Medication info
Rovacan Tablets 5mg (Rosuvastatin Calcium)

Rovacan Tablets 5mg (Rosuvastatin Calcium)

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

MFDS item code 201906608 · Approved 2019.09.23 · Insurance code 679601230

Summary

Main use
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
The initial dose is once daily 5 mg, and if a greater reduction in LDL cholesterol is needed, the maintenance dose can be adjusted accordingly. The maintenance dose is typically 10 mg once daily, and most patients are controlled at this dosage. The maintenance dose should be adjusted appropriately based on LDL cholesterol levels, therapeutic goals, and the patient's response at intervals of 4 weeks or more, with a maximum increase up to 20 mg per day.
Children's dosage
The usual dosage range for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) is once daily 5 mg to 20 mg. The dosage should be individualized according to the recommended therapeutic goals for each patient.

Ingredients

Manufacturer
(주)서흥

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

  • Hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerosis
  • homozygous familial hypercholesterolemia
  • primary dysbetalipoproteinemia
  • coronary heart disease
  • stroke
  • myocardial infarction
View approved original text

This drug is primarily used as an adjunct in patients with primary hypercholesterolemia and mixed dyslipidemia when dietary changes and exercise are not enough to control their condition. It is also used as an adjunct in the treatment of homozygous familial hypercholesterolemia. It effectively lowers total cholesterol and LDL cholesterol levels to delay the progression of atherosclerosis in patients with hypercholesterolemia. It is also used as an adjunct to diet in pediatric patients with familial hypercholesterolemia aged 10 to 17 years. It helps in the treatment of primary dysbetalipoproteinemia patients. Additionally, it reduces the risk of stroke, myocardial infarction, and arterial revascularization procedures in certain high-risk patients, thus decreasing the overall risk of cardiovascular disease. Therefore, this drug is used to improve the risks associated with dyslipidemia and cardiovascular diseases.

Dosage and Administration

Adult dosage

The initial dose is once daily 5 mg, and if a greater reduction in LDL cholesterol is needed, the maintenance dose can be adjusted accordingly. The maintenance dose is typically 10 mg once daily, and most patients are controlled at this dosage. The maintenance dose should be adjusted appropriately based on LDL cholesterol levels, therapeutic goals, and the patient's response at intervals of 4 weeks or more, with a maximum increase up to 20 mg per day.

Children's dosage

The usual dosage range for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) is once daily 5 mg to 20 mg. The dosage should be individualized according to the recommended therapeutic goals for each patient.

Precautions

This drug should not be used in certain patients. For example, it should not be administered to patients with hypersensitivity to this drug, those with active liver disease, myopathy patients, and those with severe renal impairment. Pregnant or breastfeeding women should not use this drug, and women of childbearing age should use appropriate contraceptive methods. High-dose administration is contraindicated in patients at high risk of muscle-related disorders or those with a history of certain genetic muscle diseases, and these patients should be treated with caution. This drug contains lactose, so patients with lactose intolerance should not take it. Patients who consume excessive amounts of alcohol or have a history of liver disease should undergo regular liver function tests before and during treatment with this drug. If symptoms of muscle pain or weakness occur, inform medical staff immediately and check for muscle damage through blood tests if necessary. Treatment should be discontinued if acute renal failure or severe metabolic disorders occur during the use of this drug. Particularly, elderly patients, those with renal impairment, and patients with hypothyroidism, who are at higher risk of muscle damage, should be closely monitored. This drug may interact with other medications, so inform healthcare staff of any medications currently being taken and discuss dosage adjustments or co-administration. Its safety during pregnancy has not been established, so it should not be used during pregnancy or while breastfeeding. In case of overdose, as there is no specific antidote, immediate medical treatment and monitoring should be obtained. Caution is advised while driving or operating machinery, as dizziness may occur. Rarely, during the use of this drug, serious skin reactions, liver function abnormalities, muscle damage, and other adverse effects may occur; therefore, contact medical staff immediately if abnormal symptoms appear.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, skin peeling, pain in mouth/eye mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough + fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headache, lightning headache, seizures, altered consciousness, visual disturbances, paralysis, urination

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • muscle pain
  • weakness
  • itching
  • rash
  • hematuria
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  • diarrhea
  • chest pain
  • cough
  • joint pain
  • fatigue
  • numbness
  • paresthesia
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • loss of appetite
  • abdominal distension
  • abnormalities in liver function tests
  • amnesia
  • peripheral neuropathy
  • thrombocytopenia
  • increased transaminases
  • hepatitis
  • lupus-like syndrome
  • muscle rupture
  • increased blood creatinine levels
  • depression
  • increase

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

Storage

This drug should be stored in a tightly closed container, avoiding exposure to air or moisture, and ideally at room temperature between 1 degree and 30 degrees Celsius. This storage ensures 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.

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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.