Medication info
Cresban Tablet 20mg (Rosuvastatin Calcium)

Cresban Tablet 20mg (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
성원애드콕제약(주)
Appearance
Pink round film-coated tablet
Packaging
30 tablets (10 tablets/PTP x 3)
Approval status
Active

MFDS item code 201403493 · Approved 2014.07.29 · Insurance code 664901040

Summary

Main use
Treatment for hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
Can be administered at any time of the day regardless of meals. The initial dose is 5 milligrams once daily, and if a greater reduction in LDL cholesterol is needed, the maintenance dose can be adjusted accordingly. The maintenance dose is typically 10 milligrams once daily, and most patients are adjusted to this dosage. The maintenance dose should be appropriately adjusted based on LDL cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more.
Child dose
The usual dosage range is 5 milligrams to 20 milligrams, administered once daily. Dosage should be adjusted individually based on the recommended treatment goals for each patient. Dosage should be adjusted at intervals of 4 weeks or more.

Ingredients

Manufacturer
성원애드콕제약(주)

Efficacy & effects

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

  • Hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerosis
  • heterozygous familial hypercholesterolemia
  • primary dysbetalipoproteinemia
  • stroke
  • myocardial infarction
View approved original text

This medicine is primarily used for patients with primary hypercholesterolemia and mixed dyslipidemia that are difficult to manage with diet and exercise. It can also be used in combination with other treatments for patients with homozygous familial hypercholesterolemia, reducing total cholesterol and LDL-cholesterol levels in hypercholesterolemic patients and delaying the progression of atherosclerosis. It is also used as an adjunct to diet in pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia. Additionally, it is beneficial for patients with primary dysbetalipoproteinemia. Finally, this medication is used in adult patients with elevated high-sensitivity C-reactive protein and additional cardiovascular risk factors to reduce the risk of stroke, myocardial infarction, and revascularization procedures.

How to take

Adult dose

Can be administered at any time of the day regardless of meals. The initial dose is 5 milligrams once daily, and if a greater reduction in LDL cholesterol is needed, the maintenance dose can be adjusted accordingly. The maintenance dose is typically 10 milligrams once daily, and most patients are adjusted to this dosage. The maintenance dose should be appropriately adjusted based on LDL cholesterol levels, treatment goals, and patient response at intervals of 4 weeks or more.

Child dose

The usual dosage range is 5 milligrams to 20 milligrams, administered once daily. Dosage should be adjusted individually based on the recommended treatment goals for each patient. Dosage should be adjusted at intervals of 4 weeks or more.

Precautions

This medication should not be used in certain patients. For instance, individuals allergic to its components, those with severely impaired liver function, those with muscle disorders, and women who are pregnant or breastfeeding should avoid taking this medication. Additionally, it should be avoided in patients with severely reduced kidney function or those taking specific medications. This medicine can affect muscles, so caution is warranted in patients experiencing muscle pain or myopathy symptoms. It is important to regularly monitor liver function and muscle status while using this medication. Individuals with a history of liver disease or heavy alcohol consumption should be especially cautious, and those with hypothyroidism should have this treated prior to starting therapy. If symptoms such as muscle pain, weakness, or fatigue occur, patients should immediately inform their physician and undergo examination, and in severe cases, drug therapy may need to be discontinued. This medication may raise blood sugar levels in some patients, so individuals at risk of diabetes should regularly check their blood glucose levels. Furthermore, this drug can interact with other medications, so it is crucial to inform healthcare providers of any other drugs being taken. Special caution is advised when taken with certain antiviral drugs, immunosuppressants, and fibrates. Women of childbearing potential must use appropriate contraception and should not take this medication during pregnancy. Breastfeeding women are also advised against using this drug. In the case of overdose, there is no specific antidote, so treatment should be based on symptoms, and monitoring of liver function and muscle enzyme levels is necessary. This medication is not known to significantly affect driving or machinery operation, but caution is advised as dizziness may occur. Lastly, this medication may show higher concentrations in some Asian individuals, indicating a potential need for dosage adjustments. To use safely, it is important to follow healthcare provider instructions and undergo regular testing.

Side effects and when to seek care immediately

Serious side effects

Hypersensitivity reactions including angioedema, hives, severe swelling (edema), chest tightness, difficulty breathing, Stevens-Johnson syndrome, eosinophilia and systemic symptoms of drug reaction (DRESS), jaundice, hepatitis, severe muscle weakness, rhabdomyolysis, immune-mediated necrotizing myopathy, acute kidney failure, oliguria, severe edema, severe allergic reactions, severe skin reactions, respiratory problems, liver abnormalities (jaundice)

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rashes and hives
  • myalgia
  • asthenia
  • thrombocytopenia
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  • diarrhea
  • hematuria
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal distension
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • fatigue
  • joint pain
  • sleep disturbances
  • depression
  • memory loss
  • cognitive dysfunction
  • confusion
  • sexual dysfunction
  • gynecomastia

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, at room temperature between 1 to 30 degrees Celsius. Storing it this way will help maintain the medication's efficacy and ensure safe use.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

30 tablets (10 tablets/PTP x 3)

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.