Medication info
Lobide Tablet 20mg (Rosuvastatin Calcium)

Lobide Tablet 20mg (Rosuvastatin Calcium)

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

MFDS item code 201507898 · Approved 2015.11.25 · Insurance code 669501710

Summary

Main use
Treatment for hypercholesterolemia (primary, familial) and risk reduction of cardiovascular disease
Who uses it
Adults · Children
Adult dosage
Administer 5 milligrams once daily as an initial dose at any time during the day, regardless of meals. For patients requiring more significant LDL cholesterol reduction, a maintenance dose of 10 milligrams once daily can be given, and this can be adjusted based on the patient’s response at intervals of at least 4 weeks. Dosing may be increased to a maximum of 20 milligrams per day.
Children's dosage
For pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia, administer a once daily dose between 5 milligrams and 20 milligrams. The dosage should be adjusted according to the individual patient’s treatment goals with intervals of at least 4 weeks.

Ingredients

Manufacturer
(주)씨티씨바이오

Efficacy & effects

Treatment for hypercholesterolemia (primary, familial) and risk reduction of cardiovascular disease

  • Primary hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • mixed dyslipidemia
  • homozygous familial hypercholesterolemia
  • hypercholesterolemia
  • heterozygous familial hypercholesterolemia
  • primary dysbetalipoproteinemia
  • increased 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 used for various forms of hypercholesterolemia, particularly for primary hypercholesterolemia and mixed dyslipidemia that are not controlled by diet and exercise. Additionally, it is used as an adjunct with other treatments in patients with homozygous familial hypercholesterolemia and lowers total cholesterol and LDL cholesterol levels in patients with hypercholesterolemia, slowing the progression of atherosclerosis. It is also used as an adjunct to diet in pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia to reduce total cholesterol, LDL cholesterol, and Apo-B levels. Furthermore, it is applied as an adjunct to diet in patients with primary dysbetalipoproteinemia. It contributes to lowering the risk of stroke, myocardial infarction, and arterial revascularization in men over 50 years and women over 60 years at high risk for cardiovascular disease. Overall, this medication is effectively used to improve blood lipid levels and maintain cardiovascular health.

Dosage and Administration

Adult dosage

Administer 5 milligrams once daily as an initial dose at any time during the day, regardless of meals. For patients requiring more significant LDL cholesterol reduction, a maintenance dose of 10 milligrams once daily can be given, and this can be adjusted based on the patient’s response at intervals of at least 4 weeks. Dosing may be increased to a maximum of 20 milligrams per day.

Children's dosage

For pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia, administer a once daily dose between 5 milligrams and 20 milligrams. The dosage should be adjusted according to the individual patient’s treatment goals with intervals of at least 4 weeks.

Precautions

This medication should not be used in certain patients. For instance, those who are allergic to this drug, those with severely impaired liver function, those with muscle diseases, those with severely compromised kidney function, and women who are pregnant or nursing should not take this drug. Additionally, this medication should be used with caution in individuals who consume excessive alcohol or have a history of liver disease, and regular liver function tests should be conducted. If symptoms of muscle pain or weakness occur, the physician should be notified immediately, and in severe cases, the medication should be discontinued. This medication may increase blood sugar levels in some patients, raising the risk of diabetes; therefore, patients at risk for diabetes should undergo regular blood sugar monitoring. This medication may interact with other drugs, so it is essential to inform the physician or pharmacist of any other medications being taken, especially certain antibiotics, antifungals, immunosuppressants, and fibrate class drugs, as the risk of muscle-related side effects may increase when taken together. Women of childbearing potential should use appropriate contraception and should not take this medication while pregnant. Nursing women should also avoid taking this medication for safety. In the event of an overdose, there are no specific antidotes, so treatment should be symptomatic, and liver function and muscle enzyme levels should be monitored. Dizziness may occur during driving or operating machinery, so caution is advisable. This medication may cause serious allergic reactions in the skin; if symptoms such as rash or itching occur, the medication should be stopped immediately, and a physician should be consulted.

Side effects and when to seek care immediately

Serious side effects

Hives, allergic reactions including angioedema, severe muscle weakness, ophthalmoplegia, myopathy, rhabdomyolysis, acute kidney injury, anuria, thrombocytopenia, elevated serum creatinine, severe rash with fever, blistering, skin peeling, oral/ocular mucosal pain, Stevens-Johnson syndrome, drug reaction with eosinophilia and systemic symptoms (DRESS), jaundice, hepatitis, liver failure, severe allergic reactions, severe

Mild side effects

  • Headache
  • dizziness
  • constipation
  • nausea
  • abdominal pain
  • itching
  • myalgia
  • weakness
  • diarrhea
  • syncope
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  • generalized pain
  • muscle cramps
  • gout
  • erectile dysfunction
  • fatigue
  • numbness
  • paresthesia
  • chest discomfort
  • loss of appetite
  • abdominal bloating
  • abnormal liver function tests
  • hematuria
  • depression
  • sleep disturbances
  • sexual dysfunction
  • gynecomastia
  • amnesia
  • cognitive impairment
  • forgetfulness
  • memory disorders
  • confusion

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

Storage

This medication should be stored in a tightly sealed container to prevent air or moisture from entering, and it is recommended to store it at room temperature between 1 degree and 30 degrees Celsius. By storing it this way, the effectiveness of the medication can be maintained, and it can be used safely.

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.