Medication info
Lestab 10 mg (Rosuvastatin Calcium)

Lestab 10 mg (Rosuvastatin Calcium)

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

MFDS item code 201001001 · Approved 2010.01.28 · Insurance code 640902230

Summary

Main use
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk
Who takes it
Adults · Children
Adult dose
For primary hypercholesterolemia and related conditions, initiate treatment with 5 mg once daily at any time regardless of meals, and if necessary, increase the dose to 10 mg once daily. Dosage adjustments should be made based on LDL cholesterol levels and patient response at intervals of at least 4 weeks, with a maximum dose of 20 mg once daily.
Child dose
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years), the recommended dose is between 5 mg and 20 mg once daily, with dosage adjusted individually based on treatment goals at intervals of at least 4 weeks.

Ingredients

Manufacturer
(주)일화

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

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

This medication is primarily used when dietary therapy and exercise are insufficient to control primary hypercholesterolemia and mixed dyslipidemia patients. It is also utilized as an adjunct treatment for patients with homozygous familial hypercholesterolemia, helping to lower total cholesterol and LDL cholesterol levels, thereby slowing the progression of atherosclerosis. Additionally, it can be used as an adjunct therapy for pediatric and adolescent patients with familial hypercholesterolemia who have high LDL cholesterol levels and cannot be effectively controlled with diet alone. It is also used to treat primary dysbetalipoproteinemia and contributes to reducing the risk of stroke, myocardial infarction, and vascular revascularization procedures in middle-aged and older individuals with a high risk of cardiovascular disease. Overall, this medication is effectively used to control cholesterol levels and reduce the risk of cardiovascular disease.

How to take

Adult dose

For primary hypercholesterolemia and related conditions, initiate treatment with 5 mg once daily at any time regardless of meals, and if necessary, increase the dose to 10 mg once daily. Dosage adjustments should be made based on LDL cholesterol levels and patient response at intervals of at least 4 weeks, with a maximum dose of 20 mg once daily.

Child dose

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years), the recommended dose is between 5 mg and 20 mg once daily, with dosage adjusted individually based on treatment goals at intervals of at least 4 weeks.

Precautions

This medication should not be administered to certain patients. First, individuals allergic to the ingredients of this medication or with unexplained liver dysfunction should not use it. Patients with myopathy or taking certain immunosuppressants, and those with severe renal impairment should also avoid this medication. Women who are pregnant or breastfeeding, as well as women of childbearing potential, must use appropriate contraception methods and carefully weigh the risks and benefits. This medication requires special caution for individuals prone to muscle disease. Patients with mild to moderate renal impairment, hypothyroidism, family history of muscle issues, those who consume alcohol excessively, and Asian patients may require dosage adjustment. Patients with specific genetic metabolic disorders, such as lactose intolerance, should not take this medication. Patients with a history of liver disease or those who consume excessive alcohol should undergo liver function tests before starting this medication and regularly monitor liver function during treatment. Symptoms such as muscle pain, weakness, or spasms should be reported to healthcare professionals immediately, and muscle enzyme tests should be conducted if necessary. This medication can rarely cause serious skin reactions or liver damage, so if symptoms like rash, itching, or jaundice appear, use should be discontinued immediately, and consultation with a doctor is required. There may be interactions with other medications, so it is crucial to inform healthcare professionals about any current medications being taken, especially with certain antivirals, immunosuppressants, and fibrate drugs, as the risk of muscle disease may increase. It is advised not to take this medication if pregnant or breastfeeding, and women planning to become pregnant should consult with healthcare professionals and use appropriate contraception. In case of overdose, there is no specific antidote, and treatment should be carried out based on symptoms while monitoring liver function and muscle enzyme levels. Caution is required while driving or operating machinery as this medication may cause dizziness. This medication may show higher plasma concentrations in Asian individuals, so this should be considered in dosing decisions, and pediatric or adolescent patients should be carefully monitored for growth and development.

Side effects and when to seek care immediately

Serious side effects

  • Allergic reactions including hives and angioedema, severe allergic reactions
  • Pancreatitis
  • Myopathy, rhabdomyolysis, immune-mediated necrotizing myopathy
  • Severe muscle weakness, ophthalmoplegia
  • Jaundice, hepatitis, liver abnormalities (jaundice)
  • Stevens-Johnson syndrome, eosinophilia with systemic symptoms drug reaction syndrome (DRESS), severe skin reactions
  • Acute renal failure, oliguria, elevated serum creatinine
  • Difficulty breathing, respiratory distress

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • weakness
  • diarrhea
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  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • abnormal liver function test results
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • joint pain
  • fatigue
  • numbness
  • sensory abnormalities
  • thrombocytopenia
  • memory loss
  • peripheral neuropathy
  • cough

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 it from air and moisture, at room temperature between 1 and 30 degrees Celsius. Storing it this way will help maintain the effectiveness and prevent degradation 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.

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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.