Medication info
Tenegliptin M Sustained Release Tablet 10/500 mg

Tenegliptin M Sustained Release Tablet 10/500 mg

Prescription medicationTablet경구
Ingredient · strength
Teneligliptin Hydrochloride Hydrate›13mg / 1 tabletMetformin Hydrochloride›500mg / 1 tablet
Manufacturer / importer
(주)한국파비스제약
Appearance
Orange oval-shaped sustained-release film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 202201431 · Approved 2022.04.04 · Insurance code 621804460

Summary

Main use
Improvement of blood glucose control in type 2 diabetes
Who takes it
Adults
Adult dose
Typically, this medication is administered once daily with the evening meal, and the dosage is titrated gradually to minimize gastrointestinal side effects associated with metformin. The sustained-release tablets of this medication 20/1000 mg are taken once daily, one tablet at a time. Patients taking this medication 10/750 mg or 10/500 mg sustained-release tablets are to take two tablets at the same time once daily. In patients who are unable to achieve adequate blood glucose control with metformin monotherapy, the initial dosage of this medication should provide teneligliptin 20 mg once daily along with the current metformin dose. For patients switching from a combination therapy of teneligliptin and metformin to this medication, the dose can start at the existing doses of teneligliptin and metformin. When switching from immediate-release metformin to the sustained-release formulation, blood glucose control should be closely monitored, and dosage adjustments should be made appropriately. When co-administering with sulfonylureas, consideration should be given to reducing the dosage of sulfonylureas to decrease the risk of hypoglycemia. The maximum recommended daily dosage is teneligliptin 20 mg and sustained-release metformin 2000 mg. The safety and efficacy of this medication have not been specifically evaluated in patients switching from other antidiabetic medications to this medication. Any changes in the treatment of patients with type 2 diabetes must be closely monitored due to the potential for affecting blood glucose control. To maintain the sustained-release characteristics, this medication should be swallowed whole and not split, crushed, or chewed.

Ingredients

Manufacturer
(주)한국파비스제약

Efficacy & effects

Improvement of blood glucose control in type 2 diabetes

View approved original text

This medication assists in the management of blood glucose levels in patients with type 2 diabetes by complementing dietary and exercise therapy. Teneligliptin and metformin work together to effectively lower blood glucose levels. Therefore, regular use can be beneficial for improving blood glucose management.

How to take

Adult dose

Typically, this medication is administered once daily with the evening meal, and the dosage is titrated gradually to minimize gastrointestinal side effects associated with metformin. The sustained-release tablets of this medication 20/1000 mg are taken once daily, one tablet at a time. Patients taking this medication 10/750 mg or 10/500 mg sustained-release tablets are to take two tablets at the same time once daily. In patients who are unable to achieve adequate blood glucose control with metformin monotherapy, the initial dosage of this medication should provide teneligliptin 20 mg once daily along with the current metformin dose. For patients switching from a combination therapy of teneligliptin and metformin to this medication, the dose can start at the existing doses of teneligliptin and metformin. When switching from immediate-release metformin to the sustained-release formulation, blood glucose control should be closely monitored, and dosage adjustments should be made appropriately. When co-administering with sulfonylureas, consideration should be given to reducing the dosage of sulfonylureas to decrease the risk of hypoglycemia. The maximum recommended daily dosage is teneligliptin 20 mg and sustained-release metformin 2000 mg. The safety and efficacy of this medication have not been specifically evaluated in patients switching from other antidiabetic medications to this medication. Any changes in the treatment of patients with type 2 diabetes must be closely monitored due to the potential for affecting blood glucose control. To maintain the sustained-release characteristics, this medication should be swallowed whole and not split, crushed, or chewed.

Precautions

This medication can very rarely cause a severe side effect known as lactic acidosis; if symptoms occur, you should seek medical attention immediately. Patients with moderate to severe renal impairment, heart issues, acute infections, or serious trauma should not use this medication. It is essential to discontinue this medication before undergoing tests that use radiologic iodine contrast agents, and resume only after confirming normal kidney function. This medication can induce hypoglycemia; therefore, when used in conjunction with insulin or other antidiabetic medications, be cautious of hypoglycemic symptoms and consume sugar immediately if symptoms appear. Patients with severe liver or lung impairment, persons who consume excessive alcohol, and those in poor nutritional status should use this medication with caution. Pregnant women or those who may become pregnant should not take this medication, and breastfeeding women should consult a doctor before using it. Elderly patients may experience reduced kidney function, so regular kidney function tests should be conducted, and dosage adjusted accordingly. It is advisable to avoid alcohol consumption while taking this medication, and if sudden vomiting, diarrhea, or dehydration occurs during treatment, consult healthcare professionals immediately. This medication may interact with specific drugs, so if you are taking other medications, be sure to inform your doctor or pharmacist. If severe abdominal pain, vomiting, skin rash, or shortness of breath occurs while taking this medication, seek medical attention immediately. Since the safety and efficacy of this medication have not been established in children, it is recommended not to use it in that population.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, skin peeling, pain in oral/eye mucosa, difficulty breathing or shortness of breath, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), severe lethargy, sudden and severe headaches, lightning-like headaches, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

  • Hypoglycemia
  • constipation
  • dizziness
  • tremors
  • headaches
  • weakness
  • hunger
  • fatigue
  • facial swelling
  • diarrhea
Show 26 more
  • dyspepsia
  • nausea
  • itching
  • cold sweat
  • malaise
  • allergic rhinitis
  • elevated serum uric acid
  • peripheral edema
  • rash
  • eczema
  • arthralgia
  • muscle weakness
  • back pain
  • limb pain
  • falls
  • lip injury
  • bruises
  • pressure ulcers
  • vomiting
  • gastritis
  • gastrointestinal motility disorders
  • constipation
  • abdominal bloating
  • abdominal discomfort
  • abdominal pain
  • high

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

Storage

This medication should be stored in a closed container to prevent air from entering and kept at a temperature between 1 degree and 30 degrees Celsius. Storing it this way will help maintain the medication's effectiveness and prevent deterioration.

Appearance and packaging

Appearance

Orange oval-shaped sustained-release film-coated tablet

Package unit

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.

Questions about this medicine

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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.