Medication info

Ritagen Duo Tablet 2.5/500 mg

Prescription medicationTablet경구Approval withdrawn
Ingredient · strength
Linagliptin›2.5mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
알보젠코리아(주)
Appearance
Bright yellow, oval-shaped, biconvex film-coated tablet
Packaging
30 tablets/bottle, 30 tablets/PPT [10 tablets/PTPx3]
Approval status
Approval withdrawn

MFDS item code 202106091 · Approved 2021.08.23

This product's status changed to Approval withdrawn on 2024.01.30. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of blood sugar control in adults with type 2 diabetes
Who takes it
Adults
Adult dose
The dosage of this medication is determined based on the maximum recommended doses of the individual components, Linagliptin 2.5 mg and Metformin 1000 mg, not exceeding twice a day, considering the current treatment regimen, efficacy, and tolerability of each patient. This medication is administered twice daily with meals. To reduce gastrointestinal side effects associated with Metformin, dosage increases should be gradual. 1. If currently not treated with Metformin: In cases where there has been no prior experience with diabetes drug therapy and blood sugar control is difficult with monotherapy, the initial dosage is 2.5/500 mg of this medication taken twice daily, with the option to increase to 2.5/1000 mg, one tablet twice a day. 2. In cases transferring from combination therapy with Linagliptin and Metformin: Patients transitioning from a combination therapy of Linagliptin and Metformin should continue taking the same dosage as previously prescribed. 3. If adequate blood sugar control cannot be achieved through a combination of insulin and Metformin: The initial dosage of this medication should consider Linagliptin 2.5 mg taken twice daily (total daily dosage of 5 mg) along with a similar dose to the existing Metformin dosage. When used in combination with insulin, a reduction in insulin dosage may be necessary to reduce the risk of hypoglycemia (refer to precautions for caution in certain patients). There have been no studies conducted on the safety and efficacy of transitioning patients previously treated with other oral hypoglycemic medications to this medication. Any changes in the treatment regimen for type 2 diabetes can lead to changes in blood sugar control, hence careful monitoring is required. For patients with renal impairment: This medication may be used with dose adjustments in patients with moderate renal impairment stage 3a (creatinine clearance [CrCl] 45≤~<60 ml/min or estimated glomerular filtration rate [eGFR] 45≤~<60 mL/min/1.73 m2) without accompanying symptoms that would increase the risk of lactic acidosis. The starting dose of Metformin should not commence at 500 mg or 850 mg once daily. The maximum recommended dose of Metformin is 500 mg twice daily. Kidney function should be closely monitored every 3-6 months. If CrCl < 45 ml/min or eGFR < 45 ml/min/1.73m2 indicating reduced kidney function occurs, this medication should be discontinued immediately. For patients with liver impairment: This medication should not be administered to patients with liver dysfunction due to the Metformin component. (Refer to precautions for contraindications).

Ingredients

Manufacturer
알보젠코리아(주)

Efficacy & effects

Improvement of blood sugar control in adults with type 2 diabetes

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

This medication is used to help control blood sugar levels in adults with type 2 diabetes. It assists in improving blood glucose levels while supporting dietary and exercise interventions. It is administered in cases where there has been no prior experience with diabetes medication treatment or when blood sugar control is difficult with monotherapy alone. It can also serve as an alternative to the combination therapy of Linagliptin and Metformin. When insulin and Metformin combination therapy does not provide adequate control, this medication is used in conjunction with insulin. If there is insufficient effect even with the maximum dosage of Metformin and Empagliflozin combined, this medication is administered alongside Empagliflozin to enhance blood glucose control. It is used in various cases to improve blood sugar regulation.

