Medication info
Lovastatin 10 mg Tablet (Rosuvastatin Calcium)

Lovastatin 10 mg Tablet (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
대우제약(주)
Appearance
Pink round film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201404848 · Approved 2014.10.23 · Insurance code 649604430

Summary

Main use
Treatment for hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
Can be taken any time of day, regardless of meals. The initial dose is 5 mg once daily, and the maintenance dose is typically 10 mg once daily, with most patients adjusting at this dosage. The maintenance dose should be appropriately adjusted based on LDL cholesterol levels, treatment goals, and the patient's response, with a maximum daily increase up to 20 mg if necessary, spaced at least 4 weeks apart.
Child dose
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), administer a dose between 5 mg and 20 mg once daily. The dosage should be adjusted based on the individual patient's treatment goals, usually every 4 weeks.

Ingredients

Manufacturer
대우제약(주)

Efficacy & effects

Treatment for hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk

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

This medication is used as an adjunct when dietary control and exercise do not adequately manage primary hypercholesterolemia and mixed dyslipidemia. Additionally, it is used as an adjunct to dietary therapy or lipid-lowering therapy in patients with homozygous familial hypercholesterolemia. This medication helps reduce total cholesterol and LDL cholesterol levels, thereby delaying the progression of atherosclerosis. It is particularly effective in pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia. It also serves as an adjunctive treatment for dietary management in patients with primary dysbetalipoproteinemia. Finally, it is used to reduce the risk of stroke, myocardial infarction, and arterial revascularization in adults with high cardiovascular risk.

How to take

Adult dose

Can be taken any time of day, regardless of meals. The initial dose is 5 mg once daily, and the maintenance dose is typically 10 mg once daily, with most patients adjusting at this dosage. The maintenance dose should be appropriately adjusted based on LDL cholesterol levels, treatment goals, and the patient's response, with a maximum daily increase up to 20 mg if necessary, spaced at least 4 weeks apart.

Child dose

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), administer a dose between 5 mg and 20 mg once daily. The dosage should be adjusted based on the individual patient's treatment goals, usually every 4 weeks.

Precautions

This medication should not be used in certain patients. For example, patients with allergies to any component of this medication, severely impaired liver function, muscle diseases, severe renal impairment, or pregnant or breastfeeding women should not take this medication. Additionally, caution should be exercised in patients at high risk of muscle-related side effects or those taking certain medications concurrently. This medication may affect liver function, so patients with a history of liver disease or those who consume alcohol heavily should regularly undergo liver function tests. If symptoms such as muscle pain, weakness, or damage occur, the doctor should be notified immediately, and in severe cases, discontinuation of the medication may be necessary. This medication may cause elevated blood sugar levels in some patients, so those at risk for diabetes should periodically monitor their blood sugar. This medication may reach higher concentrations in patients with specific genotypes, requiring dosage adjustment if side effects occur during treatment. Furthermore, this medication can interact with other drugs, so if other medications are being taken, it is essential to inform healthcare professionals. Care should be taken when using with some antiviral agents, antibiotics, immunosuppressants, and fibrate medications. Women of childbearing potential should use appropriate contraception while on this medication, and if pregnancy is confirmed, it should be stopped immediately. Breastfeeding women are also advised against using this medication. In case of overdose, there is no specific antidote, so treatment should be symptomatic, and liver and muscle function tests are necessary. Finally, this medication may cause dizziness or other symptoms, so caution is advised when driving or operating machinery.

Side effects and when to seek care immediately

Serious side effects

  • Hypersensitivity reactions including hives and angioedema
  • Severe allergic reactions
  • Severe rash with high fever, blisters, peeling skin, pain in mouth/eyes
  • Stevens-Johnson syndrome
  • Drug reaction with eosinophilia and systemic symptoms (DRESS)
  • Difficulty breathing, dyspnea, respiratory issues
  • Yellowing of skin or eyes (jaundice), hepatitis, liver dysfunction
  • Severe liver damage and/or high bilirubinemia or jaundice
  • Severe

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • muscle pain
  • weakness
  • hematuria
  • diarrhea
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  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • memory loss
  • peripheral neuropathy
  • cough

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air and moisture, ideally at room temperature between 1 to 30 degrees Celsius. This will help maintain the medication's effectiveness.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

30 tablets/bottle, 300 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.