Medication info
Fabist Tablets 10mg (Rosuvastatin Calcium)

Fabist Tablets 10mg (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
풍림무약(주)
Appearance
Pink, round film-coated tablet
Packaging
30 tablets (10 tablets/Alu-Alu) × 3
Approval status
Active

MFDS item code 201404672 · Approved 2014.10.13 · Insurance code 649001190

Summary

Main use
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
This medication can be taken at any time of the day, regardless of meals. The initial dose is 5 milligrams once daily. The maintenance dose is 10 milligrams once daily, and it can be adjusted based on LDL cholesterol levels, treatment goals, and patient response, typically every 4 weeks or longer. The maximum daily dose can be increased up to 20 milligrams.
Child dose
For pediatric patients aged 10 to 17 years, the dosage is administered once daily in the range of 5 milligrams to 20 milligrams. The dosage should be adjusted according to each patient's treatment goals, typically every 4 weeks or more.

Ingredients

Manufacturer
풍림무약(주)

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

  • Hypercholesterolemia
  • familial hypercholesterolemia
  • mixed dyslipidemia
  • abnormal beta-lipoproteinemia
  • 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 is primarily used as an adjunct for patients with hypercholesterolemia and dyslipidemia. It is particularly beneficial for patients with primary hypercholesterolemia and mixed hyperlipidemia that are difficult to manage with diet and exercise alone. Additionally, it is used in conjunction with other therapies to lower cholesterol levels in patients with familial hypercholesterolemia. In middle-aged patients at high risk for cardiovascular disease, it can also be expected to reduce the risk of stroke and myocardial infarction. Furthermore, it helps regulate cholesterol levels and slows the progression of atherosclerosis in certain pediatric patients. It plays a role in contributing to the management of various forms of dyslipidemia and reducing cardiovascular disease risk.

How to take

Adult dose

This medication can be taken at any time of the day, regardless of meals. The initial dose is 5 milligrams once daily. The maintenance dose is 10 milligrams once daily, and it can be adjusted based on LDL cholesterol levels, treatment goals, and patient response, typically every 4 weeks or longer. The maximum daily dose can be increased up to 20 milligrams.

Child dose

For pediatric patients aged 10 to 17 years, the dosage is administered once daily in the range of 5 milligrams to 20 milligrams. The dosage should be adjusted according to each patient's treatment goals, typically every 4 weeks or more.

Precautions

This medication should not be used in certain patients. For example, patients who are allergic to this medication, have severely impaired liver function, or have a muscular disorder may be at risk if they take it. Additionally, patients with severely reduced kidney function or pregnant or breastfeeding women should also not take this medication. Women of childbearing potential should use appropriate contraceptive methods to reduce the risk of pregnancy and should only be treated after being fully aware of the risks to the fetus. Particular caution is needed for patients at high risk of muscle-related side effects. For instance, patients with moderate to severe renal impairment, hypothyroidism, or a history of genetic muscle disorders should not use high doses of this medication. Furthermore, if taken with alcohol or certain medications, the risk of muscle damage may increase. Patients with problems breaking down lactose or lactose intolerance should avoid this medication due to the lactose it contains. It is important to regularly check liver function and muscle condition while taking this medication. Patients with a history of liver disease or those who drink excessively should have liver enzyme tests before starting and during treatment. If symptoms such as myalgia, muscle weakness, or cramps occur, healthcare professionals should be notified immediately, and the medication may need to be discontinued if necessary. Blood tests to check the levels of creatine kinase (CK), an indicator of muscle damage, should be performed when such symptoms arise. Severe muscle weakness or ocular muscle weakness may occur, and if such symptoms develop, the use of this medication should be stopped immediately. This medication may interact with other drugs, particularly antiviral drugs, immunosuppressants, antibiotics, and fibrate class medications. In particular, co-administration with gemfibrozil significantly increases the risk of muscle damage, so it should be avoided. Renal function tests may be necessary for high-dose usage, and Asian patients may require dosage adjustments due to increased drug concentrations. This medication can be used in pediatric patients aged 10 to 17 years, but growth and sexual development should be monitored. While taking this medication, rare occurrences of interstitial lung disease, severe skin reactions, liver damage, neurological disorders, and blood abnormalities have been reported; patients should consult healthcare professionals if any unusual symptoms develop. Pregnant or breastfeeding individuals should not take this medication, and women who may become pregnant should use appropriate contraceptives. In the case of overdose, there is no specific antidote, and treatment should be symptomatic, including monitoring liver and muscle function. This medication does not significantly affect driving or machinery operation; however, caution is advised if symptoms such as dizziness occur. Overall, this medication can affect the liver and muscles, so regular monitoring and prompt response to unusual symptoms are essential.

Side effects and when to seek care immediately

Serious side effects

Urticaria, hypersensitivity reactions including angioedema, rhabdomyolysis, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, severe muscle weakness, ocular muscle weakness, thrombocytopenia, polyneuropathy, memory loss, peripheral neuropathy, dyspnea, acute renal failure, oliguria, increased serum creatinine

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • myalgia
  • weakness
  • hematuria
  • diarrhea
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  • chest pain
  • cough
  • fatigue
  • numbness
  • paresthesia
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • loss of appetite
  • abdominal bloating
  • increased ALT
  • increased AST
  • increased CK

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 exposure to air and moisture, and it is best stored at a cool temperature below 30 degrees Celsius. Proper storage will help maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

Pink, round film-coated tablet

Package unit

30 tablets (10 tablets/Alu-Alu) × 3

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.