Medication info
Colestop Tablet 10mg (Rosuvastatin Calcium)

Colestop Tablet 10mg (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 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 201403173 · Approved 2014.07.16 · Insurance code 625200520

Summary

Main use
Treatment for hypercholesterolemia (primary, familial) and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
It can be administered at any time of the day, irrespective of meals. The initial dose is 5 mg once daily, and if more significant reductions in LDL-cholesterol are needed, the maintenance dose can be adjusted accordingly. Most patients are controlled at a maintenance dose of 10 mg once daily. The dosage should be appropriately adjusted every 4 weeks or longer based on LDL-cholesterol levels, treatment goals, and patient response.
Child dose
The usual dosage range for pediatric patients aged 10 to 17 years is 5 mg to 20 mg once daily. The dosing should be adjusted based on individual treatment goals for each patient, with adjustments made every 4 weeks or longer.

Ingredients

Manufacturer
(주)화이트생명과학

Efficacy & effects

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

  • Primary hypercholesterolemia
  • mixed hyperlipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • primary dysbetalipoproteinemia
  • increased 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 primarily used to improve blood lipid abnormalities such as hypercholesterolemia and hyperlipidemia. It is administered as an adjunct when dietary control or exercise is insufficient for patients with primary hypercholesterolemia and mixed hyperlipidemia. It is also used in conjunction with dietary measures or other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia, lowering total cholesterol and LDL-cholesterol levels to delay atherosclerosis progression. Furthermore, it assists in reducing blood lipid levels in pediatric patients with heterozygous familial hypercholesterolemia who meet certain criteria, and is also used as an adjunct in dietary therapy for patients with dysbetalipoproteinemia. Additionally, it helps reduce the risk of stroke, myocardial infarction, and vascular revascularization in men over 50 and women over 60 who have cardiovascular risk factors. This medication is used to improve blood lipid levels and reduce the risk of cardiovascular disease.

How to take

Adult dose

It can be administered at any time of the day, irrespective of meals. The initial dose is 5 mg once daily, and if more significant reductions in LDL-cholesterol are needed, the maintenance dose can be adjusted accordingly. Most patients are controlled at a maintenance dose of 10 mg once daily. The dosage should be appropriately adjusted every 4 weeks or longer based on LDL-cholesterol levels, treatment goals, and patient response.

Child dose

The usual dosage range for pediatric patients aged 10 to 17 years is 5 mg to 20 mg once daily. The dosing should be adjusted based on individual treatment goals for each patient, with adjustments made every 4 weeks or longer.

Precautions

This medication may not be suitable for certain patients. For instance, it should not be administered to patients who have had allergic reactions to this medication, those with severe liver dysfunction, patients with muscle diseases, or individuals with severe kidney impairment. Additionally, special caution is needed for pregnant or breastfeeding women, and fertile women who are not using effective contraception. This medication may increase the risk of muscle-related side effects; therefore, if symptoms like muscle pain or weakness occur, the healthcare provider should be notified immediately. It may affect liver function, so patients with a history of liver disease or excessive alcohol consumption require regular liver function tests. Attention should be paid to drug interactions while taking this medication, especially when used concurrently with certain antibiotics, antifungal agents, immunosuppressants, etc., as the risk of muscle damage may increase. Kidney function tests are recommended during high-dose administration, and Asian patients may require dose adjustments due to higher drug concentrations. If severe skin reactions or allergy symptoms occur while taking this medication, it should be discontinued immediately and the healthcare provider consulted. Women who could become pregnant should take care not to become pregnant while on this medication and should discontinue it immediately if pregnancy occurs. No specific antidote exists for overdose, thus treatment should be symptomatic and include liver and muscle function tests. Finally, this medication may cause dizziness; caution is advised while driving or operating machinery.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including hives and angioedema, pancreatitis, myopathy (including myositis), rhabdomyolysis, polyneuropathy, peripheral neuropathy, severe muscle weakness, shortness of breath, ophthalmoplegia, thrombocytopenia, jaundice, hepatitis, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), immune-mediated necrotizing myopathy, edema, fatal and non-fatal liver failure, acute renal failure

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • muscle pain
  • weakness
  • hematuria
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  • diarrhea
  • chest pain
  • cough
  • joint pain
  • fatigue
  • numbness
  • paresthesia
  • discomfort in the chest
  • loss of appetite
  • abdominal distension
  • abnormal liver function tests
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • memory impairment
  • forgetfulness
  • amnesia
  • cognitive impairment
  • 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 prevent air or moisture ingress, at room temperature between 1 degree and 30 degrees. Proper storage will help maintain the drug’s effectiveness for a longer period.

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.

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.