Medication info

Erostin Tablet 5 milligrams (Rosuvastatin Calcium)

Prescription medicationTabletExpired
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
(주)유유제약
Appearance
Pink round film-coated tablet
Packaging
30 tablets (15 tablets/PTP (AluAlu*2), 30 tablets/bottle, 100 tablets/bottle, 300 tablets/bottle
Approval status
Expired

MFDS item code 201903811 · Approved 2019.06.11

This product's status changed to Expired on 2024.06.11. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment for hypercholesterolemia (primary, familial) and reduced risk of cardiovascular disease
Who uses it
Adults · Children
Adult dosage
Administer 5 milligrams once daily as the initial dose at any time of the day, regardless of meals. If more LDL-cholesterol reduction is needed, adjust the maintenance dose to 10 milligrams once daily, and the dose can be increased to a maximum of 20 milligrams once daily based on the patient's response, at intervals of 4 weeks or more.
Children's dosage
Pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia should be given a dose of 5 milligrams to 20 milligrams once a day. Dosages should be adjusted according to treatment goals at intervals of 4 weeks or more.

Ingredients

Manufacturer
(주)유유제약

Efficacy & effects

Treatment for hypercholesterolemia (primary, familial) and reduced risk of cardiovascular disease

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • excessive LDL cholesterol
  • increased Apo-B protein levels
  • dysbetalipoproteinemia
  • increased high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol levels
  • smoking
View approved original text

This medication is used as an adjunct when dietary management and exercise alone are insufficient to control primary hypercholesterolemia and mixed dyslipidemia. It is also used as an adjunct to dietary management or other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia. It reduces total cholesterol and LDL-cholesterol levels to target levels to delay the progression of atherosclerosis and is particularly effective in pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia. It is also used to assist in dietary management in patients with primary dysbetalipoproteinemia. It helps reduce the risks of stroke, myocardial infarction, and arterial revascularization in high-risk cardiovascular disease patients. This medication improves various issues related to dyslipidemia.

Dosage and Administration

Adult dosage

Administer 5 milligrams once daily as the initial dose at any time of the day, regardless of meals. If more LDL-cholesterol reduction is needed, adjust the maintenance dose to 10 milligrams once daily, and the dose can be increased to a maximum of 20 milligrams once daily based on the patient's response, at intervals of 4 weeks or more.

Children's dosage

Pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia should be given a dose of 5 milligrams to 20 milligrams once a day. Dosages should be adjusted according to treatment goals at intervals of 4 weeks or more.

Precautions

This medication should not be administered to specific patients. For example, patients with an allergy to this medication or severely impaired liver function, those with muscle disorders, patients with severely impaired kidney function, and women who are pregnant or nursing should not take this medication. Additionally, high-dose use of this medication is contraindicated in patients at risk for muscle disorders or those with specific genetic traits. Since this medication contains lactose, patients with lactose intolerance should not take it. Patients with liver function issues or those who consume excessive alcohol should undergo repeated liver function tests before and during the use of this medication, and those with hypothyroidism should receive treatment prior to starting this medication. This medication may cause muscle-related side effects, including muscle pain, muscle weakness, and in severe cases, rhabdomyolysis due to muscle cell destruction, so any symptoms of muscle pain or weakness should be reported to a doctor immediately. Patients at high risk of muscle damage should have muscle enzyme levels checked before and during treatment. This medication can rarely cause serious skin reactions or liver damage, so if symptoms such as rash, jaundice, or extreme fatigue occur, treatment should be discontinued immediately and medical advice should be sought. When taken with other medications, interactions may occur, particularly when combined with specific antiviral agents, immunosuppressants, antibiotics, fibrate-class drugs, etc. Some medications can increase the blood concentration of this drug, raising the risk of side effects. Women who are pregnant or may become pregnant must have adequate contraception and should discontinue use immediately if pregnancy occurs. It is also advisable for nursing mothers not to take this medication. In the case of overdose, there is no specific antidote, so symptomatic treatment and monitoring of liver function and muscle enzyme levels are necessary. Caution should be exercised as this medication may cause dizziness when driving or operating machinery. Limited effects on growth and development have been reported in children and adolescents.

Side effects and when to seek care immediately

Serious side effects

  • Urticaria, angioedema including hypersensitivity reactions, severe allergic reactions
  • Severe skin adverse reactions: Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), lichenoid drug rash
  • Respiratory issues: dyspnea, cough
  • Liver issues (jaundice): jaundice, hepatitis, elevated transaminases, liver function test abnormalities, fatal and non-fatal liver failure
  • Serious neurological symptoms: polyneuropathy, paralysis

Mild side effects

Headache, dizziness, constipation, nausea, abdominal pain, itching, rash, myalgia, weakness, hematuria, diarrhea, fatigue, numbness, paresthesia, chest discomfort, loss of appetite, abdominal bloating, fainting, generalized pain, muscle cramps, gout, erectile dysfunction, joint pain, memory impairment, forgetfulness, memory loss, cognitive impairment, confusion, depression, sleep disorders (including insomnia and nightmares), sexual dysfunction, gynecomastia

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

Storage

This medication may be sensitive to air or moisture and should be stored in a tightly sealed container. It is advisable to maintain a storage temperature between 1 to 30 degrees Celsius to preserve the medication's effectiveness.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

30 tablets (15 tablets/PTP (AluAlu*2), 30 tablets/bottle, 100 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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.