Medication info
HURESTO Tablet 10 mg (Rosuvastatin Calcium)

HURESTO Tablet 10 mg (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
(주)휴비스트제약
Appearance
Pink, round film-coated tablets
Packaging
30 tablets (15 tablets/PTP x 2), 30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201404929 · Approved 2014.10.27 · Insurance code 628800370

Summary

Main use
Treatment for improvement of hypercholesterolemia and dyslipidemia (primary, familial) and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
Administer 5 mg once daily at any time, regardless of meals. If further LDL cholesterol reduction is required, maintain a dosage of 10 mg once daily, and adjust as needed based on LDL cholesterol levels, treatment goals, and patient's response at intervals of 4 weeks or more. The maximum daily dosage can be increased up to 20 mg.
Child dose
For pediatric patients aged 10 to 17 with heterozygous familial hypercholesterolemia, the starting dosage is 5 mg to 20 mg once daily, with the dosage adjusted individually. Dosage adjustments should be made at intervals of 4 weeks or more.

Ingredients

Manufacturer
(주)휴비스트제약

Efficacy & effects

Treatment for improvement of hypercholesterolemia and dyslipidemia (primary, familial) and reduction of cardiovascular disease risk

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

This medication is used as an adjunct therapy for patients with primary hypercholesterolemia and mixed dyslipidemia when diet and exercise are inadequate. It is administered in conjunction with diet or other lipid-lowering therapies for patients with homozygous familial hypercholesterolemia. It effectively lowers total cholesterol and LDL-cholesterol levels in patients with hypercholesterolemia, delaying the progression of atherosclerosis. It can also be administered as an adjunct to diet in pediatric patients aged 10 to 17 with heterozygous familial hypercholesterolemia. Furthermore, it helps dietary management in patients with dysbetalipoproteinemia and reduces the risk of stroke, myocardial infarction, and restenosis in men over 50 years of age and women over 60 years of age with specific cardiovascular risk factors. Hence, this medication is used to reduce the risk of dyslipidemia and related cardiovascular disease and to improve symptoms.

How to take

Adult dose

Administer 5 mg once daily at any time, regardless of meals. If further LDL cholesterol reduction is required, maintain a dosage of 10 mg once daily, and adjust as needed based on LDL cholesterol levels, treatment goals, and patient's response at intervals of 4 weeks or more. The maximum daily dosage can be increased up to 20 mg.

Child dose

For pediatric patients aged 10 to 17 with heterozygous familial hypercholesterolemia, the starting dosage is 5 mg to 20 mg once daily, with the dosage adjusted individually. Dosage adjustments should be made at intervals of 4 weeks or more.

Precautions

This medication should not be taken by certain patients. For instance, individuals with an allergy to this medication, patients with severe liver dysfunction, muscular disorders, severe renal impairment, or women who are pregnant or breastfeeding should avoid using it. Additionally, this drug may cause muscle-related side effects, so caution should be exercised for patients who are at higher risk for myalgia or myopathy. In particular, dosage adjustments should be considered for patients with moderate to severe renal impairment, hypothyroidism, a family history of such disorders, individuals with a history of alcohol abuse, specific ethnic groups (Asian patients), and those taking fibrate drugs. This medication contains lactose, so individuals with lactose intolerance or related genetic conditions should not take it. Moreover, patients sensitive to yellow dye (Yellow No. 5) should use it cautiously. Patients with poor liver function or those who consume excessive alcohol should have liver function tests before taking this medication and have their liver enzyme levels monitored regularly. It is advisable for patients with hypercholesterolemia due to hypothyroidism or certain nephrotic syndromes to receive treatment for the underlying condition before using this medication. If symptoms such as muscle pain, muscle weakness, cramps, fatigue, or fever occur during treatment, medical attention should be sought immediately, and blood tests may be needed to check for muscle damage. In severe cases, discontinuation of therapy may be required, and if symptoms improve, re-initiation at a lower dose may be considered. This medication interacts with certain other medications, so patients taking other drugs must inform their doctor or pharmacist. In particular, co-administration with cyclosporine, fibrate-class drugs, niacin, and certain antibiotics and antifungals may increase the risk of muscle side effects. Women who are pregnant or may become pregnant should use appropriate contraception and discontinue use immediately if they become pregnant. Breastfeeding women should also avoid using this medication for safety. In case of overdose, as there is no specific antidote, treatment should be symptomatic, and liver function and muscle enzyme levels should be monitored. This drug does not significantly affect driving or operating machinery; however, caution is needed as symptoms such as dizziness may occur. Finally, this medication may rarely cause serious skin reactions, liver damage, kidney issues, or muscular diseases; thus, if unusual symptoms arise, consultation with medical personnel should be sought immediately.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, Stevens-Johnson syndrome, eosinophilia and systemic symptoms drug reaction syndrome (DRESS), rhabdomyolysis, severe muscle weakness, ocular myasthenia, jaundice, hepatitis, severe allergic reactions, severe skin reactions, dyspnea, respiratory abnormalities with cough and fever, severe edema, urination abnormalities with hypertension, acute renal failure, oliguria, acute severe conditions (sepsis, hypotension, major surgery)

Mild side effects

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

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

Storage

This medication should be kept in a tightly sealed container to prevent exposure to air and moisture. It is best stored at a temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Pink, round film-coated tablets

Package unit

30 tablets (15 tablets/PTP x 2), 30 tablets/bottle, 100 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.