Medication info

Barozet Tablet 10/10 mg

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

MFDS item code 201901142 · 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
Lipid control effect by reducing LDL cholesterol and increasing HDL cholesterol in primary hypercholesterolemia (homozygous familial) and mixed hyperlipidemia.
Who takes it
Adults
Adult dose
This medication is administered once daily in the evening, regardless of meals. For patients with primary hypercholesterolemia, the dosage range is 10/10 mg to 10/40 mg daily, and the generally recommended initial dose is 10/20 mg daily. Patients with lower need for LDL cholesterol reduction may start at 10/10 mg daily. After starting treatment or adjusting the dosage, blood lipid levels should be checked after an interval of at least 4 weeks.

Ingredients

Manufacturer
안국뉴팜(주)

Efficacy & effects

Lipid control effect by reducing LDL cholesterol and increasing HDL cholesterol in primary hypercholesterolemia (homozygous familial) and mixed hyperlipidemia.

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • increased risk of atherosclerotic vascular diseases due to hypercholesterolemia
  • dyslipidemia
View approved original text

This medication helps to lower total cholesterol, LDL cholesterol, ApoB protein, and triglyceride levels while increasing HDL cholesterol in patients with primary hypercholesterolemia and mixed hyperlipidemia. It is particularly used as an adjunct to diet in patients with heterozygous familial and non-familial hypercholesterolemia. For homozygous familial hypercholesterolemia patients, it can be used in conjunction with or as a sole treatment to control cholesterol levels. This medication is recommended to be used with appropriate dietary management, especially for those who show insufficient response to other non-drug treatments. Prior to administration, secondary causes such as diabetes and hypothyroidism should be confirmed and treated if necessary, and treatment direction should be based on lipid test results. This drug is used to effectively improve blood lipid levels for treating hypercholesterolemia and resultant atherosclerosis.

How to take

Adult dose

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

Precautions

This medication can cause serious muscle disorders such as myopathy and rhabdomyolysis, so if muscle pain, muscle weakness, or unexplained muscle pain occurs during treatment, consult a physician immediately. This medication should not be administered to patients with specific liver diseases or poor liver function, and regular liver function tests are necessary if liver dysfunction is suspected. Women who are pregnant or breastfeeding should not use this medication, and women of childbearing potential must consult a physician before use and utilize appropriate contraception. This medication may interact with other drugs, especially medications that inhibit enzymes involved in drug metabolism in the liver, which could increase the risk of muscle damage; therefore, inform healthcare professionals of any other medications being taken. Elderly patients or those with reduced kidney function should also exercise caution when taking this medication, and dosage adjustments or regular testing is recommended. In some patients, blood sugar may rise due to this medication; thus, regular blood sugar testing is necessary for those at risk of diabetes. While taking this medication, consumption of certain foods, such as grapefruit juice, should be limited, and immediate treatment is required in case of overdose, so strictly adhere to the dosage. This medication is used restrictively in children and adolescents, particularly not recommended for children under 10 years old. If any adverse reactions or discomfort persist after administration, inform healthcare professionals immediately, and regular blood tests to monitor liver function and muscle status are important.

Side effects and when to seek care immediately

Serious side effects

Angioedema, severe rash, hypersensitivity reaction, pancreatitis, cholelithiasis, cholecystitis, anaphylaxis, angioedema, lupus-like erythema syndrome, polymyositis, dermatomyositis, vasculitis, purpura, thrombocytopenia, leukopenia, hemolytic anemia, positive antinuclear antibody, increased erythrocyte sedimentation rate, eosinophilia, arthritis, arthralgia, urticaria, photosensitivity, fever, chills, flushing, malaise, difficulty breathing, toxic epidermal necrolysis (Lyell’s syndrome)

Mild side effects

  • Headache
  • diarrhea
  • influenza
  • upper respiratory infection
  • muscle pain
  • limb pain
  • fatigue
  • abdominal pain
  • nausea
  • constipation
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  • dyspepsia
  • flatulence
  • itching
  • rash
  • weakness
  • progression of cataract
  • insomnia
  • dizziness
  • sensory disturbances
  • sleep disorders
  • depression
  • sore throat
  • nocturia
  • hematuria
  • alopecia
  • weight loss
  • vomiting
  • chest pain
  • chest discomfort
  • sensory decrease
  • increased serum creatine phosphokinase
  • weight loss
  • gastritis
  • atrophic gastritis
  • mucus stool

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

Storage

Store this medication in a tightly closed container that protects against air and moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius. This helps to preserve the medication's effectiveness and prevent degradation.

Appearance and packaging

Appearance

White to pale yellow, biconvex, 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.