycemia require extra caution. Seventh, before surgery or radiographic examinations involving contrast agents, this medication should be temporarily withheld and resumed only after normal kidney function is confirmed. Eighth, there are various drugs that may interact with this medication, so it is essential to inform a doctor or pharmacist of any other medications being taken, especially those affecting kidney function. Finally, the safety and efficacy of this medication have not been established in children or adolescents under 18 years of age, so its use is not recommended.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • angioedema
  • anaphylaxis
  • Stevens-Johnson syndrome
  • rash
  • cutaneous vasculitis
  • exfoliative dermatitis
  • acute pancreatitis
  • acute renal failure
  • respiratory distress
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  • severe hypoglycemia
  • severe and disabling arthralgia
  • blistering dermatitis
  • thrombocytopenia
  • acute renal failure
  • respiratory distress
  • unstable angina

Mild side effects

  • Diarrhea
  • nausea
  • vomiting
  • abdominal pain
  • headache
  • upper respiratory infection
  • nasopharyngitis
  • constipation
  • weakness
  • thrombocytopenia
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  • myalgia
  • limb pain
  • back pain
  • elevated liver enzymes
  • itching
  • dizziness
  • decreased appetite
  • weight loss
  • pruritus

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

Storage

This medication should be stored in a well-closed container that allows for air circulation, at room temperature between 1°C and 30°C. This helps maintain its efficacy and prevent degradation.

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.

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.