Medication info
Colestop Tablets 5mg (Rosuvastatin Calcium)

Colestop Tablets 5mg (Rosuvastatin Calcium)

Prescription medicationTablet경구
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 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 201405074 · Approved 2014.10.31 · Insurance code 625200970

Summary

Main use
Improvement of hypercholesterolemia and dyslipidemia (primary, familial) and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
The initial dosage is 5 milligrams taken once daily, and if a greater reduction in LDL cholesterol is needed, the maintenance dosage can be adjusted accordingly. The maintenance dosage is typically 10 milligrams taken once daily and most patients are controlled at this dosage. The maintenance dosage should be appropriately adjusted based on LDL cholesterol levels, therapeutic goals, and patient response at intervals of 4 weeks or longer, and can be increased up to a maximum of 20 milligrams daily.
Child dose
The usual dosage range for pediatric patients with familial heterozygous hypercholesterolemia (ages 10 to 17) is 5 milligrams to 20 milligrams once daily. The administered dosage should be adjusted according to the recommended therapeutic targets for each individual patient.

Ingredients

Manufacturer
(주)화이트생명과학

Efficacy & effects

Improvement of hypercholesterolemia and dyslipidemia (primary, familial) and reduction of cardiovascular disease risk

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

This medication is used as an adjunct in patients with primary hypercholesterolemia and mixed dyslipidemia where dietary measures and exercise are insufficient. It is also used as an adjunct therapy for patients with homozygous familial hypercholesterolemia. In particular, it lowers total cholesterol and LDL cholesterol levels in patients with hypercholesterolemia, thereby delaying the progression of atherosclerosis. It can also be used as an adjunct to diet in pediatric patients aged 10 to 17 years with familial heterozygous hypercholesterolemia who meet specific criteria. It also helps as an adjunct to diet in patients with primary dysbetalipoproteinemia. Lastly, it is used to reduce the risk of stroke, myocardial infarction, and vascular revascularization in high-risk patients with a high risk of cardiovascular disease. This medication is effectively used for various dyslipidemias and the reduction of cardiovascular disease risk.

How to take

Adult dose

The initial dosage is 5 milligrams taken once daily, and if a greater reduction in LDL cholesterol is needed, the maintenance dosage can be adjusted accordingly. The maintenance dosage is typically 10 milligrams taken once daily and most patients are controlled at this dosage. The maintenance dosage should be appropriately adjusted based on LDL cholesterol levels, therapeutic goals, and patient response at intervals of 4 weeks or longer, and can be increased up to a maximum of 20 milligrams daily.

Child dose

The usual dosage range for pediatric patients with familial heterozygous hypercholesterolemia (ages 10 to 17) is 5 milligrams to 20 milligrams once daily. The administered dosage should be adjusted according to the recommended therapeutic targets for each individual patient.

Precautions

This medication should not be administered to certain patients. For example, patients who are allergic to this medication, have active liver disease, have muscle disorders, have severe renal impairment, or are pregnant or nursing should not take this medication. Moreover, this medication may affect liver function, so patients with a history of liver disease or those who consume alcohol should have their liver function tested before taking this medication, and regular liver enzyme tests should be performed during treatment. Muscle-related side effects may occur, so if symptoms such as muscle pain, weakness, or cramps appear, the doctor should be notified immediately. In particular, if muscle enzyme levels are elevated or muscle symptoms are severe, it may be necessary to discontinue the use of this medication. This medication may interact with other drugs, so patients currently taking any medications must inform their healthcare provider, as the blood concentration of this medication may increase when combined with certain drugs, raising the risk of side effects. Women who may become pregnant should use appropriate contraception while taking this medication, and this medication should not be used during pregnancy or if pregnancy is planned. There is no specific antidote for overdose; treatment should be symptomatic and liver function and muscle enzyme levels monitored. Dizziness and other symptoms may occur when driving or operating machinery, so caution is necessary. This medication contains lactose, so patients with lactose intolerance should not take it. Finally, during treatment with this medication, adverse reactions such as headache, dizziness, dyspepsia, skin rash, muscle pain may occur. If symptoms are severe or persistent, consult a healthcare professional.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including urticaria and angioedema, pancreatitis, myopathy, rhabdomyolysis, peripheral neuropathy, memory loss, peripheral neuropathy, severe muscle weakness, dyspnea, ophthalmoplegia, thrombocytopenia, jaundice, hepatitis, Stevens-Johnson syndrome, eosinophilia with systemic symptoms drug reaction syndrome (DRESS), immune-mediated necrotizing myopathy, edema, acute renal failure, oliguria, fatal and non-fatal liver failure.

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • muscle pain
  • weakness
  • hematuria
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  • diarrhea
  • chest discomfort
  • loss of appetite
  • abdominal distension
  • abnormal liver function tests
  • fainting
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • fatigue
  • numbness
  • paresthesia
  • joint pain

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly sealed container. It is best to maintain a storage temperature between 1 degree and 30 degrees Celsius at room temperature. This helps to safely preserve the effectiveness of the medication.

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.