Medication info
Lobakay 5 mg Tablet (Rosuvastatin Calcium)

Lobakay 5 mg Tablet (Rosuvastatin Calcium)

Prescription medicationTablet
Ingredient · strength
Rosuvastatin Calcium›5.2mg / 1 tablet
Manufacturer / importer
주식회사케이에스제약
Appearance
Yellow round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201908151 · Approved 2019.11.28 · Insurance code 059000160

Summary

Main use
Treatment to reduce high cholesterol and cardiovascular disease risk
Who uses it
Adults · Children
Adult dosage
Administer 5 mg once daily as the initial dose at any time of day, regardless of meals. For maintenance dosing, administer 10 mg once daily if needed, with adjustments made based on the patient's LDL cholesterol levels and treatment goals at intervals of 4 weeks or more. The maximum daily dose can be increased up to 20 mg.
Children's dosage
For pediatric patients aged 10 to 17 years, the dosage is 5 mg to 20 mg once daily. The dosage should be adjusted individually based on the treatment goals, with adjustments made at intervals of 4 weeks or more. For pediatric patients under 10 years of age,

Ingredients

Manufacturer
주식회사케이에스제약

Efficacy & effects

Treatment to reduce high cholesterol and cardiovascular disease risk

  • Hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • atherosclerosis
  • familial hypercholesterolemia
  • dysbetalipoproteinemia
  • elevated high-sensitivity C-reactive protein
  • hypertension
  • low HDL cholesterol levels
  • smoking
  • family history of early coronary heart disease
View approved original text

This medication is primarily used as an adjunct therapy in patients with primary hypercholesterolemia and mixed dyslipidemia when diet and exercise alone are insufficient. It is also used in patients with homozygous familial hypercholesterolemia in combination with other lipid-lowering therapies to enhance effectiveness. By lowering total cholesterol and LDL cholesterol, it slows the progression of atherosclerosis, and is applicable in pediatric patients aged 10 to 17 who meet specific criteria to manage cholesterol levels. It is also used as an adjunct to diet in patients with primary dysbetalipoproteinemia, and in elderly patients at high risk of cardiovascular diseases, it helps to reduce the risk of stroke, myocardial infarction, and vascular reintervention. Overall, this medicine improves various diseases related to hypercholesterolemia and the risk of cardiovascular diseases.

Dosage and Administration

Adult dosage

Administer 5 mg once daily as the initial dose at any time of day, regardless of meals. For maintenance dosing, administer 10 mg once daily if needed, with adjustments made based on the patient's LDL cholesterol levels and treatment goals at intervals of 4 weeks or more. The maximum daily dose can be increased up to 20 mg.

Children's dosage

For pediatric patients aged 10 to 17 years, the dosage is 5 mg to 20 mg once daily. The dosage should be adjusted individually based on the treatment goals, with adjustments made at intervals of 4 weeks or more. For pediatric patients under 10 years of age,

Precautions

This medication should not be used in certain patients. For example, those allergic to any ingredient of this medication, those with severely impaired liver function, those with muscle disorders, patients with severe renal impairment, pregnant or breastfeeding women, and those with certain genetic disorders should not take this medicine. Moreover, caution should be exercised in cases of patients with a history of liver disease or heavy alcohol consumption, those with hypothyroidism, elderly patients, or those taking specific concurrent medications, and regular monitoring of liver function tests and muscle status is essential during treatment. This medication can cause serious muscle-related adverse effects such as myalgia, muscle weakness, and rhabdomyolysis, so if any muscle pain or fatigue occurs along with fever, immediate notification to a healthcare professional is necessary. Additionally, if liver function abnormalities or allergic reactions, severe skin rashes occur, medication should be discontinued immediately, and medical consultation sought. This medication can interact with other drugs, so it is crucial to inform healthcare professionals about any medications currently being taken, especially when combined with certain antiviral agents, immunosuppressants, antibiotics, or fibrates. Women of childbearing potential should use appropriate contraception to avoid pregnancy while taking this medicine and should not take it if pregnant or planning to become pregnant. It is also safer for breastfeeding women not to take this medication. There is no specific antidote for overdose, so immediate medical attention should be sought for appropriate treatment, and monitoring of liver function and muscle enzyme levels is necessary. Dizziness may occur while driving or operating machinery, so caution is advised. Be careful if discomfort occurs during exercise or work. This medication contains lactose, so individuals who are lactose intolerant should consult with their healthcare provider before taking it.

Side effects and when to seek care immediately

Serious side effects

Urticaria, hypersensitivity reactions including angioedema, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, liver dysfunction, rhabdomyolysis, immune-mediated necrotizing myopathy, severe muscle weakness, ocular muscle weakness, shortness of breath, cough, thrombocytopenia, acute renal failure, oliguria, severe edema

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • rash
  • myalgia
  • weakness
  • diarrhea
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  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal distension
  • syncope
  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • hematuria
  • headache
  • dizziness
  • increased ALT
  • increased AST
  • increased CK
  • joint pain
  • increased serum creatinine
  • 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. It is recommended to maintain the storage temperature between 1 degree and 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

Yellow 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.