Medication info
Crovon Tablet 5mg (Rosuvastatin Calcium)

Crovon Tablet 5mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
대원바이오텍주식회사
Appearance
Yellow round film-coated tablets
Packaging
28 tablets/box [14 tablets/PTP X 2]
Approval status
Active

MFDS item code 201906901 · Approved 2019.09.30 · Insurance code 057600300

Summary

Main use
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
For patients with primary hypercholesterolemia, mixed dyslipidemia, dysbetalipoproteinemia, and homozygous familial hypercholesterolemia, the initial dose is 5 milligrams taken once daily at any time of the day regardless of meals. If necessary, the maintenance dose can be increased to 10 milligrams once daily, and adjusted to a maximum of 20 milligrams based on LDL cholesterol levels and patient response at intervals of 4 weeks or more.
Children's dosage
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the dosage is adjusted between 5 milligrams and 20 milligrams taken once daily. Dosage adjustments should be made with intervals of 4 weeks or more.

Ingredients

Manufacturer
대원바이오텍주식회사

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

  • Hypercholesterolemia
  • dyslipidemia
  • atherosclerosis
  • dysbetalipoproteinemia
  • elevated high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol levels
  • smoking
  • family history of early coronary artery disease
  • stroke risk
  • myocardial infarction risk
  • risk of arterial revascularization
View approved original text

This medication is primarily used as an adjunct to dietary therapy for patients with hypercholesterolemia and mixed dyslipidemia. It is particularly effective for primary hypercholesterolemia and heterozygous familial hypercholesterolemia, lowering total cholesterol and LDL cholesterol levels, thereby delaying the progression of atherosclerosis. Additionally, it is used adjunctively in patients with homozygous familial hypercholesterolemia or dysbetalipoproteinemia. It is also beneficial for pediatric patients aged 10 to 17 years who meet certain criteria for familial hypercholesterolemia. Furthermore, it contributes to reducing the risks of stroke, myocardial infarction, and arterial revascularization in high-risk groups with elevated cardiovascular disease risk. Overall, this medication is used to improve blood lipid levels and prevent cardiovascular diseases.

Dosage and Administration

Adult dosage

For patients with primary hypercholesterolemia, mixed dyslipidemia, dysbetalipoproteinemia, and homozygous familial hypercholesterolemia, the initial dose is 5 milligrams taken once daily at any time of the day regardless of meals. If necessary, the maintenance dose can be increased to 10 milligrams once daily, and adjusted to a maximum of 20 milligrams based on LDL cholesterol levels and patient response at intervals of 4 weeks or more.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the dosage is adjusted between 5 milligrams and 20 milligrams taken once daily. Dosage adjustments should be made with intervals of 4 weeks or more.

Precautions

This medication should not be used in certain patients. First, individuals allergic to any ingredients of this medication should not take it. Additionally, those with persistently elevated liver enzymes of unknown origin or severe liver dysfunction should not use this medication. Patients with muscle diseases or existing muscle issues should also avoid this medication. It should not be used in conjunction with the drug cyclosporine. Patients with severe renal impairment, particularly those with very diminished renal function, should not receive this medication. Women who are pregnant or breastfeeding, and women of childbearing age who are not using adequate contraception, should not take this medication, and women who may become pregnant can only use this medication when they are highly unlikely to conceive. Also, administering high doses (40mg) to patients prone to muscle diseases is prohibited. This includes those with moderate to severe renal impairment, hypothyroidism, patients with a family history of genetic muscle disorders, alcohol abusers, and those who are taking specific drugs in combination. Since this medication contains lactose, it should not be administered to patients with lactose intolerance or specific metabolic disorders. When taking this medication, caution should be taken in patients with a history of liver disease or those who consume alcohol excessively, and liver function tests should be performed repeatedly before and during treatment. Patients with hypercholesterolemia due to hypothyroidism or nephrotic syndrome must treat the underlying conditions first. Muscle-related side effects such as myalgia, myopathy, and rarely rhabdomyolysis have been reported, so if symptoms such as muscle pain, weakness, or cramps develop, the physician should be informed immediately. Especially if there is a significant rise in muscle enzyme levels in the blood, the use of this medication should be stopped. Muscle enzyme levels may increase due to exercise or other reasons, so care is needed during testing. In cases of severe renal failure or acute illness, this medication should be discontinued. Additionally, this medication can rarely cause severe muscle weakness or ocular myasthenia, and if these symptoms occur, the medication should be stopped. The risk of muscle side effects may increase when used in combination with other specific medications, so caution is necessary during co-administration. High-dose use may produce transient proteinuria, necessitating renal function testing. Asian patients may experience increased drug exposure, necessitating caution in dosing determination. In pediatric patients, limited reports have indicated effects on growth and secondary sexual characteristics. Common side effects while taking this medication include headache, dizziness, constipation, nausea, abdominal pain, itching, myalgia, weakness, hematuria, diarrhea, discomfort in the chest, loss of appetite, abdominal bloating, abnormal liver function tests, syncope, generalized pain, muscle cramps, gout, erectile dysfunction, joint pain, fatigue, numbness, sensory disturbances, cough, thrombocytopenia, amnesia, peripheral neuropathy, depression, sleep disturbances, sexual dysfunction, gynecomastia, memory decline, forgetfulness, confusion. Rarely, serious side effects such as pancreatitis, myositis, and rhabdomyolysis may occur. Abnormal liver function or changes in blood test values have also been reported, so regular monitoring is necessary during treatment. In both domestic and overseas post-marketing studies, serious adverse reactions related to the nervous system, respiratory system, skin, and blood have been rarely reported, requiring immediate consultation with medical personnel if such symptoms appear. This medication should not be used during pregnancy, and women who may become pregnant must use adequate contraceptive methods. It is also advisable for breastfeeding women not to take this medication. In case of overdose, there is no specific antidote, so treatment should be symptomatic, with careful observation of liver function and muscle enzyme levels. Dizziness may occur while taking this medication, necessitating caution while driving or operating machinery. Finally, this medication can interact with other drugs, so if taking other medications, it is crucial to inform medical personnel, particularly with medications that may increase the risk of muscle side effects.

Side effects and when to seek care immediately

Serious side effects

  • Allergic reactions including hives and angioedema
  • Severe swelling (edema)
  • Chest tightness
  • Difficulty breathing, shortness of breath
  • Cold sweat
  • Pallor
  • Severe rash with fever, blisters
  • Skin peeling
  • Mucosal pain in mouth/eyes
  • Stevens-Johnson syndrome
Show 7 more
  • Drug reaction with eosinophilia and systemic symptoms (DRESS)
  • Severe skin reactions
  • Jaundice
  • Hepatitis
  • Liver failure
  • Severe liver damage and/or hyperbilirubinemia
  • Sudden and severe headache

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • myalgia
  • weakness
  • hematuria
  • diarrhea
Show 24 more
  • discomfort in the chest
  • loss of appetite
  • abdominal bloating
  • abnormal liver function tests
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • fatigue
  • numbness
  • sensory disturbances
  • cough
  • thrombocytopenia
  • amnesia
  • peripheral neuropathy
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • memory decline
  • forgetfulness
  • confusion.

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

Storage

This medication must be stored in a tightly sealed container to avoid exposure to air or moisture. It is important to maintain a storage temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow round film-coated tablets

Package unit

28 tablets/box [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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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.