Medication info
Rosuvastatin Calcium Tablet 20 mg

Rosuvastatin Calcium Tablet 20 mg

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›20.8mg / 1 tablet
Manufacturer / importer
(주)킵스바이오파마
Appearance
Pink round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201403883 · Approved 2014.08.20 · Insurance code 693201020

Summary

Main use
Treatment of hypercholesterolemia and dyslipidemia (primary, familial) and risk reduction of cardiovascular diseases
Who takes it
Adults · Children
Adult dose
For adults, regardless of meals, the initial dose is 5 mg taken once daily. If a greater reduction in LDL cholesterol is needed, a maintenance dose of 10 mg once daily may be administered, and the dosage should be properly adjusted based on LDL cholesterol levels, therapeutic goals, and patient response at intervals of 4 weeks or longer. The maximum daily dose can be increased up to 20 mg.
Child dose
For pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia, the dosage is administered once daily, ranging from 5 mg to 20 mg. The dosage should be individually adjusted based on the recommended therapeutic goal.

Ingredients

Manufacturer
(주)킵스바이오파마

Efficacy & effects

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

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

This medication is used as an adjunctive therapy when dietary control and exercise alone are insufficient for patients with primary hypercholesterolemia and mixed dyslipidemia. It is also administered in conjunction with dietary modification or other therapies to help lower blood cholesterol levels in patients with homozygous familial hypercholesterolemia. It helps to regulate total cholesterol and LDL cholesterol levels in patients with hypercholesterolemia, slowing the progression of atherosclerosis. It is also used as an adjunct to diet in pediatric patients aged 10 to 17 years, particularly those with familial hypercholesterolemia. This medication is beneficial in patients with primary dysbetalipoproteinemia. It contributes to improving cardiovascular health by reducing the risks of stroke, myocardial infarction, and revascularization procedures in patients at high risk for cardiovascular diseases.

How to take

Adult dose

For adults, regardless of meals, the initial dose is 5 mg taken once daily. If a greater reduction in LDL cholesterol is needed, a maintenance dose of 10 mg once daily may be administered, and the dosage should be properly adjusted based on LDL cholesterol levels, therapeutic goals, and patient response at intervals of 4 weeks or longer. The maximum daily dose can be increased up to 20 mg.

Child dose

For pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia, the dosage is administered once daily, ranging from 5 mg to 20 mg. The dosage should be individually adjusted based on the recommended therapeutic goal.

Precautions

This medication should not be used in certain patients. For example, individuals allergic to any ingredient of this medication, patients with severe liver dysfunction, those with muscular disorders, and women who are pregnant or breastfeeding should not take this medication. Additionally, caution is required for patients with significantly impaired renal function or those taking certain medications concurrently. This medication can affect liver function, so individuals with a history of liver disease or excessive alcohol consumption should undergo liver function tests prior to use. If symptoms of muscle pain or weakness occur, the physician should be informed immediately, and in severe cases, discontinuation of the medication may be necessary. Periodic renal function tests are recommended, especially when taking high doses, as it may affect renal function. This medication may elevate blood sugar levels in some patients, so individuals at risk for diabetes should regularly monitor their blood sugar. Furthermore, this medication can interact with other drugs, so it is crucial to inform the physician or pharmacist of any other medications being taken. Women of childbearing potential should ensure appropriate contraception and should not use this medication if they are pregnant or planning to become pregnant. There is no specific antidote for overdose, so symptomatic treatment and tests for liver and muscle function may be necessary. Finally, dizziness may occur during treatment with this medication, so care should be taken when driving or operating machinery.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, high fever along with severe rash, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, and diminished urine output

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • weakness
  • hematuria
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  • diarrhea
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal distension
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • memory loss
  • peripheral neuropathy
  • thrombocytopenia
  • increased transaminases
  • hepatitis
  • jaundice (very rarely)
  • lupus-like syndrome
  • muscle rupture
  • immune-mediated necrotizing myopathy

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

Storage

This medication may be sensitive to air or moisture and should be stored in a tightly closed container. It is recommended to maintain the storage temperature between 1 degree and 30 degrees Celsius at room temperature to preserve the efficacy of the medication.

Appearance and packaging

Appearance

Pink round film-coated tablet

Package unit

30 tablets/bottle, 100 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.