Medication info

Unimet 50/500 mg

Prescription medicationTablet경구Expired
Ingredient · strength
Sitagliptin Phosphate Hydrate›64.25mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
한국유니온제약(주)
Appearance
Pink oval film-coated tablet
Packaging
In-house packaging unit
Approval status
Expired

MFDS item code 201506698 · Approved 2015.09.23

This product's status changed to Expired on 2025.09.23. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
(Blood sugar control) Enhanced treatment
Who takes it
Adults
Adult dose
The dosage of this medication is determined considering each patient's current treatment regimen, efficacy, and tolerability within the maximum recommended daily doses of sitagliptin 100 mg and metformin 2000 mg. Generally, this medication is taken twice a day with meals, increasing the dose gradually to reduce gastrointestinal side effects from metformin. 1. For patients not currently treated with metformin: For those with no previous experience with antidiabetic medication and who have difficulty achieving adequate blood sugar control with monotherapy, or cannot achieve sufficient blood sugar control with sitagliptin monotherapy, the initial dosage of this medication is to take Unimet 50/500 mg 1 tablet twice daily, and it may be increased to Unimet 50/1000 mg 1 tablet twice daily. Patients with renal impairment who are currently on reduced doses of sitagliptin should not switch to this medication (refer to the precautions section regarding contraindications). 2. For patients currently on metformin treatment: - The recommended initial dosage of this medication for patients unable to achieve adequate blood sugar control with metformin monotherapy is sitagliptin 50 mg twice daily (total daily amount of 100 mg) along with the existing dose of metformin. - For patients switching from combination therapy of sitagliptin and metformin, they can initiate treatment at their previous doses of sitagliptin and metformin. 3. In cases where blood sugar control cannot be achieved with metformin and sulfonylurea combination therapy, metformin and insulin combination therapy, or metformin and thiazolidinedione combination therapy: The initial dosage of this medication is sitagliptin 50 mg twice daily (total daily amount of 100 mg), and the initial dosage of metformin should be based on the patient's blood sugar levels and current dosing. To reduce gastrointestinal side effects from metformin, the dosage should be increased gradually. When administered together with sulfonylurea or insulin, it may be necessary to consider reducing the doses of sulfonylurea or insulin to decrease the risk of hypoglycemia (refer to the general precautions section). No studies have been conducted to assess the safety and efficacy of switching from other oral hypoglycemic agents to this medication. Changes to any type of type 2 diabetes treatment regimen may cause changes in blood sugar control, and careful monitoring should be conducted. Patients with renal impairment: This medication can be used with dosage adjustments for patients with moderate renal impairment stage 3a (creatinine clearance [CrCl] ≥ 45 and < 60 mL/min or estimated glomerular filtration rate [eGFR] ≥ 45 and < 60 mL/min/1.73m2) who do not have other symptoms that may increase the risk of lactic acidosis. The starting dose of metformin should be administered as 500 mg or 850 mg once daily, and should not be initiated on this medication. The maximum recommended dose of metformin is 500 mg twice daily. Kidney function should be carefully monitored every 3-6 months. If CrCl < 45 mL/min or eGFR < 45 mL/min/1.73m2 indicates declining kidney function, this medication should be discontinued immediately. Patients with liver impairment: This medication should not be administered to patients with liver function impairment due to the metformin component (refer to the precautions section regarding contraindications).

Ingredients

Manufacturer
한국유니온제약(주)

Efficacy & effects

(Blood sugar control) Enhanced treatment

View approved original text

This medication assists patients with type 2 diabetes who have difficulty controlling blood sugar levels with diet and exercise alone, by taking sitagliptin and metformin together. It effectively lowers blood sugar levels and helps prevent diabetes-related complications. Patients can expect better blood sugar control by consistently managing their meals and exercise along with this medication. It is used to improve blood sugar safely and steadily.

