Medication info
Rosuvastatin Tablets 5 mg (Rosuvastatin Calcium)

Rosuvastatin Tablets 5 mg (Rosuvastatin Calcium)

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

MFDS item code 201603462 · Approved 2016.06.15 · Insurance code 650303510

Summary

Main use
Improvement of hypercholesterolemia and dyslipidemia, and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
For patients with primary hypercholesterolemia, mixed dyslipidemia, dysbetalipoproteinemia, and homozygous familial hypercholesterolemia, the initial dose of 5 mg should be administered once daily at any time regardless of meals. If necessary, maintenance doses can be adjusted up to 10 mg once daily, with adjustments made based on patient response at intervals of 4 weeks or more, allowing a maximum daily dose of up to 20 mg.
Children's dosage
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the dosing is from 5 mg to 20 mg once daily, adjusted individually according to therapy goals at intervals of 4 weeks or longer.

Ingredients

Manufacturer
진양제약(주)

Efficacy & effects

Improvement of hypercholesterolemia and dyslipidemia, and reduction of cardiovascular disease risk

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • atypical familial hypercholesterolemia
  • primary dysbetalipoproteinemia
  • cardiovascular disease risk factors
  • stroke risk
  • myocardial infarction risk
View approved original text

This medication is primarily used for patients with primary hypercholesterolemia and mixed dyslipidemia. It helps as an adjunct to diet when dietary and exercise controls are insufficient. Additionally, it is used alongside other treatments in patients with familial hypercholesterolemia to lower blood cholesterol levels. It is particularly effective in controlling total cholesterol and LDL cholesterol in patients with hypercholesterolemia, thereby delaying the progression of atherosclerosis. It is also used in pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia to help reduce cholesterol and Apo-B protein levels. Furthermore, it is used to reduce the risk of stroke and myocardial infarction in adults at high risk for cardiovascular diseases.

Dosage and Administration

Adult dosage

For patients with primary hypercholesterolemia, mixed dyslipidemia, dysbetalipoproteinemia, and homozygous familial hypercholesterolemia, the initial dose of 5 mg should be administered once daily at any time regardless of meals. If necessary, maintenance doses can be adjusted up to 10 mg once daily, with adjustments made based on patient response at intervals of 4 weeks or more, allowing a maximum daily dose of up to 20 mg.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the dosing is from 5 mg to 20 mg once daily, adjusted individually according to therapy goals at intervals of 4 weeks or longer.

Precautions

This medication should not be used in certain patients. For example, it should not be administered to patients with allergies to its components, severely impaired liver function, and those with muscle problems. It also should not be used in patients with severely impaired kidneys, pregnant or nursing women, or fertile women who are not using appropriate contraception. This medication may affect liver function or muscle, so caution is warranted in patients with a history of liver disease or heavy alcohol consumption. If symptoms such as muscle pain or weakness occur, patients should report them to a physician immediately and undergo examination. This medication may raise blood glucose levels in some patients, so it is advisable for those at high risk of diabetes to monitor their blood sugar regularly. This medication may interact with other medications; patients should inform their doctor or pharmacist of any medications being taken. Interactions particularly with some antivirals, immunosuppressants, and antifungals may increase the risk of muscle problems. Pregnant or nursing women should not take this medication, and women of childbearing potential should employ adequate contraception. In case of overdose, there is no specific antidote; treatment should be based on symptoms, and liver function and muscle enzyme levels should be monitored regularly. Dizziness may occur while taking this medication, so caution is required when driving or operating machinery. If symptoms such as severe rash, swelling, or difficulty breathing occur during treatment, the medication should be stopped immediately and medical consultation sought.

Side effects and when to seek care immediately

Serious side effects

Hypersensitivity reactions including urticaria and angioedema, severe muscle weakness, oculobulbar weakness, rhabdomyolysis, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, fatal and non-fatal liver failure, polyneuropathy, severe edema, acute renal failure, oliguria, thrombocytopenia, severe allergic reactions, severe skin adverse reactions, dyspnea, respiratory issues, hepatic abnormalities

Mild side effects

Headache, dizziness, constipation, nausea, abdominal pain, itching, rash, urticaria, muscle pain, myopathy, rhabdomyolysis, weakness, hypersensitivity reactions including angioedema, hematuria, thrombocytopenia, fatigue, numbness, paresthesia, chest discomfort, diarrhea, appetite loss, abdominal bloating, abnormal liver function tests, syncope, generalized pain, muscle cramps, gout, erectile dysfunction, joint pain, memory loss, peripheral neuropathy, cough, depression, sleep disorders, sexual dysfunction

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 between 1 degree and 30 degrees Celsius. This helps retain the medication's effectiveness and safety for a longer period.

Appearance and packaging

Appearance

Yellow round film-coated tablets

Package unit

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.