Medication info
Erosuvab 5 mg Tablet (Rosuvastatin Calcium (unrefined))

Erosuvab 5 mg Tablet (Rosuvastatin Calcium (unrefined))

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium Micronized›5.2mg / 1 tablet
Manufacturer / importer
(주)중헌제약
Appearance
Yellow round film-coated tablet
Packaging
Bottle - 30 tablets/bottle
Approval status
Active

MFDS item code 201906517 · Approved 2019.09.18 · Insurance code 053301010

Summary

Main use
Treatment of hypercholesterolemia and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
Can be taken at any time of the day regardless of meals. The initial dose is 5 mg once daily, and the maintenance dose is 10 mg once daily. Depending on LDL-cholesterol levels, treatment goals, and the patient's response, the dosage may be appropriately adjusted at intervals of 4 weeks or more, with a maximum daily dose of 20 mg.
Children's dosage
Pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) are administered once daily with doses ranging from 5 mg to 20 mg. The dosage should be adjusted based on the individual treatment goal at intervals of 4 weeks or more.

Ingredients

Manufacturer
(주)중헌제약

Efficacy & effects

Treatment of hypercholesterolemia and reduction of cardiovascular disease risk

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • atherosclerosis
  • heterozygous familial hypercholesterolemia
  • dysbetalipoproteinemia
  • increased high-sensitivity C-reactive protein
  • hypertension
  • low HDL-cholesterol levels
  • smoking
View approved original text

This medication is primarily used in various conditions associated with hypercholesterolemia. In patients with primary hypercholesterolemia or mixed dyslipidemia where dietary and exercise management alone is inadequate, it is used as an adjunct to dietary therapy. Additionally, it is employed as an adjunct in patients with homozygous familial hypercholesterolemia alongside dietary therapy or other lipid-lowering treatments. In patients with hypercholesterolemia, it helps lower total cholesterol and LDL-cholesterol levels to target goals, thereby delaying the progression of atherosclerosis. For pediatric patients with heterozygous familial hypercholesterolemia, where cholesterol levels remain high despite dietary intervention, it is also used as an adjunct. Furthermore, it is effective as an adjunct to dietary therapy in patients with primary dysbetalipoproteinemia. Lastly, it aids in reducing the risk of major cardiovascular events such as stroke and myocardial infarction in middle-aged individuals at risk for cardiovascular diseases. Overall, this medication is utilized for cholesterol control and reducing the risk of cardiovascular diseases.

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, and the maintenance dose is 10 mg once daily. Depending on LDL-cholesterol levels, treatment goals, and the patient's response, the dosage may be appropriately adjusted at intervals of 4 weeks or more, with a maximum daily dose of 20 mg.

Children's dosage

Pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) are administered once daily with doses ranging from 5 mg to 20 mg. The dosage should be adjusted based on the individual treatment goal at intervals of 4 weeks or more.

Precautions

This medication should not be administered to certain patients. For instance, patients with allergies to the ingredients of this medication, those with severely impaired liver function, those with muscle disorders, patients with significantly reduced kidney function, pregnant or breastfeeding women, and fertile women not using appropriate contraception should not take this medication. Moreover, high dosing of this medication is prohibited for patients at high risk of muscle-related side effects. Patients with risk factors such as genetic muscle disorders, hypothyroidism, or alcohol abuse should be particularly cautious. This medication contains lactose and should not be used by patients with lactose intolerance or certain genetic digestive disorders. Patients with a history of liver disease or excessive alcohol consumption should have regular liver function tests while using this medication, and patients with hyperlipidemia due to thyroid dysfunction or nephrotic syndrome must first treat the underlying cause. If symptoms such as myalgia, muscle weakness, or cramps occur, the patient should immediately inform their doctor and undergo necessary tests; in severe cases, discontinuation of the medication may be necessary. This medication may rarely cause serious skin reactions, liver damage, kidney abnormalities, and neurological symptoms in some patients, so immediate consultation with healthcare professionals is advised if such symptoms develop. Additionally, this medication may interact with several other drugs; therefore, patients should inform healthcare professionals about any other medications they are taking, especially when combined with certain antivirals, immunosuppressants, antifungals, some antibiotics, and fibrate drugs. Women who are pregnant or might become pregnant must ensure appropriate contraception and should stop taking this medication immediately if pregnancy is confirmed. In the event of overdose, as no specific antidote exists, treatment must be symptomatic, and liver function and muscle enzyme tests are necessary. This medication does not appear to significantly affect the ability to drive or operate machinery; however, caution is advised due to potential dizziness. Finally, this medication may show higher blood concentrations in Asians, thus dosage adjustments may be necessary.

Side effects and when to seek care immediately

Serious side effects

Urticaria, hypersensitivity reactions including angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, severe muscle weakness, rhabdomyolysis, immune-mediated necrotizing myopathy, polyneuropathy, acute renal failure, oliguria, severe edema, chest tightness, dyspnea, asthma attacks

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • myalgia
  • fatigue
  • thrombocytopenia
  • diarrhea
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  • ocular muscle weakness
  • memory loss
  • peripheral neuropathy
  • cough
  • chest discomfort
  • fatigue
  • numbness
  • paresthesia
  • loss of appetite
  • abdominal distension
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • sleep disturbances
  • depression
  • sexual dysfunction
  • gynecomastia
  • cognitive impairment

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is important to maintain a storage temperature in the range of 1 to 30 degrees Celsius. Proper storage will help maintain the efficacy and safety of the medication.

Appearance and packaging

Appearance

Yellow round film-coated tablet

Package unit

Bottle - 30 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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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.