Medication info
PM Rosuvastatin Tablets 20 mg (Rosuvastatin Calcium)

PM Rosuvastatin Tablets 20 mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›20.838mg / 1 tablet
Manufacturer / importer
파마사이언스코리아(주)
Appearance
Pink round film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201700505 · Approved 2017.01.26 · Insurance code 627600200

Summary

Main use
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
For the treatment of primary hypercholesterolemia, mixed dyslipidemia, and dysbetalipoproteinemia, this drug can be taken at any time during the day regardless of meals. The initial dose is 5 mg once daily, with a maintenance dose of 10 mg once daily, which is effective for most patients. The maintenance dose should be adjusted appropriately based on LDL cholesterol levels, treatment goals, and patient response, at intervals of 4 weeks or longer.
Children's dosage
For pediatric patients (aged 10 to 17 years) with heterozygous familial hypercholesterolemia, the usual dose is 5 to 20 mg once daily. The dosage should be adjusted based on individual treatment goals at intervals of 4 weeks or longer.

Ingredients

Importer
파마사이언스코리아(주)

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • increased LDL cholesterol
  • increased total cholesterol
  • increased Apo-B protein levels
  • primary dysbetalipoproteinemia
  • elevated high-sensitivity C-reactive protein
  • hypertension
View approved original text

This medication is used as an adjunct in patients with primary hypercholesterolemia and mixed dyslipidemia when dietary and exercise management are insufficient. It can also be used in conjunction with other lipid-lowering treatments in patients with homozygous familial hypercholesterolemia. It helps lower total cholesterol and LDL cholesterol levels, thereby slowing the progression of atherosclerosis. It can also be safely used in pediatric patients with familial hypercholesterolemia who meet certain criteria. This drug is also used as an adjunct to treat patients with primary dysbetalipoproteinemia and contributes to reducing the risk of stroke, myocardial infarction, and artery revascularization in middle-aged and older patients at high risk for cardiovascular diseases. Overall, this drug is an effective treatment option for managing dyslipidemia and reducing the risk of cardiovascular diseases.

Dosage and Administration

Adult dosage

For the treatment of primary hypercholesterolemia, mixed dyslipidemia, and dysbetalipoproteinemia, this drug can be taken at any time during the day regardless of meals. The initial dose is 5 mg once daily, with a maintenance dose of 10 mg once daily, which is effective for most patients. The maintenance dose should be adjusted appropriately based on LDL cholesterol levels, treatment goals, and patient response, at intervals of 4 weeks or longer.

Children's dosage

For pediatric patients (aged 10 to 17 years) with heterozygous familial hypercholesterolemia, the usual dose is 5 to 20 mg once daily. The dosage should be adjusted based on individual treatment goals at intervals of 4 weeks or longer.

Precautions

This drug should not be used in certain patients. For example, individuals allergic to any of this drug's ingredients, those with severely impaired liver function, or those with muscle disorders should not take this medication. Additionally, pregnant or breastfeeding women, and fertile women not using adequate contraception should also avoid this drug. This drug should be used with caution in individuals with weak liver function, those who consume excessive alcohol, and individuals with hypothyroidism. Symptoms such as muscle pain or weakness should be reported to a physician immediately, and blood tests may be necessary to check for muscle damage if needed. This drug may cause abnormal liver function tests, so it is important to have regular liver function tests. Furthermore, this drug can raise blood sugar levels, so individuals at risk for diabetes should monitor their blood sugar periodically. This drug may increase blood concentration when taken with certain medications, raising the risk of muscle damage. Therefore, anyone taking other medications should inform their doctor or pharmacist. Pregnant or breastfeeding women should avoid this drug as it may pose risks to the fetus or infant; women planning to become pregnant should use appropriate methods of contraception. In case of overdose, there is no specific antidote; treatment should be tailored to the symptoms, and monitoring of liver function and potential muscle damage is essential. This medication may cause dizziness, so caution is needed when driving or operating machinery. Lastly, this drug may show higher blood concentrations in Asians, which may require dosage adjustment.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (including angioedema), chest tightness, difficulty breathing, liver abnormalities (including jaundice and hepatitis, increased transaminases), severe allergic reactions, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), severe skin reactions, myopathy, rhabdomyolysis, immune-mediated necrotizing myopathy, severe muscular weakness, ophthalmoplegia, serious neurological symptoms

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash and hives
  • myalgia
  • weakness
  • thrombocytopenia
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  • diarrhea
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • abnormal liver function tests
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • fatigue
  • numbness
  • paresthesia
  • cough

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 or moisture, at room temperature between 1 to 30 degrees Celsius. Keeping it stored this way helps maintain its effectiveness and prevents degradation.

Appearance and packaging

Appearance

Pink 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.

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.