Medication info
Rosuvastatin Tablet 10mg (Rosuvastatin Calcium)

Rosuvastatin Tablet 10mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
한국유니온제약(주)
Appearance
Pink round film-coated tablets
Packaging
30 tablets (15 tablets/PTP × 2)
Approval status
Active

MFDS item code 201607042 · Approved 2016.12.12 · Insurance code 665506910

Summary

Main use
Treatment of hypercholesterolemia and dyslipidemia (primary, familial) and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
For adult patients with primary hypercholesterolemia, treatment can be administered once daily at any time, regardless of meals. The initial dose is 5mg once daily, while the maintenance dose is generally 10mg once daily for most patients. The maintenance dose should be adjusted appropriately based on LDL-cholesterol levels, treatment goals, and patient response, with at least 4 weeks or more intervals between adjustments, and can be increased to a maximum of 20mg per day.
Children's dosage
In pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years), the dosage ranges from 5mg to 20mg once daily, doses are adjusted according to individual treatment goals. Adjust dosage

Ingredients

Manufacturer
한국유니온제약(주)

Efficacy & effects

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

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

This medication is used as an adjunct therapy in patients with primary hypercholesterolemia and mixed hyperlipidemia when diet and exercise alone are insufficient. It is also used in conjunction with other therapies for patients with homozygous familial hypercholesterolemia to effectively lower blood cholesterol levels. By controlling total cholesterol and LDL-cholesterol levels to target values, it helps delay the progression of atherosclerosis. It can be safely used in pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia when dietary measures are insufficient. Additionally, it is used as an adjunct to dietary therapy in patients with primary dysbetalipoproteinemia. This medication is utilized to reduce the risk of cardiovascular events such as stroke and myocardial infarction in patients with elevated high-sensitivity C-reactive protein levels and cardiovascular disease risk factors. Overall, this medication is effective in improving blood lipid levels and reducing cardiovascular disease risk.

Dosage and Administration

Adult dosage

For adult patients with primary hypercholesterolemia, treatment can be administered once daily at any time, regardless of meals. The initial dose is 5mg once daily, while the maintenance dose is generally 10mg once daily for most patients. The maintenance dose should be adjusted appropriately based on LDL-cholesterol levels, treatment goals, and patient response, with at least 4 weeks or more intervals between adjustments, and can be increased to a maximum of 20mg per day.

Children's dosage

In pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years), the dosage ranges from 5mg to 20mg once daily, doses are adjusted according to individual treatment goals. Adjust dosage

Precautions

This medication should not be used in individuals who are allergic to any of the components. It should not be administered to patients with active liver disease or unexplained elevated liver enzyme levels. Patients with muscle disease or severe renal impairment should also avoid taking this medication. It should not be given to pregnant or breastfeeding women, or to women of childbearing potential who are not using effective contraception. Patients at high risk of muscle disease, such as those with moderate to severe renal impairment or hypothyroidism, should avoid high doses of this medication. Patients with genetic metabolic disorders such as lactose intolerance should not take this medication. This medication should be used with caution in individuals with a history of liver disease or those who consume excessive alcohol, and regular liver function tests are required. If symptoms of muscle pain or weakness occur, medical attention should be sought immediately for necessary testing. Individuals with reduced renal function or conditions such as hypothyroidism are at a greater risk of muscular adverse reactions, hence careful monitoring is necessary. This medication can rarely cause serious skin reactions, liver dysfunction, or muscle damage. If any adverse reactions occur, discontinue use and consult a healthcare professional immediately. Concomitant use with other drugs may increase blood concentration of this medication, raising the risk of muscle-related side effects. Therefore, any other medications being taken should be disclosed, especially since combination with fibrate drugs poses risks, and there may also be interactions with certain antiviral or antifungal medications. Pregnant or breastfeeding women should not take this medication, and women of childbearing potential should use appropriate contraception. In case of overdose, there is no specific antidote; symptom-based treatment is required, along with monitoring of liver function and muscle enzyme levels. Dizziness may occur during treatment; therefore, caution is advised when driving or operating machinery.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria and angioedema, rash and urticaria, pancreatitis, myopathy (including myositis), rhabdomyolysis, myalgia + CK elevation, thrombocytopenia, jaundice, hepatitis, Stevens-Johnson syndrome, eosinophilia with systemic symptoms associated drug reaction syndrome, immune-mediated necrotizing myopathy, hematuria, edema, acute renal failure, severe muscle weakness, ocular muscle weakness, severe skin adverse reactions, severe allergies

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • myalgia
  • weakness
  • hematuria
  • diarrhea
Show 22 more
  • arthralgia
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • appetite loss
  • abdominal distension
  • abnormal liver function tests
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • memory impairment
  • forgetfulness
  • amnesia
  • cognitive impairment
  • confusion

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 exposure to air. The recommended storage temperature is between 1°C and 30°C at room temperature. Proper storage will help maintain the medication's efficacy.

Appearance and packaging

Appearance

Pink round film-coated tablets

Package unit

30 tablets (15 tablets/PTP × 2)

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.