Medication info
Rosuvastatin Calcium Tablet 20mg

Rosuvastatin Calcium Tablet 20mg

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
(주)인트로바이오파마
Appearance
Pink round film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201603594 · Approved 2016.06.20 · Insurance code 052400140

Summary

Main use
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
Adult patients with primary hypercholesterolemia and mixed hyperlipidemia can take the medication at any time of the day, regardless of meals. The initial dose is 5 milligrams once daily, and the maintenance dose can be adjusted to 10 milligrams once daily as needed. The maintenance dose should be adjusted appropriately based on LDL cholesterol levels, treatment goals, and patient response at intervals of four weeks or more, up to a maximum of 20 milligrams daily.
Children's dosage
In pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), a dose of 5 to 20 milligrams is administered once daily; the dosage should be individually adjusted based on treatment goals at intervals of four weeks or more

Ingredients

Manufacturer
(주)인트로바이오파마

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

  • Hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerosis
  • familial hypercholesterolemia simplex
  • dysbetalipoproteinemia
  • coronary heart disease
  • stroke
  • myocardial infarction
View approved original text

This medication is used as an adjunct in patients with hypercholesterolemia and dyslipidemia when diet and exercise alone are insufficient. It is particularly beneficial for heterozygous and homozygous familial hypercholesterolemia patients. This drug lowers total cholesterol and LDL cholesterol levels, slows the progression of atherosclerosis, and can be safely used in pediatric patients over 10 years of age. It is also recommended as an adjunct to diet for patients with primary dysbetalipoproteinemia. Furthermore, it effectively reduces the risk of stroke, myocardial infarction, and revascularization in middle-aged patients with cardiovascular risk factors. Thus, this medication improves various types of hyperlipidemia and cardiovascular risk.

Dosage and Administration

Adult dosage

Adult patients with primary hypercholesterolemia and mixed hyperlipidemia can take the medication at any time of the day, regardless of meals. The initial dose is 5 milligrams once daily, and the maintenance dose can be adjusted to 10 milligrams once daily as needed. The maintenance dose should be adjusted appropriately based on LDL cholesterol levels, treatment goals, and patient response at intervals of four weeks or more, up to a maximum of 20 milligrams daily.

Children's dosage

In pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), a dose of 5 to 20 milligrams is administered once daily; the dosage should be individually adjusted based on treatment goals at intervals of four weeks or more

Precautions

This drug should not be used in certain patients. First, individuals allergic to any of the ingredients in this medication should not take it. Patients with severe liver dysfunction or unexplained elevated liver enzyme levels should also avoid this medication. Patients with muscle diseases or muscle weakness should not take this drug. Additionally, it may be hazardous when taken alongside the immunosuppressant cyclosporine. Patients with severely impaired renal function, especially those with a creatinine clearance of less than 30 mL/min, should avoid this medication. Pregnant or breastfeeding women, as well as fertile women not using proper contraception, are also advised not to use it. In particular, women who may become pregnant should only be administered this medication if they are highly unlikely to conceive and fully understand the risk it poses to the fetus. High-dose use of this drug is prohibited in patients at high risk for muscle disease. Examples include moderate renal impairment, hypothyroidism, family history or genetic history of muscle disorders, and alcoholism. Furthermore, since this medication contains lactose, patients with lactose intolerance or related genetic disorders should not take it. This medication should be used cautiously in patients who consume alcohol excessively or have a history of liver disease. It is recommended to have regular liver function tests before and during use. Patients with hypercholesterolemia due to hypothyroidism or nephrotic syndrome should treat the underlying condition before starting this medication. Additionally, this drug can cause muscle pain, myopathy, and rarely severe muscle breakdown (rhabdomyolysis). Therefore, any abnormal muscle symptoms should be immediately reported to a healthcare professional. In particular, if symptoms such as muscle pain, muscle weakness, cramps, fatigue, or fever occur, blood tests should be conducted to check for muscle damage. Patients at high risk for muscle disease (e.g., those with renal impairment, hypothyroidism, genetic muscle disorder history, alcohol abuse, the elderly, etc.) should carefully consider the risk versus benefit of treatment and require regular monitoring. Care should be taken when interpreting blood test results if muscle damage is suspected after exercise or for other reasons. This drug can rarely cause or exacerbate severe muscle weakness or ocular muscle weakness; if these symptoms appear, administration should be discontinued immediately. The risk of muscle damage may increase when this drug is taken with certain medications, especially fibrate-class drugs; therefore, caution is necessary, and high doses (40mg) are contraindicated. High-dose administration may result in transient proteinuria, so regular renal function tests are recommended. In Asians, this drug may result in increased systemic exposure; hence, careful consideration is needed when determining the dose. For children and adolescents (ages 10-17), limited information exists regarding its effects on growth and sexual characteristics; therefore, caution is warranted. This drug can affect liver function and may temporarily increase liver enzyme levels, which are usually mild and transient. While taking this medication, side effects such as headache, dizziness, dyspepsia, skin rash, muscle pain, etc., may occur, but these are mostly mild. If serious skin reactions (e.g., Stevens-Johnson syndrome) or signs of liver damage appear, use should be discontinued immediately, and medical consultation should be sought. This drug may interact with other medications, so especially when taken with specific antiviral agents, immunosuppressants, antifungal agents, antibiotics, or anticoagulants, patients should inform their doctor or pharmacist and may require dose adjustments or monitoring. Pregnant or breastfeeding individuals should not use this drug. Women who may become pregnant should ensure appropriate contraception. There is no specific antidote for overdose, so patients should go to the hospital immediately for treatment according to the symptoms, and liver function and muscle damage should be evaluated. This medication does not significantly affect driving or machinery operation ability; however, caution is advised due to the possibility of dizziness. During the use of this drug, it is essential to have regular check-ups as directed by a physician and promptly report any unusual symptoms.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria and angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), rhabdomyolysis, severe muscle weakness, ocular muscle weakness, jaundice, hepatitis, acute renal failure, oliguria, chest tightness, difficulty breathing, interstitial lung disease, severe edema, severe allergic reactions, severe skin adverse reactions, respiratory issues, liver abnormalities (jaundice), severe neurological effects

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • muscle pain
  • weakness
  • hematuria
  • diarrhea
Show 23 more
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal distension
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • memory loss
  • peripheral neuropathy
  • cough
  • thrombocytopenia
  • increased transaminases
  • muscle rupture
  • arthralgia
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • cognitive impairment

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

Storage

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture. The recommended storage temperature is room temperature between 1 degree and 30 degrees. This way, the effectiveness of the medication can be maintained for a longer period.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

30 tablets/bottle

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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.