Medication info
Rosuvam 5mg (Rosuvastatin Calcium)

Rosuvam 5mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
맥널티제약(주)
Appearance
Yellow round film-coated tablets
Packaging
30 tablets (15 tablets/PTP x 2 packs)
Approval status
Active

MFDS item code 202005250 · Approved 2020.07.21 · Insurance code 641502670

Summary

Main use
Treatment of hypercholesterolemia and dyslipidemia (primary, familial) and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
This medication can be taken at any time of the day, regardless of meals. The initial dose is 5 mg once daily. The maintenance dose is usually 10 mg once daily, with most patients adjusted to this dose. The maintenance dose should be adjusted based on LDL-cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more, with a maximum daily dosage of 20 mg.
Children's dosage
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the typical dosage range is 5 mg to 20 mg once daily. The dosage should be adjusted according to each patient's treatment goals.

Ingredients

Manufacturer
맥널티제약(주)

Efficacy & effects

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

  • Primary hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • primary dysbetalipoproteinemia
  • increased high-sensitivity C-reactive protein
  • hypertension
  • low HDL-cholesterol levels
  • smoking
  • family history of early coronary heart disease
View approved original text

This medication helps patients with primary hypercholesterolemia and mixed dyslipidemia when dietary changes and exercise are insufficient. It is also used as an adjunct to diet or other lipid-lowering therapy in patients with homozygous familial hypercholesterolemia. It lowers total cholesterol and LDL-cholesterol levels in patients with hypercholesterolemia and helps delay the progression of atherosclerosis. For children aged 10 to 17 with heterozygous familial hypercholesterolemia, it helps reduce cholesterol levels. It is also used adjunctively in patients with primary dysbetalipoproteinemia and contributes to reducing the risk of stroke, myocardial infarction, and arterial revascularization in elderly patients at high cardiovascular risk. Overall, this drug is used to effectively improve cholesterol levels and reduce cardiovascular disease risk.

Dosage and Administration

Adult dosage

This medication can be taken at any time of the day, regardless of meals. The initial dose is 5 mg once daily. The maintenance dose is usually 10 mg once daily, with most patients adjusted to this dose. The maintenance dose should be adjusted based on LDL-cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more, with a maximum daily dosage of 20 mg.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the typical dosage range is 5 mg to 20 mg once daily. The dosage should be adjusted according to each patient's treatment goals.

Precautions

This drug should not be used in certain patients. For example, individuals allergic to this medication, those with severe liver impairment, or those with muscle-related diseases should avoid it. Additionally, special caution is required for pregnant or breastfeeding women and women of childbearing age who are not using appropriate contraception; it should only be used if there is assurance of low pregnancy probability. Care should be taken when prescribing high doses to patients with a history of muscle disease or moderate to severe renal impairment due to the risk of muscle damage. Patients with genetic disorders that prevent lactose digestion should also avoid this medication. Patients with liver dysfunction or those consuming excessive alcohol should undergo regular liver enzyme tests and use the medication cautiously. If muscle pain or weakness occurs, patients should inform their doctor immediately, and in severe cases, they may need to stop the medication. Special monitoring is necessary prior to and after treatment in elderly patients, those with reduced kidney function, or those with hypothyroidism who have risk factors for muscle damage. The use of this drug should be temporarily suspended when acute severe illness occurs. This medication can rarely induce severe muscle weakness or ocular muscle weakness; if such symptoms appear, it should be stopped immediately. When used with certain other medications, the risk of muscle damage may increase; therefore, consult with a doctor about any concomitant medications. High-dose administration may result in transient kidney proteinuria, so it is advisable to undergo regular kidney function tests. Asian patients may exhibit higher drug concentrations, thus requiring dose adjustments. Pediatric and adolescent patients should be considered for their effects on growth and development. This medication has been reported to cause various adverse reactions such as liver dysfunction, increased risk of diabetes, and severe skin reactions; thus, immediate consultation with medical staff is necessary if symptoms arise. This medication should not be used during pregnancy or breastfeeding, and women planning a pregnancy should use appropriate contraceptive methods. There is no specific antidote for overdose, so treatment should be symptomatic and include liver function and muscle enzyme tests. Caution is advised when driving or operating machinery, as dizziness may occur. It is essential to consult with a doctor and undergo regular check-ups to ensure the safe use of this medication.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria and angioedema, Stevens-Johnson syndrome, eosinophilia with systemic symptoms and drug reaction with eosinophilia and systemic symptoms, rhabdomyolysis, severe muscle weakness, ocular muscle weakness, dyspnea, interstitial lung disease, jaundice, fatal and non-fatal liver failure, acute renal failure, oliguria, severe edema, thrombocytopenia, severe allergic reactions, severe skin reactions, respiratory problems, liver abnormalities (jaundice), serious kidney issues

Mild side effects

Headache, dizziness, constipation, nausea, abdominal pain, itching, rash, muscle pain, weakness, hematuria, diarrhea, chest discomfort, loss of appetite, abdominal bloating, fatigue, numbness, paraesthesia, syncope, generalized pain, muscle cramps, gout, erectile dysfunction, joint pain, amnesia, peripheral neuropathy, thrombocytopenia, transaminase elevation, hepatitis, eosinophilia, drug reaction with eosinophilia and systemic symptoms, lupus-like syndrome, immune-mediated necrosis

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 air and moisture from entering, and it is best stored at room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the effectiveness of the medication and prevent deterioration.

Appearance and packaging

Appearance

Yellow round film-coated tablets

Package unit

30 tablets (15 tablets/PTP x 2 packs)

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.

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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.