Medication info

Cretap Tablet 20 Milligrams (Rosuvastatin Calcium)

Prescription medicationTabletApproval withdrawn
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
주식회사제뉴원사이언스
Appearance
Pink circular film-coated tablet
Packaging
28 tablets (14 tablets/PTP packaging x 2), 30 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 202001672 · 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This product's status changed to Approval withdrawn on 2024.12.05.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 reduced risk of cardiovascular diseases
Who uses it
Adults · Children
Adult dosage
Patients with primary hypercholesterolemia, mixed dyslipidemia, dysbetalipoproteinemia, and homozygous familial hypercholesterolemia are administered this medication once daily at any time regardless of meals. The initial dose is 5 milligrams once daily, which may be adjusted, if necessary, at intervals of at least 4 weeks, up to a maximum of 20 milligrams once daily.
Children's dosage
Pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years) are administered between 5 milligrams and 20 milligrams once daily. The dosage should be adjusted according to individual treatment goals at intervals of at least 4 weeks.

Ingredients

Manufacturer
주식회사제뉴원사이언스

Efficacy & effects

Treatment for hypercholesterolemia and reduced risk of cardiovascular diseases

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

This medication is used as an adjunct when diet and exercise alone are inadequate to control hypercholesterolemia and mixed dyslipidemia. It is also helpful as an adjunct to diet and other therapies for patients with familial hypercholesterolemia. It effectively lowers total cholesterol and LDL cholesterol levels, thereby delaying the progression of atherosclerosis. It can also be used as an adjunct to diet in pediatric patients with heterozygous familial hypercholesterolemia. Additionally, it provides benefits for patients with primary dysbetalipoproteinemia and reduces the risk of cardiovascular diseases. Specifically, it has shown efficacy in reducing the risks of stroke, myocardial infarction, and arterial revascularization. This drug is used to improve blood lipid levels and maintain cardiovascular health.

Dosage and Administration

Adult dosage

Patients with primary hypercholesterolemia, mixed dyslipidemia, dysbetalipoproteinemia, and homozygous familial hypercholesterolemia are administered this medication once daily at any time regardless of meals. The initial dose is 5 milligrams once daily, which may be adjusted, if necessary, at intervals of at least 4 weeks, up to a maximum of 20 milligrams once daily.

Children's dosage

Pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years) are administered between 5 milligrams and 20 milligrams once daily. The dosage should be adjusted according to individual treatment goals at intervals of at least 4 weeks.

Precautions

This drug should not be used in certain patients. It should not be administered to patients who are allergic to this drug, those with serious liver problems, muscle diseases, or severe kidney impairment. Pregnant or breastfeeding women, and women who may become pregnant should only use this medication if they are fully aware of the potential risks to the fetus and have a high likelihood of not becoming pregnant. Furthermore, patients who are prone to muscle disorders or rhabdomyolysis should be particularly cautious, as high doses of this medication are contraindicated. This medication contains lactose and should not be given to patients with lactose intolerance or related genetic diseases. Patients with a history of liver disease or those who consume excessive amounts of alcohol, as well as those with hypothyroidism, should be thoroughly evaluated before taking this medication and should have regular liver function tests. If symptoms of muscle pain or weakness appear, they should immediately inform healthcare personnel, and if necessary, blood tests should be conducted to check for muscle damage. This medication may rarely cause serious skin reactions or liver damage, so if symptoms such as a skin rash or jaundice occur, it should be stopped immediately and a doctor consulted. Additionally, this medication may interact with many drugs, so if other medications are being taken, it is essential to inform healthcare personnel, particularly when used in conjunction with certain antiviral agents, antifungals, immunosuppressants, and fibrate drugs. It should not be used during pregnancy or breastfeeding, and women who may become pregnant must use appropriate contraceptive methods. In case of overdose, as there is no specific antidote, symptomatic treatment should be received while monitoring liver function and muscle condition. Finally, dizziness or muscle pain may occur while taking this medication, so caution is needed when driving or operating machinery.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria, angioedema, rhabdomyolysis, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, hyperbilirubinemia, severe muscle weakness, ocular muscle weakness, severe allergic reactions, severe skin reactions, difficulty breathing, respiratory issues accompanied by cough and fever, myopathy, immune-mediated necrotizing myopathy, acute kidney failure, oliguria, elevated blood creatinine

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • muscle pain
  • weakness
  • diarrhea
  • fatigue
Show 15 more
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • hematuria
  • thrombocytopenia
  • forgetfulness
  • peripheral neuropathy
  • cough

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1 degree and 30 degrees Celsius. By storing it this way, the efficacy and safety of the medication can be preserved for a long time.

Appearance and packaging

Appearance

Pink circular 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.