Medication info
Atorvastatin Tablets 20 mg (Atorvastatin Calcium Trihydrate)

Atorvastatin Tablets 20 mg (Atorvastatin Calcium Trihydrate)

Prescription medicationTablet
Ingredient · strength
Atorvastatin Calcium Trihydrate›21.7mg / 1 tablet
Manufacturer / importer
(주)알피바이오
Appearance
White round film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201800861 · Approved 2018.02.19 · Insurance code 661604880

Summary

Main use
Treatment for reducing the risk of myocardial infarction and stroke and improving hyperlipidemia
Who uses it
Adults · Children
Adult dosage
For hyperlipidemia, the recommended starting dose is 10 mg once daily. If more LDL cholesterol reduction is needed, it can be started at 20 mg or 40 mg once daily. The dosing range is 10 to 80 mg once daily. The initial and maintenance doses should be individualized based on treatment objectives and patient characteristics, and adjustments should be made based on lipid profile analysis within 2 to 4 weeks after starting treatment. The goal of treatment is to reduce LDL cholesterol; therefore, it is recommended to use LDL cholesterol for treatment initiation and response evaluation. However, if LDL cholesterol cannot be monitored, total cholesterol should be used for monitoring treatment response. For patients with homozygous familial hypercholesterolemia, the dosing range is 10 to 80 mg once daily, either in conjunction with other lipid-lowering therapies (e.g., LDL apheresis) or when such therapies are not feasible.
Children's dosage
The recommended starting dose for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) is 10 mg once daily, with a recommended maximum dose of 20 mg once daily. The dosage should be adjusted appropriately with intervals of 4 weeks or more.

Ingredients

Manufacturer
(주)알피바이오

Efficacy & effects

Treatment for reducing the risk of myocardial infarction and stroke and improving hyperlipidemia

  • Myocardial infarction
  • stroke
  • 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 particularly lowers the risk of myocardial infarction and stroke and reduces the risk of vascular interventions and angina. It is also effective in patients with type 2 diabetes who have multiple risk factors for heart disease. In hyperlipidemia patients, it lowers total cholesterol, LDL cholesterol, and triglycerides while increasing HDL cholesterol. This medication is especially beneficial for patients with hypercholesterolemia that is difficult to control through diet. It is also used as an adjunct treatment for familial hypercholesterolemia in children to improve blood lipid levels. Therefore, this medication is used for treating cardiovascular diseases and hyperlipidemia.

Dosage and Administration

Adult dosage

For hyperlipidemia, the recommended starting dose is 10 mg once daily. If more LDL cholesterol reduction is needed, it can be started at 20 mg or 40 mg once daily. The dosing range is 10 to 80 mg once daily. The initial and maintenance doses should be individualized based on treatment objectives and patient characteristics, and adjustments should be made based on lipid profile analysis within 2 to 4 weeks after starting treatment. The goal of treatment is to reduce LDL cholesterol; therefore, it is recommended to use LDL cholesterol for treatment initiation and response evaluation. However, if LDL cholesterol cannot be monitored, total cholesterol should be used for monitoring treatment response. For patients with homozygous familial hypercholesterolemia, the dosing range is 10 to 80 mg once daily, either in conjunction with other lipid-lowering therapies (e.g., LDL apheresis) or when such therapies are not feasible.

Children's dosage

The recommended starting dose for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) is 10 mg once daily, with a recommended maximum dose of 20 mg once daily. The dosage should be adjusted appropriately with intervals of 4 weeks or more.

Precautions

This medication may cause muscle-related symptoms; therefore, if muscle pain or weakness worsens or if creatine kinase levels significantly rise, discontinue immediately and consult a doctor. Consult a doctor before using this medication if there are issues with liver function or if there is a history of liver disease, and regular liver function tests should be conducted. This medication should not be taken by pregnant women, women who may become pregnant, or breastfeeding women; fertile women should use appropriate birth control methods during treatment. Children under 10 years old and patients with certain liver or muscle diseases should not take this medication. This medication may interact with other drugs; caution is needed when using it in combination with certain antibiotics, antifungals, antivirals, immunosuppressants, or grapefruit juice. If allergic reactions such as rash, itching, or difficulty breathing occur during treatment, discontinue immediately and inform medical personnel. Elderly patients or those with impaired kidney function may be at higher risk for muscle-related side effects, so careful monitoring is required during treatment. There are no specific antidotes for overdose; if an overdose occurs, immediately visit a medical facility for appropriate treatment. Keep this medication out of the reach of children and store it in its original container; do not transfer it to a different container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe allergic reactions, severe rash with high fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, severe skin reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanying cough and fever, breathing problems, jaundice (yellowing of skin or eyes), general malaise, liver problems (jaundice), sudden

Mild side effects

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

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

Storage

Store this medication in a tightly closed container to protect it from air and moisture. It is important to maintain storage temperatures between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

White round film-coated tablets

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.