Medication info
Glossitapomin Tablets 50/1000 milligrams

Glossitapomin Tablets 50/1000 milligrams

Prescription medicationTablet경구
Ingredient · strength
Sitagliptin Hydrochloride Hydrate›56.69mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
(주)킵스바이오파마
Appearance
Brownish-red oval film-coated tablet
Packaging
Bottle - 100 tablets/bottle, Bottle - 30 tablets/bottle
Approval status
Active

MFDS item code 202300845 · Approved 2023.03.13 · Insurance code 693202560

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who takes it
Adults
Adult dose
In diabetes therapy, the dosage of this medication should be decided considering each component's daily maximum recommended dosage, sitagliptin 100 mg and metformin 2000 mg, and taking into account each patient's current treatment regimen, efficacy, and tolerance. It is generally taken twice a day with meals, and to reduce gastrointestinal side effects caused by metformin, the dosage should be increased gradually. 1. Current patients not treated with metformin: For those who have never been treated with previous diabetes medications and find it challenging to achieve adequate blood sugar control with monotherapy or for those unable to achieve adequate blood sugar control with sitagliptin monotherapy, the initial dosage is to take this medication 50/500 mg twice daily, 1 tablet each time, and can be increased to this medication 50/1000 mg twice daily, 1 tablet each time. Patients with renal impairment who are having their sitagliptin dosage reduced should not switch to this medication (refer to Precautions: 2. Contraindications). 2. Patients currently being treated with metformin: - 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 dose 100 mg) along with the existing metformin dosage. - For patients switching to this medication from a combination of sitagliptin and metformin, treatment may begin with the existing dosages of sitagliptin and metformin. 3. When unable to achieve adequate blood sugar control with a combination of metformin and sulfonylureas, metformin and insulin, or metformin and thiazolidinediones: The initial dosage of this medication is sitagliptin 50 mg twice daily (total daily dose 100 mg), and the initial dosage of metformin must consider the patient's blood sugar levels and existing dosages. To reduce gastrointestinal side effects caused by metformin, dosage should be increased gradually. When used in combination with sulfonylureas or insulin, doses of those medications may need to be reduced to decrease the risk of hypoglycemia caused by them (refer to Precautions: 5. General precautions). There have been no studies to review the safety and efficacy for patients switching to this medication from other oral hypoglycemic agents. Any changes in the treatment regimen for type 2 diabetes can alter blood sugar control, so monitoring is important. Renal impairment: This medication may be used with dosage adjustments in 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) as long as no other symptoms that would increase the risk of lactic acidosis are present. The starting dose for metformin should be 500 mg or 850 mg taken once daily, and treatment with this medication should not start. The maximum recommended dosage for metformin is 500 mg taken twice daily. Kidney function should be monitored closely every 3-6 months. If CrCl < 45 mL/min or eGFR < 45 mL/min/1.73m2, this medication should be stopped immediately. Hepatic impairment: This medication should not be administered to patients with liver dysfunction due to the metformin component (refer to Precautions: 2. Contraindications).

Ingredients

Manufacturer
(주)킵스바이오파마

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

View approved original text

This medication is used as an adjunct to dietary and exercise therapy to improve blood sugar control in patients with type 2 diabetes. The combination of sitagliptin and metformin effectively manages blood sugar levels and aids in the treatment of diabetes.

