Medication info
Rozerowong 10/20 milligrams

Rozerowong 10/20 milligrams

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
삼천당제약(주)
Appearance
White to almost white round film-coated tablets
Packaging
30 tablets (15 tablets/PTP × 2)
Approval status
Active

MFDS item code 201606042 · Approved 2016.10.12 · Insurance code 651204860

Summary

Main use
Improvement of lipid levels and reduction of the risk of atherosclerotic vascular disease through the treatment of hypercholesterolemia (primary and mixed type)
Who takes it
Adults
Adult dose
This medication is administered once daily without regard to meals. The dosage range is 10/5 mg to 10/20 mg per day. The recommended starting dose is 10/5 mg per day. In patients requiring a greater reduction in LDL cholesterol, the dosage may be adjusted accordingly. After initiating treatment or adjusting the dose, it is recommended to check blood lipid levels at intervals of more than 4 weeks, and adjust the dosage accordingly, up to a maximum of 10/20 mg per day.

Ingredients

Manufacturer
삼천당제약(주)

Efficacy & effects

Improvement of lipid levels and reduction of the risk of atherosclerotic vascular disease through the treatment of hypercholesterolemia (primary and mixed type)

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

This medication is used to lower the levels of total cholesterol, LDL cholesterol, Apo B protein, triglycerides, and non-HDL cholesterol in patients with primary hypercholesterolemia and mixed dyslipidemia, while increasing HDL cholesterol levels. It is particularly administered as an adjunct to dietary measures in patients with increased risk of atherosclerotic vascular disease due to hypercholesterolemia to control lipid levels. It is used when adequate dietary measures and other non-pharmacological treatments are insufficient, and it is important to first identify and treat any secondary causes, such as diabetes or hypothyroidism, if necessary. Moreover, during treatment, total cholesterol, as well as LDL, HDL cholesterol, and triglyceride levels should be regularly monitored to ensure management. This helps to improve blood lipid abnormalities and thereby reduce the risk of cardiovascular disease.

How to take

Adult dose

This medication is administered once daily without regard to meals. The dosage range is 10/5 mg to 10/20 mg per day. The recommended starting dose is 10/5 mg per day. In patients requiring a greater reduction in LDL cholesterol, the dosage may be adjusted accordingly. After initiating treatment or adjusting the dose, it is recommended to check blood lipid levels at intervals of more than 4 weeks, and adjust the dosage accordingly, up to a maximum of 10/20 mg per day.

Precautions

This medication has been reported to cause rare but serious muscular problems. If severe muscle pain or weakness symptoms occur, it is essential to consult a physician immediately. This medication should not be administered to patients with impaired liver function or certain muscle disorders. It should also not be used in patients with severely impaired kidney function, or in pregnant or breastfeeding women. Patients with a history of alcohol dependence or liver disease, elderly patients, and those with hypothyroidism should exercise extra caution while using this medication. Patients at high risk of myopathy should have their muscle enzyme levels checked thoroughly before and during treatment. During the use of this medication, regular liver function tests should be conducted, and if any abnormal symptoms regarding the liver appear, the use of the medication should be discontinued immediately. Additionally, this medication can interact with other drugs, so if there are any currently taken medications, it is imperative to inform the physician or pharmacist. Special caution is needed when combined with drugs that affect blood coagulation, certain antibiotics, antifungals, and immunosuppressants. Women of childbearing potential should use appropriate contraceptive methods while taking this medication, and if pregnancy is confirmed, the medication should be discontinued immediately. This medication has not been adequately studied for safety and efficacy in children; therefore, it is not recommended for use in the pediatric population. In the case of overdose, as there are no specific antidotes, appropriate treatment should be administered based on symptoms, and monitoring of liver function and muscle enzyme levels is necessary. Finally, this medication should be stored out of the reach of children and not transferred to other containers.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling, chest tightness, difficulty breathing, cold sweats, pallor, severe rash with fever, blisters, peeling skin, pain in oral/eye mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough + fever, jaundice (skin or eyes turning yellow), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, significantly reduced urine output

Mild side effects

  • Nasopharyngitis
  • joint pain
  • headache
  • dizziness
  • upper respiratory tract infection
  • myalgia
  • constipation
  • nausea
  • abdominal pain
  • thrombocytopenia
Show 28 more
  • sweating
  • dermatitis
  • skin burning sensation
  • pruritus
  • skin disorders
  • alopecia
  • cough
  • sputum
  • nasal congestion
  • chest pain
  • chest discomfort
  • weakness
  • generalized edema
  • tremors
  • fatigue
  • paresthesia
  • nausea
  • diarrhea
  • loss of appetite
  • abdominal distension
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • depression
  • sleep disturbance
  • sexual

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly sealed container. The recommended storage temperature is between 1 and 30 degrees Celsius. Proper storage conditions will help maintain the effectiveness of the medication.

Appearance and packaging

Appearance

White to almost white round film-coated tablets

Package unit

30 tablets (15 tablets/PTP × 2)

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.