Medication info

Rosurol Tablet 2.5 mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›2.6mg / 1 tablet
Manufacturer / importer
(주)종근당
Appearance
White round film-coated tablet
Packaging
PTP - 30 tablets/box [10 tablets/PTP x 3]
Approval status
Active

MFDS item code 202302170 · Approved 2023.07.14

Summary

Main use
Improvement of hypercholesterolemia and mixed hyperlipidemia
Who uses it
Adults
Adult dosage
This medication can be taken at any time of the day regardless of meals. The initial dose is 2.5 or 5 mg once daily, and if necessary, it can be adjusted to a maintenance dose. The maintenance dose is 10 mg once daily and should be adjusted appropriately based on LDL-cholesterol levels and patient response at intervals of 4 weeks or more. The maximum dose can be increased to 20 mg per day.

Ingredients

Manufacturer
(주)종근당

Efficacy & effects

Improvement of hypercholesterolemia and mixed hyperlipidemia

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed hyperlipidemia
View approved original text

This medication is used for patients with primary hypercholesterolemia and heterozygous familial hypercholesterolemia (primarily type IIa), as well as mixed hyperlipidemia (type IIb). It is primarily prescribed as an adjunct to dietary management when not adequately controlled by diet and exercise. This helps manage blood cholesterol levels and reduce the risk of cardiovascular disease. Patients can effectively improve their hyperlipidemia by taking this medication alongside consistent dietary therapy.

Dosage and Administration

Adult dosage

This medication can be taken at any time of the day regardless of meals. The initial dose is 2.5 or 5 mg once daily, and if necessary, it can be adjusted to a maintenance dose. The maintenance dose is 10 mg once daily and should be adjusted appropriately based on LDL-cholesterol levels and patient response at intervals of 4 weeks or more. The maximum dose can be increased to 20 mg per day.

Precautions

This medication should not be administered to certain patients. For example, patients allergic to any components of this medication, those with severe liver dysfunction, those with muscle disorders, and women who are pregnant or breastfeeding should not take this medication. Additionally, this medication may be contraindicated in patients with severely impaired kidney function or those taking certain medications; therefore, caution is needed. Women of childbearing potential should only take this medication when pregnancy is unlikely and must use appropriate contraception. This medication can affect liver function and muscle health, so individuals who consume alcohol excessively or have a history of liver disease should undergo liver function tests before taking it. If symptoms of muscle pain or weakness develop, healthcare professionals should be notified immediately, and in severe cases, medication may be discontinued. Regular monitoring of kidney function is necessary, especially during high-dose administration, as it can impact kidney function. Asian patients may require dosage adjustments due to higher drug concentrations. This medication can rarely cause serious skin reactions or liver damage; therefore, if severe rashes or symptoms like jaundice occur, you should stop taking it immediately and consult a doctor. Additionally, this medication can interact with other drugs, so if you are currently taking any medications, it is crucial to inform your healthcare provider. Especially when taken with certain antibiotics, antifungals, immunosuppressants, or lipid-lowering agents, the risk of atypical muscle reactions may increase. Pregnant or breastfeeding women should not take this medication, and women who may become pregnant must use appropriate contraception. In the case of overdose, there is no specific antidote; treatment should be symptomatic, and liver function and muscle enzyme levels should be monitored. Lastly, this medication may cause dizziness, so caution is needed when driving or operating machinery.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or trouble breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urinary changes

Mild side effects

  • Dyspepsia
  • pruritus
  • headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • herpes zoster
  • vulvar pruritus
  • myalgia
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  • weakness
  • diarrhea
  • facial edema
  • thrombocytopenia
  • increased transaminases
  • sensory disturbances
  • chest discomfort
  • anorexia
  • abdominal bloating
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • fatigue
  • numbness
  • arthralgia
  • memory loss
  • peripheral neuropathy
  • cough
  • thrombocytopenia
  • fatal and non-fatal liver issues

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

Storage

This medication may be sensitive to air and moisture, so it should be stored in a tightly closed container. The recommended storage temperature is between 1 and 30 degrees Celsius to maintain the effectiveness of the medication.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

PTP - 30 tablets/box [10 tablets/PTP x 3]

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.