Medication info
Astatin 20 mg (Atorvastatin Calcium Trihydrate)

Astatin 20 mg (Atorvastatin Calcium Trihydrate)

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

MFDS item code 201701538 · Approved 2017.03.30 · Insurance code 646203890

Summary

Main use
Reduction of the risk of myocardial infarction and stroke, and improvement of hyperlipidemia
Who uses it
Adults · Children
Adult dosage
For the treatment of hyperlipidemia, the recommended starting dose is 10 mg once daily. Patients requiring a greater reduction in LDL cholesterol levels may start at 20 mg or 40 mg once daily. Typically, doses range from 10 to 80 mg once daily. Lipid levels should be analyzed to adjust the dose within 2 to 4 weeks of the treatment initiation. In patients with homozygous familial hypercholesterolemia, the dose should be 10 mg to 80 mg once daily.
Children's dosage
The recommended starting dose for pediatric patients (10–17 years) with heterozygous familial hypercholesterolemia is 10 mg per day, with a maximum dose of 20 mg per day. Dose adjustments should be made based on individual patient need at intervals of 4 weeks or more.

Ingredients

Manufacturer
(주)셀릭스

Efficacy & effects

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

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

This medication helps lower the risk of cardiovascular diseases. It can reduce the risk of myocardial infarction and stroke in adults with risk factors for coronary heart disease and patients with type 2 diabetes. Additionally, it has effects in reducing risks associated with myocardial infarction, stroke, vascular surgeries, angina, and congestive heart failure. For hyperlipidemia patients, it plays a role in lowering total cholesterol and LDL cholesterol levels, while increasing HDL cholesterol. It is especially effective for patients with familial hypercholesterolemia and can be used in combination with other treatments, generally maintaining and improving cardiovascular health.

Dosage and Administration

Adult dosage

For the treatment of hyperlipidemia, the recommended starting dose is 10 mg once daily. Patients requiring a greater reduction in LDL cholesterol levels may start at 20 mg or 40 mg once daily. Typically, doses range from 10 to 80 mg once daily. Lipid levels should be analyzed to adjust the dose within 2 to 4 weeks of the treatment initiation. In patients with homozygous familial hypercholesterolemia, the dose should be 10 mg to 80 mg once daily.

Children's dosage

The recommended starting dose for pediatric patients (10–17 years) with heterozygous familial hypercholesterolemia is 10 mg per day, with a maximum dose of 20 mg per day. Dose adjustments should be made based on individual patient need at intervals of 4 weeks or more.

Precautions

This medication may cause severe adverse effects in the muscles, so if there is severe muscle pain or weakness, or if creatine kinase levels rise significantly, use should be discontinued immediately. Patients with liver dysfunction or very elevated liver enzyme levels should not use this medication and should undergo regular liver function tests. Women who are pregnant or may become pregnant, and breastfeeding women should not use this medication, and women of childbearing potential should use appropriate contraception. Children, especially those under 10 years old, should not use this medication, and children and adolescents over 10 years old should use it cautiously under medical guidance. This medication may interact with certain drugs, which can increase or decrease its blood concentration, so it is essential to inform your doctor or pharmacist if you are taking other medications. Particular care is needed when combined with potent CYP3A4 inhibitors or certain antibiotics, antifungals, and antivirals. Patients with a history of liver disease or those who consume excessive alcohol should use this medication cautiously, as the risk of myopathy may increase, necessitating careful monitoring for muscle symptoms. During treatment with this medication, if symptoms such as muscle pain, fatigue, or fever appear, you must inform healthcare professionals immediately for further examination. If severe rashes, blisters, itching, or angioedema occurs, discontinue use immediately. Elderly patients or patients with decreased kidney function are at higher risk of muscle adverse reactions, so dose adjustments and careful observation are necessary. In case of overdose, as there is no specific antidote, management should be based on symptoms and through liver function and blood tests. Store out of reach of children and keep in the original container to prevent deterioration in quality or misuse.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema, anaphylactic edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with fever, blisters, skin peeling, mucosal pain in mouth/eyes, severe skin reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, liver abnormalities (jaundice), sudden and severe reactions

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
  • pharyngitis and laryngeal pain
  • nosebleed
  • insomnia
  • nightmares
  • headache
  • dizziness
  • altered perception
  • sensory loss
  • altered taste
  • 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 may be sensitive to air and moisture, so it should be stored in a tightly closed container. Additionally, it is best kept at room temperature between 1 to 30 degrees Celsius. Avoid keeping it in excessively hot or cold places.

Appearance and packaging

Appearance

White round film-coated tablet

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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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.