Medication info
Rosuvastatin Tablet 10 mg (Rosuvastatin Calcium)

Rosuvastatin Tablet 10 mg (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
진양제약(주)
Appearance
Pink round film-coated tablet
Packaging
28 tablets (14 tablets x 2 PTP), 30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201000994 · Notified 2010.01.28 · Insurance code 650302670

Summary

Main use
Treatment of hypercholesterolemia (primary, familial) and dyslipidemia, and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
It can be taken at any time of the day, regardless of food. The initial dosage is 5 mg once daily, while the maintenance dosage is 10 mg once daily, with most patients controlled at this dosage. The maintenance dosage can be adjusted based on LDL cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more, with a maximum increase of 20 mg per day.
Child dose
For pediatric patients aged 10 to 17 years, the dosage is 5 mg to 20 mg once daily, with no clinical data for doses exceeding 20 mg. The dosage should be adjusted based on individual patient recommendations for treatment goals. Adjustments should be made at intervals of 4 weeks or more.

Ingredients

Manufacturer
진양제약(주)

Efficacy & effects

Treatment of hypercholesterolemia (primary, familial) and dyslipidemia, and reduction of cardiovascular disease risk

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

This medicine helps manage dyslipidemia such as primary hypercholesterolemia and mixed dyslipidemia when dietary changes and exercise are not enough. It is also used in conjunction with dietary therapy or other treatments to lower cholesterol levels in patients with homozygous familial hypercholesterolemia. This medication helps reduce total cholesterol and LDL cholesterol in patients with hypercholesterolemia, thereby slowing the progression of atherosclerosis. It can also be used in some pediatric patients aged 10 to 17 years who meet strict criteria for heterozygous familial hypercholesterolemia to lower cholesterol levels. It also aids in the treatment of primary dysbetalipoproteinemia. Furthermore, it helps reduce the risk of stroke, myocardial infarction, and revascularization in elderly patients with certain cardiovascular risk factors. It is thus used for various dyslipidemia and cardiovascular disease risk reduction.

How to take

Adult dose

It can be taken at any time of the day, regardless of food. The initial dosage is 5 mg once daily, while the maintenance dosage is 10 mg once daily, with most patients controlled at this dosage. The maintenance dosage can be adjusted based on LDL cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more, with a maximum increase of 20 mg per day.

Child dose

For pediatric patients aged 10 to 17 years, the dosage is 5 mg to 20 mg once daily, with no clinical data for doses exceeding 20 mg. The dosage should be adjusted based on individual patient recommendations for treatment goals. Adjustments should be made at intervals of 4 weeks or more.

Precautions

This medication should not be administered to certain patients. For example, patients who are allergic to any component of this medication or those with severely impaired liver function or muscle diseases should not take it. Additionally, patients with significantly reduced kidney function as well as pregnant or breastfeeding women should avoid this medication. The risk of muscle-related side effects is higher at the 40 mg dosage; therefore, patients at risk for muscle disorders should avoid higher doses. Patients with certain genetic metabolic disorders, such as lactose intolerance, should also refrain from this medication. This medication may affect liver function, so patients with a history of liver disease or those who consume a lot of alcohol should have liver function tests prior to use and regularly monitor liver status during treatment. Patients with diseases such as hypothyroidism or nephrotic syndrome should treat the underlying conditions before taking this medication. If symptoms of muscle pain or weakness occur, notify a doctor immediately, and, if necessary, check for muscle damage with a blood test. Particularly if muscle enzyme levels are significantly elevated, use of this medication should be discontinued, and dosage adjustments can be made after symptoms resolve. In rare cases, this medication may cause severe skin reactions, liver dysfunction, or kidney failure; if symptoms such as skin rash, jaundice, or severe fatigue occur, treatment should be discontinued immediately and consultation with medical personnel is necessary. This medication may interact with other drugs, particularly certain antivirals, immunosuppressants, antibiotics, and fibric acid derivatives, so caution is required when taken together. The risk of muscle side effects may increase with co-administration, so consult with a physician regarding the use and dosage. Women who are pregnant or planning to become pregnant must ensure appropriate contraception and should discontinue use immediately if pregnancy is confirmed. It is also advisable for breastfeeding women to refrain from using this medication. In cases of overdose, there is no specific antidote; therefore, appropriate treatment according to symptoms and monitoring of liver function and muscle enzyme levels are required. Caution is advised when driving or operating machinery due to potential dizziness and other symptoms. This medication may have a higher systemic exposure in Asians, so dosage adjustments may be necessary. Lastly, if there are changes in health status or new symptoms arise while taking this medication, it is essential to consult with medical personnel for appropriate management and testing.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, chest tightness, difficulty breathing, Stevens-Johnson syndrome, eosinophilia and systemic symptoms associated with drug reaction, jaundice, hepatitis, severe muscle weakness, rhabdomyolysis, immune-mediated necrotizing myopathy, acute renal failure, oliguria, severe edema, severe skin adverse reactions, severe allergic reactions, serious neurological symptoms, respiratory problems, liver abnormalities (jaundice), severe edema or urinary anomalies

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itchiness
  • rash
  • myalgia
  • weakness
  • hematuria
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  • diarrhea
  • fatigue
  • numbness
  • paresthesia
  • discomfort in the chest
  • loss of appetite
  • abdominal bloating
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • thrombocytopenia
  • memory loss
  • peripheral neuropathy
  • cough
  • ocular muscle weakness
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • cognitive impairment

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. Additionally, it is important to store it at room temperature between 1 and 30 degrees Celsius to maintain its effectiveness.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

28 tablets (14 tablets x 2 PTP), 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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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.