Medication info

Atorvastatin Calcium Trihydrate 20 mg Tablets

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

MFDS item code 201701568 · Approved 2017.03.31 · Insurance code 657203260

Summary

Main use
Reduces the risk of myocardial infarction and stroke and improves hypercholesterolemia
Who uses it
Adults · Children
Adult dosage
For hyperlipidemia treatment, the recommended initial dose is atorvastatin 10 mg once daily; for patients needing more LDL cholesterol reduction, it may be started at 20 mg or 40 mg once daily. The dosage range is 10-80 mg once daily. Lipid levels should be analyzed within 2-4 weeks after initiation and dosage adjustment, and adjustments should be made accordingly. The goal of treatment is to lower LDL cholesterol levels, and it is recommended to use LDL cholesterol levels for treatment initiation and response evaluation. If LDL cholesterol levels are not available, total cholesterol levels should be used to monitor treatment response. For patients with homozygous familial hypercholesterolemia, the dosage is 10-80 mg once daily, either in conjunction with other lipid-lowering treatments (e.g., LDL apheresis) or when such treatments are not feasible.
Children's dosage
In pediatric patients (10-17 years) with heterozygous familial hypercholesterolemia, the recommended initial dose is 10 mg once daily, with a maximum dose of 20 mg once daily. The dosage may be adjusted based on the recommended treatment goals over intervals of 4 weeks or more.

Ingredients

Manufacturer
환인제약(주)

Efficacy & effects

Reduces the risk of myocardial infarction and stroke and improves hypercholesterolemia

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

This medication is used to reduce the risk of cardiovascular diseases. It specifically lowers the risk of myocardial infarction and stroke in adults with risk factors for coronary heart disease and in patients with type 2 diabetes. Additionally, it is effective in reducing the risk of non-fatal myocardial infarction, stroke, vascular surgery, and hospitalization due to congestive heart failure in patients with heart disease. In patients with hyperlipidemia, it helps lower cholesterol, LDL cholesterol, and triglyceride levels while increasing HDL cholesterol. This medication is also used in various types of dyslipidemia that do not respond adequately to diet. It is safe for use in pediatric patients with heterozygous familial hypercholesterolemia and contributes to reducing cardiovascular risk factors. Therefore, it is used for the prevention and improvement of cardiovascular diseases and hyperlipidemia.

Dosage and Administration

Adult dosage

For hyperlipidemia treatment, the recommended initial dose is atorvastatin 10 mg once daily; for patients needing more LDL cholesterol reduction, it may be started at 20 mg or 40 mg once daily. The dosage range is 10-80 mg once daily. Lipid levels should be analyzed within 2-4 weeks after initiation and dosage adjustment, and adjustments should be made accordingly. The goal of treatment is to lower LDL cholesterol levels, and it is recommended to use LDL cholesterol levels for treatment initiation and response evaluation. If LDL cholesterol levels are not available, total cholesterol levels should be used to monitor treatment response. For patients with homozygous familial hypercholesterolemia, the dosage is 10-80 mg once daily, either in conjunction with other lipid-lowering treatments (e.g., LDL apheresis) or when such treatments are not feasible.

Children's dosage

In pediatric patients (10-17 years) with heterozygous familial hypercholesterolemia, the recommended initial dose is 10 mg once daily, with a maximum dose of 20 mg once daily. The dosage may be adjusted based on the recommended treatment goals over intervals of 4 weeks or more.

Precautions

This medication may cause unusual symptoms in muscles; if muscle pain or weakness worsens, consult a doctor immediately. This medication should not be used in patients with severe liver disease or in pregnant or nursing women, or children under 10 years of age. Since it may affect liver function, regular liver function tests are necessary, and any unusual liver symptoms should be reported immediately. It is advisable to avoid or reduce alcohol consumption while taking this medication. If taken with certain medications, drug concentrations may increase, raising the risk of side effects, so inform your doctor or pharmacist about other medications being taken. Women of childbearing potential should use appropriate contraceptive methods while taking this medication and discontinue use if pregnancy is confirmed. If muscle-related abnormal symptoms or significantly elevated muscle enzyme levels occur, discontinue the medication and consult healthcare professionals. This medication can cause severe skin reactions; if a rash or blisters develop, discontinue use immediately and seek medical attention. Elderly patients or those with impaired kidney function may have a higher risk of side effects while taking this medication and should be observed closely. This medication should be stored out of the reach of children and in a designated container to prevent misuse or deterioration of quality.

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, skin peeling, pain in mouth/eye mucosa, severe skin adverse reactions, asthma attacks, respiratory issues accompanied by cough and fever, respiratory problem, yellowing of the skin or eyes (jaundice), extreme lethargy, liver abnormalities (jaundice), sudden and severe headache, thunderclap headache

Mild side effects

  • Weakness
  • fatigue
  • chest pain
  • peripheral edema
  • tiredness
  • fever
  • nasopharyngitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
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  • decreased appetite
  • constipation
  • abdominal distension
  • dyspepsia
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • pharyngeal and laryngeal pain
  • nosebleed
  • insomnia
  • nightmares
  • headache
  • dizziness
  • paresthesia
  • sensory reduction
  • 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 medication should be stored in a tightly sealed container to protect it from air and moisture. It is important to maintain a storage temperature between 1°C and 30°C. Proper storage will help preserve the medication's efficacy and safety for an extended period.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

100 tablets/bottle, 30 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.