Medication info
Vastin Tablets 10/20 Milligrams

Vastin Tablets 10/20 Milligrams

Prescription medicationTablet경구
Ingredient · strength
Ezetimibe›10mg / 1 tabletSimvastatin›20mg / 1 tablet
Manufacturer / importer
하나제약(주)
Appearance
White to off-white, double-convex rectangular tablets
Packaging
30 tablets (10 tablets/PTP x 3)
Approval status
Active

MFDS item code 201600903 · Approved 2016.02.17 · Insurance code 657805760

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. The generally recommended starting dose is 10/20mg daily. For patients who do not require significant LDL cholesterol reduction, treatment may begin with 10/10mg daily. Blood lipid levels should be checked after starting treatment or adjusting the dosage at intervals of more than 4 weeks.

Ingredients

Manufacturer
하나제약(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 medication is used as an adjunct to diet in patients with primary hypercholesterolemia to help reduce elevated total cholesterol, LDL cholesterol, ApoB protein, and triglycerides, while increasing HDL cholesterol. Particularly in patients with homozygous familial hypercholesterolemia, it is used when other lipid-lowering treatments are not effective or used in conjunction with those treatments. This medication should be taken alongside a proper diet, and potential impacts from other conditions or medications must be confirmed beforehand. Careful consideration is required as a lipid-lowering agent for patients at high risk of cardiovascular disease. Regular blood lipid tests during treatment are important; especially in patients with acute coronary events, measuring lipid levels at the time of hospitalization or within 24 hours post-admission is recommended. Overall, this medication is used effectively to improve hypercholesterolemia and related lipid abnormalities.

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. The generally recommended starting dose is 10/20mg daily. For patients who do not require significant LDL cholesterol reduction, treatment may begin with 10/10mg daily. Blood lipid levels should be checked after starting treatment or adjusting the dosage at intervals of more than 4 weeks.

Precautions

This medication may cause adverse reactions in muscles, so it is important to immediately inform a doctor if symptoms such as muscle pain or weakness occur. There is a serious risk of muscle damage, including myopathy and rhabdomyolysis, especially when taking high doses, so extra caution is needed. Patients with allergies to any component of this medication, active liver disease, or persistent unexplained elevations in liver enzymes should not take this medication. Women who are pregnant or nursing should not take this medication, and women of childbearing age should confirm pregnancy status before taking it. When taken with strong CYP3A4 inhibitors such as certain antifungals, antibiotics, and HIV medications, the risk of muscle damage greatly increases; therefore, co-administration should be avoided. This medication should also not be taken with gemfibrozil, cyclosporine, or danazol. Elderly patients, those with hypothyroidism, or patients with decreased kidney function have a higher risk of myopathy, so caution is necessary during use. This medication can affect liver function, so patients with liver disease should have regular liver function tests and should consult a doctor immediately if symptoms of liver function abnormalities occur. If any muscle-related symptoms or liver function abnormalities develop, the use of this medication should be discontinued and healthcare personnel should be consulted. Furthermore, this medication may interact with various drugs, so when taking new medications, it is essential to inform healthcare personnel of the use of this medication. Excessive consumption of grapefruit juice may raise the blood concentration of this medication, increasing the risk of side effects. This medication is not recommended for children or those under 10 years of age, as safety and effectiveness have not been adequately established. While taking this medication, blood sugar levels may rise, so patients at risk for diabetes should regularly monitor their blood glucose levels. There is no specific antidote for overdose, so appropriate treatment based on symptoms is necessary.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, anaphylaxis, rash, mucocutaneous syndrome (Stevens-Johnson syndrome), toxic epidermal necrolysis (Lyell syndrome), erythema multiforme, severe skin adverse reactions (SCARs), drug reaction with eosinophilia and systemic symptoms (DRESS), severe allergic reactions, severe skin adverse reactions, severe edema, chest tightness, difficulty breathing, sweating, pallor, liver abnormalities (jaundice), yellowing of skin or eyes

Mild side effects

Headache, diarrhea, influenza-like symptoms, upper respiratory tract infection, muscle pain, limb pain, fatigue, nausea, abdominal pain, constipation, dyspepsia, flatulence, vomiting, dizziness, sensory disturbances, depression, gallstones, cholecystitis, thrombocytopenia, nausea, sore throat, itching, weakness, insomnia, gastritis, atrophic gastritis, mucus-like stools, irritable bowel syndrome, nocturia, hematuria, alopecia, gynecomastia, decreased libido, sexual dysfunction (including erectile dysfunction), cataracts

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. It is recommended to maintain storage temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

White to off-white, double-convex rectangular tablets

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.