Medication info
Crossta Tablet 5 mg (Rosuvastatin Calcium)

Crossta Tablet 5 mg (Rosuvastatin Calcium)

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

MFDS item code 201400415 · Approved 2014.01.29 · Insurance code 655403180

Summary

Main use
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
The initial dosage is 5 mg once daily, and if more LDL-cholesterol reduction is needed, it can be adjusted to a maintenance dose. The maintenance dose, which is 10 mg once daily, is sufficient for most patients. The maintenance dose should be adjusted appropriately after an interval of 4 weeks or more based on LDL-cholesterol levels, treatment goals, and the patient's response, with a maximum of 20 mg per day.
Child dose
The usual dosage range for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) is 5 mg to 20 mg once daily. The dosage can be adjusted according to the individual patient's treatment goals.

Ingredients

Manufacturer
일성아이에스(주)

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • increased LDL-cholesterol
  • dysbetalipoproteinemia
  • increased high-sensitivity C-reactive protein
  • hypertension
  • low HDL-cholesterol
  • smoking
View approved original text

This medication is used as an adjunct when dietary measures and exercise are insufficient for patients with primary hypercholesterolemia and mixed hyperlipidemia. It can also be used in conjunction with dietary measures or other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia. It lowers total cholesterol and LDL-cholesterol levels in patients with hypercholesterolemia, delaying the progression of atherosclerosis, and helps reduce total cholesterol, LDL-cholesterol, and Apo-B protein levels in certain pediatric patients. It can also be used as an adjunct to diet in patients with primary dysbetalipoproteinemia. Moreover, it is effective in reducing the risk of stroke, myocardial infarction, and arterial revascularization in men over 50 years and women over 60 years who have elevated high-sensitivity C-reactive protein (hsCRP) levels. In summary, this medication is used for various types of hyperlipidemia and reduction of cardiovascular disease risk.

How to take

Adult dose

The initial dosage is 5 mg once daily, and if more LDL-cholesterol reduction is needed, it can be adjusted to a maintenance dose. The maintenance dose, which is 10 mg once daily, is sufficient for most patients. The maintenance dose should be adjusted appropriately after an interval of 4 weeks or more based on LDL-cholesterol levels, treatment goals, and the patient's response, with a maximum of 20 mg per day.

Child dose

The usual dosage range for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) is 5 mg to 20 mg once daily. The dosage can be adjusted according to the individual patient's treatment goals.

Precautions

This medication should not be used in certain patients. For example, patients with an allergy to any ingredient of this medication, those with severe liver dysfunction, patients with muscle diseases, severely impaired renal function, pregnant or breastfeeding women, and women of childbearing age who do not use adequate contraception should not take this medication. Additionally, patients at risk for myopathy or rhabdomyolysis should avoid high doses. Caution is also necessary for those with a history of hypothyroidism or genetic muscle disorders. Patients with genetic issues like lactose intolerance should not take this medication. This medication can affect liver function, so patients who consume a lot of alcohol or have a history of liver disease should undergo regular liver function tests both before and during treatment. If symptoms like muscle pain or weakness occur, they should inform their doctor immediately, and the medication can be stopped if necessary. This medication may interact with other drugs, so caution is needed when taken alongside medications that may increase muscle toxicity. Some medications can increase this medication's blood levels, raising the risk of side effects, so consultation with a doctor is needed during concomitant therapy. Pregnant or breastfeeding women should not use this medication, and women with potential for pregnancy should use adequate contraception while taking this medication, as it may pose potential risks to the fetus and infant. There is no specific antidote for overdose, so treatment should be symptomatic and liver function and muscle enzyme levels should be monitored. Dizziness or muscle-related symptoms may occur during treatment, so caution is needed when driving or operating machinery. Possible side effects of this medication include headaches, dizziness, muscle pain, dyspepsia, and skin rashes, and in rare cases, severe liver damage or muscle destruction may occur. Therefore, regular check-ups and symptom observation are necessary while taking this medication under the doctor's guidance, and healthcare professionals should be consulted immediately if abnormal symptoms occur.

Side effects and when to seek care immediately

Serious side effects

Hypersensitivity reactions including urticaria, angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), liver abnormalities (jaundice), severe muscle weakness, rhabdomyolysis, dyspnea, respiratory distress and cough, multiple neuropathy, severe skin adverse reactions, acute renal failure, oliguria, chest tightness, difficulty breathing, severe allergic reactions, severe edema or urination abnormalities, severe neurological symptoms

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • muscle pain
  • weakness
  • hematuria
  • diarrhea
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  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • abnormal liver function tests
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • fatigue
  • numbness
  • dysesthesia
  • joint pain
  • memory loss
  • peripheral neuropathy
  • cough
  • thrombocytopenia
  • hepatitis
  • increased transaminases
  • lichenoid drug rash
  • lupus-like syndrome
  • muscle rupture
  • thrombocytopenia

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. It is recommended to store it at room temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow round film-coated tablet

Package unit

30 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.

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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.