Medication info
PME Rosuvastatin Tablets 10 mg (Rosuvastatin Calcium)

PME Rosuvastatin Tablets 10 mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›10.419mg / 1 tablet
Manufacturer / importer
파마사이언스코리아(주)
Appearance
Pink round film-coated tablets
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201700504 · Approved 2017.01.26 · Insurance code 627600210

Summary

Main use
Treatment of hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
This medication can be taken at any time of the day, with or without food, once daily. The initial dose is 5 mg once daily, and it can be adjusted to a maintenance dose based on therapeutic response. The maintenance dose is 10 mg once daily for most patients. The maintenance dose may be adjusted appropriately every 4 weeks or longer intervals based on LDL cholesterol levels, treatment goals, and patient response, with a maximum of 20 mg daily.
Children's dosage
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years), the usual dosage range is 5 mg to 20 mg once daily. The dosage should be adjusted based on the individual patient's treatment goals, and 4

Ingredients

Importer
파마사이언스코리아(주)

Efficacy & effects

Treatment of hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk

  • Hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerosis
  • heterozygous familial hypercholesterolemia
  • primary dysbetalipoproteinemia
  • elevated 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 when dietary control and exercise alone are insufficient for patients with primary hypercholesterolemia and mixed dyslipidemia. It is also used as an adjunct to diet or other lipid-lowering therapy in patients with familial hypercholesterolemia, specifically homozygous familial hypercholesterolemia. This medication effectively reduces total cholesterol and LDL cholesterol levels, delaying the progression of atherosclerosis. In pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia, it may be used as an adjunct to diet to reduce cholesterol levels if specific criteria are met. It also assists patients with primary dysbetalipoproteinemia as a dietary adjunct. Additionally, it contributes to reducing the risk of stroke, myocardial infarction, and revascularization procedures in high-risk patients with certain cardiovascular disease risk factors. This medication effectively improves cholesterol and cardiovascular disease risk.

Dosage and Administration

Adult dosage

This medication can be taken at any time of the day, with or without food, once daily. The initial dose is 5 mg once daily, and it can be adjusted to a maintenance dose based on therapeutic response. The maintenance dose is 10 mg once daily for most patients. The maintenance dose may be adjusted appropriately every 4 weeks or longer intervals based on LDL cholesterol levels, treatment goals, and patient response, with a maximum of 20 mg daily.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years), the usual dosage range is 5 mg to 20 mg once daily. The dosage should be adjusted based on the individual patient's treatment goals, and 4

Precautions

This medication should not be administered to certain patients. For example, it should not be used in patients with a known allergy to any component of this medication, those with severely impaired liver function, or patients with muscle disorders. Additionally, pregnant or breastfeeding women, and women of childbearing age who do not use appropriate contraception should not take this medication. Patients who consume excessive alcohol or have a history of liver disease should use this medication with caution, and it is advisable to perform liver function tests before and during treatment. If symptoms of myalgia or muscle weakness occur, the patient should inform a physician immediately, and muscle enzyme levels should be assessed if necessary. This medication may interact with other drugs, so caution is needed, especially when taken with certain antivirals, immunosuppressants, antibiotics, etc. Taking this medication with certain drugs may increase its blood concentration, raising the risk of muscle damage, so consultation with a healthcare provider is essential. Pregnant or breastfeeding women should not use this medication, and women of childbearing age should ensure appropriate contraception during use. If pregnancy occurs, this medication should be discontinued immediately. In the event of overdose, there is no specific antidote; treatment should be symptomatic, and liver function and muscle enzyme tests are needed. This medication may cause dizziness, so caution is required when driving or operating machinery. It is important to consult healthcare professionals immediately if any unusual symptoms or suspected side effects occur while taking this medication.

Side effects and when to seek care immediately

Serious side effects

Hypersensitivity reactions including urticaria, angioedema, severe swelling, chest tightness, difficulty breathing, pallor, severe rash with fever, blisters, skin peeling, sores on mucous membranes in the mouth/eyes, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, severe muscle weakness, immune-mediated necrotizing myopathy, rhabdomyolysis, polyneuropathy, severe skin adverse reactions

Mild side effects

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

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, ideally at room temperature between 1 degree and 30 degrees Celsius. This storage method will help maintain the medication's effectiveness over time.

Appearance and packaging

Appearance

Pink round film-coated tablets

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.