Medication info

Cretap 10 mg (Rosuvastatin Calcium)

Prescription medicationTabletApproval withdrawn
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
주식회사제뉴원사이언스
Appearance
Pink round film-coated tablet
Packaging
28 tablets (14 tablets/PTP packaging x 2), 30 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 202001671 · Approved 2020.03.11

This product's status changed to Approval withdrawn on 2024.12.05. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk.
Who uses it
Adults · Children
Adult dosage
The initial dose is 5 mg once daily, which may be adjusted to maintain therapeutic levels as needed. The maintenance dose is 10 mg once daily, which can be increased to a maximum of 20 mg daily at intervals of 4 weeks or more. It can be taken at any time of the day regardless of meals.
Children's dosage
For pediatric patients aged 10 to 17 years, the dosage is to be given once a day, between 5 mg and 20 mg. Dosage should be adjusted based on individual treatment goals at intervals of at least 4 weeks. For patients under 10 years of age, the safety and efficacy are not established.

Ingredients

Manufacturer
주식회사제뉴원사이언스

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk.

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • heterogeneous familial hypercholesterolemia
  • primary dysbetalipoproteinemia
  • elevated high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol levels
  • smoking
  • family history of early coronary heart disease.
View approved original text

This medication is primarily used as an adjunct in patients with hypercholesterolemia and mixed hyperlipidemia when diet and exercise alone are not sufficient. It also helps lower LDL cholesterol levels in patients with familial hypercholesterolemia and slows the progression of atherosclerosis. It may be used as an adjunct to diet for pediatric patients aged 10 to 17 years who meet specific criteria. It helps patients with primary dysbetalipoproteinemia and is effective in reducing cardiovascular risk. This improves health by reducing the risk of stroke, myocardial infarction, and arterial revascularization.

Dosage and Administration

Adult dosage

The initial dose is 5 mg once daily, which may be adjusted to maintain therapeutic levels as needed. The maintenance dose is 10 mg once daily, which can be increased to a maximum of 20 mg daily at intervals of 4 weeks or more. It can be taken at any time of the day regardless of meals.

Children's dosage

For pediatric patients aged 10 to 17 years, the dosage is to be given once a day, between 5 mg and 20 mg. Dosage should be adjusted based on individual treatment goals at intervals of at least 4 weeks. For patients under 10 years of age, the safety and efficacy are not established.

Precautions

This drug should not be administered to certain patients. For example, patients with allergies to any ingredient of this drug, those with liver dysfunction, individuals with muscular diseases, patients taking certain medications in combination, and those with severe kidney dysfunction, pregnant or lactating women. Additionally, this drug should be used with caution in patients with liver dysfunction or those consuming large amounts of alcohol, and repeated liver function tests before and during treatment are recommended. If symptoms such as muscle pain or weakness occur, healthcare professionals should be notified immediately, and in severe cases, administration should be stopped. Rarely, this drug may cause serious skin reactions or liver damage, and muscle-related adverse effects, so if these symptoms appear, treatment should be stopped immediately and healthcare professionals should be consulted. Moreover, there may be drug interactions with other medications, so if you are taking other drugs, you must inform your healthcare provider, especially with certain antiviral agents, immunosuppressants, and fibrate drugs. Women who are pregnant or of childbearing potential should use appropriate contraception and discontinue use immediately if pregnancy is confirmed. It is also recommended that breastfeeding women avoid this medication. In the case of overdose, there are no specific antidotes, so management should involve treatment for symptoms along with monitoring liver function and muscle enzyme levels. This drug may cause dizziness, so caution is required when driving or operating machinery. Finally, this drug contains lactose, so patients with lactose intolerance should not take it. Additionally, Asian patients may exhibit higher drug concentrations; thus dose adjustment may be necessary.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including hives and angioedema, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, severe liver damage, severe muscle weakness, ocular muscle weakness, myopathy, rhabdomyolysis, immune-mediated effects.

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • weakness
  • diarrhea
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  • fatigue
  • numbness
  • paresthesia
  • nausea
  • abdominal pain
  • loss of appetite
  • abdominal distension
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • hematuria
  • thrombocytopenia
  • amnesia
  • peripheral neuropathy
  • cough
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • abnormal liver function test results
  • elevated ALT
  • elevated AST
  • increased CK.

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 suitable storage temperature is between 1 and 30 degrees Celsius at room temperature, and it is advisable to avoid very hot or very cold places.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

28 tablets (14 tablets/PTP packaging x 2), 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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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.