Medication info
Vistar Tablets 10/20mg

Vistar Tablets 10/20mg

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

MFDS item code 201601009 · Approved 2016.02.24 · Insurance code 650303450

Summary

Main use
Improvement of cholesterol and lipids in hypercholesterolemia (primary, familial) and mixed hyperlipidemia
Who takes it
Adults
Adult dose
This medication should be administered once daily in the evening regardless of meals. Patients with primary hypercholesterolemia may be given a dose within the range of 10/10mg to 10/40mg daily, with the generally recommended initial dose being 10/20mg daily. Patients with less need for LDL-cholesterol reduction may start at 10/10mg daily. The recommended dose for patients with homozygous familial hypercholesterolemia is 10/40mg daily.

Ingredients

Manufacturer
진양제약(주)

Efficacy & effects

Improvement of cholesterol and lipids in hypercholesterolemia (primary, 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 helps lower high cholesterol and LDL-cholesterol levels in patients with primary hypercholesterolemia, especially heterozygous familial and non-familial hypercholesterolemia, while also reducing ApoB protein and triglycerides and increasing HDL-cholesterol. It can be used alone or in conjunction with other lipid-lowering therapies to effectively manage total cholesterol and LDL-cholesterol levels in patients with homozygous familial hypercholesterolemia. This medication should be used in conjunction with an appropriate dietary regimen and is administered when there is a lack of response to dietary measures or non-drug interventions. It's essential to check for dyslipidemia due to other causes before usage and to treat as necessary. During treatment, periodic monitoring of total cholesterol, LDL and HDL-cholesterol, and triglyceride levels is recommended to ensure appropriate control. Overall, this medication is used to improve blood lipid levels and reduce the risk of cardiovascular diseases.

How to take

Adult dose

This medication should be administered once daily in the evening regardless of meals. Patients with primary hypercholesterolemia may be given a dose within the range of 10/10mg to 10/40mg daily, with the generally recommended initial dose being 10/20mg daily. Patients with less need for LDL-cholesterol reduction may start at 10/10mg daily. The recommended dose for patients with homozygous familial hypercholesterolemia is 10/40mg daily.

Precautions

This medication may cause serious muscle-related side effects, such as myopathy and rhabdomyolysis, so if muscle pain or weakness occurs, you must consult a doctor immediately. This medication should not be used by individuals who are allergic to its components, those with severely impaired liver function, and those who are pregnant or breastfeeding. Particularly, this medication may harm the fetus during pregnancy, so women planning to become pregnant or who may be pregnant should consult a doctor before taking it, and should immediately discontinue use if pregnancy is confirmed. The risk of muscle damage significantly increases when this medication is used with potent CYP3A4 inhibitors, including certain antifungals, antibiotics, and antivirals, so these should not be taken together. Additionally, this medication should not be used in combination with certain other medications, such as gemfibrozil, cyclosporine, or danazol; consult a doctor for appropriate alternative medications if necessary. This medication contains lactose, so it should not be taken by patients with lactose intolerance or related genetic disorders. Elderly patients, those with impaired kidney function, and those with hypothyroidism should be monitored closely due to increased risk of myopathy. To reduce the risk of myopathy, regular blood tests to check muscle enzyme levels are recommended during the course of this medication. The risk of myopathy may increase if other interacting medications are taken, so always consult a doctor or pharmacist when starting or stopping any new medication. If unexplained muscle pain, tenderness, or weakness occurs during treatment, notify healthcare professionals immediately and stop taking this medication. Patients with impaired liver function or a history of liver disease should have regular liver function tests before and after taking this medication, and should stop taking it if symptoms of liver damage occur. This medication can rarely cause respiratory issues such as interstitial lung disease, so consult a healthcare professional if experiencing shortness of breath or persistent cough. Blood sugar levels may rise during the use of this medication, so patients at high risk for diabetes should check their blood sugar regularly. In clinical trials and post-marketing surveillance, this medication has generally demonstrated excellent tolerability, but side effects such as headaches, indigestion, diarrhea, cold symptoms, and muscle pain have been reported. There is limited data on safety in children and adolescents, therefore its use in children under 10 years of age is not recommended. Patients taking this medication should inform other physicians when prescribed new medications and should not discontinue or alter dosages arbitrarily.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, yellowing of the skin or eyes (jaundice), general malaise, sudden and severe headache, thunderclap headache, seizures, confusion, vision changes, paralysis, significantly reduced urine output, severe generalized edema with elevated blood pressure, anaphylaxis

Mild side effects

  • Headache
  • diarrhea
  • influenza
  • upper respiratory tract infection
  • muscle pain
  • limb pain
  • fatigue
  • abdominal pain
  • viral infection
  • pharyngitis
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  • sinusitis
  • arthralgia
  • low back pain
  • cough
  • weakness
  • cataract of the eyes
  • constipation
  • indigestion
  • flatulence
  • nausea
  • eczema
  • itching
  • rash
  • fainting
  • sensory abnormalities
  • insomnia
  • gastritis
  • atrophic gastritis
  • mucous stools
  • irritable bowel syndrome
  • sore throat
  • nocturia
  • hematuria
  • alopecia
  • various skin changes
  • gynecomastia
  • sexual

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 exposure to air and moisture, and should be kept at room temperature between 1 and 30 degrees Celsius. Storing it this way helps maintain the medication's efficacy and prevents degradation.

Appearance and packaging

Appearance

White to off-white, 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.