Medication info
Ezetimibe/Simvastatin 10/10 mg Tablet

Ezetimibe/Simvastatin 10/10 mg Tablet

Prescription medicationTablet경구
Ingredient · strength
Ezetimibe›10mg / 1 tabletSimvastatin›10mg / 1 tablet
Manufacturer / importer
알리코제약(주)
Appearance
White to pale yellow, biconvex, rectangular tablet
Packaging
30 tablets (10 tablets in PTP packaging × 3)
Approval status
Active

MFDS item code 201601735 · Approved 2016.03.31 · Insurance code 656004130

Summary

Main use
Lipid-regulating effect through the reduction of LDL cholesterol and increase of HDL cholesterol in patients with hypercholesterolemia (primary, homozygous familial) and mixed hyperlipidemia
Who takes it
Adults
Adult dose
This medication is taken once daily in the evening regardless of meals. The dosage range for patients with primary hypercholesterolemia is 10/10mg to 10/40mg daily. The generally recommended starting dose is 10/20mg daily, and the dosage may be adjusted at intervals of at least 4 weeks as necessary. The recommended dosage for patients with homozygous familial hypercholesterolemia is 10/40mg daily, taken once in the evening. In cases of renal impairment,

Ingredients

Manufacturer
알리코제약(주)

Efficacy & effects

Lipid-regulating effect through the reduction of LDL cholesterol and increase of HDL cholesterol in patients with hypercholesterolemia (primary, homozygous familial) and mixed hyperlipidemia

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerotic vascular diseases due to hypercholesterolemia
  • dyslipidemia
View approved original text

This medication is used as an adjunct to diet for the reduction of total cholesterol, LDL cholesterol, Apo B, and triglycerides, and the increase of HDL cholesterol in patients with primary hypercholesterolemia, especially heterozygous familial and non-familial, as well as mixed hyperlipidemia. In patients with homozygous familial hypercholesterolemia, it is either used alone or in combination with other lipid-lowering therapies to control cholesterol levels. This medication is prescribed when diet and non-pharmacological treatment are insufficient. It is important to confirm and treat any secondary causes when applicable. Additionally, careful risk assessment is necessary for patients at risk of atherosclerotic vascular disease due to hypercholesterolemia. Regular lipid testing to monitor therapeutic effects is also required. This medication is effectively used to improve hyperlipidemia and its related complications.

How to take

Adult dose

This medication is taken once daily in the evening regardless of meals. The dosage range for patients with primary hypercholesterolemia is 10/10mg to 10/40mg daily. The generally recommended starting dose is 10/20mg daily, and the dosage may be adjusted at intervals of at least 4 weeks as necessary. The recommended dosage for patients with homozygous familial hypercholesterolemia is 10/40mg daily, taken once in the evening. In cases of renal impairment,

Precautions

This medication helps lower blood cholesterol levels. However, serious muscle diseases such as myopathy or rhabdomyolysis may occur while taking this medication, so caution is advised. Particularly, muscle problems can be more prevalent when taken at high doses or in conjunction with specific other medications. If muscle pain or weakness occurs, or if there is pain in the muscles, you should inform your doctor immediately and discontinue the medication if necessary. This medication may affect liver function, hence it should not be taken by patients with liver disease or abnormally elevated liver enzymes. Pregnant or nursing women should also not take this medication, and women of childbearing age should use it only when there is almost no possibility of pregnancy. Furthermore, taking this medication in combination with potent CYP3A4 inhibitors such as certain antifungals, antibiotics, and antivirals may increase the risk of muscle adverse reactions, so co-administration should be avoided. Since there are many interactions with other medications, it is essential to inform your doctor or pharmacist if you are taking any other medications. Elderly patients, patients with decreased kidney function, and patients with severe muscular dystrophy should use this medication cautiously and should undergo regular blood tests to monitor muscle and liver function. During treatment with this medication, specific food intake such as grapefruit juice should also be consumed with caution, and it’s advisable to avoid excessive alcohol. The safety of this medication has not been sufficiently established in children, thus it is recommended that it not be given to children under the age of 10. If there are unusual symptoms or discomfort while taking this medication, consulting medical personnel immediately is crucial, and receiving regular check-ups for safe treatment is important.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in oral and ocular mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, jaundice (yellowing of the skin or eyes), extreme lethargy, sudden and severe headache, lightning-like headache, seizure, confusion, visual disturbances, paralysis, urinary issues

Mild side effects

  • Headache
  • diarrhea
  • influenza
  • upper respiratory tract infection
  • myalgia
  • limb pain
  • fatigue
  • abdominal pain
  • pharyngitis
  • sinusitis
Show 28 more
  • arthralgia
  • low back pain
  • cough
  • nausea
  • dizziness
  • paresthesia
  • depression
  • cholelithiasis
  • cholecystitis
  • pruritus
  • asthenia
  • photosensitivity
  • fever
  • chills
  • flushing
  • malaise
  • appetite loss
  • vomiting
  • constipation
  • dyspepsia
  • flatulence
  • cataract
  • alopecia
  • various skin changes
  • gynecomastia
  • decreased libido
  • sexual dysfunction
  • anemia

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

Storage

This medication is sensitive to air and moisture, so it should be stored in a tightly sealed container. It is essential to maintain a storage temperature between 1 to 30 degrees Celsius to preserve the medication's effectiveness and prevent degradation.

Appearance and packaging

Appearance

White to pale yellow, biconvex, rectangular tablet

Package unit

30 tablets (10 tablets in PTP packaging × 3)

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.