Medication info
Rovasta Tablet 5 Milligrams (Rosuvastatin Calcium)

Rovasta Tablet 5 Milligrams (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
한국유나이티드제약(주)
Appearance
Yellow, convex round film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201403561 · Approved 2014.07.31 · Insurance code 644308800

Summary

Main use
Treatment of hypercholesterolemia and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
For primary hypercholesterolemia and other adult conditions, this medication can be administered at any time of day, regardless of meals. The initial dosage is 5 milligrams once daily, and if necessary, it can be adjusted to a maintenance dosage of 10 milligrams once daily. The maintenance dosage should be adjusted at intervals of 4 weeks or more, with a maximum daily dosage of 20 milligrams.
Child dose
For pediatric patients with heterozygous familial hypercholesterolemia (aged 10 to 17 years), the recommended dosage is 5 to 20 milligrams once daily. The dosage should be adjusted based on individual treatment goals at intervals of 4 weeks or more.

Ingredients

Manufacturer
한국유나이티드제약(주)

Efficacy & effects

Treatment of hypercholesterolemia and reduction of cardiovascular disease risk

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

This medicine is primarily used as an adjunct therapy when diet and exercise alone are insufficient to control primary hypercholesterolemia and mixed hyperlipidemia patients. It is also effective as an adjunct to diet or other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia. In patients with hypercholesterolemia, it helps lower total cholesterol and LDL cholesterol levels to target levels, delaying the progression of atherosclerosis. Moreover, it is used as an adjunct therapy to reduce total cholesterol, LDL cholesterol, and Apo-B levels in pediatric patients aged 10 to 17 years who meet specific criteria. Additionally, it can be utilized as an adjunct to diet in patients with primary dysbetalipoproteinemia. Finally, it helps reduce the risk of stroke, myocardial infarction, and arterial revascularization in certain high-risk patients, aiding in the prevention of cardiovascular disease. In summary, this medicine is effectively used for the treatment of various forms of hyperlipidemia and the reduction of cardiovascular disease risk.

How to take

Adult dose

For primary hypercholesterolemia and other adult conditions, this medication can be administered at any time of day, regardless of meals. The initial dosage is 5 milligrams once daily, and if necessary, it can be adjusted to a maintenance dosage of 10 milligrams once daily. The maintenance dosage should be adjusted at intervals of 4 weeks or more, with a maximum daily dosage of 20 milligrams.

Child dose

For pediatric patients with heterozygous familial hypercholesterolemia (aged 10 to 17 years), the recommended dosage is 5 to 20 milligrams once daily. The dosage should be adjusted based on individual treatment goals at intervals of 4 weeks or more.

Precautions

This medication should not be administered to certain patients. For example, individuals allergic to the components of this medication or those with severely impaired liver function should not take it. Additionally, it should not be used by individuals with muscle disorders, severely impaired kidney function, pregnant or breastfeeding women, and women of childbearing age who do not practice appropriate contraception. \n\nCaution should be exercised when using this medication in patients at high risk for myopathy or rhabdomyolysis, and high-dose administration is contraindicated. This medication contains lactose, so those with lactose intolerance should not take it. \n\nFor patients who consume alcohol excessively or have a history of liver disease, liver function tests should be conducted multiple times before initiating this medication. If a patient has conditions such as hypothyroidism or nephrotic syndrome, the underlying condition should be treated before using this medication. \n\nDuring treatment, if symptoms such as muscle pain, muscle weakness, or muscle cramps occur, the doctor should be informed immediately, and a blood test should be conducted. Notably, if muscle enzyme levels rise significantly, the medication should be discontinued. \n\nThis medication may temporarily raise liver enzyme levels; therefore, liver function tests may be necessary. Rarely, skin rashes, urticaria, and severe skin reactions may occur, so if symptoms arise, discontinuation and consultation with a physician are necessary. \n\nThis medication may interact with other drugs, leading to increased blood concentrations of this medication and a heightened risk of muscle damage if taken concurrently with certain drugs. Thus, any concomitant medications should be disclosed to a physician or pharmacist. \n\nPregnant or breastfeeding women should not take this medication, and women who could become pregnant should use safe contraception methods. \n\nIn case of overdose, there is no specific antidote; treatment should be based on symptoms, and careful monitoring of liver function and muscle enzyme levels is necessary. \n\nThis medication may cause dizziness; therefore, caution is needed when driving or operating machinery. \n\nFinally, children and adolescents can also use this medication, but careful monitoring of their growth and developmental status is necessary.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria and angioedema, chest tightness, difficulty breathing, severe rash with fever, blisters, skin peeling, oral/conjunctival mucosal pain, jaundice, severe lethargy, significant edema, markedly reduced urine output, sudden and severe headache, thunderclap headache, seizure, altered consciousness, visual disturbances, paralysis, severe allergic reactions, severe skin adverse reactions, respiratory issues, liver abnormalities (jaundice),

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • myalgia
  • weakness
  • hematuria
  • cough
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  • diarrhea
  • ocular muscle weakness
  • thrombocytopenia
  • lichenoid drug rash
  • lupus-like syndrome
  • arthralgia
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal distension
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • memory impairment
  • forgetfulness
  • amnesia

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. Furthermore, it should be kept at room temperature, ideally between 1 to 30 degrees Celsius, where it is not excessively high or low.

Appearance and packaging

Appearance

Yellow, convex round film-coated tablet

Package unit

30 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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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.