Medication info
Hyel 20 mg Tablet (Rosuvastatin Calcium)

Hyel 20 mg Tablet (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
신일제약(주)
Appearance
Pink round film-coated tablet
Packaging
28 tablets (14 tablets/PTP*2), 30 tablets/bottle, 90 tablets/bottle
Approval status
Active

MFDS item code 201000970 · Approved 2010.01.28 · Insurance code 653804400

Summary

Main use
Improvement of hypercholesterolemia and dyslipidemia (primary, familial) and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
The initial dose is 5 mg once daily, and if more LDL cholesterol reduction is needed, the maintenance dose can be adjusted. The maintenance dose is 10 mg once daily, which is sufficient for most patients. The maintenance dose should be adjusted according to LDL cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more, with a maximum daily increase of 20 mg.
Child dose
The usual dosage range is 5 mg to 20 mg once daily. The dosing is adjusted individually according to the recommended treatment goals for each patient. The dose should be adjusted at intervals of 4 weeks or more.

Ingredients

Manufacturer
신일제약(주)

Efficacy & effects

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

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

This medication is used as an adjunctive treatment when dietary and exercise control is difficult for patients with primary hypercholesterolemia and mixed dyslipidemia. It particularly helps lower LDL cholesterol levels in patients with familial hypercholesterolemia, aiding vascular health and slowing the progression of atherosclerosis. It is also used in pediatric patients aged 10 to 17 who meet the criteria for hyperlipidemia in conjunction with dietary management. Additionally, it can aid in the treatment of dysbetalipoproteinemia. The medication is effective in reducing the risk of stroke, myocardial infarction, and arterial revascularization procedures in adult patients at high risk of cardiovascular disease. Overall, it is used to improve hypercholesterolemia and the risk of cardiovascular diseases.

How to take

Adult dose

The initial dose is 5 mg once daily, and if more LDL cholesterol reduction is needed, the maintenance dose can be adjusted. The maintenance dose is 10 mg once daily, which is sufficient for most patients. The maintenance dose should be adjusted according to LDL cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more, with a maximum daily increase of 20 mg.

Child dose

The usual dosage range is 5 mg to 20 mg once daily. The dosing is adjusted individually according to the recommended treatment goals for each patient. The dose should be adjusted at intervals of 4 weeks or more.

Precautions

This medication should not be used by individuals with certain allergic reactions. It should not be administered to patients with active liver disease or severely impaired liver function. Patients with muscular diseases or past problems with muscles should also avoid using this medication. Caution is advised when taken with certain immunosuppressants. Patients with severely impaired kidney function or women who are pregnant or nursing should not use this medication. Patients at high risk of muscle damage should avoid high doses, and if they have risk factors, consultation with a doctor is required. This medication contains lactose and is not suitable for patients with lactose intolerance or other genetic metabolic issues. Individuals who consume large amounts of alcohol or have a history of liver disease should undergo regular liver function tests. If symptoms of muscle pain, weakness, or spasms occur, patients should inform their doctor immediately, and drug discontinuation may be necessary. This medication may increase blood sugar levels in some patients, so those at risk of diabetes should be monitored carefully. Liver function anomalies or rare skin adverse reactions may occur during treatment with this medication, so contact healthcare professionals immediately if symptoms arise. Drug interactions can occur, so if on other medications, patients must inform their doctor or pharmacist. There is no specific antidote for overdose, so treatment should be symptomatic, and liver function and muscle enzyme tests may be needed. Dizziness may occur while driving or operating machinery, so caution is necessary. This medication may show higher blood concentration in Asians, so dose adjustment is important. Women of childbearing potential should use appropriate contraception and avoid use during pregnancy.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria
  • severe swelling (edema)
  • chest tightness
  • difficulty breathing
  • cold sweat
  • paleness
  • angioedema
  • severe rash with fever
  • blisters
  • skin peeling
Show 14 more
  • mucosal pain in the mouth/eyes
  • Stevens-Johnson syndrome
  • respiratory distress
  • asthma attacks
  • jaundice
  • hepatitis
  • severe liver damage
  • sudden severe headache
  • thunderclap headache
  • seizures
  • confusion
  • visual disturbances
  • paralysis
  • and elevated CK (creatine kinase).

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • weakness
  • hematuria
Show 24 more
  • diarrhea
  • chest pain
  • cough
  • fatigue
  • numbness
  • paresthesia
  • nausea
  • diarrhea
  • loss of appetite
  • abdominal distension
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • loss of appetite
  • abnormal liver function tests
  • memory loss
  • peripheral neuropathy
  • thrombocytopenia
  • hepatitis
  • increased transaminases
  • and symptoms accompanying eosinophilia.

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

Storage

This medication should be stored in a tightly closed container to prevent air or moisture. It is best kept at room temperature, between 1 and 30 degrees Celsius. This method of storage helps maintain the efficacy of the medication for a longer duration.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

28 tablets (14 tablets/PTP*2), 30 tablets/bottle, 90 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.