Medication info
Crosstein 20 mg (Rosuvastatin Calcium)

Crosstein 20 mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
(주)셀트리온제약
Appearance
Pink round film-coated tablet
Packaging
28 tablets (14 tablets/PTP*2), 30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201707534 · Approved 2017.10.20 · Insurance code 693902690

Summary

Main use
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
The initial dose is 5 mg once daily, and if a greater reduction in LDL cholesterol is needed, it can be adjusted to the maintenance dose. The maintenance dose is usually 10 mg once daily for most patients. The maintenance dose should be appropriately adjusted based on LDL cholesterol levels, treatment goals, and patient response, with a maximum daily increase of 20 mg.
Children's dosage
The usual dosage range for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years) is 5 mg to 20 mg once daily. The recommended dosage should be adjusted based on individual patient therapeutic goals.

Ingredients

Manufacturer
(주)셀트리온제약

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

  • Hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerosis
  • dysbetalipoproteinemia
  • coronary heart disease
  • elevated high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol
  • smoking
  • family history of early coronary heart disease
View approved original text

This medication helps lower blood cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia when diet and exercise alone are insufficient. It can be used as an adjunct to diet therapy or other treatments in patients with familial hypercholesterolemia. Additionally, it has the effect of lowering total cholesterol and LDL cholesterol levels in hypercholesterolemic patients, thus delaying the progression of atherosclerosis. It is also safely used in children and adolescents meeting specific criteria for familial hypercholesterolemia and as an adjunct to diet therapy in patients with dysbetalipoproteinemia. Furthermore, it helps reduce the risks associated with stroke, myocardial infarction, and vascular revascularization in adults with a high risk of cardiovascular disease. Therefore, this medication is used for the treatment of several diseases associated with dyslipidemia and the reduction of cardiovascular disease risk.

Dosage and Administration

Adult dosage

The initial dose is 5 mg once daily, and if a greater reduction in LDL cholesterol is needed, it can be adjusted to the maintenance dose. The maintenance dose is usually 10 mg once daily for most patients. The maintenance dose should be appropriately adjusted based on LDL cholesterol levels, treatment goals, and patient response, with a maximum daily increase of 20 mg.

Children's dosage

The usual dosage range for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years) is 5 mg to 20 mg once daily. The recommended dosage should be adjusted based on individual patient therapeutic goals.

Precautions

This medication should not be used in certain patients. For instance, patients with allergies to this medication's ingredients, severe liver dysfunction, muscle disorders, as well as pregnant or breastfeeding women should not take this medication. Patients with severely impaired kidney function or those taking certain medications also need to be cautious. Notably, patients at high risk for muscle-related side effects should not take the 40 mg dose of this medication. It is important to regularly check liver function and muscle condition before and while taking this medication. If symptoms such as muscle pain or weakness occur, immediate consultation with a physician is necessary. Patients who consume large amounts of alcohol or have a history of liver disease should also exercise caution while taking this medication, and those with hypothyroidism or nephrotic syndrome should use this medication only after treating the underlying causes. This medication contains lactose and is unsuitable for patients with lactose intolerance. This medication may interact with other drugs, so it is crucial to inform your physician or pharmacist if you are taking other medications. Particularly, the risk of muscle side effects may increase when combined with certain antiviral agents, immunosuppressants, antifungals, and antibiotics. Women of childbearing potential should use appropriate contraception before taking this medication and should not take it during pregnancy. Adverse reactions during use may include headache, dizziness, muscle pain, gastrointestinal disturbances, and in rare cases, severe liver damage or muscle rupture. In cases of overdose, there is no specific antidote, and treatment should be symptomatic and include liver and muscle function tests. Patients should be aware that dizziness may occur while driving or operating machinery. This medication may have higher plasma concentrations in Asians, necessitating dose adjustments. All these considerations must be followed for safe and effective treatment, and it is important to adequately consult with healthcare professionals before and during use.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), severe allergic reactions, jaundice, liver abnormalities (jaundice), acute renal failure, thrombocytopenia, severe skin adverse reactions, severe neurological symptoms, severe edema or urination abnormalities, severe muscle weakness, rhabdomyolysis, immune-mediated necrotizing myopathy, respiratory issues.

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • muscle pain
  • weakness
  • cough
Show 26 more
  • diarrhea
  • oculomotor nerve palsy
  • thrombocytopenia
  • increased transaminases
  • hematuria
  • edema
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • memory impairment
  • forgetfulness
  • amnesia
  • memory loss
  • confusion
  • arthralgia
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • fainting
  • generalized pain
  • muscle cramps
  • pain.

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

Storage

This medication should be stored in a tightly sealed container to prevent exposure to air or moisture. It is important to maintain a storage temperature of 1 to 30 degrees Celsius in a cool, dry place. This will help preserve the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

Pink round film-coated tablet

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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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.