Medication info
Dongkwang Rosuvastatin Calcium Tablets 10mg

Dongkwang Rosuvastatin Calcium Tablets 10mg

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
동광제약(주)
Appearance
Pink round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle, 300 tablets/bottle, 30 tablets/box [(10 tablets/PTP) × 3]
Approval status
Active

MFDS item code 201400371 · Approved 2014.01.28 · Insurance code 645905560

Summary

Main use
Treatment for hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
The initial dose is 5 milligrams once daily; if a greater reduction in LDL-cholesterol is needed, the maintenance dose can be adjusted. The maintenance dose is typically 10 milligrams once daily for most patients. The maintenance dose should be adjusted appropriately based on LDL-cholesterol levels, treatment goals, and patient response, with a maximum daily dose of 20 milligrams.
Child dose
The usual dosage range for children with heterozygous familial hypercholesterolemia (aged 10 to 17 years) is 5 milligrams to 20 milligrams once daily. The dosing should be adjusted based on the recommended treatment target for each individual patient.

Ingredients

Manufacturer
동광제약(주)

Efficacy & effects

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

  • Hypercholesterolemia
  • familial hypercholesterolemia
  • mixed hyperlipidemia
  • atherosclerosis
  • dysbetalipoproteinemia
  • elevated high-sensitivity C-reactive protein
  • hypertension
  • low HDL-cholesterol levels
  • smoking
  • family history of early coronary heart disease
  • stroke risk
  • myocardial infarction risk
View approved original text

This medication is used as an adjunct when dietary and exercise interventions alone are inadequate for patients with various forms of hypercholesterolemia and hyperlipidemia. It is particularly effective for patients with primary hypercholesterolemia, heterozygous familial hypercholesterolemia, and mixed hyperlipidemia. Additionally, it helps lower cholesterol levels in patients with homozygous familial hypercholesterolemia when used alongside dietary and other lipid-lowering therapies. This medication plays a role in delaying the progression of atherosclerosis by lowering total cholesterol and LDL-cholesterol levels to target levels. It is also applicable to pediatric patients aged 10 to 17 years with familial hypercholesterolemia, aiding in cholesterol control based on risk factors. Moreover, it helps reduce the risk of stroke, myocardial infarction, and arterial revascularization in adult patients at high cardiovascular disease risk. Thus, this medication is used to improve various conditions associated with hypercholesterolemia.

How to take

Adult dose

The initial dose is 5 milligrams once daily; if a greater reduction in LDL-cholesterol is needed, the maintenance dose can be adjusted. The maintenance dose is typically 10 milligrams once daily for most patients. The maintenance dose should be adjusted appropriately based on LDL-cholesterol levels, treatment goals, and patient response, with a maximum daily dose of 20 milligrams.

Child dose

The usual dosage range for children with heterozygous familial hypercholesterolemia (aged 10 to 17 years) is 5 milligrams to 20 milligrams once daily. The dosing should be adjusted based on the recommended treatment target for each individual patient.

Precautions

This medication should not be used in certain patients. For example, patients with allergies to the components of this medication, those with severe liver dysfunction, patients with muscle disorders, and women who are pregnant or nursing should not take this medication. Additionally, patients with significantly impaired kidney function should also avoid this medication for safety. This medication may affect liver function; therefore, patients with liver disease or those who consume alcohol heavily should undergo liver function tests before taking it and should regularly monitor liver status during treatment. If symptoms such as muscle pain or muscle weakness occur, the healthcare provider should be notified immediately, and if severe muscle damage is suspected, the medication should be discontinued. Since this medication contains lactose, caution is advised for patients with lactose intolerance. Furthermore, as there may be drug interactions, patients taking other medications should consult with a doctor or pharmacist. Women of childbearing potential should practice appropriate contraception while taking this medication and discontinue it immediately if they become pregnant. It is important to regularly check liver function and muscle status during the course of this medication and to promptly inform healthcare providers of any adverse symptoms.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria and angioedema, severe muscle weakness, ocular myasthenia, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms, jaundice, hepatitis, severe skin adverse reactions, rhabdomyolysis, acute renal failure, oliguria, thrombocytopenia, increased serum creatinine, severe edema, dyspnea, interstitial lung disease, severe allergic reactions, severe skin adverse reactions, respiratory problems

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • muscle pain
  • weakness
  • hematuria
  • diarrhea
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  • chest pain
  • cough
  • fatigue
  • numbness
  • paresthesia
  • loss of appetite
  • abdominal distension
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • 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 sealed container to avoid exposure to air or moisture. The appropriate storage temperature is between 1 degree and 30 degrees Celsius at room temperature, and it is advisable to avoid excessively hot or cold places.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle, 300 tablets/bottle, 30 tablets/box [(10 tablets/PTP) × 3]

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.