Medication info
CreaZinc 10mg (Rosuvastatin Calcium)

CreaZinc 10mg (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
영진약품(주)
Appearance
Pink round film-coated tablets
Packaging
28 tablets/Alu-Alu PTP (7 tablets/Alu-Alu PTP*4)
Approval status
Active

MFDS item code 201400409 · Approved 2014.01.29 · Insurance code 642403840

Summary

Main use
Treatment of hypercholesterolemia and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
For adults with primary hypercholesterolemia, this medication can be taken at any time of day with or without food. The initial dose is 5 mg once daily, and it can be adjusted to maintain a dose of 10 mg once daily as needed. Maintenance doses should be adjusted based on LDL cholesterol levels and patient response at intervals of at least 4 weeks, up to a maximum of 20 mg once daily.
Child dose
For pediatric patients with heterozygous familial hypercholesterolemia (aged 10 to 17 years), the dosage is administered once daily in the range of 5 mg to 20 mg. The dosage is adjusted individually according to therapeutic objectives.

Ingredients

Manufacturer
영진약품(주)

Efficacy & effects

Treatment of hypercholesterolemia and reduction of cardiovascular disease risk

  • Hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • arteriosclerosis
  • 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 medication is used in cases of primary hypercholesterolemia, mixed dyslipidemia, and severe lipid disorders such as homozygous familial hypercholesterolemia that are difficult to control with diet and exercise alone. It also helps lower total cholesterol and LDL-cholesterol levels in patients with hypercholesterolemia, thereby slowing the progression of arteriosclerosis. It can be used as an adjunct to diet in pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia. It is also used as an adjunct in the treatment of patients with primary dysbetalipoproteinemia. Additionally, it can reduce the risk of stroke, myocardial infarction, and vascular re-intervention in middle-aged and elderly individuals at high risk for cardiovascular disease. Overall, this medication effectively improves dyslipidemia and the risk of cardiovascular disease.

How to take

Adult dose

For adults with primary hypercholesterolemia, this medication can be taken at any time of day with or without food. The initial dose is 5 mg once daily, and it can be adjusted to maintain a dose of 10 mg once daily as needed. Maintenance doses should be adjusted based on LDL cholesterol levels and patient response at intervals of at least 4 weeks, up to a maximum of 20 mg once daily.

Child dose

For pediatric patients with heterozygous familial hypercholesterolemia (aged 10 to 17 years), the dosage is administered once daily in the range of 5 mg to 20 mg. The dosage is adjusted individually according to therapeutic objectives.

Precautions

This medication should not be used in certain patients. For example, it should not be administered to patients who are allergic to any of its components, patients with severely impaired liver function, patients with muscle diseases, or patients with severe renal impairment, as well as women who are pregnant or breastfeeding. Furthermore, patients who consume excessive alcohol or have a history of liver disease should frequently undergo liver function tests before taking this medication. They should inform healthcare providers immediately if they experience any symptoms of muscle pain or weakness, and in severe cases, they may need to discontinue the medication. This medication may increase the risk of muscle damage when taken with certain drugs, so patients must consult with healthcare providers if they are taking other medications. Caution is especially needed when combined with fibrate drugs. Women of childbearing potential should use appropriate contraception, and this medication should not be taken during pregnancy. It is also advisable to avoid this medication while breastfeeding. In case of overdose, there is no specific antidote, and treatment should be based on symptoms, monitoring liver function and muscle enzyme levels. This medication may rarely cause side effects such as headache, dizziness, muscle pain, dyspepsia, skin rash, so if any unusual symptoms persist or worsen, patients should consult healthcare providers. Caution is required as dizziness may occur when driving or operating machinery. Lastly, this medication may have a higher plasma concentration in Asians, so dosage adjustments may be necessary.

Side effects and when to seek care immediately

Serious side effects

Hypersensitivity reactions including urticaria and angioedema, severe swelling (edema), chest tightness, difficulty breathing, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, severe liver damage, acute renal failure, oliguria, severe muscle weakness, ocular muscle weakness, immune-mediated necrotizing myopathy, rhabdomyolysis, severe skin adverse reactions, dyspnea, asthma attacks, headache, confusion

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • weakness
  • hematuria
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  • diarrhea
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • abnormal liver function tests
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • fatigue
  • numbness
  • paresthesia
  • joint pain
  • thrombocytopenia
  • memory loss
  • peripheral neuropathy
  • cough
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • cognitive impairment

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 air or moisture from entering and should be kept at room temperature between 1 and 30 degrees Celsius. Storing it this way will help maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

Pink round film-coated tablets

Package unit

28 tablets/Alu-Alu PTP (7 tablets/Alu-Alu PTP*4)

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.