Medication info
Rosuzet Tablets 10/5 mg

Rosuzet Tablets 10/5 mg

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
한국프라임제약(주)
Appearance
Pink oval film-coated tablet
Packaging
30 tablets/box [10 tablets/PTP × 3], 30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202004593 · Approved 2020.06.23 · Insurance code 663608250

Summary

Main use
Improvement of hypercholesterolemia (primary and mixed) and reduction of the risk of atherosclerotic vascular diseases
Who takes it
Adults
Adult dose
This medication is administered once daily, regardless of meals. A starting dose of 10/5 mg once daily is recommended. For patients requiring a greater reduction in LDL cholesterol, the dosage can be adjusted. After starting treatment or adjusting the dose, blood lipid levels should be checked at intervals of at least 4 weeks, and the dosage may be adjusted accordingly, with a maximum of 10/20 mg per day.

Ingredients

Manufacturer
한국프라임제약(주)

Efficacy & effects

Improvement of hypercholesterolemia (primary and mixed) and reduction of the risk of atherosclerotic vascular diseases

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • elevated total cholesterol
  • increased LDL cholesterol
  • increased apolipoprotein B
  • increased triglycerides
  • increased non-HDL cholesterol
  • increased risk of atherosclerotic vascular disease due to hypercholesterolemia
  • dyslipidemia
  • diabetes
View approved original text

This medication helps control cholesterol and lipid levels in patients with primary hypercholesterolemia, especially heterozygous familial and non-familial hypercholesterolemia, as well as mixed dyslipidemia. Its main functions include reducing total cholesterol, LDL cholesterol, apolipoprotein B, triglycerides, and non-HDL cholesterol, while increasing HDL cholesterol, which is the good cholesterol. This medication is used in conjunction with dietary management to effectively control blood lipid levels and aims to reduce the risk of atherosclerotic vascular diseases. Before treatment, it is essential to check for other diseases or medications that may cause dyslipidemia and to administer necessary therapies alongside. Additionally, regular lipid testing should be conducted to monitor cholesterol levels during the treatment process. Overall, this medication is used to lower risks associated with hypercholesterolemia and improve cardiovascular health.

How to take

Adult dose

This medication is administered once daily, regardless of meals. A starting dose of 10/5 mg once daily is recommended. For patients requiring a greater reduction in LDL cholesterol, the dosage can be adjusted. After starting treatment or adjusting the dose, blood lipid levels should be checked at intervals of at least 4 weeks, and the dosage may be adjusted accordingly, with a maximum of 10/20 mg per day.

Precautions

This medication can have rare side effects that may cause serious muscle problems, therefore, you should immediately inform your doctor if you experience muscle pain or weakness. Especially, if there is a risk of impaired kidney function due to serious infections, low blood pressure, major surgery, or trauma, the use of this medication should be temporarily suspended or stopped. Patients who are allergic to any of the components of this medication or have liver disease, muscle disease, or severe kidney dysfunction should not use it. Women who are pregnant or may become pregnant and those who are breastfeeding should avoid using this medication. Alcoholics or patients with impaired liver function should use this medication cautiously, and special care is needed for those at high risk of myopathy. Additionally, this medication contains lactose, so individuals with lactose intolerance should not take it. If symptoms such as abnormal liver function, muscle pain, muscle cramps, or muscle weakness occur during the period of taking this medication, it is essential to consult a doctor. Regular liver function tests should be conducted, and if abnormalities are found, dosage adjustments or discontinuation may be necessary. Drug interactions may occur if taken with other medications, so if you are taking any other drugs, inform your doctor or pharmacist. During pregnancy or breastfeeding, this medication should be strictly avoided as it can be harmful to the fetus or infant, and women of childbearing age should use appropriate contraception. Special precautions are necessary for children and the elderly, particularly as the elderly may have a higher risk of myopathy, so they should follow doctor's instructions. In case of overdose, there is no specific antidote, so immediately visit a hospital for appropriate treatment. Keep this medication out of the reach of children and do not transfer it to other containers.

Side effects and when to seek care immediately

Serious side effects

Acute renal failure accompanied by myoglobinuria and rhabdomyolysis, hypersensitivity reactions including angioedema, active liver disease, persistent elevation of serum aminotransferases, severe renal failure, myopathy, rhabdomyolysis, myositis, liver toxicity, acute hepatitis, toxic hepatitis, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, severe allergic reactions, breathing difficulties, respiratory issues,

Mild side effects

  • Pharyngitis
  • dyspepsia
  • headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • dry mouth
  • increased serum lactate dehydrogenase
  • pruritus
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  • arthralgia
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • diarrhea
  • loss of appetite
  • abdominal distension
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • somnolence
  • neurodegenerative disorders
  • orthostatic dizziness
  • migraine
  • bronchitis
  • rhinitis
  • cystitis
  • onychomycosis
  • soft tissue inflammation
  • dermatitis
  • skin

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

Storage

This medication should be stored in a tightly closed container to avoid exposure to air or moisture. It is recommended to store it at room temperature between 1°C and 30°C.

Appearance and packaging

Appearance

Pink oval film-coated tablet

Package unit

30 tablets/box [10 tablets/PTP × 3], 30 tablets/bottle, 100 tablets/bottle

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.