Medication info
Arotin Tablet 20 mg (Atorvastatin Calcium Trihydrate)

Arotin Tablet 20 mg (Atorvastatin Calcium Trihydrate)

Prescription medicationTablet
Ingredient · strength
Atorvastatin Calcium Trihydrate›21.7mg / 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 201507738 · Approved 2015.11.17 · Insurance code 669501570

Summary

Main use
Reduction of risks of myocardial infarction and stroke and improvement of hyperlipidemia
Who uses it
Adults · Children
Adult dosage
For hyperlipidemia, the recommended initial dosage is 10 mg once daily; however, if greater reduction in LDL cholesterol levels is needed, treatment may begin with 20 mg or 40 mg once daily. The dosing may be individualized within a range of 10 to 80 mg once daily based on treatment goals and patient response, with adjustments made based on testing intervals of 2-4 weeks. In homozygous familial hypercholesterolemia patients, the dosage is once daily.
Children's dosage
The recommended initial dosage for pediatric patients with heterozygous familial hypercholesterolemia (ages 10-17) is 10 mg per day, and the maximum dosage is 20 mg per day. Dosage adjustments should be made after intervals of at least 4 weeks for individual patients.

Ingredients

Manufacturer
(주)씨티씨바이오

Efficacy & effects

Reduction of risks of myocardial infarction and stroke and improvement of hyperlipidemia

  • Myocardial infarction
  • stroke
  • chronic stable angina
  • retinopathy
  • albuminuria
  • congestive heart failure
  • hypercholesterolemia
  • dyslipidemia
  • abetalipoproteinemia
  • increased serum triglycerides
  • homozygous familial hypercholesterolemia
  • heterozygous familial hypercholesterolemia
View approved original text

This medication helps reduce the risk of cardiovascular diseases. In particular, it lowers the risk of myocardial infarction and stroke, and also reduces the risk of hospitalization due to vascular procedures, angina, and congestive heart failure. It is beneficial in managing cardiovascular health in adults with diabetes or multiple risk factors for heart disease. Additionally, it improves cholesterol levels in patients with hyperlipidemia, lowering total cholesterol, LDL cholesterol, and triglyceride levels, while increasing HDL cholesterol levels. It is also used to control cholesterol levels in pediatric patients aged 10 to 17 with heterozygous familial hypercholesterolemia. Therefore, this medication is used for the prevention of cardiovascular diseases and improvement of blood lipid levels.

Dosage and Administration

Adult dosage

For hyperlipidemia, the recommended initial dosage is 10 mg once daily; however, if greater reduction in LDL cholesterol levels is needed, treatment may begin with 20 mg or 40 mg once daily. The dosing may be individualized within a range of 10 to 80 mg once daily based on treatment goals and patient response, with adjustments made based on testing intervals of 2-4 weeks. In homozygous familial hypercholesterolemia patients, the dosage is once daily.

Children's dosage

The recommended initial dosage for pediatric patients with heterozygous familial hypercholesterolemia (ages 10-17) is 10 mg per day, and the maximum dosage is 20 mg per day. Dosage adjustments should be made after intervals of at least 4 weeks for individual patients.

Precautions

This medicine may cause muscle-related side effects, so if muscle pain or weakness occurs, treatment should be stopped immediately and a doctor should be consulted. Particularly, in cases of severe muscle pain or signs of muscle damage, attention is needed as it may affect kidney function. This medication can impact liver function; thus, patients with liver disease or elevated liver enzymes should consult a doctor before use. Pregnant women or those who may become pregnant, along with nursing mothers, should not use this medication. Children, especially those under 10 years of age, should not take this medication, and long-term safety in adolescents under 18 has not been fully established. Patients with a history of alcohol abuse or liver disease should monitor liver function closely while taking this medication. This drug may interact with certain other medications, so if you are taking other drugs, be sure to inform your doctor or pharmacist. Particularly, caution is necessary when used in combination with some antibiotics, antifungal agents, HIV treatments, and certain antihypertensive medications due to required dose adjustments. Regular blood tests to monitor liver function and muscle condition are important while taking this medication. This medication contains lactose, so patients with lactose intolerance should be cautious before use. Elderly patients or those with reduced kidney function face a higher risk of muscle side effects, requiring dose adjustment and monitoring. In case of overdose, no specific antidote exists, and appropriate treatment and testing are needed based on symptoms. This medication should be stored out of the reach of children, and it is safest to keep it in its original container.

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 high fever, blisters, skin peeling, pain in oral/eye mucosa, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory difficulties accompanied by coughing and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, liver abnormalities (jaundice), sudden and severe headaches, thunderclap headache, seizure

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
  • pharyngitis/laryngitis
  • nosebleeds
  • insomnia
  • nightmares
  • headaches
  • dizziness
  • sensory disturbances
  • numbness
  • taste disturbances
  • amnesia
  • peripheral neuropathy
  • myalgia
  • arthralgia
  • limb pain
  • musculoskeletal pain
  • muscle cramps
  • joints

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

Storage

This medication should be stored in a sealed container to prevent air and moisture ingress, ideally at room temperature between 1 to 30 degrees Celsius. Storing it this way will help maintain the drug's efficacy 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.