Medication info

Rosutap 20 mg (Rosuvastatin Calcium)

Prescription medicationExpired
Ingredient · strength
Rosuvastatin Calcium›Strength being verified
Manufacturer / importer
신신제약(주)
Appearance
Pink round film-coated tablets
Packaging
100 tablets/bottle, 30 tablets/bottle
Approval status
Expired

MFDS item code 201803719 · Approved 2018.09.14

This product's status changed to Expired on 2023.09.14. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of hypercholesterolemia and dyslipidemia (primary, familial) and reduction of cardiovascular disease risk
Who uses it
Adults
Adult dosage
In patients with primary hypercholesterolemia, combined hyperlipidemia, and primary dysbetalipoproteinemia, it is administered once daily at any time, regardless of meals. The initial dose is 5 mg once daily, which can be adjusted to a maintenance dose as needed. A maintenance dose of 10 mg once daily is suitable for most patients and should be adjusted based on LDL cholesterol levels and patient response at intervals of no less than 4 weeks.

Ingredients

Manufacturer
신신제약(주)

Efficacy & effects

Treatment of hypercholesterolemia and dyslipidemia (primary, familial) and reduction of cardiovascular disease risk

  • Hypercholesterolemia
  • hyperlipidemia
  • familial hypercholesterolemia
  • dysbetalipoproteinemia
  • increased high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol levels
  • smoking
  • family history of premature coronary artery disease
View approved original text

This medication is used as an adjunctive agent in cases of primary hypercholesterolemia and combined hyperlipidemia that are difficult to control with diet and exercise. It is also helpful for patients with homozygous familial hypercholesterolemia along with dietary measures or other lipid-lowering therapies. In patients with hypercholesterolemia, it effectively lowers total cholesterol and LDL cholesterol levels, slowing the progression of atherosclerosis. It is also used as an adjunct to dietary measures in patients with primary dysbetalipoproteinemia. In middle-aged or older patients at high risk for cardiovascular disease, it helps reduce the risk associated with stroke, myocardial infarction, and arterial revascularization. In summary, this medication is effectively used for various forms of hyperlipidemia and reduction of cardiovascular disease risk.

Dosage and Administration

Adult dosage

In patients with primary hypercholesterolemia, combined hyperlipidemia, and primary dysbetalipoproteinemia, it is administered once daily at any time, regardless of meals. The initial dose is 5 mg once daily, which can be adjusted to a maintenance dose as needed. A maintenance dose of 10 mg once daily is suitable for most patients and should be adjusted based on LDL cholesterol levels and patient response at intervals of no less than 4 weeks.

Precautions

This drug should not be administered to certain patients. For example, it should not be used in those with allergies to any of its components, severely impaired liver function, muscle disorders, patients taking certain immunosuppressants, those with severe renal impairment, pregnant or nursing women, and patients with genetic lactose intolerance. Caution is advised when using this drug in patients with a history of heavy alcohol use or liver disease, and regular liver function tests should be conducted. Additionally, if symptoms such as muscle pain or weakness occur, the patient should inform their doctor immediately, and patients at high risk of muscle damage should undergo regular muscle enzyme tests before and during treatment. This drug may increase blood concentration when taken with certain medications, raising the risk of muscle damage, so dosage adjustments or discontinuation may be necessary when used with specific drugs. Caution is particularly needed when combined with fibrate-class medications. Women of childbearing potential should use appropriate contraceptive methods while taking this medication, and this drug should not be used during pregnancy. It may be transmitted through breast milk; therefore, nursing mothers should also avoid using it. In case of overdose, there is no specific antidote, so treatment should be based on symptoms, and liver function and muscle enzyme levels should be monitored. Dizziness may occur during the use of this drug, so caution is advised when driving or operating machinery. While taking this drug, it is important to regularly check liver and muscle health status and consult medical personnel immediately if any abnormal symptoms arise.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including hives and angioedema, pancreatitis, myopathy, rhabdomyolysis, polyneuropathy, amnesia, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), immune-mediated necrotizing myopathy, jaundice, hepatitis, acute renal failure, oliguria, thrombocytopenia, increased serum creatinine, severe liver damage and/or hyperbilirubinemia, interstitial lung disease, severe allergic reactions

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • weakness
  • diarrhea
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  • chest pain
  • cough
  • arthralgia
  • fatigue
  • numbness
  • paresthesia
  • loss of appetite
  • abdominal distension
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • amnesia
  • peripheral neuropathy
  • hematuria

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture, and it is recommended to keep it at room temperature between 1 degree and 30 degrees Celsius. This way of storage helps maintain the effectiveness of the medication and prevents degradation.

Appearance and packaging

Appearance

Pink round film-coated tablets

Package unit

100 tablets/bottle, 30 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.