Medication info

Barozet Tablet 10/20 mg

Prescription medicationTablet경구Expired
Ingredient · strength
Ezetimibe›10mg / 1 tabletSimvastatin›20mg / 1 tablet
Manufacturer / importer
안국뉴팜(주)
Appearance
White to pale yellow, double-convex, rectangular tablet
Packaging
30 tablets (10 tablets/PTP × 3)
Approval status
Expired

MFDS item code 201901143 · Approved 2019.02.22

This product's status changed to Expired on 2024.02.22. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Improvement of cholesterol and lipids in hypercholesterolemia (primary, homozygous familial) and mixed hyperlipidemia
Who takes it
Adults
Adult dose
This medication is administered once a day in the evening, regardless of meals. For patients with primary hypercholesterolemia, the dosage range is 10/10 mg to 10/40 mg per day, and the generally recommended initial dose is 10/20 mg per day. Patients with less need for LDL-cholesterol reduction may start at 10/10 mg once daily. After initiation of therapy or dose adjustment, blood lipid levels should be checked after an interval of at least 4 weeks.

Ingredients

Manufacturer
안국뉴팜(주)

Efficacy & effects

Improvement of cholesterol and lipids 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 medicine is used alongside dietary therapy in patients with primary hypercholesterolemia and mixed hyperlipidemia to reduce elevated total cholesterol, LDL-cholesterol, apolipoprotein B, and triglycerides, and to increase good cholesterol, HDL-cholesterol. Additionally, in patients with homozygous familial hypercholesterolemia, this medication can be used as an adjunct to other therapies, or it may be used alone if other treatments are ineffective. This medication helps lower the risk of atherosclerotic vascular disease due to hypercholesterolemia and is appropriate when dietary and non-drug therapies are insufficient. It is important to confirm the causes of secondary dyslipidemia before administration and treat the underlying causes if necessary. Lipid tests should be done to help establish an adequate treatment plan considering multiple lipid parameters. Thus, this medication is effective in improving hypercholesterolemia and related lipid abnormalities.

How to take

Adult dose

This medication is administered once a day in the evening, regardless of meals. For patients with primary hypercholesterolemia, the dosage range is 10/10 mg to 10/40 mg per day, and the generally recommended initial dose is 10/20 mg per day. Patients with less need for LDL-cholesterol reduction may start at 10/10 mg once daily. After initiation of therapy or dose adjustment, blood lipid levels should be checked after an interval of at least 4 weeks.

Precautions

This medicine is used to lower cholesterol levels. However, it can cause muscle-related issues, with symptoms such as muscle pain or weakness. In particular, there is a risk of rare side effects like rhabdomyolysis, which involves severe muscle damage, so caution is required. If experiencing muscle pain, tenderness, or weakness while taking this medication, you should inform your doctor immediately. Also, this medication may affect liver function, so it is not recommended for patients with liver disease or elevated liver enzyme levels. Women who are pregnant or nursing should not take this medication, and women who may become pregnant should consult a doctor before use. The risk of muscle damage can increase when taken with certain drugs, so you must inform your doctor if you are on other medications. Caution is especially needed when used with drugs that inhibit enzymes that metabolize drugs in the liver, certain antibiotics, antiviral drugs, or immunosuppressants. Elderly patients or those with reduced kidney function also have a higher risk of muscle problems while taking this medication, necessitating careful monitoring. It is recommended to regularly check liver function and muscle condition through blood tests while using this medication. There is no specific antidote for overdose, so if overdosed, immediate medical treatment is necessary. Finally, it is advisable to avoid excessive consumption of grapefruit juice while taking this medication, as it can increase the drug's concentration in the blood and elevate the risk of side effects.

Side effects and when to seek care immediately

Serious side effects

Myopathy, rhabdomyolysis, increased serum creatine kinase, persistent elevation of serum aminotransferase levels, marked elevation of serum aminotransferases, liver failure, cholestatic jaundice, severe liver injury, severe allergic reactions (urticaria, angioedema, rash), toxic epidermal necrolysis (Lyell syndrome), mucosal hypersensitivity syndrome (Stevens-Johnson syndrome), severe skin adverse reactions, urticaria, facial swelling, angioedema,

Mild side effects

  • Headache
  • diarrhea
  • influenza
  • upper respiratory infection
  • muscle pain
  • limb pain
  • weakness
  • abdominal pain
  • nausea
  • constipation
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  • indigestion
  • flatulence
  • itching
  • rash
  • dizziness
  • fatigue
  • sensory loss
  • insomnia
  • gastritis
  • atrophic gastritis
  • mucous stools
  • irritable bowel syndrome
  • sore throat
  • nocturia
  • hematuria
  • alopecia
  • facial swelling
  • edema
  • thirst
  • upper abdominal pain
  • vomiting
  • chest pain
  • chest discomfort
  • infection
  • pharyngitis
  • sinusitis
  • joint pain
  • low back pain
  • cough

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain the storage temperature between 1 and 30 degrees Celsius at room temperature to ensure the drug's effects and safety remain intact over time.

Appearance and packaging

Appearance

White to pale yellow, double-convex, rectangular tablet

Package unit

30 tablets (10 tablets/PTP × 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.