Medication info
Biel Ator Tablet 10 mg (Atorvastatin Calcium Hydrate)

Biel Ator Tablet 10 mg (Atorvastatin Calcium Hydrate)

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

MFDS item code 201904723 · Approved 2019.07.12 · Insurance code 680500780

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 dose is 10 mg of atorvastatin once daily, although patients requiring greater LDL cholesterol reduction may start treatment at 20 mg or 40 mg once daily. The dosage should be administered within the range of 10 to 80 mg once daily, individualized according to therapeutic goals and response. Lipid levels should be analyzed within 2 to 4 weeks after the initiation of therapy to adjust the dosage. The objective of therapy is to reduce LDL cholesterol levels, so it is recommended to use LDL cholesterol levels for evaluating treatment initiation and response. If LDL cholesterol levels cannot be utilized, total cholesterol levels can be used to monitor therapeutic response. In patients with homozygous familial hypercholesterolemia, the dosage of this medication is 10 to 80 mg once daily, either in conjunction with other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unfeasible.
Children's dosage
The recommended initial dose for pediatric patients (ages 10 to 17) with heterozygous familial hypercholesterolemia is 10 mg once daily, and the maximum recommended dose is 20 mg once daily. The dosage should be adjusted based on the individual patient's treatment goals at intervals of 4 weeks or longer.

Ingredients

Manufacturer
동방에프티엘(주)

Efficacy & effects

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

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

This medication helps reduce the risk of cardiovascular disease. It decreases the risks of myocardial infarction and stroke in adults with multiple risk factors for coronary heart disease or in patients with type 2 diabetes, and also reduces the risks associated with vascular interventions and stable angina. Additionally, it helps reduce the risk of non-fatal myocardial infarction, fatal and non-fatal strokes, vascular interventions, heart failure-related hospitalizations, and angina in patients with clinical evidence of heart disease. It is effective for the treatment of hyperlipidemia, improving cholesterol and triglyceride levels in patients with primary hypercholesterolemia and mixed dyslipidemia, and increases HDL cholesterol levels. It is also used as an adjunct to dietary therapy in pediatric patients with heterozygous familial hypercholesterolemia. In summary, this medication is used to lower the risk of cardiovascular disease and hyperlipidemia and improve blood lipid levels.

Dosage and Administration

Adult dosage

For hyperlipidemia, the recommended initial dose is 10 mg of atorvastatin once daily, although patients requiring greater LDL cholesterol reduction may start treatment at 20 mg or 40 mg once daily. The dosage should be administered within the range of 10 to 80 mg once daily, individualized according to therapeutic goals and response. Lipid levels should be analyzed within 2 to 4 weeks after the initiation of therapy to adjust the dosage. The objective of therapy is to reduce LDL cholesterol levels, so it is recommended to use LDL cholesterol levels for evaluating treatment initiation and response. If LDL cholesterol levels cannot be utilized, total cholesterol levels can be used to monitor therapeutic response. In patients with homozygous familial hypercholesterolemia, the dosage of this medication is 10 to 80 mg once daily, either in conjunction with other lipid-lowering treatments (e.g., LDL apheresis) or if such treatments are unfeasible.

Children's dosage

The recommended initial dose for pediatric patients (ages 10 to 17) with heterozygous familial hypercholesterolemia is 10 mg once daily, and the maximum recommended dose is 20 mg once daily. The dosage should be adjusted based on the individual patient's treatment goals at intervals of 4 weeks or longer.

Precautions

This medication may cause unusual symptoms in muscles, so if you experience severe muscle pain or weakness, you should stop taking it immediately and consult your doctor. This medication may affect liver function, so it should not be used if you have liver disease or if your liver function tests are abnormal. Women who are pregnant or may become pregnant should not take this medication and should use appropriate contraception during treatment. Nursing mothers should also avoid this medication and cease breastfeeding while taking it. Children under 10 years old should not take this medication, and adolescents over 10 should take it cautiously and under medical supervision. This medication may increase blood concentration and the risk of side effects when taken with certain drugs, so if you are taking other medications, you must inform your doctor or pharmacist. Patients with liver disease, kidney disease, alcoholism, the elderly, and hypothyroidism need to be particularly cautious when taking this medication. There is a risk of serious muscle-related symptoms such as myopathy or rhabdomyolysis, so if you experience muscle pain, weakness, or fever, seek medical attention immediately. Regular monitoring of liver function tests and blood creatine kinase (CK) levels is important during treatment. Taking this medication with grapefruit juice may increase its blood concentration, so it is advisable to avoid grapefruit juice. This medication contains lactose, so patients with lactose intolerance should not take it. In case of overdose, there is no specific antidote, and treatment should be based on symptoms while regularly monitoring liver function and muscle-related tests. This medication should be kept out of reach of children and stored in its 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, pallor, severe rash with fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory difficulties accompanied by cough and fever, jaundice (yellowing of skin or eyes), extreme fatigue, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination abnormalities

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
  • throat and larynx pain
  • nosebleeds
  • insomnia
  • nightmares
  • headaches
  • dizziness
  • paresthesia
  • sensory loss
  • taste disorders
  • memory loss
  • peripheral neuropathy
  • myalgia
  • arthralgia
  • limb pain
  • musculoskeletal pain
  • muscle cramps
  • joint aches

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

Storage

This medication may be sensitive to air or moisture, so it should be stored in a tightly closed container. The storage temperature should be maintained between 1 to 30 degrees Celsius at room temperature to ensure 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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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.