Medication info
Hiaeol Tablets 10mg (Rosuvastatin Calcium)

Hiaeol Tablets 10mg (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 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 201000968 · Approved 2010.01.28 · Insurance code 653804410

Summary

Main use
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
For primary hypercholesterolemia and related conditions, this medication can be taken at any time of the day, regardless of meals. The initial dosage is 5mg once daily and can be adjusted to a maintenance dosage as needed. The maintenance dose is commonly 10mg once daily, and adjustments can be made based on LDL cholesterol levels and patient response at intervals of 4 weeks or more. The maximum dose can be increased to 20mg daily.
Child dose
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years), the recommended dosage is 5mg to 20mg once daily. The dose should be adjusted individually based on treatment goals.

Ingredients

Manufacturer
신일제약(주)

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

  • Hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • combined hyperlipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerosis
  • 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 to manage hypercholesterolemia and hyperlipidemia. It is particularly effective as an adjunct to diet in patients with familial hypercholesterolemia, heterozygous familial hypercholesterolemia, combined hyperlipidemia, and dysbetalipoproteinemia. It also lowers total cholesterol and LDL-cholesterol levels, thereby delaying the progression of atherosclerosis and reducing the risk of cardiovascular diseases. It can be used in children aged 10 years and older for the management of hypercholesterolemia and helps in reducing the risks of stroke, myocardial infarction, and vascular intervention in high-risk patients with elevated high-sensitivity C-reactive protein levels. Overall, this medication is used to improve cardiovascular health and effectively regulate blood lipids.

How to take

Adult dose

For primary hypercholesterolemia and related conditions, this medication can be taken at any time of the day, regardless of meals. The initial dosage is 5mg once daily and can be adjusted to a maintenance dosage as needed. The maintenance dose is commonly 10mg once daily, and adjustments can be made based on LDL cholesterol levels and patient response at intervals of 4 weeks or more. The maximum dose can be increased to 20mg daily.

Child dose

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years), the recommended dosage is 5mg to 20mg once daily. The dose should be adjusted individually based on treatment goals.

Precautions

This medication should not be used by certain patients. First, individuals who are allergic to any component of this medication should not take it. Patients with active liver disease or very high liver enzyme levels should also avoid this medication. Those with muscle disorders or severe renal impairment should not use it either. Caution is needed when using this medication in pregnant or lactating women and fertile women who do not use adequate contraception. Additionally, high dosages are contraindicated in patients at high risk for muscle disorders. This medication contains lactose and is not suitable for patients with lactose intolerance. Care should be taken when administering this medication to patients with a history of significant alcohol consumption or liver disease. Regular liver function tests should be performed, and this medication should be used only after treating any underlying conditions in patients with hypothyroidism or nephrotic syndrome. Muscle-related side effects such as myalgia, myopathy, or rhabdomyolysis can occur, so any symptoms should be reported to healthcare professionals immediately. Patients particularly at risk for muscle disorders should have muscle enzyme tests performed before and during treatment to monitor their condition. If severe muscle pain or weakness occurs, the medication should be stopped and a doctor consulted. This medication can affect liver function, so it should be stopped immediately if symptoms of liver damage appear. Blood sugar levels may rise, so patients at risk for diabetes should monitor their blood sugar periodically. This medication may interact with other drugs, so if there are any concomitant medications, it is essential to inform the healthcare provider. Particularly, the risk of muscle-related side effects can be increased when used with certain antivirals, immunosuppressants, antifungals, antibiotics, and fibrate class drugs. Additionally, there is a potential for interactions with antacids or certain anticoagulants, so caution is advised. During pregnancy or breastfeeding, this medication should be avoided due to potential harm to the fetus or infant. Women planning to become pregnant should use appropriate contraception and discontinue the medication immediately if pregnancy is confirmed. In the event of overdose, there is no specific antidote, so symptomatic treatment should be provided while monitoring liver function and muscle enzyme levels. Lastly, this medication can rarely cause severe skin reactions or interstitial lung disease, so healthcare professionals should be consulted immediately if skin rashes, breathing difficulties, or other unusual symptoms occur.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria and angioedema, Stevens-Johnson syndrome, eosinophilia and systemic symptoms related to drug reaction with eosinophilia and systemic symptoms (DRESS), rhabdomyolysis, severe edema, liver-related jaundice, hepatitis, severe myasthenia, ocular myasthenia, severe skin reactions, acute renal failure, oliguria, chest tightness, difficulties in breathing, dyspnea, severe allergic reactions, severe neurological symptoms (headache, seizures, loss of consciousness)

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • weakness
  • diarrhea
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  • discomfort in the chest
  • loss of appetite
  • abdominal distension
  • abnormal liver function test results
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • fatigue
  • numbness
  • sensory disturbances
  • hematuria
  • 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 should be stored in a tightly sealed container to protect it from air and moisture, ideally between temperatures of 1 degree to 30 degrees Celsius. This will help maintain the effectiveness of the medication and prevent degradation.

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.