Medication info
Cretin 5 mg (Rosuvastatin Calcium)

Cretin 5 mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
대웅바이오(주)
Appearance
Yellow round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201602576 · Approved 2016.05.10 · Insurance code 694001090

Summary

Main use
Treatment for hypercholesterolemia (primary and familial) and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
Administer 5 mg once daily as an initial dose at any time of the day, regardless of meals. The maintenance dose is 10 mg once daily, with adjustments made considering LDL-cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more. It can be increased to a maximum of 20 mg once daily.
Children's dosage
For pediatric patients aged 10 to 17 years, administer 5 mg to 20 mg once daily. The dosage should be adjusted according to the individual patient's treatment goals at intervals of 4 weeks or more.

Ingredients

Manufacturer
대웅바이오(주)

Efficacy & effects

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

  • Hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerosis
  • dysbetalipoproteinemia
  • cardiovascular disease risk factors
  • stroke risk
  • myocardial infarction risk
View approved original text

This medication is used as an adjunct when dietary measures and exercise alone are inadequate for controlling cholesterol abnormalities such as primary hypercholesterolemia, familial hypercholesterolemia, and mixed hyperlipidemia. It may be particularly beneficial for pediatric patients with elevated LDL-cholesterol levels. Additionally, it contributes to lowering total cholesterol and LDL-cholesterol levels in patients with hypercholesterolemia, helping to delay the progression of atherosclerosis. It is also used as an adjunct in the treatment of primary dysbetalipoproteinemia. In men over 50 years and women over 60 years with specific cardiovascular risk factors, it helps reduce the risk of stroke, myocardial infarction, and vascular revascularization. This medication is effectively used for reducing cardiovascular disease risk.

Dosage and Administration

Adult dosage

Administer 5 mg once daily as an initial dose at any time of the day, regardless of meals. The maintenance dose is 10 mg once daily, with adjustments made considering LDL-cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more. It can be increased to a maximum of 20 mg once daily.

Children's dosage

For pediatric patients aged 10 to 17 years, administer 5 mg to 20 mg once daily. The dosage should be adjusted according to the individual patient's treatment goals at intervals of 4 weeks or more.

Precautions

This medication should not be used in certain patients. Patients allergic to any of the ingredients contained in this medication, those with persistently elevated liver enzyme levels for unknown reasons or severely impaired liver function, as well as patients with muscle diseases should not take this medication. Additionally, patients currently taking the immunosuppressant cyclosporine, patients with severely impaired kidney function, women who are pregnant or breastfeeding, and women of childbearing age who are not using adequate contraception should also refrain from taking this medication. Patients at increased risk for muscle diseases, such as those with moderately impaired kidney function, hypothyroidism, a family history of or past experience of muscle toxicity reactions, alcoholics, those taking certain medications concurrently, and Asians should consider dosage adjustments or careful monitoring. This medication contains lactose, and patients with lactose intolerance or related genetic disorders should not take it. While taking this medication, excessive alcohol intake or previous history of liver disease may require regular liver function tests, and patients with hypercholesterolemia due to hypothyroidism or nephrotic syndrome must treat the underlying causes first. Muscle-related side effects such as myalgia, myopathy, and rarely rhabdomyolysis may occur, so any symptoms of myalgia or muscle weakness should be reported to a healthcare professional immediately. If muscle enzyme levels rise more than five times the normal upper limit, or if severe muscle symptoms occur, this medication should be discontinued. This medication may cause temporary proteinuria in some patients but is generally not associated with severe kidney damage. This medication may temporarily increase liver enzyme levels, so consult a healthcare provider if symptoms indicating liver function abnormalities occur. Rarely, severe skin reactions, liver failure, neurological symptoms, respiratory problems, and other adverse effects have been reported, requiring caution. This medication may interact with other drugs, so inform the healthcare professional of any other medications being taken. Particular caution is needed when using concurrently with some antiviral medications, immunosuppressants, antifungals, antibiotics, and fibrate-class drugs due to an increased risk of muscle damage. Women who are pregnant or may become pregnant should ensure appropriate contraception while taking this medication, and if pregnancy is confirmed, they should discontinue it immediately. Women who are breastfeeding are also advised against taking this medication unless consulting with a healthcare professional. There are no specific antidotes for overdose; management should be based on symptoms and monitoring liver function and muscle enzyme levels. This medication does not appear to significantly impair driving or operating machinery, but caution is needed due to the potential for dizziness.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria and angioedema, pancreatitis, myopathy (including myositis), rhabdomyolysis, hematuria, polyneuropathy, amnesia, peripheral neuropathy, severe muscle weakness, dyspnea, ophthalmoplegia, thrombocytopenia, jaundice, hepatitis, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), lupus-like syndrome, immune-mediated necrotizing myopathy, edema, fatal

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • asthenia
  • diarrhea
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  • discomfort in the chest
  • loss of appetite
  • abdominal bloating
  • abnormal liver function tests
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • fatigue
  • numbness
  • paresthesia

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. It is important to maintain storage temperatures between 1 degree and 30 degrees Celsius to preserve the medication's efficacy and safety.

Appearance and packaging

Appearance

Yellow round film-coated tablet

Package unit

30 tablets/bottle, 100 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.