Medication info
Huresto 5 mg (Rosuvastatin Calcium)

Huresto 5 mg (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
(주)휴비스트제약
Appearance
Yellow round film-coated tablet
Packaging
PTP - 30 tablets/PTP [(15 tablets/PTP x 2)]
Approval status
Active

MFDS item code 201404928 · Approved 2014.10.27 · Insurance code 628800360

Summary

Main use
Treatment for high cholesterol and reduced risk of cardiovascular disease
Who takes it
Adults · Children
Adult dose
This medication can be administered at any time of the day, regardless of meals. The initial dose is 5 mg once daily, and if a greater reduction in LDL cholesterol levels is needed, the maintenance dose can be adjusted. The maintenance dose is typically 10 mg once daily for most patients who are adjusted to this dosage. Adjustments should be made at intervals of 4 weeks or longer based on LDL cholesterol levels, therapeutic goals, and patient response. The maximum daily dose is 20 mg.
Child dose
The usual dose range is 5 mg to 20 mg once a day. The dosing should be adjusted based on the therapeutic goals for each individual patient, and dose adjustment should be made at intervals of 4 weeks or more. For children under 10 years old, safety and efficacy have not been established.

Ingredients

Manufacturer
(주)휴비스트제약

Efficacy & effects

Treatment for high cholesterol and reduced risk of cardiovascular disease

  • Hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • high cholesterol
  • 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 primarily used in patients with hypercholesterolemia and hyperlipidemia. It is effective for patients with primary hypercholesterolemia and mixed dyslipidemia that are difficult to manage with diet and exercise and is used in conjunction with other treatments for homozygous familial hypercholesterolemia patients. This drug lowers total cholesterol and LDL cholesterol levels and delays the progression of atherosclerosis. It is also used as an adjunct to dietary therapy in children aged 10 years and older with familial hypercholesterolemia. It is beneficial for patients with primary dysbetalipoproteinemia. In particular, it contributes to reducing the risk of stroke, myocardial infarction, and vascular revascularization in high-risk men and women with elevated high-sensitivity C-reactive protein levels and cardiovascular disease risk factors. This drug improves the risk factors for hyperlipidemia and cardiovascular disease.

How to take

Adult dose

This medication can be administered at any time of the day, regardless of meals. The initial dose is 5 mg once daily, and if a greater reduction in LDL cholesterol levels is needed, the maintenance dose can be adjusted. The maintenance dose is typically 10 mg once daily for most patients who are adjusted to this dosage. Adjustments should be made at intervals of 4 weeks or longer based on LDL cholesterol levels, therapeutic goals, and patient response. The maximum daily dose is 20 mg.

Child dose

The usual dose range is 5 mg to 20 mg once a day. The dosing should be adjusted based on the therapeutic goals for each individual patient, and dose adjustment should be made at intervals of 4 weeks or more. For children under 10 years old, safety and efficacy have not been established.

Precautions

This drug should not be used in certain patients. For example, it should not be administered to patients with allergies to its components, severely impaired liver function, muscle diseases, those taking specific immunosuppressants, those with severely reduced kidney function, pregnant or nursing women, and those at risk for muscle disease. Caution should be exercised when administering this drug to patients with compromised liver function or those who consume large amounts of alcohol, and it is advisable to perform repeat liver function tests before and during treatment. Additionally, if symptoms of muscle pain or weakness occur, medical personnel should be notified immediately and an examination should be conducted. Patients at high risk of muscle damage, such as those with kidney disorders, hypothyroidism, a family history or past incidents of muscle toxic reactions, the elderly, and those with alcohol abuse, should use this drug with increased caution and regular muscle-related examinations are necessary. This drug contains lactose and should not be administered to patients with lactose intolerance. While taking this drug, rare side effects such as headache, dizziness, indigestion, skin rash, and muscle pain may occur, and in severe cases, serious muscle damage such as myositis or rhabdomyolysis may develop. Pregnant or nursing women should not take this medication, and women who might become pregnant should use appropriate contraception. This drug may interact with other medications, so caution is required, especially when taken with specific antiviral drugs, immunosuppressants, antibiotics, and fibrate medications. When taken with certain drugs, the blood concentration of this medication may increase, raising the risk of muscle damage. In case of overdose, there is no specific antidote, and symptom-based treatment and liver function and muscle enzyme examinations are necessary. Caution should be exercised as dizziness may occur during driving or operating machinery. If severe skin reactions, liver function abnormalities, severe muscle pain, or other abnormal symptoms occur while taking this drug, consumption should be stopped immediately, and medical personnel should be consulted.

Side effects and when to seek care immediately

Serious side effects

  • Allergic reactions including hives, angioedema
  • Severe swelling (edema)
  • Chest tightness
  • Difficulty breathing, dyspnea, cough
  • Severe rash, blisters, skin peeling, mucous membrane pain in mouth/eyes accompanied by high fever
  • Stevens-Johnson syndrome
  • Drug reaction with eosinophilia and systemic symptoms (DRESS)
  • Severe skin abnormal reactions on the skin
  • Yellowing of the skin or eyes (jaundice)
  • Hepatitis, both fatal and non-fatal liver failure

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • muscle pain
  • weakness
  • hematuria
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  • diarrhea
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • memory loss
  • peripheral neuropathy
  • thrombocytopenia
  • increased transaminases
  • hepatitis
  • drug-induced psoriasis-like rash
  • lupus-like syndrome
  • muscle rupture
  • increased blood creatinine
  • depression
  • sleep disturbances

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 from entering. It is best to store it at normal room temperature between 1°C and 30°C, avoiding excessively hot or cold environments.

Appearance and packaging

Appearance

Yellow round film-coated tablet

Package unit

PTP - 30 tablets/PTP [(15 tablets/PTP x 2)]

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.

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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.