Medication info
Arotor Tablet 20 mg (Atorvastatin Calcium Hydrate)

Arotor Tablet 20 mg (Atorvastatin Calcium Hydrate)

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

MFDS item code 201707527 · Approved 2017.10.19 · Insurance code 648603580

Summary

Main use
Reduction of risk of myocardial infarction and stroke and improvement of hypercholesterolemia
Who uses it
Adults · Children
Adult dosage
For hyperlipidemia, the recommended initial dose is 10 mg once daily as atorvastatin, but patients requiring more LDL cholesterol reduction may start at 20 mg or 40 mg once daily. The dose range for this medication is 10 to 80 mg once daily. The initiation and adjustment of dosage should be individualized based on therapeutic goals and patient response, with lipid levels analyzed within 2 to 4 weeks after starting or adjusting the dose.
Children's dosage
The recommended initial dose for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) is 10 mg once daily, with a maximum recommended dose of 20 mg per day. Dosage should be adjusted according to therapeutic goals at intervals of 4 weeks or more.

Ingredients

Manufacturer
(주)씨엠지제약

Efficacy & effects

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

  • Coronary artery disease
  • myocardial infarction
  • stroke
  • chronic stable angina
  • retinopathy
  • albuminuria
  • congestive heart failure
  • hypercholesterolemia
  • dyslipidemia
  • dysbetalipoproteinemia
  • elevated serum triglycerides
  • hypercholesterolemia
View approved original text

This medication helps lower the risk of cardiovascular disease. It particularly reduces the risk of myocardial infarction, stroke, and angina in adults who are over the age of 55, or have risk factors such as smoking, hypertension, low HDL cholesterol levels, or a family history of early coronary heart disease. It also reduces the risk of myocardial infarction and stroke in patients with type 2 diabetes who have specific risk factors. In patients with clinical evidence of coronary artery disease, it reduces the risk of non-fatal myocardial infarction, stroke, and hospitalization for congestive heart failure. In the treatment of hyperlipidemia, it acts as an adjunct to diet by improving cholesterol and triglyceride levels, and effectively lowers lipid levels in patients with familial hypercholesterolemia, contributing to vascular health. Additionally, it is used to reduce cardiovascular disease risk by lowering lipid levels in some pediatric patients aged 10 to 17 years with familial hypercholesterolemia.

Dosage and Administration

Adult dosage

For hyperlipidemia, the recommended initial dose is 10 mg once daily as atorvastatin, but patients requiring more LDL cholesterol reduction may start at 20 mg or 40 mg once daily. The dose range for this medication is 10 to 80 mg once daily. The initiation and adjustment of dosage should be individualized based on therapeutic goals and patient response, with lipid levels analyzed within 2 to 4 weeks after starting or adjusting the dose.

Children's dosage

The recommended initial dose for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) is 10 mg once daily, with a maximum recommended dose of 20 mg per day. Dosage should be adjusted according to therapeutic goals at intervals of 4 weeks or more.

Precautions

This medication may cause muscle abnormalities, so if severe muscle pain or weakness occurs, or if creatine kinase levels significantly increase, it should be discontinued immediately. Patients with impaired liver function or liver disease should not use this medication, and if symptoms of liver dysfunction arise, they should consult a doctor immediately. Women who are pregnant, may become pregnant, or are breastfeeding should not take this medication. Children, especially those under 10 years of age, should not use this medication, and children aged 10 to 17 years should use it with caution. Individuals with a history of alcohol abuse or liver disease, patients with impaired kidney function, and individuals with hypothyroidism should consult a doctor before taking this medication. There may be interactions with other medications, so patients should inform their doctor or pharmacist of any medications they are currently taking. Particular caution is required when taken with certain antibiotics, antifungals, antivirals, immunosuppressants, and some medications for hyperlipidemia. During the use of this medication, report symptoms such as muscle pain, fatigue, or fever to healthcare personnel immediately, and it is important to regularly monitor liver function and muscle status through blood tests. This medication should be avoided with grapefruit juice, as it may increase blood concentration and the risk of side effects, so avoid consuming grapefruit juice. Keep out of reach of children and store in the original container to maintain quality.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe allergic reaction, fever accompanied by severe rash, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, severe skin reactions, shortness of breath or difficulty breathing, asthma attack, respiratory issues accompanied by cough + fever, yellowing of the skin or eyes (jaundice), extreme lethargy, liver issues (jaundice), sudden and very severe symptoms

Mild side effects

  • Weakness
  • fatigue
  • chest pain
  • peripheral edema
  • fever
  • nasopharyngitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
  • decreased appetite
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  • constipation
  • abdominal bloating
  • dyspepsia
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • throat/laryngeal pain
  • nosebleed
  • insomnia
  • nightmares
  • headache
  • dizziness
  • paresthesia
  • sensory loss
  • 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 closed container to protect it from air and moisture. It is advisable to store at room temperature between 1 and 30 degrees Celsius. Proper storage will maintain the drug's efficacy and safety.

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.

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.