Medication info

Arbatin Tablet 20 mg (Atorvastatin Calcium Hydrate)

Prescription medicationTabletExpired
Ingredient · strength
Atorvastatin Calcium Hydrate›21.7mg / 1 tablet
Manufacturer / importer
메딕스제약(주)
Appearance
White oval film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Expired

MFDS item code 201900171 · Approved 2019.01.14

This product's status changed to Expired on 2024.01.14. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Reduction of risk of myocardial infarction and stroke, improvement of hypercholesterolemia
Who uses it
Adults · Children
Adult dosage
For the treatment of hyperlipidemia, the recommended initial dose is 10 mg once daily; for patients needing greater reductions in LDL cholesterol, treatment may begin at 20 mg or 40 mg once daily. The dose should be adjusted within the range of 10 to 80 mg once daily, individualized based on treatment goals and patient response. Lipid levels should be analyzed within 2 to 4 weeks after treatment initiation to adjust the dose. The treatment goal is to lower LDL cholesterol levels, so LDL cholesterol should be monitored during treatment initiation and evaluation. If LDL cholesterol levels are not available, total cholesterol levels can be used to monitor therapeutic response.
Children's dosage
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the recommended initial dose is 10 mg once daily, with a maximum dose of 20 mg once daily. Dose adjustment should be made according to treatment goals.

Ingredients

Manufacturer
메딕스제약(주)

Efficacy & effects

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

  • Myocardial infarction
  • stroke
  • vascular surgery
  • chronic stable angina
  • retinopathy
  • albuminuria
  • congestive heart failure
  • angina
  • hypercholesterolemia
  • dyslipidemia
  • dysbeta-lipoproteinemia
  • increased serum triglycerides
View approved original text

This medication is used to reduce the risk of cardiovascular disease. It decreases the risk of myocardial infarction, stroke, need for vascular interventions, angina, and hospitalization for congestive heart failure in adults with multiple risk factors for coronary heart disease and in patients with type 2 diabetes. It also effectively helps improve cholesterol and lipid levels in patients with primary hypercholesterolemia or mixed dyslipidemia, dysbeta-lipoproteinemia, and hypertriglyceridemia. It can be safely used in pediatric patients aged 10 to under 17 years with hypercholesterolemia persisting despite dietary measures. This medication is used to manage risk factors for cardiovascular disease and improve cholesterol levels to enhance overall heart health.

Dosage and Administration

Adult dosage

For the treatment of hyperlipidemia, the recommended initial dose is 10 mg once daily; for patients needing greater reductions in LDL cholesterol, treatment may begin at 20 mg or 40 mg once daily. The dose should be adjusted within the range of 10 to 80 mg once daily, individualized based on treatment goals and patient response. Lipid levels should be analyzed within 2 to 4 weeks after treatment initiation to adjust the dose. The treatment goal is to lower LDL cholesterol levels, so LDL cholesterol should be monitored during treatment initiation and evaluation. If LDL cholesterol levels are not available, total cholesterol levels can be used to monitor therapeutic response.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the recommended initial dose is 10 mg once daily, with a maximum dose of 20 mg once daily. Dose adjustment should be made according to treatment goals.

Precautions

This medication may cause unusual muscle symptoms, and if severe muscle pain or weakness occurs or creatine kinase levels rise significantly, it should be discontinued immediately. Patients with impaired liver function or active liver disease should not use this medication. Patients with muscle disorders or suspected muscle disorders, pregnant or potentially pregnant women, children under 10 years of age, and patients taking certain medications should also avoid using this medication. Patients with a history of alcohol dependence or liver disease should use this medication cautiously, and those at risk for muscle issues should have their muscle enzyme levels checked before treatment. This medication is generally safe, but side effects such as muscle pain, dyspepsia, headache, allergic reactions, and liver function abnormalities may occasionally occur, so consultation with a physician is advisable if symptoms worsen. Taking this medication in conjunction with certain antibiotics, antifungals, and antiviral agents may increase blood concentration and risk of side effects; therefore, inform your physician of any concomitant medications. Women who are pregnant or breastfeeding should not take this medication, and women of childbearing age should use appropriate contraception while on treatment. Elderly patients or those with reduced kidney function are at higher risk for muscle-related side effects, so careful administration under physician guidance is necessary. In case of overdose, there is no specific antidote, so symptomatic treatment should be given, and liver function and muscle enzymes should be monitored regularly. Keep this medication out of reach of children, store it in its original container, and do not transfer it 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 rash accompanied by high fever, blisters, skin peeling, pain in mouth/eye mucosa, severe skin reactions, shortness of breath or difficulty breathing, asthma attack, respiratory issues with cough + fever, jaundice (yellowing of skin or eyes), extreme lethargy, liver abnormalities (jaundice), sudden and severe headache, thunderclap headache, fainting

Mild side effects

  • Weakness
  • fatigue
  • chest pain
  • peripheral edema
  • tiredness
  • fever
  • nasopharyngitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
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  • appetite loss
  • constipation
  • abdominal bloating
  • dyspepsia
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • throat and larynx 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 may be sensitive to air and moisture; therefore, it should be stored in a tightly closed container. Additionally, avoid extremely hot or cold places, and it is recommended to store it at room temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

White oval 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.

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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.