Medication info
Gontrol Tablet 10 mg (Ezetimibe)

Gontrol Tablet 10 mg (Ezetimibe)

Prescription medicationTablet
Ingredient · strength
Ezetimibe›10mg / 1 tablet
Manufacturer / importer
건일바이오팜주식회사
Appearance
White to almost white oblong tablet
Packaging
30 tablets (10 tablets/PTPX3)
Approval status
Active

MFDS item code 201902435 · Approved 2019.04.19

Summary

Main use
Lipid control effect through cholesterol reduction in hypercholesterolemia (primary, familial) and sitosterolemia
Who uses it
Adults
Adult dosage
The recommended dose of this medication is 10 mg once daily, to be taken regardless of meals. When used in combination with HMG-CoA reductase inhibitors, this medication should be initiated at the recommended starting dose of the HMG-CoA reductase inhibitor. If the patient is already receiving a high dose of HMG-CoA reductase inhibitor, the dose of the HMG-CoA reductase inhibitor should be maintained while adding this medication.

Ingredients

Manufacturer
건일바이오팜주식회사

Efficacy & effects

Lipid control effect through cholesterol reduction in hypercholesterolemia (primary, familial) and sitosterolemia

  • Primary hypercholesterolemia
  • elevated total cholesterol
  • elevated low-density lipoprotein cholesterol
  • elevated apolipoprotein B
  • mixed hyperlipidemia
  • elevated non-high-density lipoprotein cholesterol
  • homozygous familial hypercholesterolemia
  • elevated sitosterol
  • elevated campesterol
View approved original text

This medication helps lower blood cholesterol and lipid levels in patients with hyperlipidemia and phytosterolemia, such as primary hypercholesterolemia, mixed hyperlipidemia, homozygous familial hypercholesterolemia, and homozygous sitosterolemia. It is particularly effective in improving vascular health by reducing total cholesterol, low-density lipoprotein cholesterol (LDL-C), apolipoprotein B, and non-high-density lipoprotein cholesterol (non-HDL-C). This drug can be used alone or in combination with other lipid-lowering agents alongside dietary control, especially for patients at high risk of atherosclerotic vascular disease due to hypercholesterolemia. It is important to exclude and treat secondary causes of dyslipidemia before administration and to confirm treatment effectiveness with regular lipid tests. Overall, this medication contributes to reducing cardiovascular disease risk through the control of cholesterol and lipid levels.

Dosage and Administration

Adult dosage

The recommended dose of this medication is 10 mg once daily, to be taken regardless of meals. When used in combination with HMG-CoA reductase inhibitors, this medication should be initiated at the recommended starting dose of the HMG-CoA reductase inhibitor. If the patient is already receiving a high dose of HMG-CoA reductase inhibitor, the dose of the HMG-CoA reductase inhibitor should be maintained while adding this medication.

Precautions

This medication should not be used in patients with hypersensitivity to certain components. In patients with active liver disease or significantly elevated liver enzyme levels, concomitant use with certain lipid-lowering agents should be avoided. Women who are pregnant or breastfeeding should be cautious as some lipid-lowering agents, including this one, are contraindicated in combination. The concomitant use of this medication with certain drugs is not recommended in patients with severely impaired liver function, gallbladder disease, or severe renal impairment. Patients with moderate or greater liver dysfunction may experience increased exposure to this drug, leading to unexpected side effects, so it should be used with caution. This medication is generally safe but may cause side effects such as headache, abdominal pain, diarrhea, fatigue, and muscle pain; if symptoms persist, consult a physician. When used in combination with other lipid-lowering agents, there may be a slight increase in the risk of elevated liver enzyme levels or muscle-related side effects, necessitating regular monitoring. If symptoms such as muscle pain or weakness occur, medical personnel should be notified immediately, and medication may be discontinued if necessary. Patients with impaired renal function may also use this medication, but dose adjustment or caution may be required, so they should follow medical advice. This drug may interact with other medications, so it is essential to inform healthcare professionals of any concurrent medications. Women who are pregnant or planning to become pregnant should consult their physician before using this drug, and nursing women should also exercise caution. Use in children below 6 years of age is not recommended, and children over 6 should follow the guidance of healthcare providers. The elderly can generally use this medication, but attention is needed for age-related sensitivity differences. In cases of drug overdose, visit a medical institution immediately for proper treatment, and store out of reach of children.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), anaphylaxis, skin and mucous membrane syndrome (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), severe skin adverse reactions including polymorphic erruptions, drug reaction with eosinophilia and systemic symptoms (DRESS), drug-induced liver injury, hepatitis, thrombocytopenia, pancreatitis, skin adverse reactions, renal failure, liver dysfunction, severe edema, severe liver dysfunction, persistent elevation of aminotransferase levels

Mild side effects

  • Fatigue
  • abdominal pain
  • diarrhea
  • viral infections
  • pharyngitis
  • sinusitis
  • arthralgia
  • lumbago
  • cough
  • chest pain
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  • dizziness
  • headache
  • constipation
  • bloating
  • nausea
  • muscle pain
  • upper respiratory tract infections
  • myopathy-related weakness or muscle pain
  • retching
  • dyspepsia
  • chest pain
  • chest discomfort
  • edema
  • asthenia
  • systemic edema
  • diabetic neuropathy
  • tremor
  • epigastric pain
  • vomiting
  • gastritis
  • dry mouth
  • epigastric discomfort
  • belching
  • gastrointestinal disturbances
  • gastroesophageal reflux

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

Storage

Store this medication in a tightly closed container to protect it from air and moisture, ideally at room temperature between 1°C and 30°C. Storing it this way helps maintain the effectiveness of the medication for a longer period.

Appearance and packaging

Appearance

White to almost white oblong tablet

Package unit

30 tablets (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.

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.