Medication info
CRESBA Tablet 5mg (Rosuvastatin Calcium)

CRESBA Tablet 5mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
한국휴텍스제약(주)
Appearance
Yellow round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201702136 · Approved 2017.04.26 · Insurance code 649103420

Summary

Main use
Treatment of hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
This medication can be administered once daily at any time of the day, regardless of meals. The initial dose is 5 milligrams once daily, and the maintenance dose can be adjusted up to 10 milligrams once daily. The LDL cholesterol levels, treatment goals, and patient responses should be monitored at intervals of 4 weeks or more to appropriately adjust the dosage, which can be increased to a maximum of 20 milligrams per day.
Children's dosage
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years), the dosage is 5 to 20 milligrams once daily. The dose should be adjusted individually based on the recommended treatment goal.

Ingredients

Manufacturer
한국휴텍스제약(주)

Efficacy & effects

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

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

This medication is used as an adjunct when dietary management and exercise are insufficient to control lipid disorders such as primary hypercholesterolemia and mixed hyperlipidemia. Additionally, it is used as an adjunct in patients with homozygous familial hypercholesterolemia along with dietary therapy or LDL apheresis. This drug lowers total cholesterol and LDL cholesterol levels in patients with hypercholesterolemia, delaying the progression of atherosclerosis, and acts as an adjunct to dietary therapy even in pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia. It is also used as an adjunct to dietary therapy in patients with primary dysbetalipoproteinemia and helps reduce the risk of stroke, myocardial infarction, and arterial revascularization in adults with a high risk of cardiovascular disease. Overall, this medication is effectively used for various types of hyperlipidemia and in the reduction of cardiovascular disease risk.

Dosage and Administration

Adult dosage

This medication can be administered once daily at any time of the day, regardless of meals. The initial dose is 5 milligrams once daily, and the maintenance dose can be adjusted up to 10 milligrams once daily. The LDL cholesterol levels, treatment goals, and patient responses should be monitored at intervals of 4 weeks or more to appropriately adjust the dosage, which can be increased to a maximum of 20 milligrams per day.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years), the dosage is 5 to 20 milligrams once daily. The dose should be adjusted individually based on the recommended treatment goal.

Precautions

This medication should not be used in certain patients. For example, it should not be administered to patients allergic to any components of this drug, patients with severely impaired liver function, those with muscle disorders, and patients with severe renal impairment. Additionally, it is safe not to use this medication in pregnant or breastfeeding women and in fertile women who are not using appropriate contraception. It should only be administered to women of childbearing potential after adequately explaining the risks of pregnancy and to the fetus. This drug must be used with caution in patients at high risk of muscle disorders, and high-dose administration is contraindicated. For instance, caution is needed in patients with moderate to severe renal impairment, hypothyroidism, a family history of muscle disorders, alcohol abuse, certain races (Asians), and those taking other specific medications. While taking this medication, regular liver function and muscle-related tests should be performed, and if symptoms such as myalgia, muscle weakness, fatigue, or fever occur, a physician should be notified immediately. The medication may be discontinued if severe muscle damage or liver damage is suspected. Moreover, this medication may interact with several other drugs, so any other medications being taken must be disclosed to the healthcare provider. In particular, the risk of muscle damage may increase when used with certain antibiotics, antifungals, immunosuppressants, antivirals, and fibrate medications. This medication should not be used during pregnancy or lactation, and women of childbearing potential should use appropriate contraception. If this medication is taken during pregnancy, it should be discontinued immediately and healthcare personnel should be consulted. In case of overdose, there are no specific antidotes, so treatment should be symptomatic, and careful monitoring of liver function and muscle enzyme levels should be undertaken. This medication is known not to significantly affect the ability to drive or operate machinery, but caution is advised due to potential dizziness. Finally, since this medication contains lactose, patients with lactose intolerance are advised not to use it.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with fever, blisters, skin peeling, pain in mouth/eye mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headaches, lightning headaches, seizures, confusion of consciousness, visual disturbances, paralysis, urination abnormalities

Mild side effects

Headache, dizziness, constipation, nausea, abdominal pain, itching, rash, myalgia, weakness, diarrhea, chest pain, cough, hematuria, fatigue, numbness, paresthesia, anorexia, abdominal bloating, syncope, generalized pain, muscle cramps, gout, erectile dysfunction, arthralgia, increased serum creatinine, elevated ALT, elevated AST, increased CK, thrombocytopenia, amnesia, peripheral neuropathy, hypersensitivity reactions including angioedema, diabetes, depression, sleep disturbances

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

Storage

This medication should be stored in a tightly closed container to avoid exposure to air or moisture and should be kept at a temperature between 1 to 30 degrees Celsius at room temperature. This storage method helps maintain the medication's efficacy and safety.

Appearance and packaging

Appearance

Yellow 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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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.