Medication info
Rosuvastatin Calcium 10mg Tablets

Rosuvastatin Calcium 10mg Tablets

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
경동제약(주)
Appearance
Pink round film-coated tablets
Packaging
30 tablets (10 tablets/Alu-Alu X3)
Approval status
Active

MFDS item code 201400154 · Approved 2014.01.15 · Insurance code 648103340

Summary

Main use
Treatment to reduce high cholesterol and cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
Regardless of food intake, the initial dose begins at 5 mg once daily and is adjusted at intervals of more than 4 weeks according to the patient’s LDL cholesterol level and therapeutic goals. The standard maintenance dose is 10 mg taken once daily, and the maximum dose is 20 mg taken once daily.
Child dose
Children aged 10 to 17 years may be administered 5 mg to 20 mg once daily, with dosage adjusted individually at intervals of more than 4 weeks based on therapeutic goals. For children under 10 years of age, the safe...

Ingredients

Manufacturer
경동제약(주)

Efficacy & effects

Treatment to reduce high cholesterol and cardiovascular disease risk

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • primary dysbetalipoproteinemia
  • cardiovascular disease risk factors
  • stroke risk
  • myocardial infarction risk
  • risk of coronary artery revascularization
View approved original text

This medication is used as an adjunct therapy when diet and exercise do not adequately control primary hypercholesterolemia and mixed dyslipidemia. It can also be prescribed together with other treatments for patients with homozygous familial hypercholesterolemia. This drug helps lower total cholesterol and LDL cholesterol levels, thus delaying the progression of atherosclerosis. It is also used as an adjunctive agent to reduce total cholesterol and LDL cholesterol levels in pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia. It is utilized as adjunctive therapy for patients with primary dysbetalipoproteinemia. Additionally, it contributes to reducing the risk of stroke, myocardial infarction, and coronary artery revascularization in middle-aged and older adults with cardiovascular disease risk factors. Overall, this medication is used to improve dyslipidemia and reduce the risk of related cardiovascular diseases.

How to take

Adult dose

Regardless of food intake, the initial dose begins at 5 mg once daily and is adjusted at intervals of more than 4 weeks according to the patient’s LDL cholesterol level and therapeutic goals. The standard maintenance dose is 10 mg taken once daily, and the maximum dose is 20 mg taken once daily.

Child dose

Children aged 10 to 17 years may be administered 5 mg to 20 mg once daily, with dosage adjusted individually at intervals of more than 4 weeks based on therapeutic goals. For children under 10 years of age, the safe...

Precautions

This medication should not be administered to certain patients. For instance, it should not be used in patients who are allergic to it, have severely impaired liver function, suffer from muscle diseases, have severely reduced kidney function, or are pregnant or breastfeeding. Additionally, it should be used with caution in cases where regular monitoring of liver function tests and muscle status is necessary. Particular care is needed for patients with a history of liver disease or high alcohol intake, those with hypothyroidism, elderly individuals over 70 years old, and those exhibiting muscle abnormal symptoms. If symptoms such as muscle pain, muscle weakness, fatigue, or fever occur during treatment, the physician should be notified immediately for evaluation. If such symptoms are severe or if there is a significant increase in muscle enzyme levels, discontinuation of the medication may be required. As this medication may affect liver function, usage must be stopped immediately if symptoms of liver dysfunction or jaundice, or severe fatigue occur. Furthermore, this medication can raise blood sugar levels, so patients at risk of diabetes should maintain strict blood sugar control. This medication may interact with other drugs, so it is crucial to inform your physician or pharmacist of any other medications being taken. Particularly, co-administration with certain antiviral agents, immunosuppressants, and fibrate drugs may increase the risk of muscle abnormalities. Women who are pregnant or planning a pregnancy must use appropriate contraception and should discontinue the medication immediately upon confirmation of pregnancy. Nursing mothers should also ideally avoid taking this medication. In the case of overdose, there is no specific antidote, and treatment is symptomatic while monitoring liver function and muscle enzyme levels. Finally, this medication may cause side effects such as dizziness or headaches, so caution is needed when driving or operating machinery.

Side effects and when to seek care immediately

Serious side effects

  • Allergic reactions, including hives and angioedema → severe allergic reactions
  • Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS) → severe skin reactions
  • Jaundice, hepatitis → liver dysfunction (jaundice)
  • Difficulty breathing, respiratory distress → respiratory issues
  • Myopathy, rhabdomyolysis, immune-mediated necrotizing myopathy → severe edema or urination issues (including acute kidney failure due to rhabdomyolysis)

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • weakness
  • hematuria
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  • diarrhea
  • discomfort in the chest
  • loss of appetite
  • abdominal distension
  • abnormal liver function tests
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • fatigue
  • numbness
  • abnormal sensation
  • joint pain
  • thrombocytopenia
  • memory loss
  • peripheral neuropathy
  • cough
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • cognitive impairment

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

Storage

This medication can be sensitive to air and moisture, so it must be stored in a tightly closed container. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius at room temperature. This will help keep the medication effective and safe for a long time.

Appearance and packaging

Appearance

Pink round film-coated tablets

Package unit

30 tablets (10 tablets/Alu-Alu X3)

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.