Medication info
Rosuvastatin Calcium Tablets 10mg

Rosuvastatin Calcium Tablets 10mg

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
(주)이든파마
Appearance
Pink round film-coated tablets
Packaging
28 tablets/Alu-Alu, 30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201405416 · Approved 2014.11.20 · Insurance code 628900310

Summary

Main use
Treatment of hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
This medication can be administered at any time during the day regardless of meals. The initial dose is 5 milligrams once daily, and if further reduction of LDL-cholesterol levels is needed, it can be titrated to a maintenance dose. The maintenance dose is typically 10 milligrams once daily, which is adequate for most patients. The maintenance dose should be adjusted at intervals of 4 weeks or more based on LDL-cholesterol levels, treatment goals, and patient response.
Child dose
For pediatric patients with atypical familial hypercholesterolemia (ages 10 to 17), administer a dosage range of 5 milligrams to 20 milligrams once daily. The administration dosage should be individually adjusted based on the recommended treatment goals for each patient.

Ingredients

Manufacturer
(주)이든파마

Efficacy & effects

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

  • Primary hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • atypical familial hypercholesterolemia
  • primary dysbetalipoproteinemia
  • elevated 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 used as an adjunctive treatment in patients with primary hypercholesterolemia and mixed dyslipidemia when diet and exercise alone are insufficient for management. It is also used in conjunction with dietary therapy or other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia. It helps effectively lower total cholesterol and LDL-cholesterol levels, thus delaying the progression of atherosclerosis. Particularly, it is suitable for pediatric patients aged 10 to 17 years with high LDL-cholesterol levels despite dietary intervention and is used as an adjunct in the treatment of primary dysbetalipoproteinemia. Additionally, it contributes to reducing the risks of stroke, myocardial infarction, and arterial revascularization procedures in middle-aged and older adults with high-sensitivity C-reactive protein levels. This drug plays an important role in improving cardiovascular health.

How to take

Adult dose

This medication can be administered at any time during the day regardless of meals. The initial dose is 5 milligrams once daily, and if further reduction of LDL-cholesterol levels is needed, it can be titrated to a maintenance dose. The maintenance dose is typically 10 milligrams once daily, which is adequate for most patients. The maintenance dose should be adjusted at intervals of 4 weeks or more based on LDL-cholesterol levels, treatment goals, and patient response.

Child dose

For pediatric patients with atypical familial hypercholesterolemia (ages 10 to 17), administer a dosage range of 5 milligrams to 20 milligrams once daily. The administration dosage should be individually adjusted based on the recommended treatment goals for each patient.

Precautions

This drug should not be used in certain patients. For example, individuals allergic to any of the components of this drug, patients with severe liver dysfunction, those with muscle disorders, patients with severely impaired kidney function, and pregnant or breastfeeding women should not be administered this medication. Furthermore, high-dose administration is prohibited in patients at high risk for muscle-related disorders, and patients with genetic disorders such as lactose intolerance should also avoid using this drug. Care should be taken when administering this drug to patients with poor liver function or those who consume high amounts of alcohol, and regular liver function tests before and during treatment are recommended. Muscle-related side effects such as myalgia, myopathy, and rhabdomyolysis can occur, although they are rare, so if severe muscle pain or weakness develops, immediate medical consultation and testing are required. Patients who are elderly, have kidney diseases, hypothyroidism, or a family history of muscle disorders are at an increased risk for muscle side effects, thus requiring careful monitoring before and after treatment. This drug may affect liver and kidney function, thus regular monitoring of liver and kidney function is important. The drug may interact with other specific medications, so it is essential to inform healthcare providers about any concomitant medications being taken. Pregnant or breastfeeding women should not use this drug, and women who could become pregnant should use appropriate contraception. In cases of overdose, there is no specific antidote, and treatment according to symptoms along with liver and muscle function tests is necessary. Finally, this drug may rarely cause serious skin reactions; if symptoms such as rashes, swelling, fever, etc. occur, immediately discontinue use and consult a physician. Caution is advised when driving or operating machinery as dizziness may occur.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, tightness in the chest, difficulty breathing, severe allergic reaction, severe rash with high fever, blisters, skin peeling, pain in the oral/ocular mucosa, severe skin aberrations, shortness of breath or difficulty breathing, asthma attacks, cough with fever accompanying respiratory abnormalities, jaundice, liver dysfunction, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, serious neurological symptoms, decreased urine output

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • muscle pain
  • weakness
  • diarrhea
  • hematuria
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  • thrombocytopenia
  • increased transaminases
  • arthralgia
  • fatigue
  • numbness
  • paraesthesia
  • discomfort in the chest
  • loss of appetite
  • abdominal distension
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • memory impairment
  • forgetfulness
  • amnesia
  • memory disorders
  • confusion

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

Storage

This medication may be sensitive to air and humidity, so it must be stored in a tightly sealed container. It is important to maintain the storage temperature between 1 to 30 degrees Celsius. Proper storage ensures the efficacy and safety of the drug can be retained over time.

Appearance and packaging

Appearance

Pink round film-coated tablets

Package unit

28 tablets/Alu-Alu, 30 tablets/bottle, 300 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

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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.