Medication info
Rosuvastatin Calcium 10mg Tablet

Rosuvastatin Calcium 10mg Tablet

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

MFDS item code 201400605 · Approved 2014.02.11 · Insurance code 660702640

Summary

Main use
Improvement of hypercholesterolemia and dyslipidemia and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
This medication can be taken at any time during the day, regardless of meals. The initial dose is 5 milligrams once daily, and if further reduction of LDL-cholesterol is needed, adjustment can be made to the maintenance dose. The maintenance dose is typically 10 milligrams once daily, with most patients adjusted to this dose. The maintenance dose should be adjusted appropriately based on LDL-cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more.
Child dose
The usual dosage range for pediatric patients aged 10 to 17 years is 5 to 20 milligrams once daily. The dosing is adjusted according to each patient’s treatment goals, with a minimum interval of 4 weeks or more.

Ingredients

Manufacturer
위더스제약(주)

Efficacy & effects

Improvement of hypercholesterolemia and dyslipidemia and reduction of cardiovascular disease risk

  • Hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerosis
  • heterozygous familial hypercholesterolemia
  • dysbetalipoproteinemia
  • coronary heart disease risk factors
  • stroke risk
  • myocardial infarction risk
  • arterial revascularization risk
View approved original text

This medicine is used as an adjunct in patients with primary hypercholesterolemia and mixed dyslipidemia when diet and exercise alone do not suffice. It particularly aids in improving cholesterol levels when used alongside dietary treatment in patients with heterozygous familial hypercholesterolemia, dysbetalipoproteinemia, and homozygous familial hypercholesterolemia. Furthermore, it lowers LDL-cholesterol and total cholesterol levels in patients with hypercholesterolemia, delaying the progression of atherosclerosis. It is also used in adolescents aged 10 to 17 years with heterozygous familial hypercholesterolemia to reduce cholesterol and apo-B protein levels and mitigate cardiovascular risk. This medication is effective in reducing the risk of stroke, myocardial infarction, and arterial revascularization in patients over 50 years of age who have elevated high-sensitivity C-reactive protein levels and additional cardiovascular risk factors. In summary, this medication is used for the treatment of various types of hypercholesterolemia and reducing the risk of cardiovascular disease.

How to take

Adult dose

This medication can be taken at any time during the day, regardless of meals. The initial dose is 5 milligrams once daily, and if further reduction of LDL-cholesterol is needed, adjustment can be made to the maintenance dose. The maintenance dose is typically 10 milligrams once daily, with most patients adjusted to this dose. The maintenance dose should be adjusted appropriately based on LDL-cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more.

Child dose

The usual dosage range for pediatric patients aged 10 to 17 years is 5 to 20 milligrams once daily. The dosing is adjusted according to each patient’s treatment goals, with a minimum interval of 4 weeks or more.

Precautions

This medication should not be used in individuals with certain allergic reactions. It is contraindicated in patients with active liver disease or severely impaired liver function. Patients with muscle disorders or muscular problems should not take this medication. There is an increased risk of side effects when used with certain immunosuppressants, so care should be taken. It should not be administered to patients with severely impaired renal function. Pregnant or breastfeeding women should not take this medication, and women of childbearing potential should employ suitable contraceptive methods to reduce the possibility of pregnancy. The 40mg dosage is prohibited for patients at high risk for muscle disorders. Patients with lactose intolerance or related genetic conditions should not take this medication. This medication requires regular liver function tests for individuals with a history of significant alcohol consumption or liver disease. In cases of hypothyroidism or certain kidney diseases, this medication should only be used after treating the underlying condition. If symptoms of muscle pain or weakness occur, medical personnel should be notified immediately, and testing should determine whether to discontinue treatment. Caution is needed after vigorous exercise as test results for muscle damage may be distorted. This medication should be discontinued in cases of acute severe conditions or significant metabolic disturbances. Occasionally, severe myasthenia or ocular myasthenia may occur, and this medication should be discontinued if these symptoms arise. There is an increased risk of muscle side effects when taken with other specific medications, so caution is advised when co-administering. Renal function tests may be necessary during high-dosage usage. Dosage adjustment is needed in Asian patients as drug concentrations may increase. This medication may cause side effects such as headache, dizziness, dyspepsia, myalgia, etc., most of which are mild and temporary. Rarely, severe side effects such as liver function abnormalities, muscle damage, or skin rashes can occur. If adverse reactions are severe or persistent, medical consultation is necessary. Pregnant or breastfeeding women should avoid this medication, and women who may become pregnant must ensure contraception. In cases of overdose, there is no specific antidote; therefore, treatment should be symptomatic and include monitoring liver function and muscle enzyme levels. This medication does not significantly affect driving or operating machinery, but caution should be taken due to possible dizziness.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including hives and angioedema, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rashes with fever, blisters, skin peeling, pain in the oral/ocular mucosa, dyspnea or difficulty breathing, asthma attacks, abnormal breathing with cough and fever, jaundice (yellowing of the skin or eyes), extreme fatigue, sudden severe headache, thunderclap headache, seizures, loss of consciousness

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • weakness
  • hematuria
Show 21 more
  • diarrhea
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal distension
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • depression
  • sleep disorders
  • sexual dysfunction
  • gynecomastia
  • memory decline
  • amnesia
  • cognitive dysfunction
  • confusion
  • cough

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

Storage

This medication must be stored in a tightly sealed container to protect it from air and moisture, and it is safest to store it at room temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Pink round film-coated tablets

Package unit

30 tablets/box [(10 tablets/Alu-Alu x 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.

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.