Medication info
Rosuvastatin Calcium 5mg

Rosuvastatin Calcium 5mg

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

MFDS item code 201405050 · Approved 2014.10.30 · Insurance code 657805460

Summary

Main use
Improvement of hypercholesterolemia and dyslipidemia and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
Irrespective of meals, take 5 mg once daily as the initial dose. If greater reductions in LDL cholesterol are required, adjust to a maintenance dose of 10 mg once daily. The maintenance dose may be adjusted based on LDL cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more, with a maximum daily dose of 20 mg.
Child dose
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the dosing range is 5 mg to 20 mg once daily. The dosing should be adjusted individually based on the recommended treatment goals.

Ingredients

Manufacturer
하나제약(주)

Efficacy & effects

Improvement of hypercholesterolemia and dyslipidemia and reduction of cardiovascular disease risk

  • Hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • primary dysbetalipoproteinemia
  • cardiovascular disease risk factors
  • stroke risk
  • myocardial infarction risk
View approved original text

This medication acts as an adjunct to diet and exercise in patients with primary hypercholesterolemia and mixed dyslipidemia who are not adequately controlled by diet and exercise alone. It is also used in conjunction with diet and other therapies to lower cholesterol levels in patients with homozygous familial hypercholesterolemia. It helps lower total cholesterol and LDL cholesterol levels in patients with hypercholesterolemia to target levels, thereby slowing the progression of atherosclerosis. It is used as a dietary adjunct in pediatric patients with heterozygous familial hypercholesterolemia aged 10 to 17 years. Additionally, it supports treatment in patients with primary dysbetalipoproteinemia and helps reduce the risk of stroke, myocardial infarction, and the need for vascular interventions in middle-aged and older adults at high risk for cardiovascular diseases. This medication is effective in improving cardiovascular health.

How to take

Adult dose

Irrespective of meals, take 5 mg once daily as the initial dose. If greater reductions in LDL cholesterol are required, adjust to a maintenance dose of 10 mg once daily. The maintenance dose may be adjusted based on LDL cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more, with a maximum daily dose of 20 mg.

Child dose

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the dosing range is 5 mg to 20 mg once daily. The dosing should be adjusted individually based on the recommended treatment goals.

Precautions

This medication should not be used in certain patients. For example, individuals who are allergic to this medication, those with severely impaired liver function, patients with muscle disorders, those with severely impaired kidney function, and pregnant or breastfeeding women should not take this medication. Furthermore, high doses of this medication are contraindicated in patients at high risk of muscle problems. This medication contains lactose, so individuals with genetic issues like lactose intolerance should avoid it. It is important to regularly monitor liver function and muscle condition while taking this medication. Patients who consume alcohol heavily or have a history of liver disease should exercise extra caution, and those with hypothyroidism or other specific diseases should receive treatment first. If symptoms such as muscle pain or weakness occur, immediate notification of healthcare personnel is advised, and the medication may be discontinued if necessary. Taking this medication with certain drugs may increase blood concentrations, increasing the risk of muscle damage, so it is essential to consult a physician before combining it with other medications. In particular, it is advisable not to combine it with fibrate class drugs. Women who are pregnant or may become pregnant should ensure they use appropriate contraceptive measures before taking this medication and should avoid it during pregnancy. Breastfeeding mothers should also avoid this medication as it may be passed into breast milk. In case of overdose, there is no specific antidote, so treatment should be symptom-based and liver function and muscle enzyme levels should be monitored regularly. Dizziness may occur during treatment with this medication, so caution is required when driving or operating machinery. Finally, this medication may show higher blood concentrations in Asians, which may necessitate dosage adjustments.

Side effects and when to seek care immediately

Serious side effects

Rash, allergic reactions including angioedema, Stevens-Johnson syndrome, eosinophilia and systemic symptoms of drug reaction (DRESS), rhabdomyolysis, immune-mediated necrotizing myopathy, severe muscle weakness, ocular muscle weakness, hepatitis, jaundice, fatal and non-fatal liver failure, acute kidney failure, oliguria, chest tightness, difficulty breathing, dyspnea, serious skin reactions, severe allergic reactions, etc.

Mild side effects

Headache, dizziness, constipation, nausea, abdominal pain, itching, myalgia, weakness, diarrhea, chest discomfort, loss of appetite, abdominal bloating, syncope, generalized pain, muscle cramps, gout, erectile dysfunction, fatigue, numbness, sensory abnormalities, joint pain, hematuria, thrombocytopenia, memory loss, peripheral neuropathy, cough, increased serum creatinine, increased ALT, increased AST, abnormal liver function tests, increased CK, elevated HbA1c and fasting blood sugar levels, etc.

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture. It is recommended to maintain storage temperatures between 1 and 30 degrees Celsius.

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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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.