Medication info
Lobakay Tablet 20 mg (Rosuvastatin Calcium)

Lobakay Tablet 20 mg (Rosuvastatin Calcium)

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

MFDS item code 201908152 · Approved 2019.11.28 · Insurance code 059000060

Summary

Main use
Treatment for hypercholesterolemia and reduction of cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
Administer 5 mg once daily as the starting dose at any time of the day, regardless of meals. The maintenance dose is 10 mg once daily, and it can be adjusted to a maximum of 20 mg once daily based on patient response at an interval of 4 weeks or more.
Children's dosage
For pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia, administer 5 mg to 20 mg once daily and adjust the dosage according to individual treatment goals with at least a 4-week interval.

Ingredients

Manufacturer
주식회사케이에스제약

Efficacy & effects

Treatment for hypercholesterolemia and reduction of cardiovascular disease risk

  • Hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerosis
  • 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 used as an adjunct therapy for patients with hypercholesterolemia and dyslipidemia when dietary control and exercise are insufficient, especially effective for familial hypercholesterolemia and mixed dyslipidemia. It also helps reduce total cholesterol and LDL cholesterol levels in high-risk patients with cardiovascular disease risk factors, aiding in the slowing of atherosclerosis progression. It is applicable to pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia, used alongside dietary therapy to control cholesterol levels. Additionally, it is used as an adjunct to dietary therapy for patients with primary dysbetalipoproteinemia and is effective in reducing cardiovascular disease risk. Particularly in middle-aged individuals with high-sensitivity C-reactive protein levels, this medication contributes to lowering the risk of stroke, myocardial infarction, and arterial revascularization procedures. This medication improves cardiovascular health and effectively treats dyslipidemia.

Dosage and Administration

Adult dosage

Administer 5 mg once daily as the starting dose at any time of the day, regardless of meals. The maintenance dose is 10 mg once daily, and it can be adjusted to a maximum of 20 mg once daily based on patient response at an interval of 4 weeks or more.

Children's dosage

For pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia, administer 5 mg to 20 mg once daily and adjust the dosage according to individual treatment goals with at least a 4-week interval.

Precautions

This medication should not be administered to certain patients. For example, it should not be given to patients who are allergic to any component of this medication, those with severely impaired liver function, patients with muscle disorders, and those with severe renal impairment. Additionally, pregnant or breastfeeding women and women of childbearing age who do not use appropriate contraception should not use this medication. This medication can affect muscles, so caution is necessary for patients at high risk of muscle pain or myopathy. Especially at high doses, the risk of muscle damage increases, making dose adjustment important. Patients with liver dysfunction or those who consume excessive alcohol should have liver function tests before taking this medication and periodically monitor liver function during treatment. During treatment with this medication, if muscle pain, muscle weakness, or unexplainable fatigue or fever appear, inform medical personnel immediately. If these symptoms are severe or if blood tests indicate significantly elevated muscle damage markers, discontinuation of the medication may be warranted. This medication can interact with certain drugs when taken together, so if other medications are being taken, healthcare providers must be informed. Particularly, caution is needed when used in combination with drugs that increase the risk of muscle toxicity. Pregnant or breastfeeding women should not use this medication, and women of childbearing age should use appropriate contraception methods. In cases of overdose, there is no specific antidote available, so treatment should be symptomatic and liver function and muscle damage markers should be tested. This medication does not significantly impact driving or machinery operation abilities but caution is needed due to potential dizziness. Finally, during treatment with this medication, liver function and muscle health should be regularly monitored, and if abnormal symptoms appear, healthcare providers should be consulted immediately.

Side effects and when to seek care immediately

Serious side effects

Allergic reactions including hives and angioedema, chest tightness, difficulty breathing, severe swelling (edema), Stevens-Johnson syndrome, eosinophilia and systemic symptom drug reaction syndrome (DRESS), jaundice, hepatitis, increased transaminases, acute renal failure, oliguria, increased serum creatinine, severe myopathy (including myositis), rhabdomyolysis, immune-mediated necrotizing myopathy, severe muscle weakness, ophthalmoplegia

Mild side effects

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

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. Additionally, it is recommended to store the medication at room temperature between 1°C and 30°C. This helps maintain the drug's effectiveness over time.

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.

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.