Medication info

RosuCo Tablet 10 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Prescription medicationApproval withdrawn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Approval withdrawn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 201404474 · 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This product's status changed to Approval withdrawn on 2023.06.29.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 and dyslipidemia (primary and familial) and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
This medication can be taken at any time during the day, regardless of meals. The initial dosage is 5 mg once daily, which can be adjusted to a maintenance dose based on treatment goals. The maintenance dose is typically 10 mg once daily, and most patients are adjusted at this dosage. The maintenance dose should be appropriately adjusted based on LDL cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or longer, with a maximum daily dose 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 the treatment goals for individual patients over intervals of 4 weeks or more.

Ingredients

Importer
한국노바티스(주)

Efficacy & effects

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

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

This medication is used as an adjunct in patients with primary hypercholesterolemia and mixed dyslipidemia when diet and exercise alone are insufficient. It is also used in conjunction with diet or other treatments in patients with homozygous familial hypercholesterolemia, lowering total cholesterol and LDL cholesterol levels, thereby slowing the progression of atherosclerosis. It can also be used as an adjunct treatment for pediatric patients aged 10 to 17 with familial hypercholesterolemia and is beneficial for patients with dysbetalipoproteinemia. In patients with a high risk of cardiovascular disease, it plays a role in reducing the risk of stroke, myocardial infarction, and vascular revascularization. Overall, this medication is effectively used for cholesterol management and the prevention of cardiovascular diseases.

Dosage and Administration

Adult dosage

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

Precautions

This medication should not be used in certain patients. For example, individuals allergic to its components or with severely impaired liver function or muscle disorders should avoid taking it. Additionally, patients with severely impaired kidney function, pregnant or nursing women should also not use this medication. Before taking this medication, regular liver function tests and muscle-related examinations should be conducted. Patients with liver disease or those who consume a significant amount of alcohol should be particularly cautious. If symptoms of muscle pain or weakness occur, they should inform their doctor immediately, and in severe cases, discontinue the medication. This medication may interact with certain drugs when taken together, so it is essential to consult a physician or pharmacist if taking other medications. The risk of muscle-related side effects may increase, particularly when combined with certain antiviral agents, antifungals, antibiotics, immunosuppressants, etc. Women of childbearing potential should use appropriate contraception while taking this medication, and those planning to become pregnant or who are pregnant should avoid it. Additionally, this medication contains lactose, so those with lactose intolerance should exercise caution. There is no specific antidote for overdose, so it is vital to adhere to the prescribed dosage, and if unusual symptoms arise, one should seek medical attention immediately. This medication may cause symptoms such as dizziness or headaches, so caution is advised when driving or operating machinery. Finally, while this medication can be used in children and adolescents, regular examinations are necessary as it may affect growth and development. Side effects may include muscle pain, abnormal liver function, gastrointestinal symptoms, and consultation with a healthcare professional is advised if symptoms occur.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including hives, angioedema, chest tightness, difficulty breathing, severe allergic reactions, high fever with severe rash, blisters, peeling skin, pain in the mucous membranes of the mouth/eyes, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, severe skin reactions, serious liver damage, hyperbilirubinemia, sudden and severe headaches, seizures, confusion

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash and hives
  • muscle pain
  • weakness
  • blood in urine
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  • thrombocytopenia
  • diarrhea
  • memory loss
  • peripheral neuropathy
  • cough
  • lupus-like syndrome
  • joint pain
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal distension
  • abnormal liver function tests
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • cognitive impairment

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

Storage

This medication may be sensitive to air and moisture and should be stored in a tightly sealed container. It is recommended to maintain the storage temperature between 1 and 30 degrees Celsius to safely preserve its efficacy.

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.

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.