Medication info

Rosuvastatin Calcium 20 mg Tablet

Prescription medicationTabletExpired
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
대우제약(주)
Appearance
Pink round film-coated tablet
Packaging
30 tablets (15 tablets/PTP x 2 packs)
Approval status
Expired

MFDS item code 201905854 · Approved 2019.08.19

This product's status changed to Expired on 2024.08.19. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment of hyperlipidemia and familial hypercholesterolemia (including the risk of cardiovascular disease) and effect on reducing cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
The medication can be administered at any time of the day regardless of meals. The initial dose is 5 mg once daily. The maintenance dose is 10 mg once daily and can be adjusted based on LDL cholesterol levels and patient response at intervals of 4 weeks or more. The maximum daily dose can be increased to 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 dosage should be adjusted based on the individual treatment goals of each patient and maintained at intervals of at least 4 weeks.

Ingredients

Manufacturer
대우제약(주)

Efficacy & effects

Treatment of hyperlipidemia and familial hypercholesterolemia (including the risk of cardiovascular disease) and effect on reducing cardiovascular disease risk

  • Primary hypercholesterolemia
  • combined hyperlipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • primary 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 helps to manage various types of dyslipidemia associated with hypercholesterolemia. It is used as an adjunct to diet and exercise when management is difficult alone in patients with primary hypercholesterolemia and combined hyperlipidemia. It is also prescribed as an adjunct to diet in patients with homozygous familial hypercholesterolemia and dysbetalipoproteinemia. Additionally, it effectively lowers total cholesterol and LDL cholesterol levels in patients with hypercholesterolemia, slowing the progression of atherosclerosis. It may be used in children with heterozygous familial hypercholesterolemia who meet certain criteria, and it helps reduce the risk of stroke, myocardial infarction, and vascular revascularization in high-risk patients with elevated high-sensitivity C-reactive protein levels, aiding in cardiovascular disease prevention. This medication is particularly effective in improving cardiovascular health.

Dosage and Administration

Adult dosage

The medication can be administered at any time of the day regardless of meals. The initial dose is 5 mg once daily. The maintenance dose is 10 mg once daily and can be adjusted based on LDL cholesterol levels and patient response at intervals of 4 weeks or more. The maximum daily dose can be increased to 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 dosage should be adjusted based on the individual treatment goals of each patient and maintained at intervals of at least 4 weeks.

Precautions

This medication should not be used in certain patients. Individuals allergic to any of the components included in this medication should not take it. Patients with active and severe liver dysfunction or markedly elevated liver enzyme levels may be at risk if they take this medication. Patients with muscle diseases or problems with their muscles should also avoid this medication. Patients who are taking specific immunosuppressants such as cyclosporine and those with severely impaired kidney function should avoid this medication as well. Women who are pregnant or breastfeeding should not take this medication, and women of childbearing potential should use appropriate contraception to reduce the chance of pregnancy. Particularly, high doses should be avoided in patients with conditions that make them prone to myopathy or rhabdomyolysis. Additionally, this medication contains lactose and may not be suitable for people with lactose intolerance or related genetic disorders. This medication should be used cautiously in individuals with impaired liver function or those who consume large amounts of alcohol. Regular liver function tests are recommended before and during administration of this medication. In cases of certain conditions like hypothyroidism or nephrotic syndrome, these conditions should be treated first before using this medication. If symptoms such as muscle pain or muscle weakness appear, it should be reported to a doctor immediately for testing. If muscle enzyme levels are markedly elevated or symptoms are severe, discontinuation of the medication should be considered. Testing should be avoided in situations where muscle enzyme levels may temporarily rise, such as immediately after exercising. Patients with severe acute illnesses or significant muscle weakness should also discontinue this medication. When taken with other medications, there may be an increased risk of muscle-related side effects, so caution is required. During treatment with this medication, side effects such as headache, dizziness, constipation, nausea, abdominal pain, myalgia, skin rash, itching, and fatigue may occur. Most of these are mild and transient, but in rare cases, severe muscle damage or liver dysfunction may occur. Particularly with high doses, kidney function tests may be necessary. Rare side effects such as memory impairment or muscle weakness have also been reported in some patients. This medication may rarely cause pulmonary disease with long-term use, so if there is difficulty in breathing or persistent coughing, a doctor should be consulted. If significant liver damage or jaundice appears, the medication should be discontinued immediately. Blood glucose levels may increase, so patients at risk for diabetes should carefully manage their blood sugar levels. Due to genetic factors, responses to the medication may vary, necessitating individual dosage adjustments. If severe skin reactions occur, the medication should be stopped immediately and medical personnel should be notified. When taken with other medications, the serum concentration of this medication may change, so attention should be paid to drug interactions. In particular, co-administration with certain antiviral drugs, immunosuppressants, antifungals, antibiotics, and fibrate medications may increase the risk of muscle side effects. Antacids may reduce the absorption of this medication, but adjusting the timing of administration can mitigate the effects. Additionally, if this medication is used with warfarin, periodic blood coagulation tests are needed as it may affect the test results. Women who are pregnant or breastfeeding should not take this medication, and those planning to become pregnant should ensure appropriate contraception. If this medication is taken during pregnancy, it should be discontinued immediately and a doctor should be consulted. There is no specific antidote for overdose, so treatment should be symptomatic while carefully monitoring liver function and muscle enzyme levels. This medication is not known to significantly affect driving or machinery operation, but caution should be exercised due to potential symptoms like dizziness. Overall, this medication may affect the liver and muscles, so regular testing and symptom monitoring are important, and decisions regarding dosage adjustments and use should be made based on the patient's condition.

Side effects and when to seek care immediately

Serious side effects

Hypersensitivity reactions including urticaria, angioedema, pancreatitis, myopathy (including myositis), rhabdomyolysis, severe muscle weakness, ocular muscle weakness, Stevens-Johnson syndrome, eosinophilia with systemic symptoms and drug reaction with eosinophilia and systemic symptoms (DRESS), immune-mediated necrotizing myopathy, polyneuropathy, jaundice, hepatitis, increased transaminases, acute renal failure, oliguria, thrombocytopenia, increased serum creatinine, severe edema,

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • weakness
  • hematuria
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  • diarrhea
  • chest discomfort
  • loss of appetite
  • abdominal distension
  • abnormal liver function tests
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • fatigue
  • numbness
  • paresthesia
  • chest pain
  • thrombocytopenia
  • memory loss
  • peripheral neuropathy
  • cough
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • memory decline
  • forgetfulness
  • memory impairment
  • confusion

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

Storage

This medication should be stored in a tightly sealed container to avoid exposure to air or moisture and should be kept at room temperature between 1 and 30 degrees Celsius. Storing it this way will help maintain the medication's effectiveness and prevent degradation.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

30 tablets (15 tablets/PTP x 2 packs)

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.