Medication info

Simvastatin/Ezetimibe Tablets 10/20 mg

Prescription medicationTablet경구Expired
Ingredient · strength
Ezetimibe›10mg / 1 tabletSimvastatin›20mg / 1 tablet
Manufacturer / importer
(유)한풍제약
Appearance
White to off-white, bilaterally convex rectangular tablets
Packaging
30 tablets/PTP [10 tablets/PTP X 3]
Approval status
Expired

MFDS item code 201905599 · Approved 2019.08.08

This product's status changed to Expired on 2024.08.08. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of cholesterol and lipid levels in hypercholesterolemia (primary, homozygous familial) and mixed dyslipidemia
Who takes it
Adults
Adult dose
This medication is taken once daily in the evening, regardless of meals. For patients with primary hypercholesterolemia, the dosage range is 10/10 mg to 10/40 mg daily, with the generally recommended initial dosage being 10/20 mg once daily. Patients for whom a reduction in LDL cholesterol is not needed can start with 10/10 mg once daily. For patients with homozygous familial hypercholesterolemia, the recommended dosage is 10/40 mg once daily in the evening.

Ingredients

Manufacturer
(유)한풍제약

Efficacy & effects

Improvement of cholesterol and lipid levels in hypercholesterolemia (primary, homozygous familial) and mixed dyslipidemia

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerotic vascular disease due to hypercholesterolemia
  • dyslipidemia
  • diabetes
  • hypothyroidism
  • obstructive liver disease
  • chronic kidney failure
View approved original text

This medication helps lower total cholesterol, LDL cholesterol, apoB protein, and triglycerides in patients with primary hypercholesterolemia and mixed dyslipidemia, while increasing HDL cholesterol, often referred to as 'good cholesterol.' It can be used in patients with homozygous familial hypercholesterolemia when other treatments are ineffective or as adjunct therapy. This drug must be used in conjunction with dietary management, and dyslipidemia caused by other factors should be addressed first. It’s important to check lipid levels before treatment, and in the case of acute coronary events, lipid testing should be conducted as soon as possible. Through these processes, the risk of atherosclerotic vascular disease due to hypercholesterolemia can be effectively reduced. In summary, this drug is used to improve lipid levels associated with hypercholesterolemia and enhance vascular health.

How to take

Adult dose

This medication is taken once daily in the evening, regardless of meals. For patients with primary hypercholesterolemia, the dosage range is 10/10 mg to 10/40 mg daily, with the generally recommended initial dosage being 10/20 mg once daily. Patients for whom a reduction in LDL cholesterol is not needed can start with 10/10 mg once daily. For patients with homozygous familial hypercholesterolemia, the recommended dosage is 10/40 mg once daily in the evening.

Precautions

This drug can cause muscle-related side effects, such as myopathy and rhabdomyolysis. The risk of these increases, particularly at high doses, so patients should report muscle pain or weakness to their doctor immediately. Patients with liver dysfunction or liver disease should not use this medication. Women who are pregnant or breastfeeding should also avoid this drug and consult a doctor if planning to become pregnant. The risk of muscle side effects can increase when this drug is taken with certain other medications, so patients should consult their doctor about any other medications they are taking. Elderly patients over the age of 65, or those with hypothyroidism or decreased kidney function must use this drug with caution. Regular liver function and muscle-related tests should be conducted during treatment, and any abnormal symptoms should be reported to healthcare providers immediately. This medication should be used with caution in children and adolescents, especially not recommended in patients under 10 years of age. Since there is no specific antidote for overdose, appropriate treatment should be sought at the hospital immediately.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, chest tightness, difficulty breathing, cold sweat, pallor, allergic reactions including angioedema and rash, severe allergic reactions, severe swelling (edema), anaphylaxis, toxic epidermal necrolysis (Lyell's syndrome), Stevens-Johnson syndrome, erythema multiforme, high fever accompanied by severe rash, blistering, skin peeling, pain in oral/ocular mucosa, severe skin adverse reactions, shortness of breath or difficulty breathing

Mild side effects

Headache, diarrhea, influenza, upper respiratory tract infection, myalgia, limb pain, fatigue, nausea, abdominal pain, constipation, dyspepsia, flatulence, weakness, itching, rash, increased serum creatine phosphokinase (CPK), weight loss, nocturia, hematuria, insomnia, gastritis, atrophic gastritis, mucus stools, irritable bowel syndrome, sore throat, cataract progression (lens opacity), gynecomastia, decreased libido, sexual dysfunction (including erectile dysfunction), anemia, and hypothyroidism

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 closed container. Additionally, it is important to store it at room temperature between 1°C and 30°C to maintain its effectiveness.

Appearance and packaging

Appearance

White to off-white, bilaterally convex rectangular tablets

Package unit

30 tablets/PTP [10 tablets/PTP 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

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.