Medication info
Crezin Tablet 10mg (Rosuvastatin Calcium)

Crezin Tablet 10mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium Micronized›10.4mg / 1 tablet
Manufacturer / importer
아이큐어(주)
Appearance
Pink round film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201603369 · Approved 2016.06.10 · Insurance code 674401230

Summary

Main use
Treatment for hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
This medication can be taken at any time of the day, regardless of meals. The initial dose is 5 mg once daily and can be adjusted to a maintenance dose as needed. The maintenance dose is usually 10 mg once daily, and most patients are controlled at this dose. The maintenance dose should be adjusted appropriately based on LDL cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more, with a maximum increase up to 20 mg per day.
Children's dosage
The usual dosage range for pediatric patients aged 10 to 17 years is once daily at 5 mg to 20 mg. The dosage should be adjusted individually based on the recommended treatment target and readjusted at intervals of 4 weeks or more.

Ingredients

Manufacturer
아이큐어(주)

Efficacy & effects

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

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

This medicine is used as an adjunct when diet and exercise alone do not suffice for patients with primary hypercholesterolemia and mixed dyslipidemia. It is also used as an adjunct for patients with rare homozygous familial hypercholesterolemia. This medication effectively lowers total cholesterol and LDL cholesterol levels, delaying the progression of atherosclerosis and thereby reducing the risk of cardiovascular disease. It can be safely used as an adjunct to diet in certain high-risk groups of children aged 10 to 17. It is also beneficial for patients with primary dysbetalipoproteinemia, reducing the risk of cardiovascular events such as stroke, myocardial infarction, and recurrence after vascular revascularization. Overall, this medication is used effectively for improving blood lipids and preventing cardiovascular complications.

Dosage and Administration

Adult dosage

This medication can be taken at any time of the day, regardless of meals. The initial dose is 5 mg once daily and can be adjusted to a maintenance dose as needed. The maintenance dose is usually 10 mg once daily, and most patients are controlled at this dose. The maintenance dose should be adjusted appropriately based on LDL cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more, with a maximum increase up to 20 mg per day.

Children's dosage

The usual dosage range for pediatric patients aged 10 to 17 years is once daily at 5 mg to 20 mg. The dosage should be adjusted individually based on the recommended treatment target and readjusted at intervals of 4 weeks or more.

Precautions

This medication should not be used in patients with an allergy to specific ingredients. It should not be administered to individuals with severely impaired liver function or persistently elevated liver enzyme levels of unknown cause. Patients with muscle diseases or previous muscle issues should not take this medication. It is contraindicated for patients taking cyclosporine. Patients with very poor kidney function, particularly those with a creatinine clearance of less than 30 mL/min, should not use this medication. Pregnant or breastfeeding women, as well as women of childbearing age who do not use adequate contraceptive methods, should not take this medication. Women with a potential for pregnancy can only use this medication if they are very unlikely to conceive and have been adequately informed about the risks to the fetus. High doses (40 mg) are contraindicated in patients at high risk of muscle-related diseases. Risk factors include moderate renal impairment, hypothyroidism, family history or genetic history of muscle disorders, previous myotoxicity with similar medications, alcohol dependency, increased plasma concentration scenarios, Asian patients, and co-administration with fibrate drugs. This medication contains lactose, thus should not be administered to patients with lactose intolerance or related genetic disorders. Before taking this medication, liver function tests should be repeated to assess liver status, and patients with a history of high alcohol consumption or liver disease should exercise caution. Patients with hypercholesterolemia due to hypothyroidism or nephrotic syndrome should treat the underlying disease before administering this medication. Muscle-related side effects, such as myalgia, myopathy, and, rarely, rhabdomyolysis can occur, necessitating immediate communication with healthcare providers if any muscle-related symptoms arise. If there is a significant increase in creatine kinase levels alongside muscle-related symptoms, this medication should be discontinued. Creatine kinase levels can also increase after intense exercise or for other reasons, making caution necessary during testing. In acute severe conditions or severe diseases, this medication should be discontinued, and if severe muscle weakness or ocular muscle weakness occurs, administration should cease immediately. The risk of muscle toxicity may increase with co-administration of other medications, especially with high doses of fibrate drugs. Regular kidney function tests are recommended for patients taking high doses of this medication. Asian patients may experience increased body exposure to the drug, requiring careful dose adjustment. In pediatric patients, monitoring for growth and pubertal development is necessary, and attention should be given to elevated muscle enzyme levels post-exercise. Mild and transient side effects have been reported, with common symptoms including headache, dizziness, abdominal pain, constipation, myalgia, weakness, diarrhea, chest pain, cough, fatigue, numbness, paresthesia, loss of appetite, abdominal bloating, syncope, generalized pain, muscle cramps, gout, erectile dysfunction, joint pain, hematuria, thrombocytopenia, memory loss, peripheral neuropathy, polyneuropathy, depression, sleep disorders (including insomnia and nightmares), sexual dysfunction, gynecomastia, increased ALT, and AST.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria and angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, severe swelling, chest tightness, difficulty breathing, respiratory distress, ocular muscle weakness, severe muscle weakness, immune-mediated necrotizing myopathy, rhabdomyolysis, acute renal failure, oliguria, sudden and severe headache, seizures, confusion.

Mild side effects

Headache, dizziness, constipation, nausea, abdominal pain, itching, rash, myalgia, weakness, diarrhea, chest pain, cough, fatigue, numbness, paresthesia, loss of appetite, abdominal bloating, syncope, generalized pain, muscle cramps, gout, erectile dysfunction, joint pain, hematuria, thrombocytopenia, memory loss, peripheral neuropathy, polyneuropathy, depression, sleep disorders (including insomnia and nightmares), sexual dysfunction, gynecomastia, increased ALT, increased AST

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, and it is best to keep it at room temperature between 1 to 30 degrees Celsius. This will help maintain the drug's efficacy and safety.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

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.

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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.