Medication info
Rosuvastatin Calcium 5 mg (Rocsta Tablets)

Rosuvastatin Calcium 5 mg (Rocsta Tablets)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
코오롱제약(주)
Appearance
Yellow round film-coated tablets
Packaging
28 tablets (14 tablets/PTP x 2)
Approval status
Active

MFDS item code 202005179 · Approved 2020.07.18 · Insurance code 670304530

Summary

Main use
Treatment of hypercholesterolemia and reduction of the risk of cardiovascular diseases
Who uses it
Adults · Children
Adult dosage
The initial dose is 5 mg once daily, and if greater reduction of LDL cholesterol levels is needed, it can be adjusted to a maintenance dose. The maintenance dose is typically 10 mg once daily, with most patients being adjusted on this dose. The maintenance dose should be adjusted appropriately based on LDL cholesterol levels, treatment goals, and patient response, with a maximum daily dose of 20 mg.
Children's dosage
For pediatric patients with heterozygous familial hypercholesterolemia (aged 10 to 17 years), the usual dosage range is 5 mg to 20 mg once daily. The administered dosage should be adjusted individually according to the recommended treatment goals for each patient.

Ingredients

Manufacturer
코오롱제약(주)

Efficacy & effects

Treatment of hypercholesterolemia and reduction of the risk of cardiovascular diseases

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • primary dysbetalipoproteinemia
View approved original text

This medication is used as an adjunct for dietary and exercise management in primary hypercholesterolemia and mixed dyslipidemia when these measures are insufficient. It helps lower total cholesterol and LDL cholesterol levels, particularly in patients with familial hypercholesterolemia, thus slowing down the progression of atherosclerosis. It may also be used in pediatric patients aged 10 to 17 years who meet certain criteria to improve lipid levels. This drug is also utilized as an adjunct to diet for patients with primary dysbetalipoproteinemia. In patients at risk for cardiovascular diseases, it also aids in reducing the risk of stroke, myocardial infarction, and vascular reconstruction. Therefore, it is effectively used to alleviate hypercholesterolemia and the risks of cardiovascular diseases.

Dosage and Administration

Adult dosage

The initial dose is 5 mg once daily, and if greater reduction of LDL cholesterol levels is needed, it can be adjusted to a maintenance dose. The maintenance dose is typically 10 mg once daily, with most patients being adjusted on this dose. The maintenance dose should be adjusted appropriately based on LDL cholesterol levels, treatment goals, and patient response, with a maximum daily dose of 20 mg.

Children's dosage

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

Precautions

This medication should not be used in certain patients. For example, it is contraindicated in patients with allergies to any component of this drug, severe liver dysfunction, muscular disorders, significantly reduced kidney function, and pregnant or breastfeeding women. Additionally, this medication can potentially cause muscular issues, so it must be used with caution in patients with risk factors for myalgia or myopathy. If significant muscle pain occurs or if muscle enzyme levels rise significantly, the drug should be stopped immediately and a doctor consulted. Regular liver function tests should also be performed to monitor for any abnormalities. Patients with a history of significant alcohol consumption or liver disease require particular caution. This medication may interact with other drugs, so patients taking other medications must inform their healthcare provider. Co-administration with certain medications may increase the concentration of this drug, raising the risk of side effects. Women who may become pregnant should use appropriate contraception and must not take this medication while pregnant. Breastfeeding women should also avoid taking this medication. In cases of overdose, there is no specific antidote, so symptomatic treatment should be administered, and liver function and muscle enzyme levels should be monitored. During treatment, dizziness may occur, so caution is required when driving or operating machinery. Lastly, this medication contains lactose, so patients with lactose intolerance should not take it.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, and other allergic reactions, severe swelling (edema), chest tightness, difficulty breathing, Stevens-Johnson syndrome, eosinophilia and systemic symptoms associated with drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, acute kidney injury, oliguria, thrombocytopenia, elevated serum creatinine, rhabdomyolysis, severe muscle weakness, ocular muscle weakness, severe skin reactions, serious liver injury and/or hyperbilirubinemia, severe

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • weakness
  • hematuria
Show 25 more
  • diarrhea
  • chest pain
  • cough
  • fatigue
  • numbness
  • paresthesia
  • nausea
  • abdominal pain
  • loss of appetite
  • abdominal distension
  • abnormal liver function tests
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • memory impairment
  • forgetfulness
  • amnesia
  • cognitive dysfunction
  • confusion

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 stored in a tightly sealed container. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius to preserve the drug's effectiveness and safety.

Appearance and packaging

Appearance

Yellow round film-coated tablets

Package unit

28 tablets (14 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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.