How to take

Adult dose

The dosage of this medication is determined based on the maximum recommended doses of the individual components, Linagliptin 2.5 mg and Metformin 1000 mg, not exceeding twice a day, considering the current treatment regimen, efficacy, and tolerability of each patient. This medication is administered twice daily with meals. To reduce gastrointestinal side effects associated with Metformin, dosage increases should be gradual. 1. If currently not treated with Metformin: In cases where there has been no prior experience with diabetes drug therapy and blood sugar control is difficult with monotherapy, the initial dosage is 2.5/500 mg of this medication taken twice daily, with the option to increase to 2.5/1000 mg, one tablet twice a day. 2. In cases transferring from combination therapy with Linagliptin and Metformin: Patients transitioning from a combination therapy of Linagliptin and Metformin should continue taking the same dosage as previously prescribed. 3. If adequate blood sugar control cannot be achieved through a combination of insulin and Metformin: The initial dosage of this medication should consider Linagliptin 2.5 mg taken twice daily (total daily dosage of 5 mg) along with a similar dose to the existing Metformin dosage. When used in combination with insulin, a reduction in insulin dosage may be necessary to reduce the risk of hypoglycemia (refer to precautions for caution in certain patients). There have been no studies conducted on the safety and efficacy of transitioning patients previously treated with other oral hypoglycemic medications to this medication. Any changes in the treatment regimen for type 2 diabetes can lead to changes in blood sugar control, hence careful monitoring is required. For patients with renal impairment: This medication may be used with dose adjustments in patients with moderate renal impairment stage 3a (creatinine clearance [CrCl] 45≤~<60 ml/min or estimated glomerular filtration rate [eGFR] 45≤~<60 mL/min/1.73 m2) without accompanying symptoms that would increase the risk of lactic acidosis. The starting dose of Metformin should not commence at 500 mg or 850 mg once daily. The maximum recommended dose of Metformin is 500 mg twice daily. Kidney function should be closely monitored every 3-6 months. If CrCl < 45 ml/min or eGFR < 45 ml/min/1.73m2 indicating reduced kidney function occurs, this medication should be discontinued immediately. For patients with liver impairment: This medication should not be administered to patients with liver dysfunction due to the Metformin component. (Refer to precautions for contraindications).

Precautions

This medication may cause serious side effects such as lactic acidosis due to its Metformin Hydrochloride component, and there have been reported fatalities. It should not be administered to certain patients, such as those allergic to the active ingredients, or those with type 1 diabetes, lactic acidosis, or diabetic ketoacidosis. Additionally, it should not be given to patients with severe renal impairment, severe liver dysfunction, acute infections or dehydration, or acute diseases such as acute myocardial infarction. Pregnant or breastfeeding women are also advised against using this medication. There is a possibility of hypoglycemia; therefore, special caution should be taken when used with insulin or sulfonylureas, and dosages of other medications may need to be adjusted as necessary. Patients with reduced renal function should assess their kidney function prior to using this medication and undergo regular kidney function tests. Serious pancreatic diseases, such as acute pancreatitis, may occur; therefore, if severe abdominal pain develops during use, immediate consultation with a physician is necessary. This medication may reduce vitamin B12 levels, so it is essential to regularly check for vitamin B12 deficiency during long-term use. Furthermore, this drug may interact with other medications; thus, it is crucial to inform the doctor or pharmacist of any current medications being taken. If planning to become pregnant or if already pregnant, it is advised to avoid using this medication and to consider alternative methods such as insulin treatment for blood glucose management. Elderly patients may have a higher risk of reduced kidney function; therefore, starting at the lowest possible dose and monitoring kidney function regularly is necessary for effective blood glucose management. It is important to consult healthcare professionals immediately if any unusual symptoms or side effects occur during use.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, lactic acidosis, pancreatitis, similar pemphigus, severe rash with fever, blistering, peeling skin, pain in mouth/eyes mucosa, difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), systemic lethargy, sudden and very severe headache, lightning headache, seizures, clouding of consciousness, visual disturbances, paralysis, significant decrease in urine output, systemic severe edema, increased blood pressure

Mild side effects

Nasopharyngitis, hypersensitivity, hypoglycemia, taste disturbances, cough, decreased appetite, diarrhea, constipation, nausea, vomiting, abdominal pain, oral ulcer formation, abnormal liver function tests, hepatitis, pruritus, erythema, rashes, arthralgia associated with severe and disabling conditions, increase in lipase, increase in amylase, decrease in vitamin B12, angioedema, dyspepsia, upper abdominal pain, gastrointestinal disturbances, stomatitis, dehydration, hyperglycemia, dizziness, drowsiness, fatigue, itching,

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature. This helps to preserve the effectiveness of the medication for a longer period.

Appearance and packaging

Appearance

Bright yellow, oval-shaped, biconvex film-coated tablet

Package unit

30 tablets/bottle, 30 tablets/PPT [10 tablets/PTPx3]

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.