Medication info

Rosuko Tablet 20mg (Rosuvastatin Calcium)

Prescription medicationApproval withdrawn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Approval withdrawn

MFDS item code 201404473 · 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This product's status changed to Approval withdrawn on 2023.06.29.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 for hypercholesterolemia and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
The initial dose is 5mg once daily, and if a greater reduction in LDL cholesterol is necessary, it can be adjusted to a maintenance dose. The maintenance dose is typically 10mg once daily, with most patients managed at this dose. The maintenance dose should be adjusted appropriately based on LDL cholesterol levels, therapeutic goals, and the patient's response, with a maximum daily dose of 20mg.
Children's dosage
The usual dosage range for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) is 5mg to 20mg once daily. The dosing should be adjusted according to the individual patient's therapeutic goals.

Ingredients

Importer
한국노바티스(주)

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • dysbetalipoproteinemia
  • coronary artery disease
  • stroke
  • myocardial infarction
View approved original text

This medication is primarily used as an adjunct in patients with primary hypercholesterolemia and mixed hyperlipidemia where dietary management and exercise alone are inadequate. It also helps patients with homozygous familial hypercholesterolemia when used in conjunction with other lipid-lowering therapies. It lowers total cholesterol and LDL cholesterol levels, delaying the progression of atherosclerosis, and is useful in managing children aged 10 and older with high LDL cholesterol levels due to heterozygous familial hypercholesterolemia. Additionally, it is used as an adjunct to dietary management in patients with primary dysbetalipoproteinemia. Furthermore, it contributes to reducing the risk of stroke, myocardial infarction, and vascular revascularization in high-risk groups with elevated high-sensitivity C-reactive protein levels. In summary, this drug is effectively used to lower the risk of hypercholesterolemia and cardiovascular diseases.

Dosage and Administration

Adult dosage

The initial dose is 5mg once daily, and if a greater reduction in LDL cholesterol is necessary, it can be adjusted to a maintenance dose. The maintenance dose is typically 10mg once daily, with most patients managed at this dose. The maintenance dose should be adjusted appropriately based on LDL cholesterol levels, therapeutic goals, and the patient's response, with a maximum daily dose of 20mg.

Children's dosage

The usual dosage range for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) is 5mg to 20mg once daily. The dosing should be adjusted according to the individual patient's therapeutic goals.

Precautions

This medication should not be administered to certain patients. For example, patients who are allergic to this medication, those with severely impaired liver function, patients with muscle disorders, severely impaired kidney function, and pregnant or breastfeeding women should not use this medication. Additionally, women of childbearing potential should only take this medication if they are unlikely to become pregnant and must use appropriate contraceptive methods. This medication can cause muscle-related side effects; therefore, if symptoms of muscle pain or muscle weakness occur, patients must inform their doctor immediately. In particular, patients with reduced kidney function or a history of hypothyroidism or genetic muscle diseases should exercise extra caution. There may be abnormal liver function; hence, patients with a history of liver disease or those consuming alcohol excessively should have regular liver function tests. Concurrently taking this medication with some other medications may increase blood concentrations, thus raising the risk of muscle damage; always consult with a doctor when taking other medications together. Pregnant or breastfeeding women should not take this medication, and women who may become pregnant must use appropriate contraceptive methods. During the course of this medication, blood sugar levels may occasionally rise, so patients at risk for diabetes should regularly monitor their blood sugar levels. In cases of overdose, there is no specific antidote; therefore, treatment should be based on symptoms, while monitoring liver function and muscle enzyme levels. This medication may cause symptoms such as dizziness, so caution is advised when driving or operating machinery. Lastly, if severe rash or allergic reactions occur during the use of this medication, it must be stopped immediately, and medical attention should be sought.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria and angioedema, Stevens-Johnson syndrome, eosinophilia and systemic symptoms associated drug reaction syndrome, jaundice, hepatitis, fatal and non-fatal hepatic failure, rhabdomyolysis, immune-mediated necrotizing myopathy, acute kidney injury, anuria, dyspnea, interstitial lung disease

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • weakness
  • diarrhea
Show 27 more
  • thrombocytopenia
  • amnesia
  • peripheral neuropathy
  • hematuria
  • edema
  • depression
  • sleep disorders
  • sexual dysfunction
  • gynecomastia
  • memory impairment
  • forgetfulness
  • memory disorders
  • confusion
  • chest discomfort
  • loss of appetite
  • abdominal distension
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • fatigue
  • numbness
  • sensory abnormalities
  • chest pain
  • cough

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

Storage

This medication may be sensitive to air and moisture, so it must be stored in a tightly closed container. It is recommended to keep it at room temperature between 1 degree and 30 degrees Celsius. This helps maintain the drug's efficacy over time.

Appearance and packaging

Appearance

Brown round film-coated tablets

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.

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.