Medication info
Crovaz 5mg (Rosuvastatin Calcium)

Crovaz 5mg (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
대원제약(주)
Appearance
Yellow round film-coated tablet
Packaging
Domestic: 28 tablets (14 tablets/PTP X 2), Export: 28 tablets (14 tablets/PTP X 2)
Approval status
Active

MFDS item code 201400429 · Approved 2014.01.29 · Insurance code 671805690

Summary

Main use
Treatment of hypercholesterolemia and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
For adult patients with primary hypercholesterolemia, the initial dose is 5 milligrams once daily. The maintenance dose is 10 milligrams once daily, adjusted according to LDL-cholesterol levels and patient response every 4 weeks or more. The maximum dose is 20 milligrams once daily. It can be taken at any time of day regardless of meals.
Child dose
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), 5 milligrams to 20 milligrams should be administered once daily. Dosage should be adjusted according to individual patient treatment goals for more than 4 weeks.

Ingredients

Manufacturer
대원제약(주)

Efficacy & effects

Treatment of hypercholesterolemia and reduction of cardiovascular disease risk

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

This medication is used as an adjunct when dietary changes and exercise alone are insufficient to control primary hypercholesterolemia and mixed dyslipidemia. It is also beneficial as an adjunct to diet or other lipid-lowering therapy in patients with homozygous familial hypercholesterolemia. It effectively lowers total cholesterol and LDL-cholesterol levels in patients with hypercholesterolemia, thereby slowing the progression of atherosclerosis. In pediatric patients aged 10 to 17 with elevated LDL-cholesterol levels, it can also be used as an adjunct to dietary management. It is helpful in patients with primary dysbetalipoproteinemia and contributes to the reduction of stroke, myocardial infarction, and revascularization risk in middle-aged patients with high-sensitive C-reactive protein levels and additional cardiovascular risk factors. Therefore, this drug is effectively used for various dyslipidemias and patients at risk for cardiovascular diseases.

How to take

Adult dose

For adult patients with primary hypercholesterolemia, the initial dose is 5 milligrams once daily. The maintenance dose is 10 milligrams once daily, adjusted according to LDL-cholesterol levels and patient response every 4 weeks or more. The maximum dose is 20 milligrams once daily. It can be taken at any time of day regardless of meals.

Child dose

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), 5 milligrams to 20 milligrams should be administered once daily. Dosage should be adjusted according to individual patient treatment goals for more than 4 weeks.

Precautions

This drug should not be used in certain patients. For example, individuals allergic to any component of this medication, those with severely impaired liver function, those with muscle disorders, those taking certain immunosuppressants, individuals with significantly reduced kidney function, pregnant or nursing women, and those at high risk for muscle diseases should not take this drug. It is important to periodically check liver function and muscle condition while taking this drug. Particularly, individuals who consume large amounts of alcohol, have a history of liver disease, have hypothyroidism, have reduced kidney function, are elderly (over 70 years), or are taking certain medications should exercise additional caution. If symptoms such as muscle pain, muscle weakness, or cramps occur, report to a doctor immediately and get examined. If these symptoms are severe or if muscle enzyme levels rise significantly, discontinuation of the drug may be necessary. This drug contains lactose, so individuals with lactose intolerance should not take it. There may be drug interactions when taken with certain medications, so if currently taking any drugs, they must inform their doctor or pharmacist. Women who are pregnant or planning to become pregnant must use appropriate contraception, and if pregnancy is confirmed, they should discontinue taking this drug immediately. Additionally, nursing women should avoid taking this drug for safety reasons. There is no specific antidote in case of overdose, so treatment should be symptomatic while monitoring liver function and muscle enzyme levels. Caution is needed while driving or operating machinery due to possible dizziness. Finally, this drug may rarely cause serious skin reactions, liver damage, or muscle adverse reactions, so if new symptoms appear, consult medical personnel immediately.

Side effects and when to seek care immediately

Serious side effects

Rash, hypersensitivity reactions including angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, severe muscle weakness, rhabdomyolysis, severe edema, dyspnea, respiratory disturbance accompanied by cough and fever, acute renal failure, oliguria, seizures, altered consciousness, visual disturbances, paralysis, severe allergic reactions, severe skin adverse reactions

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • muscle pain
  • weakness
  • hematuria
  • diarrhea
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  • chest pain
  • cough
  • fatigue
  • numbness
  • abnormal sensations
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • fainting
  • increased serum creatinine
  • memory loss
  • peripheral neuropathy
  • multiple neuropathy
  • thrombocytopenia
  • elevated transaminases
  • muscle rupture
  • lupus-like syndrome
  • immune-mediated necrosis

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. It is best to store the drug at room temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the effectiveness of the medication.

Appearance and packaging

Appearance

Yellow round film-coated tablet

Package unit

Domestic: 28 tablets (14 tablets/PTP X 2), Export: 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

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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.