Medication info
Rovast 10 mg (Rosuvastatin Calcium)

Rovast 10 mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
(유)한풍제약
Appearance
Pink round film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201904551 · Approved 2019.07.04 · Insurance code 658106570

Summary

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

Ingredients

Manufacturer
(유)한풍제약

Efficacy & effects

Treatment for hypercholesterolemia and reduced cardiovascular disease risk

  • Hypercholesterolemia
  • Heterozygous familial hypercholesterolemia
  • Mixed dyslipidemia
  • Homozygous familial hypercholesterolemia
  • Dysbetalipoproteinemia
  • Risk of stroke
  • Risk of myocardial infarction
  • Risk of arterial revascularization
View approved original text

This medicine is used as an adjunct to diet and exercise in patients with primary hypercholesterolemia and mixed dyslipidemia when these are not adequate for control. It is also helpful in patients with homozygous familial hypercholesterolemia along with other lipid-lowering therapies. It is effective in lowering total cholesterol and LDL cholesterol levels in patients with hypercholesterolemia, thereby delaying the progression of atherosclerosis. For pediatric patients aged 10 to 17 with heterozygous familial hypercholesterolemia, it is also used as an adjunct to diet to contribute to reducing cholesterol levels. It is also utilized as an adjunct to diet in patients with primary dysbetalipoproteinemia. Furthermore, it helps decrease the risk of stroke, myocardial infarction, and arterial revascularization in middle-aged and older patients with elevated high-sensitivity C-reactive protein levels and other cardiovascular risk factors. In summary, this medicine is used for various dyslipidemias and to reduce cardiovascular disease risk.

Dosage and Administration

Adult dosage

The initial dose is 5 mg once daily, and maintenance doses can be adjusted as needed for more LDL cholesterol reduction. The maintenance dose is typically 10 mg once daily, as most patients are adjusted at this dose. The maintenance dose should be adjusted appropriately based on LDL cholesterol levels, treatment goals, and patient response, typically at intervals of 4 weeks or more, with a maximum daily dose of 20 mg.

Children's dosage

The usual dosage range for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) is between 5 mg and 20 mg once daily. The dosage should be adjusted according to the treatment goals for each individual patient.

Precautions

This medicine should not be used in certain patients. For example, it should not be administered to patients who are allergic to this drug, have severe liver dysfunction, have muscle diseases, take specific immunosuppressants, have severe kidney dysfunction, are pregnant or breastfeeding, or have genetic issues such as lactose intolerance. Additionally, as this medicine can affect the liver or muscles, it should be used cautiously in patients who consume large amounts of alcohol or have a history of liver disease, those with hypothyroidism, those with renal impairment, and elderly patients; regular liver function tests and muscle-related tests should be performed before and during treatment. If symptoms such as muscle pain, weakness, fatigue, or warmth occur, medical personnel should be informed immediately, and if these symptoms are severe or if muscle damage levels increase significantly, discontinuation of the drug should be considered. This medicine can interact with other medications, so caution is needed when taken with certain antiviral drugs, immunosuppressants, antibiotics, and fibrate class drugs, as the risk of muscle damage may increase with concurrent use. Women who are pregnant or planning to become pregnant must consult with healthcare providers before taking this medicine and should use appropriate contraception. Breastfeeding should also be avoided, as use during pregnancy or nursing can pose risks to the fetus or infant. In case of overdose, there is no specific antidote, so treatment should be symptomatic, and liver function and muscle enzyme levels should be monitored. Finally, this medicine is known not to significantly affect the ability to drive or operate machinery, but caution is advised due to possible side effects such as dizziness.

Side effects and when to seek care immediately

Serious side effects

Hives, hypersensitivity reactions including angioedema, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe allergic reactions, severe rashes with fever, blisters, skin peeling, pain in oral/ocular mucosa, severe skin adverse reactions, difficulty breathing or shortness of breath, asthma attacks, respiratory abnormalities associated with cough and fever, jaundice (yellowing of the skin or eyes), profound lethargy, and liver abnormalities.

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • muscle pain
  • weakness
  • hematuria
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  • diarrhea
  • chest pain
  • cough
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal distension
  • liver function test abnormalities
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • headache
  • dizziness
  • ALT increase
  • CK increase
  • AST increase
  • joint pain
  • thrombocytopenia
  • memory loss
  • peripheral neuropathy
  • depression
  • sleep disorders
  • sexual dysfunction

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

Storage

This medicine should be stored in a tightly sealed container to prevent exposure to air or moisture. It should be kept in a location that avoids extreme heat or cold, preferably at a temperature between 1 and 30 degrees Celsius, which is room temperature.

Appearance and packaging

Appearance

Pink round film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle

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.