Medication info

Rojastin Tablet 10mg (Rosuvastatin Calcium)

Prescription medicationTabletExpired
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
(주)파마킹
Appearance
Pink round film-coated tablet
Packaging
28 tablets/PTP (14 tablets/PTP × 2)
Approval status
Expired

MFDS item code 201400395 · Approved 2014.01.28

This product's status changed to Expired on 2024.01.28. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of hypercholesterolemia (primary, mixed type) and familial hypercholesterolemia, reduction of cardiovascular disease risk (stroke, myocardial infarction)
Who uses it
Adults
Adult dosage
This medication can be taken at any time of the day, with or without meals. The initial dose is 5 mg once daily, and the maintenance dose can be adjusted for further reduction of LDL cholesterol levels. The maintenance dose is usually 10 mg once daily, with most patients being managed at this dosage. Maintenance dosages should be adjusted based on LDL cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more.

Ingredients

Manufacturer
(주)파마킹

Efficacy & effects

Treatment of hypercholesterolemia (primary, mixed type) and familial hypercholesterolemia, reduction of cardiovascular disease risk (stroke, myocardial infarction)

  • Hypercholesterolemia
  • hyperlipidemia
  • familial hypercholesterolemia
  • dysbetalipoproteinemia
  • coronary heart disease risk factors
  • hypertension
  • low HDL cholesterol levels
  • smoking
  • family history of early coronary heart disease
  • stroke risk
  • myocardial infarction risk
View approved original text

This medication is primarily used as an adjunct in patients with primary hypercholesterolemia and mixed hyperlipidemia when dietary changes and exercise alone are insufficient. It is also helpful for patients with homozygous familial hypercholesterolemia in conjunction with dietary measures and LDL apheresis. It significantly contributes to lowering total cholesterol and LDL cholesterol levels, thereby slowing the progression of atherosclerosis. Additionally, it is used as an adjunct in the dietary management of primary dysbetalipoproteinemia. In men over 50 years old and women over 60 years old with elevated high-sensitivity C-reactive protein levels, it helps reduce the risk of stroke, myocardial infarction, and vascular revascularization procedures. It is an effective therapeutic agent for reducing the risk of cardiovascular diseases.

Dosage and Administration

Adult dosage

This medication can be taken at any time of the day, with or without meals. The initial dose is 5 mg once daily, and the maintenance dose can be adjusted for further reduction of LDL cholesterol levels. The maintenance dose is usually 10 mg once daily, with most patients being managed at this dosage. Maintenance dosages should be adjusted based on LDL cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more.

Precautions

This medication should not be administered to certain patients. Patients with allergies to any component of this medication, those with severe liver impairment, those with muscle diseases, patients taking certain medications, those with severe kidney dysfunction, and women who are pregnant or breastfeeding should not take this medication. Additionally, this medication contains lactose and caution should be exercised in patients with lactose intolerance. Patients taking this medication should have liver function and muscle status monitored regularly, especially those who consume alcohol in excess or have a history of liver disease. If symptoms such as muscle pain or weakness occur, medical personnel should be notified immediately, and in severe cases, discontinuation of the medication may be warranted. Moreover, this medication may interact with other drugs, hence current medications must be disclosed, as concomitant use of certain drugs may increase the risk of muscle damage. Women who may become pregnant must use appropriate contraception and should not take this medication during pregnancy. In the case of overdose, there are no specific antidotes, so treatment should be symptomatic, and liver function and muscle enzyme levels should be monitored. Finally, this medication can cause symptoms like dizziness, so caution is needed when driving or operating machinery.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria and angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, severe rashes accompanied by high fever, blisters, skin peeling, pain in oral/ocular mucosa, difficulty breathing, respiratory distress, asthma attacks, thrombocytopenia, immune-mediated necrotizing myopathy, rhabdomyolysis, severe myopathy, acute renal failure, oliguria, edema, severe allergy

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • myalgia
  • weakness
  • diarrhea
  • fatigue
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  • numbness
  • altered sensations
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • memory loss
  • peripheral neuropathy
  • cough

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

Storage

This medication is sensitive to air and moisture, so it should be stored in a tightly sealed container. It is best to store the medication at room temperature, between 1°C and 30°C, avoiding extremes of temperature.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

28 tablets/PTP (14 tablets/PTP × 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.

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.