Medication info
Rosuvastatin Calcium 5mg Tablet

Rosuvastatin Calcium 5mg Tablet

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
(주)킴스제약
Appearance
Yellow round film-coated tablet
Packaging
28 tablets/box [28 tablets (14 tablets/PTPX2)]
Approval status
Active

MFDS item code 201901570 · Approved 2019.03.14 · Insurance code 059600300

Summary

Main use
Treatment for hypercholesterolemia and reduced risk of cardiovascular disease
Who uses it
Adults · Children
Adult dosage
Administer 5 milligrams once daily as the initial dose at any time of the day, regardless of meals. If further reduction of LDL cholesterol is needed, maintain the dose at 10 milligrams once daily and adjust as needed based on treatment goals and patient response at intervals of 4 weeks or more, with a maximum daily dose of 20 milligrams.
Children's dosage
For pediatric patients aged 10 to 17 years, administer 5 milligrams to 20 milligrams once daily. The dosage should be adjusted individually based on treatment goals at intervals of 4 weeks or more. For children under 10 years, safety and efficacy have not been established.

Ingredients

Manufacturer
(주)킴스제약

Efficacy & effects

Treatment for hypercholesterolemia and reduced risk of cardiovascular disease

  • Hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerosis
  • heterozygous familial hypercholesterolemia
  • dysbetalipoproteinemia
  • coronary heart disease
  • elevated high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol
  • smoking
View approved original text

This medication is used as an adjunct to diet for patients with primary hypercholesterolemia and mixed dyslipidemia who cannot be controlled by diet and exercise. It also aids in dietary therapy or other lipid-lowering therapies for patients with homozygous familial hypercholesterolemia. This drug lowers total cholesterol and LDL cholesterol levels in patients with hypercholesterolemia, thereby slowing the progression of atherosclerosis. It is also used as a dietary adjunct to reduce cholesterol levels in pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia. It is also used in patients with primary dysbetalipoproteinemia. Additionally, it helps reduce the risk of stroke, myocardial infarction, and vascular revascularization procedures in certain age groups of high-risk cardiovascular disease patients. This medication is used to improve various cardiovascular risks associated with dyslipidemia.

Dosage and Administration

Adult dosage

Administer 5 milligrams once daily as the initial dose at any time of the day, regardless of meals. If further reduction of LDL cholesterol is needed, maintain the dose at 10 milligrams once daily and adjust as needed based on treatment goals and patient response at intervals of 4 weeks or more, with a maximum daily dose of 20 milligrams.

Children's dosage

For pediatric patients aged 10 to 17 years, administer 5 milligrams to 20 milligrams once daily. The dosage should be adjusted individually based on treatment goals at intervals of 4 weeks or more. For children under 10 years, safety and efficacy have not been established.

Precautions

This medication should not be used in certain patients. For example, people who are allergic to any ingredients of this medication, those with severely impaired liver function, and those with muscle diseases should not take it. Women with severe kidney diseases or those who are pregnant or nursing should also refrain from using this medication. It should be used with caution in patients at risk of muscle problems, with high doses prohibited. Patients with specific genetic metabolic issues should not take this medication. It is important to regularly monitor liver function and muscle status while on this medication. If symptoms such as muscle pain or weakness, or sudden fatigue occur, contact a doctor immediately. Additionally, this medication should be administered cautiously to patients who consume large amounts of alcohol or have a history of liver disease, requiring frequent liver function tests if necessary. There are other medications that may increase risks when taken with this medication, so inform your doctor or pharmacist if you are taking any other medications. Women who could become pregnant should use appropriate contraception before taking this medication and discontinue immediately if pregnant. In case of overdose, there is no specific antidote, and treatment should be supportive based on symptoms, monitoring liver function and muscle enzyme levels. This medication does not significantly affect driving or operation of machinery, but caution is advised due to potential dizziness. Lastly, severe adverse reactions like serious skin reactions may occur during treatment, and immediate medical attention should be sought if these symptoms arise.

Side effects and when to seek care immediately

Serious side effects

Hypersensitivity reactions, including urticaria and angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms, jaundice, hepatitis, increased transaminases, acute kidney injury, oliguria, thrombocytopenia, increased serum creatinine, rhabdomyolysis, severe muscle weakness, ophthalmoplegia, dyspnea, interstitial lung disease, severe allergic reactions, severe skin adverse reactions, respiratory problems, liver abnormalities (jaundice), heart

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • myalgia
  • weakness
  • hematuria
  • diarrhea
Show 21 more
  • erectile dysfunction
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • anorexia
  • abdominal distension
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • joint pain
  • amnesia
  • peripheral neuropathy
  • cough
  • immune-mediated necrotizing myopathy
  • depression
  • sleep disorders
  • 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 protect it from air and moisture, and the storage temperature should be maintained at room temperature between 1°C and 30°C. Therefore, it is important to avoid direct sunlight and not to place it in extremely hot or cold places.

Appearance and packaging

Appearance

Yellow round film-coated tablet

Package unit

28 tablets/box [28 tablets (14 tablets/PTPX2)]

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

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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.