How to take

Adult dose

In diabetes therapy, the dosage of this medication should be decided considering each component's daily maximum recommended dosage, sitagliptin 100 mg and metformin 2000 mg, and taking into account each patient's current treatment regimen, efficacy, and tolerance. It is generally taken twice a day with meals, and to reduce gastrointestinal side effects caused by metformin, the dosage should be increased gradually. 1. Current patients not treated with metformin: For those who have never been treated with previous diabetes medications and find it challenging to achieve adequate blood sugar control with monotherapy or for those unable to achieve adequate blood sugar control with sitagliptin monotherapy, the initial dosage is to take this medication 50/500 mg twice daily, 1 tablet each time, and can be increased to this medication 50/1000 mg twice daily, 1 tablet each time. Patients with renal impairment who are having their sitagliptin dosage reduced should not switch to this medication (refer to Precautions: 2. Contraindications). 2. Patients currently being treated with metformin: - 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 dose 100 mg) along with the existing metformin dosage. - For patients switching to this medication from a combination of sitagliptin and metformin, treatment may begin with the existing dosages of sitagliptin and metformin. 3. When unable to achieve adequate blood sugar control with a combination of metformin and sulfonylureas, metformin and insulin, or metformin and thiazolidinediones: The initial dosage of this medication is sitagliptin 50 mg twice daily (total daily dose 100 mg), and the initial dosage of metformin must consider the patient's blood sugar levels and existing dosages. To reduce gastrointestinal side effects caused by metformin, dosage should be increased gradually. When used in combination with sulfonylureas or insulin, doses of those medications may need to be reduced to decrease the risk of hypoglycemia caused by them (refer to Precautions: 5. General precautions). There have been no studies to review the safety and efficacy for patients switching to this medication from other oral hypoglycemic agents. Any changes in the treatment regimen for type 2 diabetes can alter blood sugar control, so monitoring is important. Renal impairment: This medication may be used with dosage adjustments in 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) as long as no other symptoms that would increase the risk of lactic acidosis are present. The starting dose for metformin should be 500 mg or 850 mg taken once daily, and treatment with this medication should not start. The maximum recommended dosage for metformin is 500 mg taken twice daily. Kidney function should be monitored closely every 3-6 months. If CrCl < 45 mL/min or eGFR < 45 mL/min/1.73m2, this medication should be stopped immediately. Hepatic impairment: This medication should not be administered to patients with liver dysfunction due to the metformin component (refer to Precautions: 2. Contraindications).

Precautions

This medication consists of sitagliptin and metformin and is primarily used for the treatment of type 2 diabetes. While taking this medicine, severe allergic reactions may occur, so if symptoms such as skin rash, difficulty breathing, or swelling of the face or neck occur, immediately stop use and seek medical attention. Additionally, this medication may pose a risk of acute pancreatitis, which causes inflammation of the pancreas, so if symptoms such as sudden abdominal pain, vomiting, or fever occur, inform a healthcare provider immediately. Patients with severely impaired kidney function or those with serious infections or dehydration should not use this medication, and its use should be discontinued for a certain period before and after tests using iodinated contrast agents. It is also safe for women who are pregnant or may become pregnant, as well as nursing mothers, to avoid this medication. This medication can cause a rare but serious side effect known as lactic acidosis, in which lactic acid builds up in the body, and symptoms may include muscle pain, weakness, difficulty breathing, abdominal pain, and confusion. If these symptoms occur, immediate medical attention is necessary. Regular kidney function and blood tests are recommended during treatment, and Vitamin B12 levels should also be monitored periodically. Furthermore, when used with other blood sugar-lowering medications or insulin, the risk of hypoglycemia may increase, so it is important to closely monitor blood sugar changes. Excessive alcohol consumption, intense exercise, or irregular eating patterns may increase the risk of hypoglycemia or other side effects, so they should be avoided. If surgery is planned, this medication should be discontinued 48 hours before the procedure and resumed only after confirming that kidney function is normal following recovery. During treatment, there is a potential for drug interactions, so inform a doctor or pharmacist if taking other medications. Finally, it is not recommended for use in children and adolescents under 18 years of age as its safety and efficacy have not been adequately established.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, chest tightness, difficulty breathing, anaphylaxis, Stevens-Johnson syndrome including exfoliative skin disorders, severe rash with high fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, shortness of breath, asthma attacks, respiratory difficulties accompanied by cough and fever, jaundice of the skin or eyes, generalized fatigue, sudden and very severe headache, seizures, confusion, visual disturbances, paralysis, significantly reduced urine output, systemic effects

Mild side effects

  • Nausea
  • vomiting
  • diarrhea
  • abdominal pain
  • upper respiratory infection
  • nasopharyngitis
  • headache
  • hypoglycemia
  • myalgia
  • limb pain
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  • back pain
  • pruritus
  • thrombocytopenia
  • rhabdomyolysis
  • itching
  • dizziness
  • decreased appetite
  • gastrointestinal disturbances

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 air and moisture from entering, and it is best stored at room temperature between 1 and 30 degrees Celsius. Storing it this way helps maintain the medication's efficacy.

Appearance and packaging

Appearance

Brownish-red 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.

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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.