Medication info
PME Rosuvastatin Tablets 5 mg (Rosuvastatin Calcium)

PME Rosuvastatin Tablets 5 mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›5.21mg / 1 tablet
Manufacturer / importer
파마사이언스코리아(주)
Appearance
Yellow colored round film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201700506 · Approved 2017.01.26 · Insurance code 627600220

Summary

Main use
Lipid improvement in hypercholesterolemia and familial hypercholesterolemia (including cardiovascular disease risk) and treatment for reducing cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
The initial dosage is 5 mg once daily, and if greater reduction in LDL cholesterol is required, the maintenance dose can be adjusted. The maintenance dose is typically 10 mg once daily, which is sufficient for most patients. The maintenance dosage should be adjusted appropriately based on LDL cholesterol levels, treatment goals, and patient's response at intervals of 4 weeks or more, with a maximum daily dose of 20 mg.
Children's dosage
The usual dosage range is 5 mg to 20 mg once daily. The administered dose should be adjusted individually based on the recommended treatment targets for each patient. The dosage should be adjusted at intervals of 4 weeks or more.

Ingredients

Importer
파마사이언스코리아(주)

Efficacy & effects

Lipid improvement in hypercholesterolemia and familial hypercholesterolemia (including cardiovascular disease risk) and treatment for reducing cardiovascular disease risk

  • Hypercholesterolemia
  • dyslipidemia
  • atherosclerosis
  • dysbetalipoproteinemia
  • elevated high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol levels
  • smoking
  • family history of early coronary artery disease
  • stroke risk
  • myocardial infarction risk
  • risk of arterial revascularization surgery
View approved original text

This medication is used as an adjunctive treatment in cases where diet and exercise alone are insufficient to control primary hypercholesterolemia and mixed dyslipidemia. It is also prescribed to patients with homozygous familial hypercholesterolemia alongside other lipid-lowering therapies to help lower blood cholesterol levels. It particularly helps decline total cholesterol and LDL cholesterol to target levels in patients with hypercholesterolemia, thereby delaying the progression of atherosclerosis. It is also used as an adjunct for diet in pediatric patients aged 10 to 17 years who meet specific criteria for heterozygous familial hypercholesterolemia. It serves as an adjunct to diet for patients with primary dysbetalipoproteinemia and helps reduce the risk of stroke, myocardial infarction, and revascularization procedures in patients at high risk of cardiovascular disease. Therefore, this medication is used to improve hypercholesterolemia and the associated risk of cardiovascular disease.

Dosage and Administration

Adult dosage

The initial dosage is 5 mg once daily, and if greater reduction in LDL cholesterol is required, the maintenance dose can be adjusted. The maintenance dose is typically 10 mg once daily, which is sufficient for most patients. The maintenance dosage should be adjusted appropriately based on LDL cholesterol levels, treatment goals, and patient's response at intervals of 4 weeks or more, with a maximum daily dose of 20 mg.

Children's dosage

The usual dosage range is 5 mg to 20 mg once daily. The administered dose should be adjusted individually based on the recommended treatment targets for each patient. The dosage should be adjusted at intervals of 4 weeks or more.

Precautions

This medication should not be used in individuals who are allergic to any of its components. Patients with active liver disease or significantly elevated liver enzyme levels should not take this medication. Patients with muscle disorders or issues related to muscles should also refrain from using this medication. Particularly, individuals with severely impaired renal function, pregnant or breastfeeding women, and women of childbearing potential who are not using appropriate contraception should not take this medication. Dosages exceeding 40 mg are contraindicated in individuals at risk for muscle disorders. Caution should be exercised when using this medication in patients who consume large amounts of alcohol or have a history of liver disease, and regular liver function tests should be performed. Any occurrence of myalgia or muscle weakness should be reported to a healthcare provider immediately, and the medication should be discontinued if necessary. It is advisable to stop using this medication during acute severe illnesses. This medication may rarely cause severe myopathy or ocular myopathy, so it should be discontinued if such symptoms occur. In cases of concomitant use with certain medications, there may be an increased risk of muscle disorders, so exercise caution. It is recommended to perform regular kidney function tests when using 40 mg dosage. In Asian patients, drug concentrations may be higher, requiring dosage adjustment. Children and adolescents can use it, but their growth status should be monitored periodically. While taking this medication, side effects such as liver function abnormalities, increased blood sugar, myalgia, headache, dizziness, and other abnormal symptoms may occur, hence medical consultation should be sought if any adverse effects manifest. In case of severe skin rash or allergic reactions, the medication should be discontinued immediately and appropriate treatment sought. This medication may interact with other medications, so it's essential to inform your healthcare provider of any concurrent medication use. Pregnant or breastfeeding women should not use this medication and women planning to conceive should employ appropriate contraceptive methods. There is no specific antidote for overdose, so immediate medical attention is required.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness (severe allergic reaction), severe rash accompanied by high fever, blisters, skin peeling, pain in oral/ocular mucosa (severe skin adverse reaction), shortness of breath or difficulty breathing, asthma attacks, respiratory difficulties accompanied by cough and fever (respiratory problems), yellowing of the skin or eyes (jaundice), significant lethargy (liver dysfunction), sudden and

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash and urticaria
  • myalgia
  • weakness
  • hematuria
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  • diarrhea
  • chest pain
  • cough
  • fatigue
  • numbness
  • paresthesia
  • discomfort in the chest
  • loss of appetite
  • abdominal bloating
  • abnormal liver function test results
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • thrombocytopenia
  • memory loss
  • peripheral neuropathy
  • depression
  • sleep disorders
  • sexual dysfunction
  • gynecomastia
  • post-marketing

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

Storage

This medication should be stored in a tightly sealed container as it may be sensitive to air or moisture. It is advisable to maintain storage temperatures between 1 degree and 30 degrees Celsius at room temperature. Storing it this way helps maintain the medication's efficacy safely over time.

Appearance and packaging

Appearance

Yellow colored round film-coated tablet

Package unit

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.

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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.