Medication info
Simvastatin/Ezetimibe Tablet 10/10

Simvastatin/Ezetimibe Tablet 10/10

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

MFDS item code 201601716 · Approved 2016.03.31 · Insurance code 649103020

Summary

Main use
Improvement of cholesterol and lipid levels in hypercholesterolemia (primary, homozygous familial) and mixed hyperlipidemia
Who takes it
Adults
Adult dose
This medication is administered once daily in the evening, regardless of meals. The dosage range for patients with primary hypercholesterolemia is 10/10mg to 10/40mg daily, and the generally recommended initial dosage is 10/20mg daily. Patients who do not require much reduction in LDL cholesterol can start at 10/10mg daily. After starting this medication or adjusting the dosage, blood lipid levels should be checked at intervals of more than 4 weeks.

Ingredients

Manufacturer
한국휴텍스제약(주)

Efficacy & effects

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

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

This drug helps to lower total cholesterol, LDL cholesterol, ApoB, and triglyceride levels, and to raise HDL cholesterol levels in patients with primary hypercholesterolemia and mixed hyperlipidemia when used in conjunction with a dietary regimen. In particular, it can be used in conjunction with or as an alternative therapy for patients with homozygous familial hypercholesterolemia. This drug is used as an adjunct when dietary measures and other non-drug interventions, which limit saturated fat and cholesterol intake, are ineffective without relying solely on medications. It is important to identify and manage other causes of hypercholesterolemia, such as diabetes and hypothyroidism, before administration, and to routinely check and manage total cholesterol, LDL, HDL, and triglyceride levels during treatment. This drug is effectively used to reduce the risk of hypercholesterolemia and related atherosclerotic vascular diseases.

How to take

Adult dose

This medication is administered once daily in the evening, regardless of meals. The dosage range for patients with primary hypercholesterolemia is 10/10mg to 10/40mg daily, and the generally recommended initial dosage is 10/20mg daily. Patients who do not require much reduction in LDL cholesterol can start at 10/10mg daily. After starting this medication or adjusting the dosage, blood lipid levels should be checked at intervals of more than 4 weeks.

Precautions

This drug is primarily used to lower blood cholesterol levels. However, serious muscle-related side effects such as myopathy or rhabdomyolysis may occur while taking this medication, so caution is advised. The risk may be higher when taken in high doses or in conjunction with certain other medications. This drug should not be administered to patients with poor liver function, pregnant women, or nursing mothers. Special monitoring is necessary when this drug is used in patients with liver dysfunction or a history of liver disease. If severe muscle weakness symptoms appear, consult a physician immediately and discontinue use of the drug. This drug can interact with several other medications, so it is essential to inform healthcare professionals of any other medications being taken. In particular, combining with certain antibiotics, antifungals, immunosuppressants, and some heart medications can increase the risk of muscle damage. If symptoms such as muscle pain, muscle weakness, or severe fatigue occur during use, notify a healthcare facility immediately. Use in the elderly or children requires caution, and for children, consultation with a specialist is advised before use. Additionally, this drug may affect blood glucose levels, so regular blood glucose testing is recommended for patients at risk of diabetes. Regular liver function tests and muscle-related examinations during treatment are safe. There is no specific antidote for overdose, so immediate medical attention is required for appropriate treatment. Finally, women who plan to become pregnant or are pregnant should not use this medication, and it should be discontinued immediately if pregnancy is confirmed.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), rash, angioedema, mucocutaneous syndrome (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell syndrome), polymorphic erythema, anaphylaxis, elevation of liver amino transferase levels, hepatitis, pancreatitis, thrombocytopenia, myopathy, rhabdomyolysis, acute renal failure, jaundice, liver failure, severe muscle weakness, oculomotor weakness, headache, altered consciousness, seizures, visual disturbances, paralysis, respiratory distress

Mild side effects

  • Headache
  • diarrhea
  • influenza
  • upper respiratory tract infection
  • muscle pain
  • limb pain
  • fatigue
  • abdominal pain
  • nausea
  • constipation
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  • dyspepsia
  • flatulence
  • vomiting
  • dizziness
  • sensory abnormalities
  • depression
  • cholelithiasis
  • cholecystitis
  • pruritus
  • eczema
  • rash
  • alopecia
  • various skin changes
  • drug rash resembling lichen planus
  • gynecomastia
  • decreased libido
  • sexual dysfunction
  • cataract
  • ocular muscle paralysis
  • anemia
  • insomnia
  • gastritis
  • atrophic gastritis
  • mucous stool
  • irritable bowel syndrome

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

Storage

This drug should be stored in a tightly sealed container to prevent exposure to air and moisture. The appropriate storage temperature is room temperature between 1 and 30 degrees Celsius, and it is advisable to avoid excessively hot or cold locations.

Appearance and packaging

Appearance

White to light yellow, double convex, rectangular tablet

Package unit

30 tablets (10 tablets PTP packaging 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.