Medication info
Rosuvastatin 10/20 mg

Rosuvastatin 10/20 mg

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tabletEzetimibe›10mg / 1 tablet
Manufacturer / importer
(주)경보제약
Appearance
Pink oval film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle, 30 tablets/PTP [10 tablets/PTP X 3]
Approval status
Active

MFDS item code 201506790 · Approved 2015.09.24 · Insurance code 665002070

Summary

Main use
Improvement of hypercholesterolemia (primary and mixed) and inhibition of the risk of atherosclerotic vascular disease
Who takes it
Adults
Adult dose
This medication is administered once daily regardless of meals. For primary hypercholesterolemia, it starts at 10/5 mg once a day and can be increased to a maximum of 10/20 mg daily as needed. After administration, cholesterol levels should be monitored at intervals of at least 4 weeks to adjust the dosage.

Ingredients

Manufacturer
(주)경보제약

Efficacy & effects

Improvement of hypercholesterolemia (primary and mixed) and inhibition of the risk of atherosclerotic vascular disease

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • non-familial hypercholesterolemia
  • mixed dyslipidemia
  • elevated total cholesterol
  • elevated LDL cholesterol
  • elevated Apo B protein
  • elevated triglycerides
  • elevated non-HDL cholesterol
View approved original text

This medication helps reduce elevated total cholesterol, LDL cholesterol, Apo B protein, triglycerides, and non-HDL cholesterol in patients with primary hypercholesterolemia, including heterozygous familial and non-familial hypercholesterolemia, as well as those with mixed dyslipidemia. It also plays a role in increasing HDL cholesterol, commonly known as 'good cholesterol'. This medication should be used in conjunction with dietary restrictions on saturated fats and cholesterol, and is administered as an adjunctive treatment if sufficient effectiveness is not achieved with diet alone. For patients at increased risk of atherosclerotic vascular disease due to hypercholesterolemia, an appropriate treatment plan considering risk factors is necessary. Before use, it is essential to check for other causes that may induce dyslipidemia, such as diabetes, hypothyroidism, and chronic renal failure, and treat them accordingly, while regularly checking lipid levels to monitor for effectiveness. This medication is used to improve blood lipid levels and reduce the risk of atherosclerotic vascular disease.

How to take

Adult dose

This medication is administered once daily regardless of meals. For primary hypercholesterolemia, it starts at 10/5 mg once a day and can be increased to a maximum of 10/20 mg daily as needed. After administration, cholesterol levels should be monitored at intervals of at least 4 weeks to adjust the dosage.

Precautions

This medication may rarely cause rhabdomyolysis, which can damage muscle tissue and lead to acute renal failure, so if serious muscle pain or weakness occurs, it should be reported to a physician immediately. This medication is contraindicated for patients with certain diseases or those who are sensitive to the drug, such as patients with severely impaired liver function, those with muscular disorders, and women who are pregnant or nursing. Careful attention is necessary when prescribing this medication to patients with a history of alcoholism or liver disease, the elderly, and those at high risk for muscle problems, who should be monitored regularly for liver function and muscle condition. While taking this medication, liver enzyme levels and muscle enzyme levels should be checked regularly, and if abnormal signs are found, medication should be discontinued or adjusted. This medication can interact with other medications, so consultation with a doctor or pharmacist is necessary, especially when taken with anticoagulants, certain antibiotics, immunosuppressants, and fibrates. Pregnant women or women who may become pregnant should avoid taking this medication and should use appropriate contraceptive methods during treatment. Safety in children and adolescents has not been fully established; therefore, it is not recommended for pediatric patients. Patients with liver disease or decreased kidney function should carefully evaluate whether to adjust the dose or continue administering this medication, and should consult healthcare professionals immediately if adverse reactions occur. In the case of overdose, there is no specific antidote, so appropriate treatment and supportive care should be provided based on symptoms while monitoring liver function and muscle enzyme levels. This medication should be stored out of the reach of children, and precautions should be taken when transferring it to other containers as this may lead to quality degradation or accidents.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in oral/eye mucous membranes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), severe lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urination issues

Mild side effects

  • Headache
  • dizziness
  • indigestion
  • elevated ALT
  • swelling
  • myalgia
  • dry mouth
  • elevated liver enzymes
  • abnormal liver function tests
  • increased blood lactate dehydrogenase
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  • pruritus
  • elevated blood glucose
  • increased CPK levels
  • chest discomfort
  • diarrhea
  • constipation
  • nausea
  • abdominal pain
  • weakness
  • joint pain
  • fatigue
  • numbness
  • sensory disturbances
  • loss of appetite
  • abdominal bloating
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • drowsiness
  • neurodegenerative disorders

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a sealed container. It is recommended to maintain a storage temperature between 1 degrees and 30 degrees Celsius. Proper storage can safely maintain the efficacy of the medication.

Appearance and packaging

Appearance

Pink oval film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle, 30 tablets/PTP [10 tablets/PTP 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

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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.