Medication info
Novonorm Tablet 2.0 mg (Repaglinide)

Novonorm Tablet 2.0 mg (Repaglinide)

Prescription medicationTabletOral
Ingredient · strength
Repaglinide›2mg / 1 tablet
Manufacturer / importer
Novo Nordisk Pharma Korea, Ltd.
Appearance
Convex red round tablet
Packaging
90 tablets/box [15 tablets/PTPX6]
Approval status
Active

MFDS item code 199907080 · Approved 1999.04.21 · Insurance code 654400050

Summary

Main use
Improvement of glycemic control in type 2 diabetes mellitus
Who takes it
Adults
Adult dose
This medicine is administered orally before each meal. Because the insulin secretory response to food occurs within 30 minutes after taking this medicine, it is generally best to take it within 15 minutes before a meal; the timing may be adjusted from 30 minutes before a meal to immediately before eating. The physician should determine the dose according to each patient's requirements based on changes in blood glucose. 1. Monotherapy The recommended initial dose is 0.5 mg of repaglinide per dose. The dose is determined through titration at intervals of 1 or 2 weeks. Patients taking another oral hypoglycemic agent may switch directly to this medicine; in this case, the recommended initial dose is 1 mg per dose. The recommended maximum dose is 4 mg per administration, given before meals 2, 3, or 4 times daily according to the patient's meal pattern. The total daily dose must not exceed 16 mg. Exercise greater caution when administering this medicine and titrating the dose in debilitated or malnourished patients. Although this medicine is excreted mostly via the bile, caution should also be exercised in patients with renal impairment. 2. Combination therapy If blood glucose is not adequately controlled with monotherapy, this medicine may be used in combination with metformin or a thiazolidinedione. The initial dose and dose adjustment are the same as for monotherapy. The dose of each agent should be adjusted very carefully to the minimum amount required to achieve the desired pharmacologic effect. If this adjustment is not performed properly, hypoglycemic episodes may occur more frequently. Adequate monitoring of fasting blood glucose (FBG) and glycated hemoglobin (HbA1c) is necessary to prevent overdose or an increased risk of treatment failure with the second agent.

Ingredients

Importer
Novo Nordisk Pharma Korea, Ltd.

Efficacy & effects

Improvement of glycemic control in type 2 diabetes mellitus

  • Blood sugar control issues in patients with type 2 diabetes
View approved original text

This medication is used as an adjunct to diet and exercise to improve blood sugar control in patients with type 2 diabetes. It can be administered as monotherapy or in combination with metformin, sulfonylureas, or thiazolidinediones when adequate blood sugar control cannot be achieved with monotherapy. This helps to enhance blood sugar control effectiveness and improve patients' blood sugar management.

How to take

Adult dose

This medicine is administered orally before each meal. Because the insulin secretory response to food occurs within 30 minutes after taking this medicine, it is generally best to take it within 15 minutes before a meal; the timing may be adjusted from 30 minutes before a meal to immediately before eating. The physician should determine the dose according to each patient's requirements based on changes in blood glucose. 1. Monotherapy The recommended initial dose is 0.5 mg of repaglinide per dose. The dose is determined through titration at intervals of 1 or 2 weeks. Patients taking another oral hypoglycemic agent may switch directly to this medicine; in this case, the recommended initial dose is 1 mg per dose. The recommended maximum dose is 4 mg per administration, given before meals 2, 3, or 4 times daily according to the patient's meal pattern. The total daily dose must not exceed 16 mg. Exercise greater caution when administering this medicine and titrating the dose in debilitated or malnourished patients. Although this medicine is excreted mostly via the bile, caution should also be exercised in patients with renal impairment. 2. Combination therapy If blood glucose is not adequately controlled with monotherapy, this medicine may be used in combination with metformin or a thiazolidinedione. The initial dose and dose adjustment are the same as for monotherapy. The dose of each agent should be adjusted very carefully to the minimum amount required to achieve the desired pharmacologic effect. If this adjustment is not performed properly, hypoglycemic episodes may occur more frequently. Adequate monitoring of fasting blood glucose (FBG) and glycated hemoglobin (HbA1c) is necessary to prevent overdose or an increased risk of treatment failure with the second agent.

Precautions

This medication lowers blood sugar but may cause a condition called hypoglycemia, where blood sugar drops too low. The risk of hypoglycemia may increase when used with other insulin secretagogues. Care should be taken when taken in conjunction with metformin as it may further increase the risk of hypoglycemia. If blood sugar remains high even during combination therapy, switching to insulin treatment may be necessary. In stressful situations such as fever, trauma, infection, or surgery, the risk of hypoglycemia may be higher, necessitating additional caution. This medication is not recommended for certain patients. For example, individuals allergic to this medication or its components, those with type 1 diabetes, patients with diabetic ketoacidosis, women who are pregnant or breastfeeding, children under 18 years of age, patients with severe liver dysfunction, and those taking the medication gemfibrozil should not use it. Additionally, patients with significantly impaired liver or kidney function, those with heart disease, hormonal imbalances, poor nutritional status, excessive alcohol consumption, and the elderly should use this medication with caution. This medication may also cause gastrointestinal disturbances such as hypoglycemia, temporary visual disturbances, abdominal pain, diarrhea, nausea, vomiting, constipation, increased liver enzymes, skin rash, itchiness, and other allergic reactions. Particularly when combined with thiazolidinedione medications, there is an increased risk of hypoglycemia and peripheral edema, as well as heart failure. Caution is also required when driving or operating machinery due to the potential for hypoglycemia. Blood sugar should be monitored frequently, and if effects are insufficient after 2-3 months of use, a change in therapy should be considered. This medication may interact with other drugs. Some medications may enhance or prolong blood sugar-lowering effects, while others may decrease efficacy, so it is essential to consult a doctor or pharmacist about any other medications being taken. Women who are pregnant or breastfeeding should not take this medication, and its safety and efficacy have not been established in children under 18 years of age. Elderly patients should be monitored carefully for blood sugar changes due to potential declines in bodily functions. In case of overdose, symptoms of hypoglycemia such as dizziness, sweating, trembling, and headaches may occur, necessitating immediate carbohydrate intake or, in severe cases, hospitalization for glucose injection. This medication should be stored out of the reach of children and in its original container sealed to maintain quality.

Side effects

  • Hypoglycemia
  • visual impairment
  • abdominal pain
  • diarrhea
  • nausea
  • vomiting
  • constipation
  • increased liver enzymes
  • liver function abnormalities
  • erythema
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  • itching
  • rash
  • hives
  • systemic hypersensitivity reaction
  • vasculitis
  • peripheral edema
  • congestive heart failure
  • headache
  • sensory disturbances
  • chest pain
  • urinary tract infection
  • dental disorders
  • leukopenia
  • thrombocytopenia
  • alopecia
  • hemolytic anemia
  • pancreatitis
  • Stevens-Johnson syndrome
  • severe liver dysfunction
  • chest discomfort
  • renal function abnormalities
  • dizziness
  • sweating
  • tremor
  • headache

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

Storage

This medication should be stored in a tightly closed container in a cool dry place, ideally between 15 and 25 degrees Celsius. This helps to maintain the medication's effectiveness over time.

Appearance and packaging

Appearance

Convex red round tablet

Package unit

90 tablets/box [15 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.