Medication info
Simvazet Tablet 10/10

Simvazet Tablet 10/10

Prescription medicationTablet경구
Ingredient · strength
Ezetimibe›10mg / 1 tabletSimvastatin›10mg / 1 tablet
Manufacturer / importer
(주)비보존제약
Appearance
White to pale yellow, bilaterally convex rectangular tablet
Packaging
30 tablets/Alu-Alu packaging (10 tablets/Alu-Alu * 3)
Approval status
Active

MFDS item code 201603858 · Approved 2016.06.24 · Insurance code 658203270

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 10/10 mg to 10/40 mg per day, and the generally recommended starting dose is 10/20 mg per day. Patients who require less reduction of LDL cholesterol may start at 10/10 mg per day. After starting treatment or adjusting the dosage, serum lipid levels should be checked after an interval of more than 4 weeks.

Ingredients

Manufacturer
(주)비보존제약

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
  • increased risk of atherosclerotic vascular disease due to hypercholesterolemia
  • dyslipidemia
  • diabetes
  • hypothyroidism
  • obstructive liver disease
  • chronic renal failure
View approved original text

This medication primarily helps patients with hypercholesterolemia, such as primary hypercholesterolemia, lower total cholesterol and bad LDL cholesterol, and triglyceride levels, while increasing good HDL cholesterol levels. It is especially effective in patients with familial hypercholesterolemia when used in conjunction with dietary modifications. For patients with homozygous familial hypercholesterolemia, it is used as an adjunctive therapy when other treatments are insufficient or difficult. It is important to consider risk factors adequately while using this medication, and it should be used in combination with a diet that restricts saturated fats and cholesterol intake. Additionally, it should be administered after a thorough review of serum lipid levels and the causes of dyslipidemia, and, if necessary, other underlying cause treatments should be prioritized. Considering these points, this medication is used to improve cholesterol regulation and enhance vascular health.

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 10/10 mg to 10/40 mg per day, and the generally recommended starting dose is 10/20 mg per day. Patients who require less reduction of LDL cholesterol may start at 10/10 mg per day. After starting treatment or adjusting the dosage, serum lipid levels should be checked after an interval of more than 4 weeks.

Precautions

This medication can cause serious muscle-related side effects such as myopathy and rhabdomyolysis. The risk of these side effects may increase especially when taken in high doses or in combination with certain medications. Patients with hypersensitivity to the components of this medication or active liver disease, as well as women who are pregnant or nursing, should not take it. Additionally, patients taking strong CYP3A4 inhibitors, gemfibrozil, cyclosporine, or danazol should also avoid this medication. Caution is advised for patients with severe myasthenia gravis or ocular myasthenia gravis, and if symptoms such as myalgia, tenderness, or muscle weakness appear during use, consult a physician immediately. Patients with liver dysfunction should also be monitored carefully, and treatment should be discontinued if liver function tests consistently show abnormalities. During the course of this medication, do not take other medications without consulting a physician, and when prescribed new medications, it is essential to inform the physician that this medication is being taken. Women who are planning to become pregnant or may be pregnant should consult a physician before taking this medication and must discontinue use immediately if pregnancy is confirmed. It is also safest for nursing women to discontinue breastfeeding while on this medication. Elderly patients, especially those over 65, may respond more sensitively to this medication, hence caution is needed while using it. Additionally, this medication may raise blood sugar levels, so patients at risk for diabetes should check their blood sugar regularly. In the event of overdose, there is no specific antidote, so symptomatic treatment should be received, and regular check-ups and monitoring are crucial to prevent and manage side effects.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blistering, skin peeling, pain in mucous membranes of mouth/eyes, breathing difficulties, asthma attacks, abnormal breathing accompanied by cough and fever, yellowing of skin or eyes (jaundice), profound lethargy, sudden and severe headache, thunderclap headache, seizure, confusion, vision disturbances, paralysis, urination

Mild side effects

  • Headache
  • diarrhea
  • influenza
  • upper respiratory tract infection
  • myalgia
  • limb pain
  • fatigue
  • nausea
  • abdominal pain
  • constipation
Show 30 more
  • dyspepsia
  • flatulence
  • vomiting
  • itching
  • nocturia
  • hematuria
  • dizziness
  • paresthesia
  • insomnia
  • sore throat
  • alopecia
  • gynecomastia
  • decreased libido
  • sexual dysfunction
  • cataract
  • anemia
  • weight loss
  • weakness
  • malaise
  • flushing
  • fever
  • chills
  • photosensitivity
  • depression
  • urticaria
  • rash
  • muscle cramps
  • arthralgia
  • low back pain
  • blood

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

Storage

This medication is sensitive to air and humidity, so it must be stored in a tightly sealed container. Additionally, avoid storing it in extremely hot or cold places and store it at room temperature between 1°C and 30°C.

Appearance and packaging

Appearance

White to pale yellow, bilaterally convex rectangular tablet

Package unit

30 tablets/Alu-Alu packaging (10 tablets/Alu-Alu * 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.