Medication info

Samsung Linagliptin Duo Tablet 2.5/500 mg

Prescription medicationTablet경구Expired
Ingredient · strength
Linagliptin›2.5mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
삼성제약(주)
Appearance
Bright yellow oval film-coated tablet
Packaging
60 tablets/PTP[(10 tablets/PTP×6)]
Approval status
Expired

MFDS item code 201907497 · Approved 2019.10.28

This product's status changed to Expired on 2024.10.28. 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 dose of this medication should be determined based on the current treatment plan, efficacy, and tolerability for each patient, not exceeding the maximum recommended doses of linagliptin 2.5 mg and metformin 1000 mg, taken twice a day. This medication should be administered twice a day with meals. To reduce gastrointestinal side effects associated with metformin, the dosage should be increased gradually. 1. If currently not treated with metformin: For patients who have not previously received diabetes medication and have difficulty achieving adequate blood sugar control with monotherapy, the initial dose of this medication 2.5/500 mg should be taken twice a day, 1 tablet per dose, and can be titrated up to 2.5/1000 mg twice a day, 1 tablet per dose. 2. For transitioning from a combination of linagliptin and metformin: Patients transitioning from a combination of linagliptin and metformin should take the same doses as their previous treatment as an initial dose. 3. In cases where sufficient blood sugar control cannot be achieved with a combination of insulin and metformin: The initial dose of this medication should be considered similar to that of linagliptin 2.5 mg taken twice a day (total daily dose of 5 mg) and the existing metformin dosing should be considered. When this medication is used in combination with insulin, there may be a need to reduce the insulin dose to minimize the risk of hypoglycemia (see precautions for careful administration in certain patients). Studies assessing the safety and efficacy of transitioning from other oral hypoglycemic agents to this medication have not been conducted. Any changes in the treatment regimen for type 2 diabetes could affect blood sugar control, therefore careful monitoring is required.

Ingredients

Manufacturer
삼성제약(주)

Efficacy & effects

Improvement of blood sugar control in adults with type 2 diabetes

  • Difficulty in blood sugar control in adults with type 2 diabetes
View approved original text

This medication helps adults with type 2 diabetes to manage blood sugar levels more effectively while following dietary and exercise recommendations. It is particularly used for patients who have not previously received diabetes medication or where blood sugar control is difficult with monotherapy. It can also be used in conjunction with insulin when blood sugar control is insufficient with insulin and metformin combination therapy. In cases where blood sugar control is difficult even with the maximum doses of metformin and empagliflozin, it is used in combination with empagliflozin. This medication is effective in improving blood sugar control in various situations.

How to take

Adult dose

The dose of this medication should be determined based on the current treatment plan, efficacy, and tolerability for each patient, not exceeding the maximum recommended doses of linagliptin 2.5 mg and metformin 1000 mg, taken twice a day. This medication should be administered twice a day with meals. To reduce gastrointestinal side effects associated with metformin, the dosage should be increased gradually. 1. If currently not treated with metformin: For patients who have not previously received diabetes medication and have difficulty achieving adequate blood sugar control with monotherapy, the initial dose of this medication 2.5/500 mg should be taken twice a day, 1 tablet per dose, and can be titrated up to 2.5/1000 mg twice a day, 1 tablet per dose. 2. For transitioning from a combination of linagliptin and metformin: Patients transitioning from a combination of linagliptin and metformin should take the same doses as their previous treatment as an initial dose. 3. In cases where sufficient blood sugar control cannot be achieved with a combination of insulin and metformin: The initial dose of this medication should be considered similar to that of linagliptin 2.5 mg taken twice a day (total daily dose of 5 mg) and the existing metformin dosing should be considered. When this medication is used in combination with insulin, there may be a need to reduce the insulin dose to minimize the risk of hypoglycemia (see precautions for careful administration in certain patients). Studies assessing the safety and efficacy of transitioning from other oral hypoglycemic agents to this medication have not been conducted. Any changes in the treatment regimen for type 2 diabetes could affect blood sugar control, therefore careful monitoring is required.

Precautions

This medication is composed of two components, metformin and linagliptin, and is primarily used for the treatment of type 2 diabetes. This medication can cause a very rare but serious side effect known as lactic acidosis, and should not be administered to patients with severely impaired kidney function, liver dysfunction, or acute heart failure. Additionally, it should not be used in patients who are allergic to the components of this medication, those with type 1 diabetes, women who are pregnant or breastfeeding, or individuals with acute alcohol intoxication. During the course of taking this medication, symptoms of hypoglycemia may occur, and blood sugar should be monitored regularly, especially when taken with insulin or sulfonylurea medications, and patients should consult a doctor immediately if symptoms arise. In patients with impaired kidney function or conditions that may affect kidney function, such as acute infections, dehydration, or severe trauma, the use of this medication should be temporarily suspended, and it can be resumed once kidney function stabilizes. Caution is also required in patients with liver dysfunction, and adjustments may need to be made in cases of severe gastrointestinal disorders. If conditions such as acute pancreatitis or bullous pemphigoid are suspected, the medication should be discontinued immediately and a healthcare professional should be consulted. This medication may reduce vitamin B12 levels, so if taken over a long period, regular assessment of vitamin B12 levels is recommended. Caution is advised when taken in combination with other medications due to potential interactions, especially with drugs that may affect kidney function, and management should be carried out according to a doctor’s instructions. Women who are pregnant or planning to become pregnant are advised not to take this medication, and breastfeeding women should also avoid it. It is advisable not to use this medication in children under 10 years of age as safety and efficacy have not been established. In elderly patients, since impaired kidney function is common, it is recommended to administer the minimum dose while regularly monitoring kidney function and to avoid maximum dosing. In cases of overdose, serious side effects such as lactic acidosis may occur; therefore, it is important to seek immediate medical attention for appropriate treatment. This medication should be stored in a tightly sealed container, away from moisture and direct sunlight, and should not be transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, lactic acidosis, pancreatitis, bullous pemphigoid, abnormal liver function (abnormal liver function tests, suspected hepatitis, jaundice), acute myocardial infarction, angina pectoris, unstable angina, cardiac arrest, congestive heart failure, pulmonary embolism, shortness of breath, asthma attacks, respiratory distress accompanied by cough and fever, breathing problems, acute kidney injury, end-stage renal disease, significantly reduced urine output, severe generalized edema, associated hypertension.

Mild side effects

Pharyngitis, hypersensitivity, hypoglycemia (when used in combination with sulfonylureas), taste disturbance, cough, decreased appetite, diarrhea, constipation, nausea, vomiting, abdominal pain, formation of mouth ulcers, abnormal liver function tests, hepatitis, pruritus, erythema, rashes, arthralgia without severe or disabling symptoms, elevated lipase, elevated amylase, decreased and deficient vitamin B12, increased triglycerides in blood, reduced hemoglobin, itching, insomnia, depression

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

Storage

This medication must be stored in a tightly sealed container to avoid exposure to air or moisture. It is best stored at room temperature between 1 and 30 degrees Celsius. This helps to maintain the effectiveness of the medication over time.

Appearance and packaging

Appearance

Bright yellow oval film-coated tablet

Package unit

60 tablets/PTP[(10 tablets/PTP×6)]

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.