Medication info
Rovitan Tablet 10 mg (Rosuvastatin Calcium)

Rovitan Tablet 10 mg (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
삼일제약(주)
Appearance
Pink round film-coated tablets
Packaging
14 tablets/blister X 2
Approval status
Active

MFDS item code 201001008 · Approved 2010.01.28 · Insurance code 643902810

Summary

Main use
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
This medication can be taken at any time of the day regardless of meals. The initial dose is 5 mg once daily, and if greater reduction in LDL cholesterol is needed, the dose can be adjusted to the maintenance dose. The maintenance dose is usually 10 mg once daily for most patients. The maintenance dosage is adjusted at intervals of 4 weeks or more based on LDL cholesterol levels, treatment goals, and patient response.
Child dose
The usual dosage range is 5 mg to 20 mg once daily. The administration dosage is adjusted individually according to the treatment goals recommended for each patient. Dosage should be adjusted at intervals of 4 weeks or more.

Ingredients

Manufacturer
삼일제약(주)

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

  • Hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • dysbetalipoproteinemia
  • increased total cholesterol
  • increased LDL cholesterol
  • increased apolipoprotein B levels
  • elevated high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol
  • smoking
View approved original text

This medication is used as an adjunct when dietary changes and exercise alone are insufficient for patients with primary hypercholesterolemia and mixed dyslipidemia. It is also utilized as an adjunct in patients with homozygous familial hypercholesterolemia alongside dietary treatments or other lipid-lowering therapies. It helps to lower total cholesterol and LDL cholesterol in patients with hypercholesterolemia, thus delaying the progression of atherosclerosis. Specifically, it is used as an adjunct therapy for children and adolescents aged 10 to 17 years in high-risk groups to reduce cholesterol levels. It is also effective for patients with primary dysbetalipoproteinemia, helping to lower the risk of stroke, myocardial infarction, and revascularization procedures in elderly patients at high cardiovascular risk. Overall, this medication is used to improve blood lipid levels and reduce the risk of cardiovascular diseases.

How to take

Adult dose

This medication can be taken at any time of the day regardless of meals. The initial dose is 5 mg once daily, and if greater reduction in LDL cholesterol is needed, the dose can be adjusted to the maintenance dose. The maintenance dose is usually 10 mg once daily for most patients. The maintenance dosage is adjusted at intervals of 4 weeks or more based on LDL cholesterol levels, treatment goals, and patient response.

Child dose

The usual dosage range is 5 mg to 20 mg once daily. The administration dosage is adjusted individually according to the treatment goals recommended for each patient. Dosage should be adjusted at intervals of 4 weeks or more.

Precautions

This medication should not be used in patients who are allergic to specific ingredients. Administration should be avoided in patients with liver issues or elevated liver enzyme levels. Patients with muscle diseases or concerns about muscle damage should not take this medication. Caution is required when taken with certain immunosuppressants due to potential risks. Patients with severe renal impairment or those who are pregnant or breastfeeding should not use this medication. High doses over 40 mg can increase the risk of muscle-related side effects, so careful attention is warranted. This medication contains lactose, so those with lactose intolerance should not take it. Patients who consume excessive alcohol or have a history of liver disease should have regular liver function tests. If symptoms of muscle pain or weakness arise, consult a doctor immediately and discontinue the medication if required. This medication can interact with other drugs, so inform your healthcare provider of any other medications being taken. Particularly when taken with fibrate-class drugs, the risk of muscle side effects increases, so caution is advised. Pregnant or breastfeeding women should avoid this medication as it may pose risks to the fetus or infant. In the case of overdose, there is no specific antidote, so immediate medical treatment is necessary, and liver and muscle status should be monitored. This medication may cause dizziness, so caution is needed when driving or operating machinery. If severe skin rashes or allergic reactions occur while taking this medication, discontinue use immediately and seek medical attention. For children and adolescents, it is recommended to regularly monitor growth and developmental status.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, chest tightness, difficulty breathing, respiratory disturbance, jaundice, sudden and severe headache, seizures, confusion, visual disturbances, paralysis, markedly reduced urine output, severe generalized edema, severe allergic reactions, serious skin adverse reactions (Stevens-Johnson syndrome, DRESS), severe myopathy, ophthalmoplegia, rhabdomyolysis, acute renal failure, thrombocytopenia, hepatitis, severe skin abnormalities

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • myalgia
  • weakness
  • increased blood sugar levels
  • diarrhea
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  • joint pain
  • fatigue
  • numbness
  • sensory disturbances
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • hematuria
  • cough

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

Storage

This medication is sensitive to air and moisture, so it should be stored in a tightly closed container. Additionally, it is best kept at room temperature between 1°C and 30°C. Avoid storing it in very hot or very cold places to maintain its effectiveness.

Appearance and packaging

Appearance

Pink round film-coated tablets

Package unit

14 tablets/blister 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.

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.