Medication info

Rosuco 5 mg (Rosuvastatin Calcium)

Prescription medicationApproval withdrawn
Ingredient · strength
Rosuvastatin Calcium›Strength being verified
Manufacturer / importer
한국노바티스(주)
Appearance
Brown, round, film-coated tablet
Packaging
28 tablets (7 tablets/Alu-Alu x 4)
Approval status
Approval withdrawn

MFDS item code 201404475 · Approved 2014.09.30

This product's status changed to Approval withdrawn on 2023.06.29. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
For adult patients with primary hypercholesterolemia, the medication can be administered at any time of day, regardless of meals. The initial dose is 5 mg once daily, and the maintenance dose should be adjusted according to treatment goals. Most patients are adjusted to 10 mg per day, and the dose can be increased to a maximum of 20 mg per day based on LDL cholesterol levels and patient response, with at least a 4-week interval between adjustments.
Children's dosage
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years), the usual dosage range is 5 mg to 20 mg once daily. Dosage should be adjusted according to the treatment goals with intervals of at least 4 weeks.

Ingredients

Importer
한국노바티스(주)

Efficacy & effects

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

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

This medication is primarily used as an adjunct therapy for patients with primary hypercholesterolemia and mixed dyslipidemia when diet and exercise alone are not sufficient. It is also used in combination with other therapies for patients with homozygous familial hypercholesterolemia. It helps lower total cholesterol and LDL cholesterol levels in patients with hypercholesterolemia, thereby slowing the progression of atherosclerosis. It can also be used as an adjunct to dietary therapy in children with certain familial hypercholesterolemia and is applicable for patients with primary dysbetalipoproteinemia. Furthermore, it may provide risk reduction for stroke, myocardial infarction, and artery revascularization in middle-aged patients at high risk for cardiovascular diseases. In summary, this medication is effectively used for reducing the risk of various dyslipidemias and cardiovascular diseases.

Dosage and Administration

Adult dosage

For adult patients with primary hypercholesterolemia, the medication can be administered at any time of day, regardless of meals. The initial dose is 5 mg once daily, and the maintenance dose should be adjusted according to treatment goals. Most patients are adjusted to 10 mg per day, and the dose can be increased to a maximum of 20 mg per day based on LDL cholesterol levels and patient response, with at least a 4-week interval between adjustments.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years), the usual dosage range is 5 mg to 20 mg once daily. Dosage should be adjusted according to the treatment goals with intervals of at least 4 weeks.

Precautions

This medication should not be administered to certain patients. First, individuals with an allergy to the components of this medication should not use it. Additionally, patients with severely impaired liver function or unexplained elevated liver enzyme levels should not take this medication. Those with muscle problems or myopathy should also avoid this medication. Co-administration with the immunosuppressant cyclosporine is contraindicated. Patients with significantly impaired kidney function should not take this medication. Pregnant or breastfeeding women and fertile women not using appropriate contraception should also refrain from using this medication. Particularly, in high doses (40 mg), this medication should not be administered to patients at high risk for muscle complications. This medication contains lactose, so individuals with lactose intolerance should avoid it. Regular monitoring of liver function or muscle condition is required during use, and patients with a history of heavy alcohol consumption or liver disease should take extra caution. If symptoms such as muscle pain, weakness, or cramps occur, medical personnel should be notified immediately, and if accompanied by elevated muscle enzyme levels, the medication should be discontinued. Muscle enzyme levels may increase after exercise or due to other causes, so testing should be performed at an appropriate time. This medication may interact with other drugs, so any concomitant medications should be reported to healthcare providers. Particularly, concomitant use with some antiviral agents, immunosuppressants, certain antibiotics, and fibrate medications may increase the risk of muscle damage. The safety of this medication has not been established during pregnancy or lactation, and women of childbearing potential must use appropriate contraception. In cases of overdose, since there is no specific antidote, treatment should be symptomatic with monitoring of liver function and muscle enzyme levels. This medication can rarely cause severe skin reactions or liver damage, so if symptoms such as skin rash or jaundice occur, it should be discontinued immediately, and healthcare providers should be consulted. Caution is required in daily life as dizziness may occur, especially when driving or operating machinery.

Side effects and when to seek care immediately

Serious side effects

Urticaria, hypersensitivity reactions including angioedema, rhabdomyolysis, jaundice, Stevens-Johnson syndrome, severe allergic reactions, severe skin reactions, respiratory distress, liver abnormalities (jaundice), acute renal failure, oliguria, edema, severe swelling or urination abnormalities, serious neurological symptoms, immune-mediated myopathy, polyneuropathy, peripheral neuropathy, Stevens-Johnson syndrome, severe skin reactions, immune-mediated necrotizing myopathy

Mild side effects

Headache, dizziness, constipation, nausea, abdominal pain, itching, rash, myalgia, weakness, hematuria, diarrhea, fatigue, numbness, paresthesia, chest discomfort, loss of appetite, abdominal distension, syncope, generalized pain, muscle cramps, gout, erectile dysfunction, joint pain, memory loss, cough, thrombocytopenia, hepatitis, increased transaminases, elevated eosinophils, and drug reaction with eosinophilia and systemic symptoms (DRESS), lupus-like syndrome, muscle rupture

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. It is recommended to maintain a storage temperature between 1 and 30 degrees Celsius in order to preserve its efficacy and safety for a long time.

Appearance and packaging

Appearance

Brown, round, film-coated tablet

Package unit

28 tablets (7 tablets/Alu-Alu x 4)

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.