Medication info
Lipicure Tablet 10 mg (Atorvastatin Calcium Trihydrate)

Lipicure Tablet 10 mg (Atorvastatin Calcium Trihydrate)

Prescription medicationTablet
Ingredient · strength
Atorvastatin Calcium Trihydrate›10.845mg / 1 tablet
Manufacturer / importer
아이큐어(주)
Appearance
White oval film-coated tablet
Packaging
30 tablets, 100 tablets
Approval status
Active

MFDS item code 201601761 · Approved 2016.03.23 · Insurance code 674400750

Summary

Main use
Reduction of the risk of myocardial infarction and stroke, improvement of hyperlipidemia
Who uses it
Adults · Children
Adult dosage
The recommended starting dose for treating hyperlipidemia is 10 mg of atorvastatin administered once daily. For patients needing greater LDL cholesterol reduction, treatment may begin at 20 mg or 40 mg once daily. The dosage should be individualized based on the treatment goals and response, in the range of 10 to 80 mg once daily. Lipid levels should be analyzed within 2-4 weeks after treatment initiation and/or dose adjustment to modify the dosage accordingly. The goal of treatment is to lower LDL cholesterol; therefore, it is recommended to use LDL cholesterol levels when evaluating treatment initiation and response. If LDL cholesterol levels are unavailable, total cholesterol levels may be used to monitor treatment response. For patients with homozygous familial hypercholesterolemia, the dosing regimen is 10 to 80 mg daily, often administered in conjunction with other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are not feasible. 2. Pediatric patients with heterozygous familial hypercholesterolemia (10-17 years) The recommended starting dose is 10 mg daily, and the recommended maximum dose is 20 mg daily (there is no clinical data pertaining to doses over 20 mg in this pediatric cohort). Dosages should be adjusted appropriately according to the recommended therapeutic goals for each patient. Adjustments should be made at intervals of 4 weeks or longer. ○ In patients with renal impairment: Renal disease does not affect plasma concentrations of atorvastatin or its LDL cholesterol-lowering effects; therefore, dosage adjustment is unnecessary. ○ In elderly patients: The efficacy and safety in patients aged 70 and older are similar to those in the general adult population.
Children's dosage
The recommended starting dose for pediatric patients (10-17 years) with heterozygous familial hypercholesterolemia is 10 mg once daily, with a maximum dose of 20 mg per day. The dosage should be appropriately titrated according to therapeutic goals.

Ingredients

Manufacturer
아이큐어(주)

Efficacy & effects

Reduction of the risk of myocardial infarction and stroke, improvement of hyperlipidemia

  • Myocardial infarction
  • stroke
  • chronic stable angina
  • retinopathy
  • albuminuria
  • congestive heart failure
  • hyperlipidemia
  • primary hypercholesterolemia
  • mixed dyslipidemia
  • abnormal beta-lipoproteinemia
  • elevated serum triglycerides
  • homozygous familial hypercholesterolemia
View approved original text

This medication is effective in reducing the risk of various cardiovascular diseases. It helps lower the risk of myocardial infarction and stroke in adults with multiple risk factors for coronary artery disease and patients with type 2 diabetes. It also significantly reduces the risk of hospitalization due to vascular interventions, angina, and congestive heart failure. In patients with hyperlipidemia, it is used to lower total cholesterol, LDL-cholesterol, Apo-B protein, and triglyceride levels, while increasing good cholesterol levels (HDL-cholesterol). It particularly helps improve blood lipid levels in pediatric patients with familial hypercholesterolemia when used alongside dietary therapy. This medication is used to overall improve cardiovascular health and reduce the risk of related diseases.

Dosage and Administration

Adult dosage

The recommended starting dose for treating hyperlipidemia is 10 mg of atorvastatin administered once daily. For patients needing greater LDL cholesterol reduction, treatment may begin at 20 mg or 40 mg once daily. The dosage should be individualized based on the treatment goals and response, in the range of 10 to 80 mg once daily. Lipid levels should be analyzed within 2-4 weeks after treatment initiation and/or dose adjustment to modify the dosage accordingly. The goal of treatment is to lower LDL cholesterol; therefore, it is recommended to use LDL cholesterol levels when evaluating treatment initiation and response. If LDL cholesterol levels are unavailable, total cholesterol levels may be used to monitor treatment response. For patients with homozygous familial hypercholesterolemia, the dosing regimen is 10 to 80 mg daily, often administered in conjunction with other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are not feasible. 2. Pediatric patients with heterozygous familial hypercholesterolemia (10-17 years) The recommended starting dose is 10 mg daily, and the recommended maximum dose is 20 mg daily (there is no clinical data pertaining to doses over 20 mg in this pediatric cohort). Dosages should be adjusted appropriately according to the recommended therapeutic goals for each patient. Adjustments should be made at intervals of 4 weeks or longer. ○ In patients with renal impairment: Renal disease does not affect plasma concentrations of atorvastatin or its LDL cholesterol-lowering effects; therefore, dosage adjustment is unnecessary. ○ In elderly patients: The efficacy and safety in patients aged 70 and older are similar to those in the general adult population.

Children's dosage

The recommended starting dose for pediatric patients (10-17 years) with heterozygous familial hypercholesterolemia is 10 mg once daily, with a maximum dose of 20 mg per day. The dosage should be appropriately titrated according to therapeutic goals.

Precautions

This medication poses a risk of muscle problems; thus, discontinue use immediately and consult a doctor if symptoms such as muscle pain or weakness occur. It should not be administered to those with an allergy to this medication or those with liver diseases or muscular disorders. Pregnant or breastfeeding women should not take this medication, and women of childbearing age must use appropriate contraception during its use. Patients with impaired liver function should exercise special caution when using this medication and should have regular liver function tests. This medication may interact with other drugs, so patients taking certain antibiotics, antifungals, antivirals, immunosuppressants, etc., must inform their doctor or pharmacist and exercise caution. Elderly patients or patients with reduced kidney function are at higher risk for muscle damage, requiring closer monitoring during use. During treatment, if symptoms such as muscle pain, fatigue, or fever occur, medical staff should be notified immediately. Children, especially those under 10 years old, should not take this medication, while adolescents over 10 years should only take it under a specialist's guidance. In case of overdose, there is no specific antidote, so one should go to the hospital immediately for treatment based on symptoms. Store this medication out of reach of children and ensure it is kept in its original container for safety. During treatment, closely monitor for symptoms of muscle abnormalities and signs of liver dysfunction, and notify a doctor if any abnormal symptoms occur.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, peeling skin, pain in the oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, jaundice (skin or eyes turning yellow), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion of consciousness, visual disturbances, paralysis, urination

Mild side effects

  • Weakness
  • fatigue
  • chest pain
  • peripheral edema
  • tiredness
  • fever
  • pharyngitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
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  • loss of appetite
  • constipation
  • abdominal bloating
  • indigestion
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • throat and larynx pain
  • nosebleeds
  • insomnia
  • nightmares
  • headache
  • dizziness
  • paresthesia
  • sensory loss
  • taste disturbance
  • memory loss
  • peripheral neuropathy
  • muscle pain
  • joint pain
  • limb pain
  • musculoskeletal pain
  • muscle cramps
  • joint pain

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

Storage

This medication should be stored in a sealed container to protect it from air or moisture. It is best to maintain storage temperatures between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

White oval film-coated tablet

Package unit

30 tablets, 100 tablets

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.