Medication info

Ridipho M Tablet 2.5/1000 mg

Prescription medicationTablet경구
Ingredient · strength
Linagliptin›2.5mg / 1 tabletMetformin Hydrochloride›1000mg / 1 tablet
Manufacturer / importer
동광제약(주)
Appearance
A light pink, bilaterally convex, oval film-coated tablet.
Packaging
30 tablets/box [(10 tablets/PTPX3)], 60 tablets/box [(10 tablets/PTPX6)]
Approval status
Active

MFDS item code 202204204 · Approved 2022.11.22

Summary

Main use
Improvement of blood sugar control in type 2 diabetes
Who takes it
Adults
Adult dose
The dosage of this medication should be determined based on the maximum recommended doses of linagliptin 2.5 mg and metformin 1000 mg, not exceeding two times a day, while considering each patient’s current treatment regimen, efficacy, and tolerability. This medication is administered 2 times daily with meals. 1. If currently not treated with metformin: This medication 2.5/500 mg is taken 2 times a day, 1 tablet per dose, and can be escalated to 2.5/1000 mg 1 tablet, taken 2 times a day. 2. If unable to achieve adequate glycemic control with metformin monotherapy: For initial dosing, administer linagliptin 2.5 mg 2 times a day (total daily amount 5 mg) along with the existing dosage of metformin (e.g., for patients taking metformin 1000 mg twice daily, take linagliptin 2.5 mg/metformin 1000 mg 2 times daily with meals). 3. If switching from combination therapy of linagliptin and metformin: Patients transitioning from combination therapy of linagliptin and metformin should start at the previously established dosing for both medications. 4. If unable to achieve adequate glycemic control with combination therapy of metformin and sulfonylureas: Initial dosing should consider linagliptin 2.5 mg 2 times a day (total daily amount 5 mg) along with the existing metformin dosage. When used with sulfonylureas, a reduction of the sulfonylurea dose may be necessary to decrease the risk of hypoglycemia (see precautions regarding careful administration with certain patients). 5. If unable to achieve adequate glycemic control with combination therapy of insulin and metformin: Initial dosing should consider linagliptin 2.5 mg 2 times a day (total daily amount 5 mg) similar to the existing dosage of metformin. When taken with insulin, a reduction of insulin dosage may be necessary to reduce the risk of hypoglycemia (see precautions regarding careful administration with certain patients). Studies evaluating the safety and efficacy of switching patients previously treated with other oral hypoglycemics to this medication have not been conducted. Any changes in type 2 diabetes treatment can affect blood glucose control, and therefore careful monitoring is required. In patients with renal impairment: This medication can be used with specific dose adjustments among patients with moderate renal impairment stage 3a (creatinine clearance [CrCl] 45-<60 ml/min or estimated GFR 45-<60 mL/min/1.73 m2) without accompanying symptoms that increase the risk of lactic acidosis. The initial dose of metformin should be 500 mg or 850 mg once a day, therefore do not initiate treatment with this medication. The maximum recommended dose of metformin is 500 mg twice a day. Renal function should be carefully monitored every 3-6 months. If CrCl < 45 ml/min or eGFR < 45 ml/min/1.73m2 indicates reduced renal function, this medication should be immediately discontinued. In patients with liver dysfunction: This medication should not be administered to patients with hepatic dysfunction due to its metformin component (refer to the precautions against administration in patients with liver dysfunction).

Ingredients

Manufacturer
동광제약(주)

Efficacy & effects

Improvement of blood sugar control in type 2 diabetes

View approved original text

This medication is used to help control blood sugar in patients with type 2 diabetes who are taking linagliptin and metformin together. It assists in effectively improving blood sugar management when combined with dietary adjustments and exercise therapy. Therefore, it contributes to maintaining stable blood sugar levels and reducing the risk of complications.

