Medication info
Arotatin Tablet 10 mg (Atorvastatin Calcium Hydrate)

Arotatin Tablet 10 mg (Atorvastatin Calcium Hydrate)

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

MFDS item code 201803135 · Approved 2018.07.30

Summary

Main use
Reduction of the risk of myocardial infarction and stroke, improvement of hypercholesterolemia
Who uses it
Adults · Children
Adult dosage
For hyperlipidemia, the recommended initial dose is 10 mg taken once daily; patients requiring greater LDL cholesterol reduction may start with 20 mg or 40 mg taken once daily. This drug can be administered within a range of 10 to 80 mg once daily, and the dosage should be individualized based on treatment goals and patient response. After initiation of treatment, lipid levels should be analyzed within 2-4 weeks, and dosages should be adjusted accordingly.
Children's dosage
The recommended initial dose for pediatric patients (ages 10-17) with heterozygous familial hypercholesterolemia is 10 mg per day, with a maximum recommended dose of 20 mg per day. Dosage adjustments should be made with intervals of at least 4 weeks.

Ingredients

Manufacturer
(주)유앤생명과학

Efficacy & effects

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

  • Coronary heart disease
  • myocardial infarction
  • stroke
  • vascular intervention
  • chronic stable angina
  • retinopathy
  • albuminuria
  • hypertension
  • congestive heart failure
  • angina
  • hypercholesterolemia
  • dyslipidemia
View approved original text

This medication helps reduce the risk of cardiovascular disease. It is particularly effective in decreasing the risk of myocardial infarction and stroke, the need for vascular intervention, and chronic stable angina in adults aged 55 and over or those with multiple risk factors, including smoking, hypertension, and low HDL cholesterol. Additionally, it reduces the risk of myocardial infarction and stroke in type 2 diabetes patients who have risk factors such as retinopathy, albuminuria, smoking, or hypertension. For patients with clinical evidence of heart disease, it can lower the risks of myocardial infarction, stroke, vascular interventions, hospitalization for congestive heart failure, and angina. It also improves cholesterol and triglyceride levels in patients with hyperlipidemia, serving as an adjunct in some patients with dyslipidemia who do not respond to dietary modifications. In pediatric patients with heterozygous familial hypercholesterolemia, it helps improve total cholesterol and LDL cholesterol levels. In summary, this drug is widely used for reducing the risk of cardiovascular disease and treating dyslipidemia.

Dosage and Administration

Adult dosage

For hyperlipidemia, the recommended initial dose is 10 mg taken once daily; patients requiring greater LDL cholesterol reduction may start with 20 mg or 40 mg taken once daily. This drug can be administered within a range of 10 to 80 mg once daily, and the dosage should be individualized based on treatment goals and patient response. After initiation of treatment, lipid levels should be analyzed within 2-4 weeks, and dosages should be adjusted accordingly.

Children's dosage

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

Precautions

This medication may cause abnormal muscle symptoms, so if severe muscle pain, weakness, or cramps occur, discontinue use immediately and consult your physician. This drug may affect liver function; therefore, it should not be used in individuals with liver disease or abnormal liver function test results. Pregnant women, women who may become pregnant, and breastfeeding women should not take this medication and must use appropriate contraception beforehand. This medication is not indicated for children under 10 years old or patients with muscle diseases. Patients with a history of alcohol abuse or liver disease should use this drug cautiously and undergo regular liver function tests. The risk of side effects may increase if this medication is taken alongside certain antibiotics, antifungals, and antivirals; inform your doctor or pharmacist if you are taking other medications. Report any symptoms such as muscle pain, fatigue, or fever to your healthcare provider, and blood tests should be conducted to check for muscle damage. This medication contains lactose, and therefore, patients with lactose intolerance should avoid it. Be cautious when consuming grapefruit juice while taking this medication, as it may increase serum drug concentrations and the risk of side effects. Elderly patients or those with reduced kidney function are at a higher risk of muscle-related side effects and require careful monitoring during treatment. There is no specific antidote for overdose; treatment should be symptomatic, and liver function and muscle damage should be assessed. Keep out of reach of children and do not transfer the medication to other containers.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe allergic reactions, high fever with severe rash, blisters, skin peeling, oral/ocular mucosal pain, severe skin reactions, difficulty breathing or shortness of breath, asthma attacks, respiratory issues accompanied by cough and fever, jaundice, extreme lethargy, liver abnormalities (jaundice), sudden

Mild side effects

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

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

Storage

Store this medication in a tightly closed container to protect it from air and moisture. It is best to maintain a storage temperature 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.