Medication info
Roserowjeong 10/5 mg

Roserowjeong 10/5 mg

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
삼천당제약(주)
Appearance
White to almost white round film-coated tablets
Packaging
30 tablets (15 tablets/PTP x 2)
Approval status
Active

MFDS item code 201606040 · Approved 2016.10.12 · Insurance code 651204850

Summary

Main use
Improvement of hypercholesterolemia (dyslipidemia) and reduction of risk of atherosclerotic vascular disease
Who takes it
Adults
Adult dose
This medication is administered once daily regardless of meals. A starting dose of 10/5 mg once a day is recommended. The dosage range is from 10/5 mg to 10/20 mg per day. In cases where a greater reduction in LDL-cholesterol is required, the dose can be adjusted accordingly. After initiating treatment with this medication or after dose adjustments, blood lipid levels should be checked at intervals of at least 4 weeks and the dose adjusted accordingly.

Ingredients

Manufacturer
삼천당제약(주)

Efficacy & effects

Improvement of hypercholesterolemia (dyslipidemia) and reduction of risk of atherosclerotic vascular disease

  • 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 lower elevated total cholesterol, LDL-cholesterol, apolipoprotein B, triglycerides, and other abnormal lipid levels in patients with primary hypercholesterolemia and mixed dyslipidemia, while increasing the so-called good cholesterol, HDL-cholesterol. These drugs are used in conjunction with appropriate dietary habits and are recommended when dietary adjustments or lifestyle improvements alone are insufficient. Additionally, this medication is primarily prescribed to those at increased risk of vascular diseases such as atherosclerosis due to hypercholesterolemia. Before taking this medication, it is important to check for other causes such as diabetes and hypothyroidism that may require treatment. During treatment, it is essential to continuously monitor cholesterol and triglyceride levels for appropriate management. This medication is used to improve abnormal lipid levels and lower the risk of cardiovascular disease.

How to take

Adult dose

This medication is administered once daily regardless of meals. A starting dose of 10/5 mg once a day is recommended. The dosage range is from 10/5 mg to 10/20 mg per day. In cases where a greater reduction in LDL-cholesterol is required, the dose can be adjusted accordingly. After initiating treatment with this medication or after dose adjustments, blood lipid levels should be checked at intervals of at least 4 weeks and the dose adjusted accordingly.

Precautions

This medication may cause serious muscle problems, so if symptoms such as muscle pain or weakness occur, you should inform a doctor immediately. Patients at risk for serious myopathy or rhabdomyolysis should temporarily or permanently discontinue this medication. This medication should not be administered to patients with poor liver function or liver disease. Patients with severely impaired kidney function or muscle diseases should also avoid this medication. Women who are pregnant or may become pregnant and nursing mothers should not use this medication. This medication contains lactose, so patients with lactose intolerance should avoid taking it. Alcoholics or those with a history of liver disease should use this medication with caution and regularly undergo liver function tests during treatment. The risk of muscle-related side effects may increase when taken with certain medications, so consult a doctor before combining with other drugs. Regular monitoring of liver and muscle enzyme levels during treatment is essential to check for abnormalities. Symptoms such as dizziness or headache may occur, so caution is required when driving or operating machinery. In case of overdose, there is no specific antidote, so treatment and supportive care appropriate to the symptoms are necessary. The safety and efficacy of this medication have not been sufficiently established in children and the elderly, so caution is required in usage. It is important to regularly consult with a doctor during the use of this medication to check for side effects.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, severe dermatological abnormal reactions, shortness of breath or difficulty breathing, asthma attack, respiratory distress accompanied by cough and fever, respiratory issues, jaundice (yellowing of the skin or eyes), extreme lethargy, liver abnormalities (jaundice), sudden and

Mild side effects

  • Nasopharyngitis
  • arthralgia
  • headache
  • dizziness
  • upper respiratory infection
  • myalgia
  • fatigue
  • constipation
  • nausea
  • abdominal pain
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  • acneiform dermatitis
  • pruritus
  • sweating
  • dermatitis
  • skin burning sensation
  • alopecia
  • diarrhea
  • itching
  • sensory disturbance
  • nausea
  • anorexia
  • abdominal distension
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • syncope
  • thrombocytopenia
  • increased serum creatinine
  • elevated blood pressure
  • increased blood urea
  • urticaria
  • hyperhidrosis
  • chest discomfort
  • chest

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

Storage

This medication may be sensitive to air and moisture, so it must be kept in a tightly sealed container. Additionally, it is best to store the medication at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the effectiveness of the medication for a longer time.

Appearance and packaging

Appearance

White to almost white round film-coated tablets

Package unit

30 tablets (15 tablets/PTP x 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.