How to take

Adult dose

The dosage of this medication should be determined based on the maximum recommended doses of linagliptin 2.5 mg and metformin 1000 mg, not exceeding two times a day, while considering each patient’s current treatment regimen, efficacy, and tolerability. This medication is administered 2 times daily with meals. 1. If currently not treated with metformin: This medication 2.5/500 mg is taken 2 times a day, 1 tablet per dose, and can be escalated to 2.5/1000 mg 1 tablet, taken 2 times a day. 2. If unable to achieve adequate glycemic control with metformin monotherapy: For initial dosing, administer linagliptin 2.5 mg 2 times a day (total daily amount 5 mg) along with the existing dosage of metformin (e.g., for patients taking metformin 1000 mg twice daily, take linagliptin 2.5 mg/metformin 1000 mg 2 times daily with meals). 3. If switching from combination therapy of linagliptin and metformin: Patients transitioning from combination therapy of linagliptin and metformin should start at the previously established dosing for both medications. 4. If unable to achieve adequate glycemic control with combination therapy of metformin and sulfonylureas: Initial dosing should consider linagliptin 2.5 mg 2 times a day (total daily amount 5 mg) along with the existing metformin dosage. When used with sulfonylureas, a reduction of the sulfonylurea dose may be necessary to decrease the risk of hypoglycemia (see precautions regarding careful administration with certain patients). 5. If unable to achieve adequate glycemic control with combination therapy of insulin and metformin: Initial dosing should consider linagliptin 2.5 mg 2 times a day (total daily amount 5 mg) similar to the existing dosage of metformin. When taken with insulin, a reduction of insulin dosage may be necessary to reduce the risk of hypoglycemia (see precautions regarding careful administration with certain patients). Studies evaluating the safety and efficacy of switching patients previously treated with other oral hypoglycemics to this medication have not been conducted. Any changes in type 2 diabetes treatment can affect blood glucose control, and therefore careful monitoring is required. In patients with renal impairment: This medication can be used with specific dose adjustments among patients with moderate renal impairment stage 3a (creatinine clearance [CrCl] 45-<60 ml/min or estimated GFR 45-<60 mL/min/1.73 m2) without accompanying symptoms that increase the risk of lactic acidosis. The initial dose of metformin should be 500 mg or 850 mg once a day, therefore do not initiate treatment with this medication. The maximum recommended dose of metformin is 500 mg twice a day. Renal function should be carefully monitored every 3-6 months. If CrCl < 45 ml/min or eGFR < 45 ml/min/1.73m2 indicates reduced renal function, this medication should be immediately discontinued. In patients with liver dysfunction: This medication should not be administered to patients with hepatic dysfunction due to its metformin component (refer to the precautions against administration in patients with liver dysfunction).

Precautions

This medication can cause a rare but serious side effect known as lactic acidosis, and should not be used in patients with impaired kidney function or those with heart disease or liver dysfunction. It should not be administered to patients who have allergies to any component of this medication or to patients with type 1 diabetes, pregnant women or nursing mothers, or patients with acute alcohol intoxication. Caution should be taken for hypoglycemia when using this medication in conjunction with insulin or sulfonylureas, and dosage adjustments of other medications may be necessary. Elderly patients or patients taking medications that may affect kidney function should undergo regular kidney function tests and should discontinue this medication if kidney function deteriorates. This medication should be temporarily discontinued before and after acute illnesses, surgeries, or radiological contrast examinations, and can be resumed once the condition stabilizes. Patients with chronic heart failure can use this medication while periodically monitoring heart and kidney function, but it is not recommended for patients with unstable heart failure. If skin diseases, such as acute pancreatitis or bullous pemphigoid, are suspected, discontinue use immediately and consult a physician. Long-term use of this medication may decrease vitamin B12 levels; thus, patients should be checked for vitamin B12 deficiency symptoms with blood tests and receive supplementation if necessary. There are relatively few drug interactions, but caution is needed when taken with medications impacting kidney function. Pregnant women or those planning to become pregnant should not take this medication, and consider insulin therapy for blood sugar control. It is advisable not to administer this medication to children under 10 years of age, as safety and efficacy have not been established. Elderly individuals are at a higher risk of decreased kidney function and should start at the lowest effective dose and have their kidney function regularly monitored. In the event of an overdose, serious side effects such as lactic acidosis may occur, requiring immediate medical attention and possible hemodialysis.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, lactic acidosis, pancreatitis, bullous pemphigoid, abnormal liver function (hepatitis, liver function test abnormalities), pneumonia, acute renal failure, acute kidney injury, acute cholangitis, acute cholecystitis, cholangitis, angina pectoris, acute myocardial infarction, unstable angina, cardiac arrest, severe edema, fever with severe rash, blisters, skin peeling, oral/eye mucosal pain, respiratory distress, asthma attacks, severe allergic reactions (hives, ...

Mild side effects

  • Hypoglycemia
  • taste disturbances
  • cough
  • decreased appetite
  • diarrhea
  • constipation
  • nausea
  • vomiting
  • abdominal pain
  • pruritus
Show 22 more
  • erythema
  • rash
  • mouth ulcers
  • abnormal liver function tests
  • hepatitis
  • severe and disabling arthralgia
  • rhabdomyolysis
  • increased lipase
  • increased amylase
  • decreased vitamin B12 and deficiency
  • fever
  • fatigue
  • itching
  • insomnia
  • depression
  • dizziness
  • chest discomfort
  • weakness
  • pain
  • nosebleed
  • oropharyngeal pain
  • and growth unusual.

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 moisture, and the storage temperature should be at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the drug's effectiveness and prevent degradation.

Appearance and packaging

Appearance

A light pink, bilaterally convex, oval film-coated tablet.

Package unit

30 tablets/box [(10 tablets/PTPX3)], 60 tablets/box [(10 tablets/PTPX6)]

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.