Medication info
Easy Simvastatin Tablets 10/10 mg (Ezetimibe, Simvastatin)

Easy Simvastatin Tablets 10/10 mg (Ezetimibe, Simvastatin)

Prescription medicationTablet경구
Ingredient · strength
Ezetimibe›10mg / 1 tabletSimvastatin›10mg / 1 tablet
Manufacturer / importer
(주)서흥
Appearance
White to light yellow, bi-convex, rectangular tablets
Packaging
30 tablets (10 tablets/Alu-Alu x 3)
Approval status
Active

MFDS item code 201007235 · Notified 2010.11.29 · Insurance code 679601010

Summary

Main use
Improvement of lipid levels through reduction of LDL cholesterol and increase of HDL cholesterol in hypercholesterolemia (primary and homozygous familial) and mixed dyslipidemia.
Who takes it
Adults
Adult dose
This drug is taken once daily in the evening, with or without meals. For patients with primary hypercholesterolemia, the recommended dosage is between 10/10 mg and 10/40 mg daily, generally starting with a dose of 10/20 mg once daily. Patients who require less reduction in LDL cholesterol may start at 10/10 mg once daily. For patients with homozygous familial hypercholesterolemia, the recommended dose is 10/40 mg once daily in the evening.

Ingredients

Manufacturer
(주)서흥

Efficacy & effects

Improvement of lipid levels through reduction of LDL cholesterol and increase of HDL cholesterol in hypercholesterolemia (primary and homozygous familial) and mixed dyslipidemia.

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • increased risk of atherosclerotic vascular disease due to hypercholesterolemia
  • dyslipidemia.
View approved original text

This drug is used as an adjunct to diet in patients with primary hypercholesterolemia and mixed dyslipidemia, reducing total cholesterol, LDL cholesterol, apoB protein, and triglycerides, while increasing good cholesterol, HDL cholesterol. It is particularly helpful for patients with homozygous familial hypercholesterolemia (HoFH) when alternative treatments are ineffective or difficult to implement. This drug is used for lipid control in patients with a high risk of cardiovascular disease in conjunction with dietary therapy and is recommended for those who do not respond adequately to other non-drug therapies. Before administration, it is crucial to check for secondary causes such as diabetes or hypothyroidism and treat them if necessary. During treatment, total cholesterol, LDL, HDL, and triglyceride levels should be regularly monitored, and especially when triglycerides are high, accurate LDL levels should be confirmed. This drug is used to reduce the risk of hypercholesterolemia and atherosclerotic vascular disease and improve healthy blood lipid levels.

How to take

Adult dose

This drug is taken once daily in the evening, with or without meals. For patients with primary hypercholesterolemia, the recommended dosage is between 10/10 mg and 10/40 mg daily, generally starting with a dose of 10/20 mg once daily. Patients who require less reduction in LDL cholesterol may start at 10/10 mg once daily. For patients with homozygous familial hypercholesterolemia, the recommended dose is 10/40 mg once daily in the evening.

Precautions

This drug is used to lower blood cholesterol levels. While taking this drug, symptoms such as muscle pain or weakness may occur, which can lead to serious side effects such as myopathy or rhabdomyolysis. Particularly, the risk may increase when taking high doses or in combination with certain other medications, so caution is needed. Patients with impaired liver function or liver disease should not use this drug as it can worsen liver function. Women who are pregnant or nursing should not take this drug, and women who may become pregnant must consult a doctor before use. Taking this drug together with medications that inhibit certain enzymes can increase blood levels and the risk of side effects, so it is essential to inform if there are any co-administered medications. Particularly, the risk of muscle-related side effects may increase when used with antifungals, antibiotics, some cardiac medications, immunosuppressants, and fibrates. If muscle pain, muscle weakness, or unexplained muscle symptoms occur during treatment, inform a doctor immediately and discontinue the drug if necessary. Additionally, regular liver function tests and muscle enzyme tests are recommended. This drug should be used cautiously in children, especially in those under 10 years old, as safety and efficacy have not been fully established. Elderly patients may also be more sensitive to this drug, so careful monitoring is needed. Certain foods like grapefruit juice should be avoided while taking this drug, and it is important to inform healthcare providers when starting any new medications while on this drug.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, rash, anaphylaxis, myopathy, rhabdomyolysis, hepatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis (Lyell syndrome), polymorphic erythema, severe skin reactions, liver abnormalities (including jaundice), severe edema, severe allergic reactions, severe muscle weakness, ocular muscle weakness, kidney damage, fatal liver failure, acute renal failure, interstitial lung disease, severe rash, blisters, skin.

Mild side effects

  • Headache
  • diarrhea
  • influenza
  • upper respiratory tract infection
  • muscle pain
  • limb pain
  • fatigue
  • abdominal pain
  • nausea
  • constipation
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  • indigestion
  • flatulence
  • vomiting
  • dizziness
  • paraesthesia
  • depression
  • cholelithiasis
  • cholecystitis
  • itching
  • alopecia
  • hematuria
  • nocturia
  • weight loss
  • asthenia
  • hypoaesthesia
  • sore throat
  • insomnia
  • skin changes
  • gynecomastia
  • decreased libido
  • sexual dysfunction
  • cataracts
  • dizziness
  • syncope
  • insomnia
  • gastritis
  • atrophic gastritis
  • mucus stool.

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

Storage

This drug should be stored in a sealed container as it is sensitive to air and moisture. It is recommended to keep it at room temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

White to light yellow, bi-convex, rectangular tablets

Package unit

30 tablets (10 tablets/Alu-Alu x 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.