Medication info
Cresba Tablet 10mg (Rosuvastatin Calcium)

Cresba Tablet 10mg (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
한국휴텍스제약(주)
Appearance
Pink round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201400839 · Approved 2014.02.24 · Insurance code 649102290

Summary

Main use
Treatment for hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
This medication can be taken at any time of day, regardless of meals. The initial dose is 5 milligrams once daily, and the maintenance dose is 10 milligrams once daily, as most patients are adjusted to this dose. The maintenance dose should be appropriately adjusted based on LDL-cholesterol levels, treatment goals, and patient response every 4 weeks or more, up to a maximum of 20 milligrams per day.
Child dose
The usual dosage range for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) is 5 to 20 milligrams once daily. The dosage should be adjusted according to individual treatment goals over 4 weeks or more.

Ingredients

Manufacturer
한국휴텍스제약(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
  • increased high-sensitivity C-reactive protein
  • hypertension
  • low HDL-cholesterol levels
  • smoking
  • family history of early coronary artery disease
View approved original text

This medication is mainly used as an adjunct therapy when diet and exercise alone are insufficient to control primary hypercholesterolemia and mixed dyslipidemia. It is also used as an adjunct to dietary changes or lipid-lowering therapy in patients with homozygous familial hypercholesterolemia. It lowers total cholesterol and LDL-cholesterol levels, delaying the progression of atherosclerosis, especially in pediatric patients aged 10 to 17 with heterozygous familial hypercholesterolemia. Additionally, it assists in dietary therapy for patients with primary dysbetalipoproteinemia and helps reduce the risk of cardiovascular disease in adults with elevated high-sensitivity C-reactive protein levels. This drug effectively improves dyslipidemia and the risk of cardiovascular disease.

How to take

Adult dose

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

Child dose

The usual dosage range for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) is 5 to 20 milligrams once daily. The dosage should be adjusted according to individual treatment goals over 4 weeks or more.

Precautions

This medication should not be used in certain patients. For example, patients with allergies to any ingredient of this medication, severely impaired liver function, muscle disorders, severe renal function impairment, or women who are pregnant or breastfeeding should not take this medication. Since this medication can affect liver function, it is important for patients with a history of liver disease or heavy alcohol consumption to undergo liver function tests before taking this medication. Additionally, if there are other conditions such as hypothyroidism or nephrotic syndrome, those should be treated prior to therapy. Muscle-related side effects have been reported, so any symptoms such as muscle pain, weakness, or cramps should be immediately reported to a doctor. In particular, if muscle enzyme levels significantly rise, the medication should be discontinued and medical advice should be followed. This medication can increase blood concentration when taken with certain drugs, thereby increasing the risk of muscle damage, so patients taking other medications should consult a doctor or pharmacist. Women of childbearing potential should use appropriate contraception while on this medication and should stop taking it immediately if they become pregnant. Breastfeeding women should also avoid taking this medication for safety reasons. There is no specific antidote for overdose, so care should be taken not to exceed the recommended dose, and medical attention should be sought if symptoms occur. This medication may cause dizziness, so caution is required when driving or operating machinery. Lastly, this medication may rarely cause serious skin reactions or liver damage, so if any skin rash or jaundice symptoms appear, the medication should be discontinued immediately and medical personnel consulted.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including hives and angioedema, pancreatitis, myopathy (including myositis), rhabdomyolysis, severe muscle weakness, difficulty breathing, oculomotor muscle weakness, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), immune-mediated necrotizing myopathy, jaundice, hepatitis, polyneuropathy, peripheral neuropathy, severe renal failure, acute renal failure, oliguria, thrombocytopenia, increased serum creatinine, liver failure

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • myalgia
  • weakness
  • hematuria
  • diarrhea
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  • sensory abnormalities
  • chest discomfort
  • loss of appetite
  • abdominal distension
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • fatigue
  • numbness
  • joint pain
  • memory loss
  • cough
  • thrombocytopenia
  • increased transaminases
  • abnormal liver function tests
  • increased ALT
  • increased AST
  • increased CK
  • hives

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

Storage

This medication must be stored in a tightly closed container to protect it from air and moisture. It is important to maintain the storage temperature between 1 and 30 degrees Celsius to ensure the effectiveness and safety of the medication.

Appearance and packaging

Appearance

Pink 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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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.