Medication info
Arotor Tablet (Atorvastatin Calcium Hydrate)

Arotor Tablet (Atorvastatin Calcium Hydrate)

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

MFDS item code 201310964 · Approved 2013.12.31 · Insurance code 648602590

Summary

Main use
Reduction of the risk of myocardial infarction and stroke, and improvement of hyperlipidemia
Who takes it
Adults · Children
Adult dose
The recommended starting dose for the treatment of hyperlipidemia is 10 mg once daily, which may be increased as necessary to 20 mg or 40 mg. It should be administered once daily within a range of 10 to 80 mg. Dosage adjustments should be made after 2 to 4 weeks based on treatment goals and responses. Patients with homozygous familial hypercholesterolemia should also be given a dose within the range of 10 to 80 mg once daily.
Child dose
The recommended starting dose for pediatric patients (ages 10 to 17) with heterozygous familial hypercholesterolemia is 10 mg once daily, with a maximum dose of 20 mg daily. Dosage adjustments should be made at intervals of 4 weeks or more based on treatment goals.

Ingredients

Manufacturer
(주)씨엠지제약

Efficacy & effects

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

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

This medication is used to reduce the risk of cardiovascular diseases and to treat hyperlipidemia. It particularly helps decrease the risk of myocardial infarction, stroke, and complications related to vascular surgery in adults with risk factors for coronary heart disease or those with type 2 diabetes. In patients already with heart disease, it assists in reducing the risk of myocardial infarction, stroke, and hospitalization due to congestive heart failure. Additionally, it decreases total cholesterol, LDL cholesterol, apo-B protein, and triglyceride levels and increases HDL cholesterol levels, aiding dietary therapy in patients with primary and mixed hyperlipidemia. It is also used in pediatric patients aged 10 to 17 with heterozygous familial hypercholesterolemia to lower cardiovascular disease risk. Overall, this drug helps improve cardiovascular health and manage hyperlipidemia.

How to take

Adult dose

The recommended starting dose for the treatment of hyperlipidemia is 10 mg once daily, which may be increased as necessary to 20 mg or 40 mg. It should be administered once daily within a range of 10 to 80 mg. Dosage adjustments should be made after 2 to 4 weeks based on treatment goals and responses. Patients with homozygous familial hypercholesterolemia should also be given a dose within the range of 10 to 80 mg once daily.

Child dose

The recommended starting dose for pediatric patients (ages 10 to 17) with heterozygous familial hypercholesterolemia is 10 mg once daily, with a maximum dose of 20 mg daily. Dosage adjustments should be made at intervals of 4 weeks or more based on treatment goals.

Precautions

This medication should be discontinued immediately if any unusual muscle symptoms appear, especially muscle pain or weakness, and a significant increase in creatine kinase levels should be closely monitored. This drug should not be administered to patients with certain conditions, such as those with liver disease or muscle diseases, women who are pregnant or breastfeeding, children under 10 years old, and patients on certain medications. Patients with a history of alcohol abuse or liver disease, impaired kidney function, and the elderly should exercise particular caution while using this medication and should be monitored frequently for muscle-related side effects. Generally, this drug is well-tolerated, but rare side effects may include liver dysfunction, myopathy, allergic reactions, gastrointestinal disturbances, headache, dizziness, and skin rashes. Any persistent or worsening symptoms should be reported to a healthcare professional. This medication can interact with other drugs; especially, it should be discussed with a doctor or pharmacist when taken with certain antibiotics, antifungals, antivirals, antidiabetic medicines, and oral contraceptives. Women who are pregnant or may become pregnant must ensure appropriate contraceptive methods during treatment with this drug, and should discontinue it immediately upon confirmation of pregnancy. Additionally, breastfeeding women should not take this medication. The safety and efficacy of this drug in children have not been adequately established, so it should be used with caution in pediatric patients under 18 years of age. Elderly patients are at a higher risk for muscle-related side effects, so they should consult healthcare professionals immediately if any unusual symptoms occur while taking this medication. In case of overdose, as there is no specific antidote, treatment should be symptomatic and the liver function and muscle status should be regularly evaluated. This medication should be stored out of reach of children, kept in the original container, and not transferred to other containers for safety.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain of mucous membranes in the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination

Mild side effects

  • Fatigue
  • malaise
  • chest pain
  • peripheral edema
  • tiredness
  • fever
  • nasopharyngitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
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  • loss of appetite
  • constipation
  • abdominal bloating
  • indigestion
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • pharyngeal and laryngeal pain
  • nosebleeds
  • insomnia
  • nightmares
  • headache
  • dizziness
  • paresthesia
  • sensory loss
  • taste disturbances
  • memory loss
  • peripheral neuropathy
  • myalgia
  • arthralgia
  • limb pain
  • musculoskeletal pain
  • muscle cramps
  • joint

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 exposure to air or moisture, at a temperature between 1°C and 30°C, as this helps maintain the medication's effectiveness.

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.