Medication info
Ezetimibe 10/10 mg Tablets

Ezetimibe 10/10 mg Tablets

Prescription medicationTablet
Ingredient · strength
Atorvastatin Calcium Trihydrate›10.85mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
(주)넥스팜코리아
Appearance
White or pale yellow, bilaterally convex coated tablets in a capsule shape
Packaging
30 tablets/box [(10 tablets/Alu-Alu)x3]
Approval status
Active

MFDS item code 202101573 · Approved 2021.02.18 · Insurance code 662504650

Summary

Main use
Improvement of lipids through cholesterol reduction and HDL increase in hypercholesterolemia (primary, homozygous familial) and dyslipidemia
Who uses it
Adults
Adult dosage
This medication is taken once daily, regardless of meals. The dosage range for primary hypercholesterolemia is 10/10 mg to 10/80 mg daily, with an initial dose of 10/10 mg or 10/20 mg once a day. For patients requiring a greater reduction in LDL cholesterol, an initial dose of 10/40 mg daily is recommended. The recommended dose for patients with homozygous familial hypercholesterolemia is 10/40 mg or 10.

Ingredients

Manufacturer
(주)넥스팜코리아

Efficacy & effects

Improvement of lipids through cholesterol reduction and HDL increase in hypercholesterolemia (primary, homozygous familial) and dyslipidemia

  • Primary hypercholesterolemia
  • elevated total cholesterol
  • LDL cholesterol
  • Apo B protein
  • triglycerides
  • non-HDL cholesterol
  • homozygous familial hypercholesterolemia
View approved original text

This medication helps lower elevated cholesterol and fat levels in the blood. It is particularly used in patients with primary hypercholesterolemia and familial or non-familial dyslipidemia to reduce total cholesterol, LDL cholesterol, Apo B protein, triglycerides, and non-HDL cholesterol, while increasing levels of HDL cholesterol, known as good cholesterol, thereby lowering the risk of cardiovascular disease. In homozygous familial hypercholesterolemia patients, it is additionally used when other treatments are insufficient to control cholesterol levels. This medication should be used in conjunction with appropriate dietary restrictions and it's important to manage other health issues such as diabetes or hypothyroidism. During treatment, blood lipid levels should be monitored regularly to confirm and adjust efficacy. This medication improves health by reducing the risk of vascular diseases associated with hypercholesterolemia.

Dosage and Administration

Adult dosage

This medication is taken once daily, regardless of meals. The dosage range for primary hypercholesterolemia is 10/10 mg to 10/80 mg daily, with an initial dose of 10/10 mg or 10/20 mg once a day. For patients requiring a greater reduction in LDL cholesterol, an initial dose of 10/40 mg daily is recommended. The recommended dose for patients with homozygous familial hypercholesterolemia is 10/40 mg or 10.

Precautions

This medication is a specific class of lipid-lowering agents and rare side effects like rhabdomyolysis, which can cause severe muscle damage, have been reported. Therefore, if severe muscle pain or weakness occurs, consult a doctor immediately. Additionally, if there are conditions that can affect renal function, such as severe infections, hypotension, or post-major surgery, it may be necessary to temporarily suspend or discontinue use of this medication. Individuals with allergies to active ingredients or components, active liver disease, unexplained liver enzyme elevation, or muscle disorders should not use this medication. Pregnant or potentially pregnant women, as well as nursing mothers, should also not take this medication. Furthermore, certain antiviral agents and patients with lactose intolerance are contraindicated for use. Caution is advised for alcoholics, individuals with impaired liver function, those with diminished renal function, patients with hypothyroidism, and the elderly, as they may have an increased risk of myopathy and may require regular monitoring. Extra caution is needed when taking this medication alongside fibrate-class drugs. During treatment, symptoms like muscle pain, fatigue, dizziness, dyspepsia, elevated liver enzymes may occur, and if any unusual symptoms appear, consult a physician. Liver function tests should be conducted regularly before and during use, and if liver damage is suspected, treatment should be stopped immediately. This medication can interact with various other drugs, so inform health professionals of any other medications being taken. Women of childbearing age should use appropriate contraception while taking this medication, and caution is required as dizziness may occur during driving or operating machinery. There is no specific antidote for overdose, and treatment needs to be symptom-oriented with supportive therapy, while monitoring liver function and muscle enzyme levels. This medication is not recommended for children as safety and efficacy have not been established. If muscle pain or weakness symptoms become severe or persistent during treatment, consult a physician, and treatment may be discontinued if necessary.

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, peeling skin, mouth/eye mucosal pain, shortness of breath or difficulty breathing, asthma attack, respiratory anomalies accompanied by cough+fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination issues

Mild side effects

  • Muscle pain
  • abdominal pain
  • elevated liver enzymes
  • dizziness
  • cough
  • nausea
  • diarrhea
  • joint pain
  • muscle weakness
  • musculoskeletal pain
Show 26 more
  • hyperkalemia
  • bronchitis
  • sinusitis
  • flushing
  • headache
  • fatigue
  • constipation
  • hyperglycemia
  • hypoglycemia
  • anorexia
  • dyspepsia
  • vomiting
  • belching
  • pancreatitis
  • pharyngeal and laryngeal pain
  • nosebleed
  • insomnia
  • nightmares
  • paresthesia
  • sensory loss
  • dysgeusia
  • amnesia
  • peripheral neuropathy
  • itchiness
  • skin rash
  • alopecia

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is best stored at room temperature between 1°C and 30°C. Proper storage helps maintain the medication's effectiveness over time.

Appearance and packaging

Appearance

White or pale yellow, bilaterally convex coated tablets in a capsule shape

Package unit

30 tablets/box [(10 tablets/Alu-Alu)x3]

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

No questions yet.

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

Related searches

Search tags

Suggested searches

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.