Medication info
Crosstin 5 mg (Rosuvastatin Calcium)

Crosstin 5 mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
(주)셀트리온제약
Appearance
Yellow round film-coated tablets
Packaging
28 tablets (14 tablets/PTP*2), 30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201707535 · Approved 2017.10.20 · Insurance code 693902680

Summary

Main use
Treatment for hypercholesterolemia (primary and familial) and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
Administer 5 mg once daily as initial dosage, regardless of meal timing. If a greater reduction in LDL cholesterol is needed, titrate to maintenance dosage, usually adjusted to 10 mg once daily. The maintenance dosage should be appropriately adjusted based on LDL cholesterol levels, treatment goals, and patient response, with a maximum daily dose of 20 mg.
Children's dosage
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years), administer 5 mg to 20 mg once daily. The dosing should be tailored according to individual patient treatment goals every 4 weeks or more.

Ingredients

Manufacturer
(주)셀트리온제약

Efficacy & effects

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

  • Hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerosis
  • homozygous familial hypercholesterolemia
  • primary dysbetalipoproteinemia
  • coronary heart disease
  • elevated high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol levels
  • smoking
View approved original text

This medication is used for patients with various types of hyperlipidemia and dyslipidemia. It is used as an adjunct when dietary control and exercise are insufficient in patients with primary hypercholesterolemia or familial hypercholesterolemia, and in patients with mixed hyperlipidemia. It particularly helps in the treatment of patients with homozygous familial hypercholesterolemia or dysbetalipoproteinemia and lowers total cholesterol and LDL cholesterol levels in patients with hypercholesterolemia, thereby slowing the progression of atherosclerosis. It is also safely used to control cholesterol levels in pediatric patients aged 10 to 17 years with familial hypercholesterolemia. For middle-aged and older patients at high risk for cardiovascular diseases, it contributes to the reduction of the risk of stroke, myocardial infarction, and revascularization. Thus, this drug is effectively used to improve various forms of dyslipidemia and cardiovascular risk factors.

Dosage and Administration

Adult dosage

Administer 5 mg once daily as initial dosage, regardless of meal timing. If a greater reduction in LDL cholesterol is needed, titrate to maintenance dosage, usually adjusted to 10 mg once daily. The maintenance dosage should be appropriately adjusted based on LDL cholesterol levels, treatment goals, and patient response, with a maximum daily dose of 20 mg.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years), administer 5 mg to 20 mg once daily. The dosing should be tailored according to individual patient treatment goals every 4 weeks or more.

Precautions

This medication should not be used in certain patients. For instance, those allergic to the components of this medication, individuals with severe liver impairment, patients with muscle disorders, and those taking certain medications should not take this drug. Women who are pregnant or breastfeeding, as well as fertile women who are not using appropriate contraceptive methods, should consult a physician before taking this medication and may only take it if it is understood that the risk to the fetus is low. Caution is advised for patients with liver disease or those who consume alcohol excessively, and regular liver function tests should be conducted. Additionally, if symptoms such as muscle pain or muscle weakness occur, the physician should be notified immediately. Patients with various factors that may increase the risk of muscle damage, such as renal impairment, hypothyroidism, a history of hereditary muscle diseases, alcohol abuse, and concomitant use of certain medications, should be monitored more closely. This drug contains lactose, so patients with lactose intolerance should avoid taking it. During treatment with this drug, liver function and muscle condition should be regularly checked, and any unusual symptoms should be reported to healthcare professionals immediately. This drug may interact with other medications; therefore, patients should inform their doctor or pharmacist about any other medications they are taking. Special caution is required when used with certain antiviral medications, immunosuppressants, antibiotics, and lipid-lowering agents. Pregnant or breastfeeding women should not use this medication, and women of childbearing potential should use appropriate contraception. In case of overdose, there is no specific antidote, and immediate medical attention should be sought for appropriate treatment and examination. This drug is not known to significantly affect driving or the operation of machinery; however, caution is advised due to the potential occurrence of dizziness and other symptoms. Lastly, while taking this medication, serious skin reactions, severe liver damage, and muscle-related anomalies may occur; if such symptoms are suspected, the medication should be discontinued immediately, and medical advice should be sought.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria and angioedema, Stevens-Johnson syndrome, drug rash with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, hyperbilirubinemia, acute kidney failure, oliguria, liver failure, severe muscle weakness, oculomotor nerve palsy, rhabdomyolysis, severe edema, dyspnea, chest tightness, fatal liver damage

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • weakness
  • hematuria
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  • diarrhea
  • chest pain
  • cough
  • fatigue
  • numbness
  • paresthesia
  • anorexia
  • abdominal bloating
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • palpitations
  • thrombocytopenia

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

Storage

This medication should be stored in a tightly closed container to protect it from air and moisture and should be kept at room temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Yellow round film-coated tablets

Package unit

28 tablets (14 tablets/PTP*2), 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.