Medication info
Rosuva Tablet 5 mg (Rosuvastatin Calcium)

Rosuva Tablet 5 mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
한국프라임제약(주)
Appearance
Pink round film-coated tablets
Packaging
30 tablets / PTP ((15 tablets / PTP (AluAlu) * 2)) 30 tablets/bottle, 100 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201903719 · Approved 2019.06.04 · Insurance code 663608680

Summary

Main use
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
The initial dose is 5 mg once daily; if a greater reduction in LDL cholesterol is needed, the maintenance dose can be adjusted accordingly. The maintenance dose is typically 10 mg once daily, with most patients being controlled at this dosage. The maintenance dose should be appropriately adjusted based on LDL cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more, with a maximum daily dose of 20 mg.
Children's dosage
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10-17), the usual dosage range is 5 mg to 20 mg once daily. The administration dosage should be adjusted according to the recommended treatment goals for each individual patient.

Ingredients

Manufacturer
한국프라임제약(주)

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • dyslipidemia
  • abnormal beta-lipoproteinemia
  • increased high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol levels
  • smoking
  • family history of early coronary heart disease
View approved original text

This medication is primarily used in patients with hypercholesterolemia and mixed dyslipidemia who have difficulty controlling cholesterol levels through diet and exercise alone. Additionally, it is used as an adjunct treatment in patients with familial hypercholesterolemia alongside diet or other treatments to lower total cholesterol and LDL cholesterol levels, delaying the progression of atherosclerosis. It also effectively improves lipid levels in pediatric patients aged 10 to 17 years who meet certain criteria. Furthermore, it assists adult patients with a high risk of cardiovascular disease in reducing the risk of stroke, myocardial infarction, and vascular reshaping procedures. Overall, this drug plays a crucial role in cholesterol management and cardiovascular health improvement.

Dosage and Administration

Adult dosage

The initial dose is 5 mg once daily; if a greater reduction in LDL cholesterol is needed, the maintenance dose can be adjusted accordingly. The maintenance dose is typically 10 mg once daily, with most patients being controlled at this dosage. The maintenance dose should be appropriately adjusted based on LDL cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more, with a maximum daily dose of 20 mg.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10-17), the usual dosage range is 5 mg to 20 mg once daily. The administration dosage should be adjusted according to the recommended treatment goals for each individual patient.

Precautions

This medication should not be used in certain patients. For instance, individuals who are allergic to this drug, those with severely impaired liver function, those with muscle disorders, and those with significantly reduced kidney function should not take it. Additionally, women who are pregnant, breastfeeding, or of childbearing potential must consult a doctor and use appropriate contraception before taking this medication. Since this drug can affect liver function, patients with a history of liver disease or those who consume large amounts of alcohol should regularly undergo liver function tests before and during treatment. If symptoms of muscle pain or weakness occur, you should notify your doctor immediately, and in severe cases, you may need to discontinue the medication. This drug can interact with other medications, so it is essential to inform your doctor or pharmacist about any other medications you are taking. Particular caution is required when taken with certain antibiotics, antifungals, immunosuppressants, anticoagulants, etc. This medication may pose risks to the fetus during pregnancy, so it should not be taken during pregnancy, and it is advisable to avoid it while breastfeeding. In case of overdose, there are no specific antidotes; you must go to the hospital immediately for appropriate treatment, and liver function and muscle condition should be monitored closely. Exercise caution when driving or operating machinery, as dizziness may occur. Finally, it is important to regularly monitor your blood and health status during the course of this medication to check for any adverse reactions.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria and angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms, severe swelling (edema), chest tightness, difficulty breathing, respiratory distress, asthma attacks, skin exfoliation, mucosal pain in mouth/eyes, severe rash with high fever, skin adverse reactions, jaundice, hepatitis, increased transaminases, sudden and severe headache, seizures, altered consciousness, vision changes

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • myalgia
  • asthenia
  • diarrhea
  • abnormal liver function tests
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  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal distension
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • hematuria
  • thrombocytopenia
  • memory loss
  • peripheral neuropathy
  • cough
  • sexual dysfunction
  • gynecomastia
  • depression
  • sleep disorders
  • cognitive impairment

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 storage temperature should be maintained between 1 and 30 degrees Celsius. Storing it this way can help preserve its effectiveness for a long time.

Appearance and packaging

Appearance

Pink round film-coated tablets

Package unit

30 tablets / PTP ((15 tablets / PTP (AluAlu) * 2)) 30 tablets/bottle, 100 tablets/bottle, 300 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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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.