Medication info
Cravast 10mg (Rosuvastatin Calcium)

Cravast 10mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
일양바이오팜(주)
Appearance
Pink round film-coated tablet
Packaging
28 tablets/box[(14 tablets/Alu-Alu) X 2]
Approval status
Active

MFDS item code 201506856 · Approved 2015.09.30 · Insurance code 696601160

Summary

Main use
Treatment of hypercholesterolemia and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
Initiate with 5 mg once daily, and if a greater reduction in LDL cholesterol is required, adjust to a maintenance dose of up to 10 mg once daily. The maintenance dose should be appropriately adjusted based on LDL cholesterol levels, treatment goals, and the patient's response at intervals of 4 weeks or longer, with a maximum daily increase of up to 20 mg. The recommended initial dosage for Asian patients and those prone to myopathy is
Children's dosage
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the dosage is administered once daily between 5 mg and 20 mg, with no clinical data available for dosages higher than 20 mg.

Ingredients

Manufacturer
일양바이오팜(주)

Efficacy & effects

Treatment of hypercholesterolemia and reduction of cardiovascular disease risk

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

This medication is used in patients with primary hypercholesterolemia and mixed dyslipidemia, particularly familial hypercholesterolemia, when diet and exercise are insufficient. It is also used as an adjunct to other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia. This medication helps lower total cholesterol and LDL cholesterol levels, thereby delaying the progression of atherosclerosis. It is also used as an adjunct to diet in pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia. Additionally, it is beneficial for patients with primary dysbetalipoproteinemia. Finally, it is used to reduce the risk of stroke, myocardial infarction, and arterial revascularization in high-risk patients with cardiovascular disease risk factors. Thus, this medication helps improve various dyslipidemia and cardiovascular disease-related risks.

Dosage and Administration

Adult dosage

Initiate with 5 mg once daily, and if a greater reduction in LDL cholesterol is required, adjust to a maintenance dose of up to 10 mg once daily. The maintenance dose should be appropriately adjusted based on LDL cholesterol levels, treatment goals, and the patient's response at intervals of 4 weeks or longer, with a maximum daily increase of up to 20 mg. The recommended initial dosage for Asian patients and those prone to myopathy is

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the dosage is administered once daily between 5 mg and 20 mg, with no clinical data available for dosages higher than 20 mg.

Precautions

This medication should not be used in certain patients. For example, it should not be administered to patients who are allergic to any of the ingredients, those with severely compromised liver function, patients with muscle diseases, and those with severe kidney dysfunction. Additionally, it is not safe to use this medication in pregnant or breastfeeding women, and fertile women who do not use adequate contraception. When using this medication, regular checks of liver function and muscle condition are required. Especially for patients who consume large amounts of alcohol or have a history of liver disease, it is important to repeatedly confirm liver enzyme tests. Muscle pain or weakness symptoms should be promptly reported to medical staff, and the medication should be discontinued if necessary. This medication may increase the risk of muscle damage when used with certain drugs, so it is essential to inform a physician or pharmacist if taking other medications. Caution is especially needed when used in combination with fibrate-class medications, and high dosages should be avoided. This medication can affect the liver and kidneys, so regular liver function and kidney function tests are recommended during use. It may also increase blood sugar levels, requiring thorough blood sugar management in patients with diabetes or at risk for diabetes. Pregnant or breastfeeding individuals should avoid taking this medication, as it can pose risks to the fetus or infant, and women planning pregnancy should use appropriate contraception. In case of overdose, there are no specific antidotes, and management should be done symptomatically with liver and muscle tests. This medication may cause dizziness when driving or operating machinery, so caution is advised. Lastly, if severe rash or allergic reactions occur during the use of this medication, immediate discontinuation and consultation with medical staff are necessary.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria and angioedema, Stevens-Johnson syndrome, eosinophilia and systemic symptom drug reaction syndrome (DRESS), jaundice, hepatitis, severe muscle weakness, ocular myasthenia, polyneuropathy, peripheral neuropathy, immune-mediated necrotizing myopathy, rhabdomyolysis, acute kidney failure, oliguria, thrombocytopenia, increased serum creatinine, severe edema, liver failure, severe allergic reactions, severe skin rash

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • weakness
  • hematuria
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  • diarrhea
  • chest pain
  • cough
  • joint pain
  • fatigue
  • numbness
  • sensory abnormalities
  • discomfort in the chest
  • loss of appetite
  • abdominal distension
  • abnormal liver function tests
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • depression
  • sleep disorders
  • sexual dysfunction
  • gynecomastia
  • memory impairment
  • forgetfulness
  • amnesia
  • memory disorders
  • confusion

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 light. Additionally, keep the storage temperature between 1 degree and 30 degrees Celsius at room temperature. Proper storage can help maintain the medication's effectiveness over time.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

28 tablets/box[(14 tablets/Alu-Alu) 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.