Medication info
Atorvastatin Calcium Trihydrate 20 mg Tablets

Atorvastatin Calcium Trihydrate 20 mg Tablets

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

MFDS item code 201904610 · Approved 2019.07.08 · Insurance code 658106620

Summary

Main use
Reduction of risk of myocardial infarction and stroke, improvement of hyperlipidemia
Who uses it
Adults · Children
Adult dosage
For the treatment of hyperlipidemia, the recommended initial dose is 10 mg once daily; for patients requiring a greater reduction in LDL cholesterol, the starting dose can be increased to 20 mg or 40 mg once daily. The dosage can range from 10 to 80 mg once daily, individualized based on treatment goals and patient response. Lipid levels should be reviewed and dosage adjusted within 2 to 4 weeks after starting treatment. The goal of treatment is to lower LDL cholesterol; therefore, it is recommended to use LDL cholesterol levels to evaluate treatment initiation and response. However, if LDL cholesterol levels cannot be obtained, total cholesterol levels may be used to monitor the treatment response. In homozygous familial hypercholesterolemia patients, the dose of this drug is 10 to 80 mg once daily, possibly combined with other lipid-lowering therapies (e.g., LDL apheresis) or given when such therapies are not feasible.
Children's dosage
The recommended initial dose for pediatric patients (ages 10-17) with heterozygous familial hypercholesterolemia is 10 mg once daily, with a maximum dose of 20 mg per day. Dosage should be adjusted at intervals of 4 weeks or more based on therapeutic goals.

Ingredients

Manufacturer
(유)한풍제약

Efficacy & effects

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

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

This drug helps reduce the risk of myocardial infarction, stroke, vascular surgeries, and angina in adults with cardiovascular disease risk factors and patients with type 2 diabetes. It is also effective in reducing the risk of myocardial infarction, stroke, admissions for congestive heart failure, and angina in patients with heart disease. For patients with hyperlipidemia, it lowers total cholesterol, LDL cholesterol, Apo-B protein, and triglyceride levels while increasing HDL cholesterol levels. It is particularly used as an adjunct to diet for patients with familial and non-familial hypercholesterolemia, mixed dyslipidemia, beta-lipoproteinemia, and homozygous familial hypercholesterolemia. It is beneficial for patients aged 10 to 17 years with heterozygous familial hypercholesterolemia, assisting in the control of high cholesterol levels. Overall, this medication is used for reducing cardiovascular disease risk and improving dyslipidemia.

Dosage and Administration

Adult dosage

For the treatment of hyperlipidemia, the recommended initial dose is 10 mg once daily; for patients requiring a greater reduction in LDL cholesterol, the starting dose can be increased to 20 mg or 40 mg once daily. The dosage can range from 10 to 80 mg once daily, individualized based on treatment goals and patient response. Lipid levels should be reviewed and dosage adjusted within 2 to 4 weeks after starting treatment. The goal of treatment is to lower LDL cholesterol; therefore, it is recommended to use LDL cholesterol levels to evaluate treatment initiation and response. However, if LDL cholesterol levels cannot be obtained, total cholesterol levels may be used to monitor the treatment response. In homozygous familial hypercholesterolemia patients, the dose of this drug is 10 to 80 mg once daily, possibly combined with other lipid-lowering therapies (e.g., LDL apheresis) or given when such therapies are not feasible.

Children's dosage

The recommended initial dose for pediatric patients (ages 10-17) with heterozygous familial hypercholesterolemia is 10 mg once daily, with a maximum dose of 20 mg per day. Dosage should be adjusted at intervals of 4 weeks or more based on therapeutic goals.

Precautions

This medication may cause muscle-related symptoms; therefore, if muscle pain, weakness, or cramps occur, discontinue use immediately and consult a doctor. This drug may affect liver function, so it should not be used in patients with liver disease or significantly elevated liver function test results. Women who are pregnant or may become pregnant should not take this drug, and must use appropriate contraceptive methods while on the medication. Breastfeeding women should also avoid taking this drug and must stop breastfeeding. Interactions may occur when taken with certain medications; thus, if other medications are being taken, it is essential to inform a doctor or pharmacist. Elderly patients or those with diminished kidney function are at higher risk of muscle-related adverse reactions, thus caution is advised when using this medication. During treatment, regular liver function and muscle-related tests should be conducted, and if any adverse symptoms occur, inform a doctor immediately. Children, especially those under 10 years, should not take this drug, and those over 10 should use it cautiously according to a doctor's advice. This drug contains lactose; therefore, patients with lactose intolerance or related genetic disorders should not take it. In case of overdose, as there is no specific antidote, treatment should be based on symptoms while closely monitoring liver function and muscle status. This medication should be kept out of reach of children and stored securely in its original container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), angioedema, anaphylaxis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures

Mild side effects

  • Fatigue
  • malaise
  • 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
  • oropharyngeal and laryngeal pain
  • nosebleeds
  • insomnia
  • nightmares
  • headache
  • dizziness
  • paresthesia
  • sensation loss
  • taste disturbance
  • memory loss
  • peripheral neuropathy
  • myalgia
  • arthralgia
  • limb pain
  • musculoskeletal pain
  • muscle cramps
  • joint pain

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

Storage

This drug should be stored in a sealed container to prevent exposure to air and moisture, and it is best kept at room temperature between 1 to 30 degrees Celsius. Storing it this way will help maintain its effectiveness and safety.

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.

Questions about this medicine

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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.