How to take

Adult dose

The dosage of this medication is determined considering each patient's current treatment regimen, efficacy, and tolerability within the maximum recommended daily doses of sitagliptin 100 mg and metformin 2000 mg. Generally, this medication is taken twice a day with meals, increasing the dose gradually to reduce gastrointestinal side effects from metformin. 1. For patients not currently treated with metformin: For those with no previous experience with antidiabetic medication and who have difficulty achieving adequate blood sugar control with monotherapy, or cannot achieve sufficient blood sugar control with sitagliptin monotherapy, the initial dosage of this medication is to take Unimet 50/500 mg 1 tablet twice daily, and it may be increased to Unimet 50/1000 mg 1 tablet twice daily. Patients with renal impairment who are currently on reduced doses of sitagliptin should not switch to this medication (refer to the precautions section regarding contraindications). 2. For patients currently on metformin treatment: - The recommended initial dosage of this medication for patients unable to achieve adequate blood sugar control with metformin monotherapy is sitagliptin 50 mg twice daily (total daily amount of 100 mg) along with the existing dose of metformin. - For patients switching from combination therapy of sitagliptin and metformin, they can initiate treatment at their previous doses of sitagliptin and metformin. 3. In cases where blood sugar control cannot be achieved with metformin and sulfonylurea combination therapy, metformin and insulin combination therapy, or metformin and thiazolidinedione combination therapy: The initial dosage of this medication is sitagliptin 50 mg twice daily (total daily amount of 100 mg), and the initial dosage of metformin should be based on the patient's blood sugar levels and current dosing. To reduce gastrointestinal side effects from metformin, the dosage should be increased gradually. When administered together with sulfonylurea or insulin, it may be necessary to consider reducing the doses of sulfonylurea or insulin to decrease the risk of hypoglycemia (refer to the general precautions section). No studies have been conducted to assess the safety and efficacy of switching from other oral hypoglycemic agents to this medication. Changes to any type of type 2 diabetes treatment regimen may cause changes in blood sugar control, and careful monitoring should be conducted. Patients with renal impairment: This medication can be used with dosage adjustments for patients with moderate renal impairment stage 3a (creatinine clearance [CrCl] ≥ 45 and < 60 mL/min or estimated glomerular filtration rate [eGFR] ≥ 45 and < 60 mL/min/1.73m2) who do not have other symptoms that may increase the risk of lactic acidosis. The starting dose of metformin should be administered as 500 mg or 850 mg once daily, and should not be initiated on this medication. The maximum recommended dose of metformin is 500 mg twice daily. Kidney function should be carefully monitored every 3-6 months. If CrCl < 45 mL/min or eGFR < 45 mL/min/1.73m2 indicates declining kidney function, this medication should be discontinued immediately. Patients with liver impairment: This medication should not be administered to patients with liver function impairment due to the metformin component (refer to the precautions section regarding contraindications).

Precautions

This medication contains sitagliptin and metformin, and is used in diabetes treatment. First, this medication may cause allergic reactions, so if symptoms such as skin rash, itching, difficulty breathing, swelling of the face or neck appear, discontinue use immediately and consult a doctor. Second, severe pancreatic inflammation known as acute pancreatitis may occur, so if symptoms such as abdominal pain, nausea, vomiting, or fever arise, inform medical personnel immediately. Third, metformin may rarely cause a serious metabolic complication known as lactic acidosis, so if sudden difficulty in breathing, muscle pain, fatigue, or abdominal pain occurs, stop taking the medication immediately and visit a hospital. Fourth, patients with severely impaired kidney function, dehydration, serious infections, or heart failure should not take this medication, and it should be temporarily discontinued before and after tests using iodine contrast agents. Fifth, it is safer for pregnant or potentially pregnant women, and nursing mothers to avoid taking this medication. Sixth, maintaining a regular diet and appropriate exercise during treatment is crucial, as irregular meals or excessive exercise can increase the risk of side effects such as hypoglycemia. Seventh, using this medication with other blood sugar-lowering agents or insulin may increase the risk of hypoglycemia, so take immediate action if symptoms occur. Eighth, elderly patients or those with weakened kidney function should have regular kidney function tests and adjust the dosage accordingly. Ninth, it is recommended to avoid alcohol consumption while taking this medication, as alcohol can increase the risk of side effects from the drug. Finally, during treatment with this medication, it is important to regularly monitor blood sugar levels, kidney function, and vitamin B12 levels to ensure there are no abnormalities.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), anaphylaxis, rash, Stevens-Johnson syndrome, severe skin reactions, acute pancreatitis, acute kidney failure, difficulty breathing, severe hypoglycemia, severe joint pain with complications and disabilities, blistering dermatosis, jaundice, acute kidney failure, difficulty breathing, unstable angina, severe edema, hypoxia, sudden and severe headache, seizures, confusion, vision problems, paralysis

Mild side effects

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

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

Storage

Store this medication in a tightly sealed container that is air-tight, preferably at room temperature between 1 and 30 degrees Celsius. This storage method helps maintain the efficacy of the drug and prevents it from deteriorating.

Appearance and packaging

Appearance

Pink oval film-coated tablet

Package unit

In-house packaging unit

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.