Medication info
Dongkwang Rosuvastatin Calcium Tablet 20 mg

Dongkwang Rosuvastatin Calcium Tablet 20 mg

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
동광제약(주)
Appearance
Pink round film-coated tablet
Packaging
Packaging unit change - 30 tablets/bottle, packaging unit change - 30 tablets/box [(10 tablets/PTP) × 3]
Approval status
Active

MFDS item code 201400370 · Approved 2014.01.28 · Insurance code 645905570

Summary

Main use
Treatment for hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
For primary hypercholesterolemia and related conditions, the initial dose is 5 mg once daily at any time regardless of meals, and the dose can be adjusted at intervals of 4 weeks or more up to a maximum of 20 mg per day as needed.
Child dose
For pediatric patients (ages 10 to 17 years) with heterozygous familial hypercholesterolemia, the dosage is adjusted individually between 5 mg and 20 mg once daily. No dosage recommendation exists for children under 10 years old.

Ingredients

Manufacturer
동광제약(주)

Efficacy & effects

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

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • dysbetalipoproteinemia
  • coronary heart disease
  • increased high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol levels
  • smoking
View approved original text

This medication is used as an adjunct in patients with primary hypercholesterolemia or mixed dyslipidemia when diet and exercise alone do not achieve adequate control. It is also used as an adjunct to dietary or other lipid-lowering therapy in patients with homozygous familial hypercholesterolemia. In patients with hypercholesterolemia, it lowers total cholesterol and LDL cholesterol levels, thereby delaying the progression of atherosclerosis and improving cardiovascular health. In pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia, this medication helps when cholesterol levels remain high despite dietary measures. It can also be used as an adjunct in patients with primary dysbetalipoproteinemia. Furthermore, in high-risk groups with elevated high-sensitivity C-reactive protein levels, it contributes to the reduction of risks for stroke, myocardial infarction, and revascularization procedures. This medication is effectively used for the prevention and treatment of cardiovascular diseases.

How to take

Adult dose

For primary hypercholesterolemia and related conditions, the initial dose is 5 mg once daily at any time regardless of meals, and the dose can be adjusted at intervals of 4 weeks or more up to a maximum of 20 mg per day as needed.

Child dose

For pediatric patients (ages 10 to 17 years) with heterozygous familial hypercholesterolemia, the dosage is adjusted individually between 5 mg and 20 mg once daily. No dosage recommendation exists for children under 10 years old.

Precautions

This medication should not be administered to certain patients. For example, individuals who are allergic to any components of this medication, those with severe liver problems, those with muscular disorders, and those with severely impaired kidney function may risk complications when taking this medication. Pregnant or breastfeeding women, and women of childbearing potential should consult a physician before taking this medication. Additionally, patients at high risk for myopathy or rhabdomyolysis should not take high doses. This medication contains lactose, so individuals with lactose intolerance should avoid it. This medication must be used with caution in patients with a history of liver disease or excessive alcohol consumption, and regular liver function tests are important before and during treatment. Patients with conditions like hypothyroidism or nephrotic syndrome should first treat these conditions before taking this medication. If symptoms such as muscle pain or weakness occur, patients should immediately notify their physician and blood tests may be necessary to check for muscle damage. Special caution is required for elderly patients over 70 years, those with reduced kidney function, and alcohol abusers for muscle-related side effects. After intense exercise, muscle enzyme levels may temporarily increase, so tests should be conducted at the appropriate time. This medication may rarely cause serious skin reactions or liver damage; therefore, if symptoms like rash, fever, or jaundice appear, the treatment should be stopped immediately, and the patient should visit a hospital. Furthermore, this medication may elevate blood glucose levels, so patients at high risk for diabetes should closely monitor their blood sugar. There may be interactions when taken with other medications, so if patients are currently taking other drugs, they must inform their healthcare provider. In particular, using with cyclosporine, fibrate drugs, and certain antibiotics or antifungals can increase the risk of muscle side effects. When taken with antacids, the absorption of this medication may be reduced, so it is advisable to adjust the timing of administration. Pregnant or breastfeeding women should not use this medication, and women of childbearing potential should use proper contraceptive methods. In case of overdose, there is no specific antidote, and treatment will be symptomatic, along with liver and muscle function tests. This medication is known to have little impact on the ability to drive or operate machinery; however, dizziness may occur, so caution is advised. Lastly, this medication may have a higher systemic concentration in Asians, which may necessitate dose adjustments during administration.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria and angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms, rhabdomyolysis, severe muscle weakness, ocular muscle weakness, jaundice, hepatitis, severe skin reactions, severe allergic reactions, serious liver damage, acute renal failure, thrombocytopenia, renal abnormalities (including hematuria), severe edema, dyspnea, respiratory issues

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • muscle pain
  • weakness
  • thrombocytopenia
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  • diarrhea
  • ocular muscle weakness
  • hematuria
  • edema
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • anorexia
  • abdominal bloating
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • headache
  • dizziness
  • ALT increase
  • muscle pain
  • CK increase
  • AST increase
  • joint pain
  • chest pain
  • cough
  • anorexia
  • abnormal liver function test

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

Storage

This medication should be stored in a tightly closed container to prevent exposure to air or moisture, and it is advisable to keep it at room temperature between 1°C and 30°C. Proper storage can maintain the medication's effectiveness for a longer period.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

Packaging unit change - 30 tablets/bottle, packaging unit change - 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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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.