Medication info
Crestor 10 mg (Rosuvastatin Calcium)

Crestor 10 mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
삼익제약(주)
Appearance
Pink round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201503219 · Approved 2015.05.27 · Insurance code 644003650

Summary

Main use
Treatment of hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk
Who uses it
Adults
Adult dosage
Can be taken at any time of the day regardless of meals. The initial dose is 5 mg once daily, with a maintenance dose of 10 mg once daily. The maintenance dose should be adjusted properly based on LDL cholesterol levels, treatment goals, and patient response, at intervals of 4 weeks or longer, up to a maximum of 20 mg per day.

Ingredients

Manufacturer
삼익제약(주)

Efficacy & effects

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

  • Hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerosis
  • homozygous familial hypercholesterolemia
  • primary dysbetalipoproteinemia
  • increased high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol levels
  • smoking
  • family history of early coronary artery disease
View approved original text

This medication is primarily used when dietary measures and exercise do not control primary hypercholesterolemia and mixed hyperlipidemia. It is also used as an adjunct to other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia. It helps to lower total cholesterol and LDL cholesterol levels in patients with hypercholesterolemia and slows the progression of atherosclerosis. It is also used as an adjunct to diet in pediatric patients aged 10 to 17 with heterozygous familial hypercholesterolemia to reduce cholesterol levels. It may also help patients with primary dysbetalipoproteinemia. Additionally, it has the effect of reducing the risk of stroke, myocardial infarction, and arterial revascularization in certain high-risk groups. Thus, this drug is effectively used for cholesterol control and reduction of cardiovascular disease risk.

Dosage and Administration

Adult dosage

Can be taken at any time of the day regardless of meals. The initial dose is 5 mg once daily, with a maintenance dose of 10 mg once daily. The maintenance dose should be adjusted properly based on LDL cholesterol levels, treatment goals, and patient response, at intervals of 4 weeks or longer, up to a maximum of 20 mg per day.

Precautions

This drug should not be used in certain patients. For example, patients who are allergic to any component of this medication, those with severely impaired liver function, patients with muscle diseases, patients with very poor kidney function, and pregnant or breastfeeding women should not take this drug. Furthermore, patients at increased risk of muscle-related diseases should avoid high doses of this medication, and such patients should consult with their physician before starting treatment. This drug contains lactose, so patients with lactose intolerance should avoid taking it. While taking this medication, regular liver function tests should be conducted, and patients with a history of alcohol abuse or liver disease should be especially cautious. If symptoms such as muscle pain or weakness, muscle cramps occur, they should notify healthcare professionals immediately, and in severe cases, they may need to discontinue the medication. If serious skin reactions or signs of liver damage appear, the medication should be discontinued immediately and healthcare professionals consulted. Additionally, this drug can interact with various medications, so if taking other medications, be sure to inform your doctor or pharmacist. Women who may become pregnant should use adequate contraception, and this medication should not be used during pregnancy or if planning to become pregnant. It is also advisable for breastfeeding women to avoid taking this medication. In case of overdose, there is no specific antidote, so seek medical attention immediately for appropriate treatment and monitoring. Caution should also be taken when driving or operating machinery as dizziness may occur while taking this medication.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), tightness in the chest, difficulty breathing, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, fatal and non-fatal liver failure, severe allergic reactions, severe skin reactions, liver abnormalities (jaundice), myopathy, rhabdomyolysis, immune-mediated necrotizing myopathy, severe muscle weakness, ocular muscle weakness, severe skin reactions,

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash and hives
  • muscle pain
  • weakness
  • diarrhea
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  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • abnormal liver function tests
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • fatigue
  • numbness
  • sensory abnormalities
  • hematuria
  • thrombocytopenia
  • memory loss
  • peripheral neuropathy
  • cough
  • thrombocytopenia
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • cognitive decline

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly closed container. It is important to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

30 tablets/bottle, 100 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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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.