Medication info

Rosuvastatin Calcium 20 mg Tablet

Prescription medicationTabletExpired
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
(주)서흥
Appearance
Pink round film-coated tablets
Packaging
28 tablets/PPT [(14 tablets/PPT * 2)]
Approval status
Expired

MFDS item code 201906604 · Approved 2019.09.23

This product's status changed to Expired on 2024.09.23. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment to improve hypercholesterolemia and familial dyslipidemia (elevated cholesterol, LDL), and to reduce the risk of cardiovascular disease
Who uses it
Adults · Children
Adult dosage
For patients with primary hypercholesterolemia, mixed hyperlipidemia, and dysbetalipoproteinemia, the initial dose is 5 mg once daily, regardless of meals. If greater LDL cholesterol reduction is needed, the maintenance dose can be adjusted, with the usual maintenance dose being 10 mg once daily. Dose adjustments should occur at intervals of 4 weeks or more, based on LDL cholesterol levels, treatment goals, and patient response.
Children's dosage
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), it is administered once daily at a dose range of 5 mg to 20 mg, adjusted according to the recommended treatment goals. Dose adjustments should be made at intervals of 4 weeks.

Ingredients

Manufacturer
(주)서흥

Efficacy & effects

Treatment to improve hypercholesterolemia and familial dyslipidemia (elevated cholesterol, LDL), and to reduce the risk of cardiovascular disease

  • Primary hypercholesterolemia
  • mixed 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 is used as an adjunct when hypercholesterolemia and hyperlipidemia cannot be controlled by diet and exercise alone. Additionally, it helps to lower cholesterol levels when administered alongside other lipid-lowering therapies in patients with familial hypercholesterolemia. This can delay the progression of atherosclerosis. It is particularly effective in adolescent patients who meet certain criteria. This medication reduces the risk of cardiovascular disease and may lower the risk of stroke, myocardial infarction, and vascular reconstruction procedures. Overall, it is used to improve cardiovascular health.

Dosage and Administration

Adult dosage

For patients with primary hypercholesterolemia, mixed hyperlipidemia, and dysbetalipoproteinemia, the initial dose is 5 mg once daily, regardless of meals. If greater LDL cholesterol reduction is needed, the maintenance dose can be adjusted, with the usual maintenance dose being 10 mg once daily. Dose adjustments should occur at intervals of 4 weeks or more, based on LDL cholesterol levels, treatment goals, and patient response.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), it is administered once daily at a dose range of 5 mg to 20 mg, adjusted according to the recommended treatment goals. Dose adjustments should be made at intervals of 4 weeks.

Precautions

This medication should not be used in individuals with specific allergic reactions. Those with liver function issues or muscle diseases should also avoid this medication. Women who are pregnant or breastfeeding should not use this medication. Patients at high risk for muscle-related side effects are prohibited from taking high doses. This medication is not suitable for individuals with lactose intolerance. Those with a history of heavy alcohol consumption or liver disease should undergo liver function tests before taking this medication. If symptoms of myalgia or muscle weakness occur, healthcare providers should be informed immediately, and the medication may need to be discontinued. In acute conditions that may worsen renal function due to severe muscle issues, the medication should be stopped. The risk of muscle toxicity may increase when used with other medications, so be sure to consult a physician regarding concomitant medications. In Asians, this medication may exhibit higher systemic concentrations, which could necessitate dose adjustments. Children and adolescents taking this medication should be closely monitored for effects on growth and sexual maturation. Rarely, severe skin reactions may occur, so treatment should be stopped immediately if any unusual skin symptoms appear. Women who are pregnant or planning to become pregnant should avoid taking this medication and employ appropriate contraception. There is no specific antidote for overdose, so treatment based on symptoms and liver and muscle function tests is needed. While this medication does not significantly affect driving or machine operation, caution is advised as dizziness may occur. It is important to have regular assessments of liver function and muscle status while taking this medication.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, allergic reactions, chest tightness, difficulty breathing, dyspnea, severe muscle weakness, oculomotor weakness, jaundice, hepatitis, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), immune-mediated necrotizing myopathy, rhabdomyolysis, thrombocytopenia, severe swelling, acute renal failure, oliguria

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • myalgia
  • weakness
  • hematuria
  • diarrhea
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  • chest pain
  • cough
  • arthralgia
  • fatigue
  • numbness
  • altered sensation
  • discomfort in the chest
  • loss of appetite
  • abdominal bloating
  • abnormal liver function tests
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • memory impairment
  • forgetfulness
  • amnesia
  • memory disorders
  • 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 protect it from air and moisture. Keep the storage temperature between 1 to 30 degrees Celsius at room temperature. This will maintain the medication's effectiveness and safety over time.

Appearance and packaging

Appearance

Pink round film-coated tablets

Package unit

28 tablets/PPT [(14 tablets/PPT * 2)]

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.