Medication info
Rostin 5mg (Rosuvastatin Calcium)

Rostin 5mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
아주약품(주)
Appearance
Pink round film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 202002665 · Approved 2020.04.16 · Insurance code 654005770

Summary

Main use
Treatment to reduce risk of hypercholesterolemia and cardiovascular diseases
Who uses it
Adults · Children
Adult dosage
The initial dose is 5mg once daily, and if more reduction of LDL-cholesterol is required, it may be adjusted to a maintenance dose. The maintenance dose is usually 10mg once daily, which suffices for most patients to achieve control. The maintenance dosage should be appropriately adjusted based on LDL-cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or longer, with a maximum daily dose of up to 20mg.
Children's dosage
The usual dosage range for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) is 5mg to 20mg once daily. The dosing should be adjusted based on the treatment goals recommended for individual patients.

Ingredients

Manufacturer
아주약품(주)

Efficacy & effects

Treatment to reduce risk of hypercholesterolemia and cardiovascular diseases

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

This medication is used to treat hypercholesterolemia and dyslipidemia. It is primarily used as an adjunctive therapy for patients with primary hypercholesterolemia and heterozygous familial hypercholesterolemia when dietary management and exercise are insufficient. Furthermore, it shows effectiveness when used in combination with other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia. This drug lowers total cholesterol and LDL-cholesterol levels, delaying the progression of atherosclerosis, and is also used as an adjunctive therapy for dietary management in pediatric patients meeting certain criteria. It also aids in the treatment of primary dysbetalipoproteinemia and reduces the risk of stroke, myocardial infarction, and arterial revascularization in high-risk cardiovascular disease patients with elevated high-sensitivity C-reactive protein levels. Therefore, it is an effective medication for improving cardiovascular health.

Dosage and Administration

Adult dosage

The initial dose is 5mg once daily, and if more reduction of LDL-cholesterol is required, it may be adjusted to a maintenance dose. The maintenance dose is usually 10mg once daily, which suffices for most patients to achieve control. The maintenance dosage should be appropriately adjusted based on LDL-cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or longer, with a maximum daily dose of up to 20mg.

Children's dosage

The usual dosage range for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) is 5mg to 20mg once daily. The dosing should be adjusted based on the treatment goals recommended for individual patients.

Precautions

This medication should not be administered to certain patients. For example, patients with an allergy to this drug, those with active liver disease, muscle disorders, or severe renal impairment should not use this medication. Women who are pregnant or breastfeeding should not take this medication, and women who may become pregnant should use appropriate contraception. Additionally, patients at risk for myopathy or rhabdomyolysis, especially when taking high doses (40mg), should avoid this drug. Before taking this medication, liver function and muscle status should be regularly monitored, and caution is required for patients with a history of liver disease or excessive alcohol consumption. If symptoms related to muscles such as muscle pain, weakness, or cramps occur, medical personnel should be notified immediately. This medication can cause various side effects such as liver dysfunction, increased blood sugar, and in rare cases, serious skin reactions or lung disease, so patients should be vigilant for symptoms. If there is a severe rash or difficulty breathing, the medication should be stopped immediately, and the patient should go to the hospital. Additionally, this medication can interact with other drugs, so patients must inform their healthcare provider of any other medications they are taking. The risk of muscle damage may increase when used in combination with certain antiviral agents, immunosuppressants, antifungals, and antibiotics. There is no specific antidote for overdose, so caution is necessary to avoid exceeding the prescribed dose, and if unusual symptoms arise, medical personnel should be consulted immediately. Finally, this medication may cause dizziness, requiring caution when driving or operating machinery. It should be used carefully in children and adolescents due to potential effects on growth and development.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria and angioedema, Stevens-Johnson syndrome, eosinophilia and systemic symptoms associated drug reaction syndrome, chest tightness, difficulty breathing, cough, respiratory distress, jaundice, acute renal failure, oliguria, severe muscle weakness, ocular muscle weakness, Stevens-Johnson syndrome, hepatitis, liver failure, severe swelling (edema), hypertension accompanied by severe edema or urinary changes, severe allergic reactions, severe

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • myalgia
  • weakness
  • diarrhea
  • thrombocytopenia
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  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal distension
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • urticaria
  • rash
  • hematuria
  • arthralgia
  • amnesia
  • peripheral neuropathy
  • cough
  • thrombocytopenia
  • jaundice
  • hepatitis
  • increased transaminase levels
  • lupus-like syndrome
  • muscle rupture
  • arthralgia
  • immune-mediated

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. It is best stored at room temperature, between 1°C and 30°C.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

30 tablets/bottle, 300 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.