Medication info
Vytorin 10/20

Vytorin 10/20

Prescription medicationTablet경구
Ingredient · strength
Ezetimibe›10mg / 1 tabletSimvastatin›20mg / 1 tablet
Manufacturer / importer
(주)바이넥스
Appearance
White to pale yellow, bilaterally convex rectangular tablet
Packaging
30 tablets (10 tablets/PTP x 3)
Approval status
Active

MFDS item code 201007275 · Notified 2010.11.30 · Insurance code 643103220

Summary

Main use
Lipid-regulating effect through reduction of total cholesterol and LDL-cholesterol, and increase of HDL-cholesterol in primary hypercholesterolemia (homozygous familial) and mixed hyperlipidemia
Who takes it
Adults
Adult dose
This medication is administered as a single dose of 1 time per day in the evening, regardless of meals. The dosing range for patients with primary hypercholesterolemia is 10/10 mg to 10/40 mg per day. The generally recommended starting dose is 10/20 mg per day. If there is little need for reduction in LDL-cholesterol, it may be initiated at 10/10 mg per day. A blood lipid profile should be checked at intervals of more than 4 weeks after starting treatment or adjusting the dose.

Ingredients

Manufacturer
(주)바이넥스

Efficacy & effects

Lipid-regulating effect through reduction of total cholesterol and LDL-cholesterol, and increase of HDL-cholesterol in primary hypercholesterolemia (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 medication is used as an adjunct to diet for the treatment of patients with primary hypercholesterolemia and mixed hyperlipidemia to reduce elevated total cholesterol, LDL cholesterol, Apo B, and triglycerides while increasing HDL cholesterol. It can be administered as an adjunct or as monotherapy in patients with homozygous familial hypercholesterolemia. This medication should be used alongside a proper diet, which includes restriction of saturated fats and cholesterol, and is administered when the response to dietary and non-pharmacological measures is inadequate. It is important to identify and treat any secondary causes of dyslipidemia before use. Regular lipid testing should be performed to monitor treatment effectiveness based on the patient's condition. This medication improves the risk of hypercholesterolemia and associated atherosclerotic vascular diseases.

How to take

Adult dose

This medication is administered as a single dose of 1 time per day in the evening, regardless of meals. The dosing range for patients with primary hypercholesterolemia is 10/10 mg to 10/40 mg per day. The generally recommended starting dose is 10/20 mg per day. If there is little need for reduction in LDL-cholesterol, it may be initiated at 10/10 mg per day. A blood lipid profile should be checked at intervals of more than 4 weeks after starting treatment or adjusting the dose.

Precautions

This medication poses a risk of severe muscle problems such as myopathy or rhabdomyolysis, so if symptoms of muscle pain or weakness occur, you should consult a doctor immediately. This medication should not be used in patients with certain liver diseases, or in women who are pregnant or breastfeeding. Additionally, it is crucial to inform the physician of any ongoing medications, as it may be dangerous to combine this medication with certain drugs due to potential hypersensitivity reactions. Elderly patients or those with impaired renal function need additional caution when taking this medication, and regular blood tests to check liver function and muscle status are essential. This medication interacts with various other drugs, especially antifungals, antibiotics, calcium channel blockers, and specific antiviral medications, which can increase the risk of muscle damage when co-administered. Women planning for pregnancy or who may be pregnant should consult a doctor before taking this medication, and discontinue use immediately if pregnancy is confirmed. Women who are breastfeeding are also advised to stop nursing while on this medication. The safety and efficacy of this medication in children or adolescents have not been sufficiently established, and it is not recommended for children under 10 years old. There is no specific antidote in case of overdose, so prompt medical attention is required. During the course of this medication, unusual symptoms such as muscle pain, fatigue, or digestive issues may occur, and healthcare providers should be notified if symptoms persist. Moreover, this medication may slightly elevate blood glucose levels, so regular monitoring of blood glucose is necessary in patients at risk of diabetes. It is advisable to avoid certain foods that may interact with this medication, such as grapefruit juice, and to inform the physician of any new medications being taken.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, unusual breathing with cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urine

Mild side effects

Headache, diarrhea, influenza, upper respiratory tract infection, muscle pain, limb pain, fatigue, abdominal pain, nausea, constipation, vomiting, chest pain, discomfort in the chest, weakness, sensory loss, sore throat, nocturia, hematuria, itching, alopecia, various skin changes (nodules, discoloration, dryness of skin/mucous membranes, hair/nail changes), gynecomastia, decreased libido, sexual dysfunction (including erectile dysfunction), cataract progression, ocular muscle paralysis, anemia, insomnia, dizziness,

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air and moisture. It is also important to store it at room temperature between 1°C and 30°C to maintain its efficacy.

Appearance and packaging

Appearance

White to pale yellow, bilaterally convex rectangular tablet

Package unit

30 tablets (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

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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.