Medication info
Atorotin Tablet 20 mg (Atorvastatin Calcium Hydrate)

Atorotin Tablet 20 mg (Atorvastatin Calcium Hydrate)

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

MFDS item code 201804618 · Approved 2018.11.21 · Insurance code 642307200

Summary

Main use
Reduction of risk for 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. If a greater reduction in LDL cholesterol is needed, the starting dose can be increased to 20 mg or 40 mg once daily. Generally, it is administered in a range of 10 to 80 mg once daily, with dosing optimized based on treatment goals and patient characteristics. Lipid levels should be assessed within 2 to 4 weeks after initiating treatment and/or after dose adjustments to inform further dosage modifications.
Children's dosage
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the recommended initial dose 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.

Ingredients

Manufacturer
삼성제약(주)

Efficacy & effects

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

  • Coronary heart disease
  • myocardial infarction
  • stroke
  • vascular interventions
  • chronic stable angina
  • retinopathy
  • albuminuria
  • hypertension
  • type 2 diabetes
  • congestive heart failure
  • angina
  • hyperlipidemia
View approved original text

This medication helps to reduce the risk of cardiovascular disease. It particularly reduces the likelihood of heart-related issues such as myocardial infarction, stroke, vascular interventions, and stable angina. It is used to protect cardiovascular health by reducing the risk of heart and cerebrovascular disease in patients with type 2 diabetes and those at high risk of heart disease. Additionally, it helps improve cholesterol and triglyceride levels in patients with primary hyperlipidemia or dyslipidemia, contributing to the prevention of cardiovascular diseases. It also aids in controlling lipid levels in pediatric patients with a family history or who belong to high-risk groups, particularly those with heterozygous familial hypercholesterolemia. In summary, this medication is used to decrease risk factors for cardiovascular diseases and promote heart health through the improvement of blood lipids.

Dosage and Administration

Adult dosage

For the treatment of hyperlipidemia, the recommended initial dose is 10 mg once daily. If a greater reduction in LDL cholesterol is needed, the starting dose can be increased to 20 mg or 40 mg once daily. Generally, it is administered in a range of 10 to 80 mg once daily, with dosing optimized based on treatment goals and patient characteristics. Lipid levels should be assessed within 2 to 4 weeks after initiating treatment and/or after dose adjustments to inform further dosage modifications.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the recommended initial dose 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.

Precautions

This medication can cause muscle problems; therefore, if symptoms of muscle pain or weakness occur, you should stop taking it immediately and consult your doctor. Patients with an allergy to this drug, those with severely impaired liver function, pre-existing muscle disease, pregnant or nursing women, and children under 10 years of age should not take this medication. Patients with a history of liver disease or alcohol addiction should take this medication with extra caution, and those at risk of muscle pathology should ideally have muscle enzyme levels checked prior to treatment. Regular liver function and muscle-related tests must be conducted during the use of this medication, and symptoms such as nausea, vomiting, malaise, muscle pain, and muscle weakness should be reported to a doctor immediately. This medication can interact with other drugs, so you must inform your doctor or pharmacist if you are taking certain antibiotics, antifungals, antivirals, or immunosuppressants. Women of childbearing age should use appropriate contraception while taking this medication, and if pregnancy is confirmed, the medication should be discontinued immediately. This medication is not recommended for nursing mothers, so it should be avoided during breastfeeding. Elderly patients or those with poor kidney function are at higher risk of muscle pathology, so caution is necessary when prescribing. There is no specific antidote for overdose; treatment should be symptom-based, and liver function and muscle enzyme levels should be monitored. This medication should be kept out of reach of children and stored in its original container for safety.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling, chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rash with high fever, blisters, skin peeling, oral/ocular mucosal pain, severe skin reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough and fever, breathing problems, jaundice, prominent yellowing of the skin or eyes, extreme fatigue, liver dysfunction, sudden and severe symptoms

Mild side effects

  • Weakness
  • malaise
  • 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
  • muscle pain
  • joint pain
  • 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 closed container to protect it from air and light, and it is safe to keep it at room temperature between 1 to 30 degrees Celsius. Proper storage will maintain the effectiveness of the medication and prevent deterioration.

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.