Medication info
Rovide 5 mg (Rosuvastatin Calcium)

Rovide 5 mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
(주)씨티씨바이오
Appearance
Yellow, round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201507896 · Approved 2015.11.25 · Insurance code 669501690

Summary

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

Ingredients

Manufacturer
(주)씨티씨바이오

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

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

This medication is primarily used as an adjunct when diet and exercise alone do not adequately 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. It helps lower total cholesterol and LDL cholesterol levels in patients with hypercholesterolemia, delaying the progression of atherosclerosis. It can be safely used in children aged 10 to 17 years with heterozygous familial hypercholesterolemia, reducing LDL cholesterol and apo-B protein levels, thereby lowering cardiovascular risk. It is also used as an adjunct to dietary therapy in patients with primary dysbetalipoproteinemia. Additionally, it can help reduce the risk of stroke, myocardial infarction, and revascularization procedures in men over 50 years old and women over 60 years old with specific cardiovascular risk factors. This medication is used to improve cholesterol levels and protect cardiovascular health.

Dosage and Administration

Adult dosage

The initial dose is 5 milligrams once daily, and if greater reduction in LDL cholesterol is needed, the maintenance dose can be adjusted. The maintenance dose is usually 10 milligrams once daily, and most patients are controlled on this dose. The maintenance dose should be adjusted appropriately every four weeks or more based on LDL cholesterol levels, treatment goals, and patient response, with a maximum increase to 20 milligrams daily.

Children's dosage

The usual dosage range for pediatric patients with heterozygous familial hypercholesterolemia (aged 10 to 17 years) is 5 milligrams to 20 milligrams once daily. The dosage should be adjusted according to the recommended therapeutic goals for each individual patient.

Precautions

This medication should not be used in certain patients. For example, patients allergic to any component of this medication, those with severe liver disease, muscular disorders, and severe renal impairment should not take this medication. Caution is also required for women who are pregnant, nursing, or of childbearing age who are not using effective contraception before taking this medication. Furthermore, high-dose administration is contraindicated for patients at high risk of muscle disease. It is important to periodically check liver function and muscle condition while taking this medication. Patients with a history of liver disease or those who consume excessive alcohol require more careful monitoring. If symptoms such as muscle pain, weakness, or cramps occur, the physician should be notified immediately for examination. This medication may interact with some other drugs, so if taking other medications, it's essential to inform the physician or pharmacist. In particular, concomitant use with certain antibiotics, antifungals, immunosuppressants, and fibrate drugs may increase the risk of muscle side effects. It is safest not to use this medication during pregnancy or breastfeeding, and women of childbearing age should undergo appropriate contraception. In cases of overdose, there is no specific antidote, so treatment should be symptomatic, monitoring liver function and muscle enzyme levels. Dizziness may occur, so caution is required while driving or operating machinery. Lastly, this medication may have higher blood concentrations in Asians, so dose adjustment may be necessary.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, chest tightness, difficulty breathing, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, severe muscle weakness, ophthalmoplegia, rhabdomyolysis, immune-mediated necrotizing myopathy, acute renal failure, oliguria, hyperbilirubinemia, hepatic failure, thrombocytopenia, polyneuropathy, severe skin reactions, severe allergic reactions, severe edema

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • asthenia
  • diarrhea
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  • chest pain
  • cough
  • muscle cramps
  • fatigue
  • numbness
  • paresthesia
  • loss of appetite
  • abdominal bloating
  • syncope
  • generalized pain
  • joint pain
  • gout
  • erectile dysfunction
  • hematuria
  • thrombocytopenia
  • memory loss
  • peripheral neuropathy
  • increased serum creatinine
  • increased ALT
  • increased AST
  • increased CK

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture, in a temperature range of 1 to 30 degrees Celsius. This helps maintain the effectiveness of the medication and prevent deterioration.

Appearance and packaging

Appearance

Yellow, round film-coated tablet

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.