Medication info
Lipostore 10 mg (Rosuvastatin Calcium)

Lipostore 10 mg (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›10.4mg / 1 tablet
Manufacturer / importer
고려제약(주)
Appearance
Pink round film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201506830 · Approved 2015.09.30 · Insurance code 642802800

Summary

Main use
Treatment of hypercholesterolemia and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
The initial dose is 5 mg once daily, and for patients needing further LDL cholesterol reduction, the maintenance dose can be adjusted accordingly. Most patients are controlled at a maintenance dose of 10 mg once daily. The maintenance dose should be appropriately adjusted based on LDL cholesterol levels, treatment goals, and patient response every 4 weeks or longer intervals, up to a maximum of 20 mg daily.
Children's dosage
The typical dosage range for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) is 5 mg to 20 mg once daily. The dosing should be adjusted according to the recommended treatment goals for each individual patient.

Ingredients

Manufacturer
고려제약(주)

Efficacy & effects

Treatment of hypercholesterolemia and reduction of cardiovascular disease risk

  • Hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerosis
  • familial hypercholesterolemia
  • dysbetalipoproteinemia
  • coronary heart disease
  • stroke
  • myocardial infarction
View approved original text

This medication is primarily used as an adjunct in patients with primary hypercholesterolemia and mixed dyslipidemia where diet and exercise alone are insufficient. It can also enhance the effectiveness when used in conjunction with diet or other lipid-lowering therapies in patients with homozygous familial hypercholesterolemia. This medication helps lower total cholesterol and LDL cholesterol levels, thereby delaying the progression of atherosclerosis. Additionally, it is indicated as an adjunct to diet in pediatric patients aged 10 to 17 who meet certain criteria for heterozygous familial hypercholesterolemia. It is effective in patients with primary dysbetalipoproteinemia and helps reduce the risk of stroke, myocardial infarction, and recurrence after arterial revascularization in high-risk patients for cardiovascular disease. Overall, this medication is used to improve blood lipid levels and reduce the risk of cardiovascular disease.

Dosage and Administration

Adult dosage

The initial dose is 5 mg once daily, and for patients needing further LDL cholesterol reduction, the maintenance dose can be adjusted accordingly. Most patients are controlled at a maintenance dose of 10 mg once daily. The maintenance dose should be appropriately adjusted based on LDL cholesterol levels, treatment goals, and patient response every 4 weeks or longer intervals, up to a maximum of 20 mg daily.

Children's dosage

The typical dosage range for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) is 5 mg to 20 mg once daily. The dosing should be adjusted according to the recommended treatment goals for each individual patient.

Precautions

This medication should not be used in certain patients. For example, individuals who are allergic to this medication, those with liver problems, or those with muscle disorders should not take this medication. Additionally, individuals with severely impaired kidney function, pregnant or breastfeeding women should not use this medication. Women of childbearing potential should only use this medication if they are highly unlikely to become pregnant and are fully aware of the risks to the fetus. Patients at high risk of muscle-related diseases should avoid high doses of this medication, and caution is necessary for patients with moderate to severe kidney impairment, hypothyroidism, family history of muscle disorders, alcoholics, Asians, or those taking certain other medications. This medication contains lactose, so individuals with lactose intolerance should not take it. Regular monitoring of liver function and muscle condition is necessary while on this medication, and individuals with a significant history of alcohol consumption or liver disease should be particularly cautious. If symptoms such as muscle pain, weakness, or cramps occur, consult a doctor immediately, and in severe cases, this medication may need to be discontinued. Moreover, the risk of muscle disorders may increase based on other medications taken concurrently, so it is essential to inform the doctor of any current medications. Pregnant or breastfeeding women should not take this medication, and women who may become pregnant should use appropriate contraceptive methods. In cases of overdose, since there is no specific antidote, treatment should be based on symptoms, and liver and muscle function tests should be performed. This medication does not significantly affect the ability to drive or operate machinery, but dizziness may occur, so caution is advised. This medication may show higher concentrations in Asians, thus dosage adjustment may be necessary.

Side effects and when to seek care immediately

Serious side effects

Urticaria, chest tightness, difficulty breathing, increased serum creatinine, severe muscle weakness, ophthalmoplegia, jaundice, severe rash, blisters, skin peeling, pain of mucous membranes in the mouth/eyes, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms, immune-mediated necrotizing myopathy, rhabdomyolysis, acute renal failure, edema, thrombocytopenia, severe allergic reactions, severe skin adverse reactions, respiratory problems

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • urticaria
  • myalgia
  • weakness
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  • hematuria
  • diarrhea
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal distension
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • arthralgia
  • memory loss
  • peripheral neuropathy
  • cough
  • thrombocytopenia
  • increased transaminases
  • abnormal liver function tests
  • depression
  • sleep disorders
  • sexual dysfunction
  • gynecomastia

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

Storage

This medication should be stored in a tightly closed container to protect from air or moisture. The recommended storage temperature is 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.

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.