Medication info
Rovide 10mg (Rosuvastatin Calcium)

Rovide 10mg (Rosuvastatin Calcium)

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

MFDS item code 201507897 · Approved 2015.11.25 · Insurance code 669501700

Summary

Main use
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
Can be taken at any time of the day regardless of meals. The initial dose is 5 mg once daily. If more reduction in LDL-cholesterol is needed, the maintenance dose can be adjusted to 10 mg once daily. The maintenance dose may be adjusted based on the patient's response at intervals of 4 weeks or more, and may be increased to a maximum of 20 mg per day.
Children's dosage
The usual dosage range for pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia is 5 mg to 20 mg once daily. The dosing should be adjusted individually based on treatment goals.

Ingredients

Manufacturer
(주)씨티씨바이오

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

  • Hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerosis
  • heterozygous familial hypercholesterolemia
  • dysbetalipoproteinemia
  • coronary heart disease
  • increased high-sensitivity C-reactive protein
  • hypertension
  • low HDL-cholesterol
  • smoking
View approved original text

This medication is used for the treatment of hypercholesterolemia and mixed dyslipidemia. It is used as an adjunct when dietary changes and exercise are insufficient and is particularly effective in patients with familial hypercholesterolemia. It helps lower total cholesterol and LDL-cholesterol, delaying the progression of atherosclerosis and reducing the risk of cardiovascular events. Additionally, it may be used as an adjunct in pediatric patients of certain ages to reduce cholesterol levels. It also has a beneficial effect in reducing the risk of cardiovascular events such as myocardial infarction and stroke. Overall, it is used to improve cardiovascular health.

Dosage and Administration

Adult dosage

Can be taken at any time of the day regardless of meals. The initial dose is 5 mg once daily. If more reduction in LDL-cholesterol is needed, the maintenance dose can be adjusted to 10 mg once daily. The maintenance dose may be adjusted based on the patient's response at intervals of 4 weeks or more, and may be increased to a maximum of 20 mg per day.

Children's dosage

The usual dosage range for pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia is 5 mg to 20 mg once daily. The dosing should be adjusted individually based on treatment goals.

Precautions

This medication should not be used in certain patients. For example, patients with allergies to any of its components or those with severely impaired liver function should avoid its use. Moreover, patients with muscle disorders, those taking cyclosporine, and those with severe renal impairment should not take this medication. Pregnant or nursing women, and fertile women who do not use adequate contraception should consult a doctor before using this drug. In particular, patients at higher risk of muscle disorders should avoid high doses, and patients with certain genetic issues such as lactose intolerance should also not take this medication. Regular monitoring of liver function and muscle status is required while taking this medication. Patients who consume excessive alcohol or have a history of liver disease need to be particularly cautious. If symptoms such as myalgia or muscle weakness occur, they should immediately inform healthcare professionals and discontinue use if necessary. Additionally, use should also be discontinued in cases of severe acute illness or symptoms of severe muscle weakness. This medication may interact with other drugs, so if you are taking other medications, you must inform your doctor or pharmacist. Particularly, when used with certain antiviral drugs, immunosuppressants, antibiotics, and fibrate medications, the risk of muscle adverse reactions may increase. Pregnant or nursing women should not use this drug, and women of childbearing potential should use appropriate contraception before taking it. This is due to the potential risks it may pose to fetuses and infants. In cases of overdose, there is no specific antidote, thus treatment according to symptoms, along with testing of liver function and muscle enzymes is needed. This medication is not known to affect driving or operating machinery, but caution is advised due to the possibility of dizziness. Finally, this drug may rarely cause severe skin reactions, liver dysfunction, and myopathy in some patients, so it is important to consult healthcare professionals immediately if any abnormal symptoms occur.

Side effects and when to seek care immediately

Serious side effects

Hives, hypersensitivity reactions including angioedema, severe allergic reactions, chest tightness, difficulty breathing, respiratory distress, Stevens-Johnson syndrome, eosinophilia and systemic symptoms associated with drug reaction syndrome, severe myasthenia, ophthalmoplegia, rhabdomyolysis, immune-mediated necrotizing myopathy, jaundice, hepatitis, severe liver damage, hyperbilirubinemia, liver failure, acute renal failure, oliguria, severe headache (thunderclap headache, lightning headache).

Mild side effects

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

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

Storage

This medication should be stored in a tightly closed container, protected from air and moisture, and it is important to maintain storage temperatures between 1°C and 30°C. Proper storage will help preserve the medication's efficacy and prevent degradation.

Appearance and packaging

Appearance

Pink 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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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.