Medication info
Cholestop Tablet 20mg (Rosuvastatin Calcium)

Cholestop Tablet 20mg (Rosuvastatin Calcium)

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

MFDS item code 201405077 · Approved 2014.10.31 · Insurance code 625200960

Summary

Main use
Treatment for reducing LDL cholesterol in hypercholesterolemia and familial hypercholesterolemia, and for reducing the risk of cardiovascular disease.
Who takes it
Adults · Children
Adult dose
Administered once daily at any time regardless of meals. The initial dose is 5 mg once daily. If greater LDL cholesterol reduction is needed, the maintenance dose may be adjusted, with the maintenance dose being 10 mg once daily. The maintenance dose should be adjusted based on LDL cholesterol levels, treatment goals, and patient response, at intervals of at least 4 weeks, with a maximum possible dose of 20 mg per day.
Child dose
For pediatric patients aged 10 to 17 years, the dosage is administered once daily within the range of 5 mg to 20 mg. The dosage is adjusted according to each individual patient's treatment goals, typically with intervals of at least 4 weeks between adjustments.

Ingredients

Manufacturer
(주)화이트생명과학

Efficacy & effects

Treatment for reducing LDL cholesterol in hypercholesterolemia and familial hypercholesterolemia, and for reducing the risk of cardiovascular disease.

  • Hypercholesterolemia
  • hyperlipidemia
  • familial hypercholesterolemia
  • dysbetalipoproteinemia
  • coronary heart disease
  • hypertension
  • low HDL cholesterol levels
  • smoking
  • family history of early coronary heart disease
  • stroke
  • myocardial infarction
View approved original text

This medication serves as an effective adjunctive therapy for patients with primary hypercholesterolemia and mixed dyslipidemia when diet and exercise alone are inadequate. It may also be used in conjunction with dietary therapy or other lipid-lowering therapies for patients with homozygous familial hypercholesterolemia to control blood cholesterol levels. It helps lower total cholesterol and LDL cholesterol in hypercholesterolemia patients, thereby slowing the progression of atherosclerosis. It is also used as an adjunctive therapy to reduce LDL cholesterol and apolipoprotein B levels in pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia. This medication is effective for patients with primary dysbetalipoproteinemia, assisting in the reduction of cardiovascular disease risk, strokes, myocardial infarctions, and the risk of arterial revascularization. It is used to improve various conditions related to hyperlipidemia and enhance cardiovascular health.

How to take

Adult dose

Administered once daily at any time regardless of meals. The initial dose is 5 mg once daily. If greater LDL cholesterol reduction is needed, the maintenance dose may be adjusted, with the maintenance dose being 10 mg once daily. The maintenance dose should be adjusted based on LDL cholesterol levels, treatment goals, and patient response, at intervals of at least 4 weeks, with a maximum possible dose of 20 mg per day.

Child dose

For pediatric patients aged 10 to 17 years, the dosage is administered once daily within the range of 5 mg to 20 mg. The dosage is adjusted according to each individual patient's treatment goals, typically with intervals of at least 4 weeks between adjustments.

Precautions

This medication should not be used in certain patients. For example, it should not be administered to those with an allergy to its components, severe liver dysfunction, muscle diseases, patients taking certain immunosuppressants, patients with severe renal impairment, pregnant or breastfeeding women, and fertile women who do not use adequate contraception. Moreover, high doses of this medication are prohibited in patients prone to myopathy or rhabdomyolysis, and careful evaluation is required for patients with these risk factors before administration. This medication contains lactose and should not be used in patients with lactose intolerance or certain inherited metabolic disorders. Patients with a history of liver disease or those consuming alcohol excessively should undergo regular liver function tests before starting this medication and while on it. If patients have specific diseases such as hypothyroidism or nephrotic syndrome, those conditions should be treated prior to therapy. This medication may cause myalgia, myopathy, and rarely severe muscle damage, such as rhabdomyolysis; thus, if muscle pain or weakness occurs, patients should notify their physician immediately. Discontinuation of the medication is advised especially if markers of muscle damage are significantly elevated in blood tests. The medication should be stopped in case of acute severe illness or if severe muscle weakness develops, and some patients may experience serious side effects such as severe skin reactions, thus any abnormal skin symptoms should prompt immediate medical consultation. This medication may interact with various other drugs, so patients taking other medications must inform their doctor or pharmacist, especially caution is warranted when used in conjunction with certain antiviral medications, immunosuppressants, or fibrates. Women of childbearing potential must ensure proper contraception during treatment and should discontinue the medication immediately if pregnancy occurs. It is also advisable not to use this medication while breastfeeding. In case of overdose, there is no specific antidote, so symptomatic treatment should be administered, and liver function and muscle injury should be closely monitored. This medication can cause symptoms like dizziness, hence caution is advised during driving or operating machinery. Lastly, this medication may show higher body concentrations in Asians, necessitating dosage adjustments.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, myopathy, rhabdomyolysis, severe muscle weakness, oculobulbar weakness, thrombocytopenia, jaundice, hepatitis, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), immune-mediated necrotizing myopathy, acute renal failure, oliguria, chest discomfort, dyspnea, severe allergic reactions, severe skin adverse reactions, respiratory issues, liver abnormalities, serious neurological symptoms

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • myalgia
  • weakness
  • hematuria
  • diarrhea
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  • chest pain
  • cough
  • fatigue
  • numbness
  • paresthesia
  • loss of appetite
  • abdominal bloating
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture. It should be kept away from excessively hot or cold places, preferably stored at room temperature, between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

Pink round film-coated tablets

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.

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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.