Medication info
Lipikrin Tablet 10mg (Atorvastatin Calcium Trihydrate)

Lipikrin Tablet 10mg (Atorvastatin Calcium Trihydrate)

Prescription medicationTablet
Ingredient · strength
Atorvastatin Calcium Trihydrate›10.85mg / 1 tablet
Manufacturer / importer
엔비케이제약(주)
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201701877 · Approved 2017.04.17 · Insurance code 054800020

Summary

Main use
Reduction of the risk of myocardial infarction and stroke, and improved hyperlipidemia
Who uses it
Adults · Children
Adult dosage
It can be taken at any time of day, regardless of food. The recommended starting dose for hyperlipidemia is 10 mg once daily, and if a greater reduction in LDL cholesterol is required, it may be started at 20 mg or 40 mg once daily (only if a reduction of 45% or more in LDL cholesterol is needed). The dosing range is 10 to 80 mg once daily. The initial and maintenance doses should be individualized based on treatment goals and responses, and lipid levels should be analyzed within 2 to 4 weeks after treatment initiation and/or dose adjustment, and doses should be adjusted accordingly. The treatment goal is to lower LDL cholesterol levels, so it is recommended to use LDL cholesterol to evaluate treatment initiation and response. However, if LDL cholesterol levels cannot be used, total cholesterol may be used to monitor treatment response. For patients with homozygous familial hypercholesterolemia, the dosing is 10 to 80 mg once daily, given in conjunction with other lipid-lowering therapies (e.g., LDL apheresis) or when such therapies are not available. For pediatric patients with heterozygous familial hypercholesterolemia (ages 10-17), the recommended starting dose is 10 mg once daily, with a maximum recommended dose of 20 mg daily (there is no clinical data in the pediatric population for dosing greater than 20 mg). The dosing may be appropriately increased or decreased based on individual patient treatment goals. Doses should be adjusted at intervals of 4 weeks or more. ○ Renal impairment: Renal disease does not affect the plasma concentration of atorvastatin or its LDL cholesterol-lowering effect, so dose adjustment is not needed. ○ Elderly: The efficacy and safety for patients aged 70 and older are similar to those in the general adult population.
Children's dosage
The recommended starting dose for pediatric patients with homozygous familial hypercholesterolemia (ages 10-17) is 10 mg once daily, and the recommended maximum dose is 20 mg once daily. The dosing may be adjusted at intervals of 4 weeks or more.

Ingredients

Manufacturer
엔비케이제약(주)

Efficacy & effects

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

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

This medication helps reduce the risk of cardiovascular disease. It lowers the risk of myocardial infarction, stroke, vascular interventions, and stable angina in adults aged 55 or older with multiple risk factors such as smoking, hypertension, low HDL cholesterol, and family history. It is also effective in reducing the risk of myocardial infarction and stroke in patients with type 2 diabetes who have risk factors for heart disease. In patients with existing coronary heart disease, it reduces the risk of myocardial infarction, stroke, vascular procedures, hospitalization due to congestive heart failure, and angina. Additionally, it lowers total cholesterol, LDL cholesterol, and triglycerides and raises HDL cholesterol in hyperlipidemic patients, assisting dietary management. It is specifically used to lower cholesterol levels in pediatric and adolescent patients with familial hypercholesterolemia. This medication is effective for improving cardiovascular health and treating hyperlipidemia.

Dosage and Administration

Adult dosage

It can be taken at any time of day, regardless of food. The recommended starting dose for hyperlipidemia is 10 mg once daily, and if a greater reduction in LDL cholesterol is required, it may be started at 20 mg or 40 mg once daily (only if a reduction of 45% or more in LDL cholesterol is needed). The dosing range is 10 to 80 mg once daily. The initial and maintenance doses should be individualized based on treatment goals and responses, and lipid levels should be analyzed within 2 to 4 weeks after treatment initiation and/or dose adjustment, and doses should be adjusted accordingly. The treatment goal is to lower LDL cholesterol levels, so it is recommended to use LDL cholesterol to evaluate treatment initiation and response. However, if LDL cholesterol levels cannot be used, total cholesterol may be used to monitor treatment response. For patients with homozygous familial hypercholesterolemia, the dosing is 10 to 80 mg once daily, given in conjunction with other lipid-lowering therapies (e.g., LDL apheresis) or when such therapies are not available. For pediatric patients with heterozygous familial hypercholesterolemia (ages 10-17), the recommended starting dose is 10 mg once daily, with a maximum recommended dose of 20 mg daily (there is no clinical data in the pediatric population for dosing greater than 20 mg). The dosing may be appropriately increased or decreased based on individual patient treatment goals. Doses should be adjusted at intervals of 4 weeks or more. ○ Renal impairment: Renal disease does not affect the plasma concentration of atorvastatin or its LDL cholesterol-lowering effect, so dose adjustment is not needed. ○ Elderly: The efficacy and safety for patients aged 70 and older are similar to those in the general adult population.

Children's dosage

The recommended starting dose for pediatric patients with homozygous familial hypercholesterolemia (ages 10-17) is 10 mg once daily, and the recommended maximum dose is 20 mg once daily. The dosing may be adjusted at intervals of 4 weeks or more.

Precautions

This medication may cause muscle-related problems; therefore, if symptoms of muscle pain or weakness arise, treatment should be stopped immediately, and consultation with a physician is required. Patients with impaired liver function or active liver disease should not take this medication. Women who are pregnant or may become pregnant should not take this medication and must use adequate contraceptive methods during treatment. Breastfeeding women should also avoid this medication and discontinue nursing. This medication is not for children under 10 years old. Patients with a history of alcohol abuse or liver disease should use this medication cautiously and undergo regular liver function tests. The risk of side effects may increase when taken with certain medications; hence, it is essential to inform a doctor or pharmacist if taking other medications. Severe muscle diseases such as myopathy or rhabdomyolysis may pose serious risks; therefore, if muscle pain is severe or persistent, inform medical personnel immediately. This medication can cause various side effects such as liver dysfunction, allergic reactions, skin rashes, gastrointestinal symptoms, etc.; if abnormal symptoms arise, consult a physician immediately. Elderly patients or those with poor kidney function are at higher risk of muscle-related side effects when taking this medication; caution is advised. There is no specific antidote for overdose; treatment should be symptomatic, and regular monitoring of liver function and muscle-related parameters should be conducted. This medication should be stored out of the reach of children and kept in its original container to maintain its quality and safety.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rash with high fever, blisters, mucous membrane pain in the mouth/eyes, severe skin reactions, difficulty breathing or shortness of breath, asthma attacks, respiratory issues associated with cough + fever, respiratory problems, yellowing of the skin or eyes (jaundice), extreme lethargy, liver abnormalities (jaundice), sudden and

Mild side effects

  • Weakness
  • fatigue
  • chest pain
  • peripheral edema
  • tiredness
  • fever
  • nasopharyngitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
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  • loss of appetite
  • constipation
  • abdominal bloating
  • dyspepsia
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • throat pain
  • nosebleed
  • insomnia
  • nightmares
  • headache
  • dizziness
  • sensory disturbances
  • paresthesia
  • taste disturbances
  • amnesia
  • peripheral neuropathy
  • muscle pain
  • joint pain
  • limb pain
  • musculoskeletal pain
  • muscle cramps
  • joint

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 exposure and kept at room temperature between 1 and 30 degrees Celsius for safety. Storing it this way will maintain the drug's efficacy and prevent degradation.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle, 300 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.