Medication info
Simvastatin and Ezetimibe Tablets 10/10 mg

Simvastatin and Ezetimibe Tablets 10/10 mg

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

MFDS item code 201601723 · Approved 2016.03.31 · Insurance code 645906030

Summary

Main use
Improvement of cholesterol and lipids in 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, with a generally recommended starting dose of 10/20mg daily. Patients who do not require significant LDL-cholesterol reduction may start with 10/10mg daily. The recommended dosage for patients with homozygous familial hypercholesterolemia is 10/40mg once daily in the evening.

Ingredients

Manufacturer
동광제약(주)

Efficacy & effects

Improvement of cholesterol and lipids in 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
View approved original text

This medication helps lower blood cholesterol and triglyceride levels in patients with primary hypercholesterolemia and mixed hyperlipidemia, while raising the levels of good cholesterol, HDL, thereby improving the balance of blood lipids. It can be used alone or in conjunction with other treatments for patients with homozygous familial hypercholesterolemia, and is also used alongside a proper diet in cases of high cardiovascular disease risk. Before use, other causative conditions such as diabetes and hypothyroidism should be confirmed and managed, and treatment direction should be adjusted based on lipid test results. This medication is used to effectively control patients' blood lipid levels to improve cardiovascular health.

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, with a generally recommended starting dose of 10/20mg daily. Patients who do not require significant LDL-cholesterol reduction may start with 10/10mg daily. The recommended dosage for patients with homozygous familial hypercholesterolemia is 10/40mg once daily in the evening.

Precautions

This medication can cause muscle-related side effects such as myopathy and rhabdomyolysis. Especially at high doses, this risk is increased; therefore, if symptoms such as muscle pain or weakness occur, the patient should immediately inform their doctor. This medication should not be used in patients with allergies to the components or severe liver dysfunction, as well as in women who are pregnant or breastfeeding, as it can interfere with cholesterol synthesis necessary for fetal development during pregnancy. Additionally, using it in conjunction with strong CYP3A4 inhibitors such as certain antifungal agents, antibiotics, and antivirals or some other medications may increase the risk of muscle side effects; patients taking these medications should not use this drug or should adjust their dosage. This medication can affect liver function, so it should be used cautiously in patients with a history of liver disease or elevated liver function test results, and regular liver function tests during treatment are advisable. Elderly patients or those with impaired kidney function may have a higher risk of side effects, so caution is required. Also, this medication may raise blood sugar levels, so patients at risk of diabetes should continuously monitor their blood sugar. During the course of treatment, if any unusual symptoms such as muscle pain, muscle weakness, liver function abnormalities, or allergic reactions occur, they should immediately consult healthcare professionals, and when taking new medications, they should always inform about this medication. Lastly, while taking this medication, it is advisable to limit grapefruit juice intake, and in the case of overdose, there is no specific antidote, thus the patient should immediately visit a medical institution for appropriate treatment.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), angioedema, chest tightness, difficulty breathing, anaphylaxis, severe allergic reactions, angioedema, skin and mucosal syndrome (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell's syndrome), erythema multiforme, severe skin adverse reactions, skin and mucosal syndrome, toxic epidermal necrolysis, acute renal failure, rhabdomyolysis, myopathy, muscle pain and tenderness, muscle weakness, severe muscle weakness, ophthalmoplegia

Mild side effects

  • Headache
  • diarrhea
  • influenza
  • upper respiratory tract infection
  • muscle pain
  • limb pain
  • fatigue
  • nausea
  • abdominal pain
  • constipation
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  • dyspepsia
  • flatulence
  • vomiting
  • itching
  • alopecia
  • dizziness
  • paresthesia
  • depression
  • asthenia
  • insomnia
  • hematuria
  • nocturia
  • weight loss
  • mucous stools
  • gastritis
  • atrophic gastritis
  • sore throat
  • cataract
  • gynecomastia
  • decreased libido
  • sexual dysfunction
  • anemia
  • increased creatine phosphokinase (CPK)
  • weight loss
  • sensory reduction

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain a room temperature between 1 degree and 30 degrees.

Appearance and packaging

Appearance

White to light yellow, biconvex, rectangular tablets

Package unit

30 tablets [(10 tablets/PTP) × 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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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.