Medication info

Cretap Tablet 5mg (Rosuvastatin Calcium)

Prescription medicationTabletApproval withdrawn
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
주식회사제뉴원사이언스
Appearance
Yellow round film-coated tablet
Packaging
28 tablets (14 tablets/PTP packaging x 2), 30 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 202001670 · 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This product's status changed to Approval withdrawn on 2024.12.05.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 milligrams once daily, and for patients requiring greater LDL cholesterol reduction, the maintenance dose can be adjusted accordingly. The maintenance dose is 10 milligrams once daily for most patients. The maintenance dose should be appropriately adjusted based on LDL cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or longer, with a maximum increase to 20 milligrams daily.
Children's dosage
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the usual dosage range is 5 to 20 milligrams once daily. The dosage should be adjusted individually based on the recommended treatment goals for each patient.

Ingredients

Manufacturer
주식회사제뉴원사이언스

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

  • Hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerosis
  • dysbetalipoproteinemia
  • increased high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol levels
  • smoking
  • family history of premature coronary heart disease
  • risk of stroke
View approved original text

This medication is primarily used to treat hypercholesterolemia and various dyslipidemias. It is taken as an adjunct when diet and exercise alone do not sufficiently control primary hypercholesterolemia and mixed hyperlipidemia, and is also used for homozygous familial hypercholesterolemia. It lowers total cholesterol and LDL cholesterol levels in patients with hypercholesterolemia, delaying the progression of atherosclerosis, and is beneficial for treating familial hypercholesterolemia in young children. Additionally, it assists dietary management in patients with dysbetalipoproteinemia and is effective in reducing the risk of cardiovascular diseases. In particular, it is used to reduce the risks of stroke, myocardial infarction, and arterial revascularization in middle-aged patients with elevated high-sensitivity C-reactive protein levels and additional risk factors. This medication is effective in improving lipid levels and protecting cardiovascular health.

Dosage and Administration

Adult dosage

The initial dose is 5 milligrams once daily, and for patients requiring greater LDL cholesterol reduction, the maintenance dose can be adjusted accordingly. The maintenance dose is 10 milligrams once daily for most patients. The maintenance dose should be appropriately adjusted based on LDL cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or longer, with a maximum increase to 20 milligrams daily.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the usual dosage range is 5 to 20 milligrams once daily. The dosage should be adjusted individually based on the recommended treatment goals for each patient.

Precautions

This medication should not be used in certain patients. For example, it should not be administered to patients allergic to its components, those with severe liver impairment, patients with muscle disorders, patients taking specific concurrent medications, patients with severe renal impairment, or women who are pregnant or breastfeeding. Additionally, high-dose administration is prohibited in patients at high risk for muscle-related side effects. Since this medication contains lactose, patients with lactose intolerance should not take it. Regular monitoring of liver function and muscle status is necessary while taking this medication, especially if there is a history of excessive alcohol use or liver disease. If symptoms such as muscle pain, muscle weakness, or cramps occur, a doctor should be notified immediately, and in severe cases, discontinuation of the medication is required. In cases of acute severe illness or the onset of muscle weakness, the use of this medication should also be discontinued. There may be interactions with other medications, so any medications currently being taken should be reported to a doctor or pharmacist. Particularly, when combined with certain antiviral drugs, immunosuppressants, antibiotics, or fibrate class drugs, the risk of muscle side effects may increase. Women who may become pregnant should use adequate contraception, and those who are pregnant or breastfeeding should not take this medication. In case of overdose, there is no specific antidote, so treatment should be symptomatic, along with monitoring liver and muscle function. This medication generally does not significantly impair the ability to drive or operate machinery, but care should be taken as dizziness may occur. Lastly, this medication may result in higher systemic concentrations in Asians, so caution is needed in determining the dosage.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria and angioedema, severe swelling (edema), chest tightness, shortness of breath, cold sweat, paleness, severe allergic reactions, severe rash with fever, blisters, skin peeling, oral/eye mucosal pain, severe skin reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanying cough and fever, jaundice (yellowing of the skin or eyes), and extreme lethargy; liver abnormalities

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • myalgia
  • weakness
  • diarrhea
  • rash
Show 25 more
  • myopathy
  • thrombocytopenia
  • amnesia
  • peripheral neuropathy
  • cough
  • hematuria
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • loss of appetite
  • abdominal distension
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • increased ALT
  • increased AST
  • increased CK

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture, and it is best to store it at room temperature between 1 degree and 30 degrees Celsius. Proper storage will help maintain the effectiveness of the medication for a longer time.

Appearance and packaging

Appearance

Yellow 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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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.