Medication info
Rosuvastatin Calcium 10 mg (Unclassified)

Rosuvastatin Calcium 10 mg (Unclassified)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium Micronized›10.4mg / 1 tablet
Manufacturer / importer
환인제약(주)
Appearance
Pink round film-coated tablets
Packaging
30 tablets (10 tablets/PTP × 3)
Approval status
Active

MFDS item code 201000989 · Approved 2010.01.28 · Insurance code 657202150

Summary

Main use
Treatment of hypercholesterolemia and risk reduction of cardiovascular diseases
Who takes it
Adults · Children
Adult dose
The medication can be taken at any time of the day, regardless of meals. The initial dose is 5 mg once daily, and it can be adjusted to a maintenance dose as necessary. The maintenance dose is typically 10 mg once daily, which is suitable for most patients. The dosage should be adjusted appropriately based on LDL cholesterol levels, treatment goals, and patient response with intervals of 4 weeks or more, and can be increased up to a maximum of 20 mg daily.
Child dose
For pediatric patients aged 10 to 17 years, a dosage of 5 mg to 20 mg is administered once daily. The dosage should be adjusted individually according to the recommended treatment goals, and intervals of 4 weeks or more should be observed.

Ingredients

Manufacturer
환인제약(주)

Efficacy & effects

Treatment of hypercholesterolemia and risk reduction of cardiovascular diseases

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

This medication is used as an adjunct for patients with primary hypercholesterolemia and mixed dyslipidemia who have difficulties in controlling their condition through diet and exercise. It lowers total cholesterol and LDL cholesterol levels in patients with hypercholesterolemia, effectively delaying the progression of atherosclerosis. Additionally, it is used as an adjunct in the treatment of patients with homozygous familial hypercholesterolemia and dysbetalipoproteinemia. It is also administered as an adjunct to diet in pediatric patients with heterozygous familial hypercholesterolemia that meet certain criteria. Furthermore, in adult patients with chronic cardiovascular risk factors, it is expected to reduce the risk of stroke, myocardial infarction, and vascular revascularization. Overall, this medication is used for the treatment of various types of dyslipidemia associated with hypercholesterolemia and for reducing the risk of cardiovascular diseases.

How to take

Adult dose

The medication can be taken at any time of the day, regardless of meals. The initial dose is 5 mg once daily, and it can be adjusted to a maintenance dose as necessary. The maintenance dose is typically 10 mg once daily, which is suitable for most patients. The dosage should be adjusted appropriately based on LDL cholesterol levels, treatment goals, and patient response with intervals of 4 weeks or more, and can be increased up to a maximum of 20 mg daily.

Child dose

For pediatric patients aged 10 to 17 years, a dosage of 5 mg to 20 mg is administered once daily. The dosage should be adjusted individually according to the recommended treatment goals, and intervals of 4 weeks or more should be observed.

Precautions

This medication should not be used in certain patients. For example, it must not be administered to patients allergic to the components of this medication, those with severely impaired liver function, patients with muscle diseases, and those with severe renal impairment. Women who are pregnant or breastfeeding, and fertile women who are not using appropriate contraception should not take this medication. Women with potential for pregnancy should only take this medication when it is highly unlikely that they are pregnant. Patients at high risk for myopathy or rhabdomyolysis, such as those with moderate or severe renal impairment, hypothyroidism, a personal history of genetic muscle diseases, alcoholism, or those taking certain other medications should be particularly cautious, and high doses are contraindicated. This medication contains lactose, so patients with genetic metabolic disorders such as lactose intolerance or galactose intolerance should not take it. Patients who consume alcohol excessively or have a history of liver disease should undergo liver function tests before taking this medication and should monitor liver function regularly during treatment. If symptoms such as muscle pain, muscle weakness, or cramps occur, they should immediately inform a physician, and necessary blood tests should be performed to check for muscle damage. If symptoms are severe or blood test results are elevated, the medication should be discontinued. This medication can cause liver function abnormalities, increase the risk of diabetes, and rarely lead to severe skin reactions or interstitial lung disease, so any unusual symptoms should be discussed with healthcare professionals immediately. Furthermore, there are many interactions with other medications, so if other medications are being taken, healthcare professionals should be informed, especially when taken with certain antiviral drugs, immunosuppressants, antibiotics, or fibrates. In case of overdose, as there is no specific antidote, the patient should visit the hospital immediately for appropriate treatment, and liver function and muscle enzyme levels should be closely monitored. Caution is advised as dizziness may occur while driving or operating machinery. Finally, this medication may show higher blood concentrations in Asians, so dose adjustment may be necessary.

Side effects and when to seek care immediately

Serious side effects

Rash, angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), rhabdomyolysis, immune-mediated necrotizing myopathy, myopathy, severe muscle weakness, ocular myasthenia gravis, jaundice, hepatitis, severe allergic reactions, liver failure, acute renal failure, oliguria, edema, chest tightness, difficulty breathing, asthma attacks, severe skin adverse reactions

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • muscle pain
  • weakness
  • diarrhea
  • joint pain
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  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • memory loss
  • peripheral neuropathy
  • hematuria
  • thrombocytopenia
  • increased transaminases
  • elevated ALT
  • elevated AST
  • increased CK
  • increased serum creatinine levels
  • abnormal liver function tests
  • 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 prevent exposure to air or moisture. It is important to maintain a storage temperature between 1 degree Celsius and 30 degrees Celsius at room temperature to preserve the medication's effectiveness and safety.

Appearance and packaging

Appearance

Pink round film-coated tablets

Package unit

30 tablets (10 tablets/PTP × 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.