Medication info
Crea-Zin 5mg (Rosuvastatin Calcium)

Crea-Zin 5mg (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
영진약품(주)
Appearance
Yellow round film-coated tablets
Packaging
28 tablets/Alu-Alu PTP (7 tablets/Alu-Alu PTP*4)
Approval status
Active

MFDS item code 201400410 · Approved 2014.01.29 · Insurance code 642403860

Summary

Main use
Treatment of hypercholesterolemia and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
Administer 5 milligrams once daily at any time of day, regardless of meals. If more LDL cholesterol reduction is needed, the maintenance dose may be adjusted to 10 milligrams once daily. The maintenance dose should be adjusted according to LDL cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more, with a maximum increase up to 20 milligrams per day. Adjustment may not be necessary for elderly patients and those with mild or moderate renal impairment.
Child dose
The usual dosage for pediatric patients with heterozygous familial hypercholesterolemia (ages 10-17) is 5 milligrams to 20 milligrams once daily. The dose should be adjusted individually based on recommended treatment goals, at intervals of more than 4 weeks.

Ingredients

Manufacturer
영진약품(주)

Efficacy & effects

Treatment of hypercholesterolemia and reduction of cardiovascular disease risk

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • dyslipidemia with heterozygous familial hypercholesterolemia
  • primary 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 patients with hypercholesterolemia and hyperlipidemia when diet and exercise alone are insufficient for control. It is particularly effective for primary hypercholesterolemia and mixed hyperlipidemia and is used as an adjunct to diet or alternative therapies for patients with homozygous familial hypercholesterolemia. It also helps slow the progression of atherosclerosis by lowering total cholesterol and LDL cholesterol. In children with heterozygous familial hypercholesterolemia, it is used as an adjunct to diet if certain criteria are met. It is also effective in patients with primary dysbetalipoproteinemia. Additionally, it is used to reduce the risk of stroke, myocardial infarction, and arterial revascularization procedures in men over 50 years old and women over 60 years old who have elevated high-sensitivity C-reactive protein levels and other cardiovascular risk factors. This drug effectively improves dyslipidemia and reduces the risk of cardiovascular disease.

How to take

Adult dose

Administer 5 milligrams once daily at any time of day, regardless of meals. If more LDL cholesterol reduction is needed, the maintenance dose may be adjusted to 10 milligrams once daily. The maintenance dose should be adjusted according to LDL cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more, with a maximum increase up to 20 milligrams per day. Adjustment may not be necessary for elderly patients and those with mild or moderate renal impairment.

Child dose

The usual dosage for pediatric patients with heterozygous familial hypercholesterolemia (ages 10-17) is 5 milligrams to 20 milligrams once daily. The dose should be adjusted individually based on recommended treatment goals, at intervals of more than 4 weeks.

Precautions

This drug should not be used in certain patients. For example, individuals allergic to any of the ingredients in this drug should not take it. Patients with severely impaired liver function or unexplained elevated liver enzyme levels should also avoid this medication. It is not safe for those with muscle-related diseases or muscle damage to use this drug. Moreover, patients taking the immunosuppressant cyclosporine or those with significantly impaired kidney function should avoid this medication. Women who are pregnant or breastfeeding, and fertile women not using adequate contraception should not use this drug. In particular, patients with a high risk of muscle damage should not take high doses (40mg). This drug contains lactose and should not be taken by individuals with lactose intolerance or certain genetic metabolic disorders. Care should be taken when using this drug in individuals with a history of liver disease or significant alcohol consumption, and repeated liver function tests are recommended before and during treatment. Patients with certain conditions such as hypothyroidism or nephrotic syndrome should treat those conditions before using this drug. Muscle pain or myopathy, and rarely severe muscle destruction (rhabdomyolysis), may occur, so report any muscle symptoms immediately. Particularly elderly patients, those with impaired kidney function, hypothyroidism patients, and those with a history of muscle disease need to be especially vigilant regarding muscle symptoms. During this drug’s use, muscle enzyme levels may increase after vigorous exercise or for other reasons, so caution should be exercised during examinations. In cases of severe infections, surgery, hypotension, or acute severe conditions, this medication may need to be discontinued. This drug can rarely cause severe muscle weakness or ocular muscle weakness, and treatment should be stopped if such symptoms appear. The risk of muscle-related side effects may increase when combined with other specific drugs, so consult with your doctor or pharmacist about any concomitant medications. High doses may cause transient proteinuria, so kidney function tests may be necessary. Asian patients may have relatively higher drug concentrations, so dosage adjustments may be required. Caution should be exercised when using this drug in children and adolescents, as safety and efficacy are limited. Common side effects of this drug may include headache, dizziness, constipation, nausea, abdominal pain, myalgia, rash, and others. Occasionally, serious liver damage, severe skin reactions, kidney problems, muscle damage, and other symptoms may occur, so consult medical personnel immediately if any symptoms arise. The safety of this drug during pregnancy or lactation has not been established, so it is advisable not to use it under those conditions. In case of overdose, as there is no specific antidote, treatment should be symptomatic, and liver and muscle function tests may be required. Dizziness may occur during the use of this drug, so caution should be taken when driving or operating machinery. This drug can interact with various medications, so inform your healthcare provider if you are taking other drugs. Particular caution is required when combining it with liver function or muscle-related medications. Finally, it is important to have a thorough consultation with medical personnel regarding your health status and any medications you are taking before using this drug.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria, angioedema, chest tightness, difficulty breathing, jaundice, hepatitis, severe muscle weakness, Stevens-Johnson syndrome, eosinophilia and systemic symptoms associated with drug reaction (DRESS), lupus-like syndrome, immune-mediated necrotizing myopathy, severe edema with elevated blood pressure, acute renal failure, oliguria, severe skin rash, blisters, skin peeling, pain in mucous membranes of mouth/eyes, severe allergic reactions

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • myalgia
  • weakness
  • thrombocytopenia
  • diarrhea
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  • ocular muscle weakness
  • hematuria
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • appetite loss
  • abdominal bloating
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • muscle rupture
  • amnesia
  • peripheral neuropathy
  • coughing
  • increased serum creatinine
  • elevated ALT
  • elevated AST
  • increased CK

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

Storage

This drug should be stored in a tightly sealed container to avoid exposure to air or moisture. It is important to maintain a temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow 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.

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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.