Medication info
Crelor 20 Milligrams (Rosuvastatin Calcium)

Crelor 20 Milligrams (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
(주)다산제약
Appearance
Pink round film-coated tablet
Packaging
For domestic use - 30 tablets/bottle
Approval status
Active

MFDS item code 201903848 · Approved 2019.06.13 · Insurance code 678601350

Summary

Main use
Treatment of hypercholesterolemia and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
Administer an initial dose of 5 milligrams once daily, which can be adjusted to a maximum of 20 milligrams as needed every 4 weeks. The maintenance dose is generally 10 milligrams once daily. It can be taken at any time during the day, regardless of meals.
Children's dosage
For pediatric patients aged 10 to 17 years, administer 5 milligrams to 20 milligrams once daily, adjusted individually based on the patient's treatment goals every 4 weeks. For children under 10 years of age,

Ingredients

Manufacturer
(주)다산제약

Efficacy & effects

Treatment of hypercholesterolemia and reduction of cardiovascular disease risk

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • dyslipidemia
  • 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 primarily used as an adjunct in cases of primary hypercholesterolemia and mixed hyperlipidemia that are difficult to control with diet and exercise. It is also used in patients with homozygous familial hypercholesterolemia together with dietary therapy or other lipid-lowering therapies. This helps to lower total cholesterol and LDL-cholesterol levels, delaying the progression of atherosclerosis. In pediatric patients with heterozygous familial hypercholesterolemia, it is also used as an adjunct to diet and helps reduce LDL-cholesterol levels exceeding specific criteria. It is prescribed as an adjunct to dietary therapy for patients with primary dysbetalipoproteinemia. Additionally, it helps to reduce the risk of stroke, myocardial infarction, and revascularization procedures in adult patients at high risk for cardiovascular disease. Overall, this medication is used to improve various conditions associated with hypercholesterolemia.

Dosage and Administration

Adult dosage

Administer an initial dose of 5 milligrams once daily, which can be adjusted to a maximum of 20 milligrams as needed every 4 weeks. The maintenance dose is generally 10 milligrams once daily. It can be taken at any time during the day, regardless of meals.

Children's dosage

For pediatric patients aged 10 to 17 years, administer 5 milligrams to 20 milligrams once daily, adjusted individually based on the patient's treatment goals every 4 weeks. For children under 10 years of age,

Precautions

This medication should not be administered to certain patients. First, patients who are allergic to any ingredient in this medication should not use it. Additionally, patients with persistently elevated liver enzyme levels of unknown cause or active liver disease should not take this medication. Patients with muscle disorders, those taking the immunosuppressant cyclosporine, and those with severe renal impairment should also avoid this drug. Pregnant women, nursing mothers, and women of childbearing potential not using adequate contraception should avoid this medication, and it should only be administered to women of childbearing potential when the likelihood of pregnancy is low. The risk of muscle disorders may increase with high doses, so a dose of 40 milligrams is contraindicated in patients with moderate or severe renal impairment, hypothyroidism, a family history of muscle disorders, those who have previously experienced muscle toxicity, patients with alcohol dependence, and those taking certain medications together. This drug contains lactose; therefore, patients with hereditary problems such as lactose intolerance should not take it. Care should be taken when administering this drug to patients with excessive alcohol consumption or a history of liver disease, and it is recommended to repeat liver function tests before and during administration. Patients with hypercholesterolemia caused by hypothyroidism or nephrotic syndrome should treat the underlying disease before administering this medication. This medication can cause myalgia, myopathy, and rarely severe muscle destruction (rhabdomyolysis). If symptoms arise indicating muscle issues, consult a physician immediately, and if necessary, confirm the degree of muscle damage through blood tests. If muscle-related symptoms are severe or if there is a significant elevation in serum muscle enzyme levels, administration should be stopped. Additionally, in cases of acute severe conditions or severe renal failure, administration of this medication should be discontinued, as rare occurrences of severe muscular weakness or ocular myasthenia can occur. Caution is necessary when co-administering this drug with certain medications, as the risk of muscle toxicity may increase; careful evaluation and monitoring are required during co-administration. Patients on high doses may experience transient proteinuria, so kidney function tests are recommended. Asian patients may have increased blood concentrations of this drug, so dosage adjustments may be necessary. Caution is advised in pediatric and adolescent patients as limited effects on growth and development have been reported. This medication may rarely cause side effects such as headache, dizziness, gastrointestinal symptoms, skin rashes, myalgia, weakness, hematuria, diarrhea, chest pain, cough, joint pain, fatigue, numbness, paresthesia, discomfort in the chest, loss of appetite, abdominal distension, abnormal liver function tests, syncope, generalized pain, muscle cramps, gout, erectile dysfunction, depression, sleep disturbances, sexual dysfunction, gynecomastia, cognitive decline, forgetfulness, amnesia, cognitive disruptions, and confusion. Severe side effects such as liver dysfunction, increased blood glucose, and rarely severe skin reactions have also been reported; immediate consultation with healthcare professionals is necessary if any abnormal symptoms arise. This medication should not be used in pregnant or nursing women, and women of childbearing potential must use adequate contraception. In cases of overdose, there is no specific antidote, so symptomatic treatment and monitoring of liver function and muscle enzymes are necessary. Caution is advised when driving or operating machinery due to the potential for dizziness from this medication. This drug can interact with various medications, so it is essential to inform your doctor or pharmacist if you are taking other medications. Particularly, the risk of muscle toxicity may be heightened when combined with certain antiviral agents, immunosuppressants, antibiotics, and fibrate medications. Therefore, it is crucial to consult with healthcare professionals before taking this medication and to regularly check your health status during treatment.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including hives, angioedema, severe swelling (edema), chest tightness, difficulty breathing, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, acute renal failure, oliguria, thrombocytopenia, increased serum creatinine, severe muscle weakness, immune-mediated necrotizing myopathy, rhabdomyolysis, severe skin reactions, respiratory distress, asthma attacks, severe

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • hives
  • myalgia
  • weakness
Show 26 more
  • hematuria
  • diarrhea
  • chest pain
  • cough
  • joint pain
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal distension
  • abnormal liver function tests
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • cognitive decline
  • forgetfulness
  • amnesia
  • cognitive disturbances
  • confusion

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air or moisture, preferably at a temperature between 1 degree and 30 degrees Celsius. Storing it this way helps maintain the effectiveness of the medication for a long time.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

For domestic use - 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.

Questions about this medicine

No questions yet.

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

Related searches

Search tags

Suggested searches

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.