Medication info
Arotin Tablet 10 mg (Atorvastatin Calcium Trihydrate)

Arotin Tablet 10 mg (Atorvastatin Calcium Trihydrate)

Prescription medicationTablet
Ingredient · strength
Atorvastatin Calcium Trihydrate›10.85mg / 1 tablet
Manufacturer / importer
(주)씨티씨바이오
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201507737 · Approved 2015.11.17 · Insurance code 669501560

Summary

Main use
Reduction of risk for myocardial infarction and stroke, improvement of hypercholesterolemia
Who uses it
Adults · Children
Adult dosage
For hyperlipidemia: The recommended starting dose is 10 mg of atorvastatin once daily; for patients needing more significant LDL cholesterol reduction, it may start at 20 mg or 40 mg once daily. This medication is administered once daily within a dose range of 10 to 80 mg. Initial and maintenance doses should be individualized based on therapeutic goals and responses, with lipid levels analyzed and dosage adjusted within 2–4 weeks after initiation or dose modification.
Children's dosage
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17): The recommended starting dose is 10 mg once daily, with a maximum recommended dose of 20 mg once daily. The dosage may be adjusted according to therapeutic goals.

Ingredients

Manufacturer
(주)씨티씨바이오

Efficacy & effects

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

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

This medication is primarily used to reduce the risk of cardiovascular disease and to improve hyperlipidemia. It reduces the risk of myocardial infarction and stroke in adults with multiple risk factors for cardiovascular disease, particularly those with coronary heart disease and patients with type 2 diabetes, as well as lowering the risk of revascularization procedures and angina. Additionally, it provides a risk-reduction effect for nonfatal myocardial infarction, fatal and non-fatal stroke, and hospitalization due to congestive heart failure in patients already diagnosed with coronary heart disease. For hyperlipidemia, it is used to control cholesterol and other lipid levels in patients with primary and mixed dyslipidemia and can be used in combination with other treatments in some familial hypercholesterolemia patients. It is also used as an adjunct to lower LDL cholesterol levels in some pediatric patients aged 10 to 17 years. This medication is effective in improving cardiovascular health and controlling lipid levels.

Dosage and Administration

Adult dosage

For hyperlipidemia: The recommended starting dose is 10 mg of atorvastatin once daily; for patients needing more significant LDL cholesterol reduction, it may start at 20 mg or 40 mg once daily. This medication is administered once daily within a dose range of 10 to 80 mg. Initial and maintenance doses should be individualized based on therapeutic goals and responses, with lipid levels analyzed and dosage adjusted within 2–4 weeks after initiation or dose modification.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17): The recommended starting dose is 10 mg once daily, with a maximum recommended dose of 20 mg once daily. The dosage may be adjusted according to therapeutic goals.

Precautions

This medication may cause muscle abnormalities; therefore, it should be discontinued immediately if muscle pain or weakness worsens or if creatine kinase levels rise significantly. This medication should not be used in patients with specific diseases or conditions, such as liver disease, muscle disorders, pregnant or breastfeeding women, children under 10 years of age, and patients taking certain medications. Patients with liver or kidney dysfunction should be particularly cautious when using this medication and should have regular liver function and muscle-related tests. During treatment, if symptoms such as muscle pain, fatigue, or fever occur, patients must inform healthcare professionals immediately, and blood tests may be done to check the condition. Moreover, this medication can interact with several other drugs, so it is essential to inform healthcare professionals if taking other medications, particularly with certain antibiotics, antifungals, and HIV treatments. Pregnant women or those who could become pregnant should not use this medication and should employ appropriate contraception during treatment. Breastfeeding women should also avoid taking this medication, and children or the elderly should use it cautiously due to a higher risk of side effects. As there is no specific antidote for overdose, treatment should be symptomatic, and liver function and muscle status should be monitored periodically. This medication should be stored out of reach of children and in its original container for safety.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with fever, blisters, skin peeling, pain of oral/ocular mucosa, shortness of breath or breathing difficulties, asthma attack, respiratory distress accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme drowsiness, sudden and severe headaches, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination issues.

Mild side effects

  • Weakness
  • fatigue
  • chest pain
  • peripheral edema
  • tiredness
  • fever
  • rhinitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
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  • loss of appetite
  • constipation
  • abdominal bloating
  • dyspepsia
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • pharyngeal/laryngeal pain
  • nosebleeds
  • insomnia
  • nightmares
  • headache
  • dizziness
  • paresthesia
  • sensory loss
  • taste alteration
  • memory loss
  • peripheral neuropathy
  • muscle pain
  • joint pain
  • limb pain
  • musculoskeletal pain
  • muscle cramps
  • and 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 prevent air or moisture entry. It should also be kept in a place that avoids extremes of temperature, ideally between 1 to 30 degrees Celsius.

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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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.