Medication info
Biel Tobab 10 mg (Atorvastatin Calcium Hydrate)

Biel Tobab 10 mg (Atorvastatin Calcium Hydrate)

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

MFDS item code 201602773 · Approved 2016.05.19 · Insurance code 622600500

Summary

Main use
Reduces the risk of myocardial infarction and stroke, and improves hypercholesterolemia
Who uses it
Adults · Children
Adult dosage
The recommended initial dose for treating hyperlipidemia is 10 mg once daily; however, if greater LDL-cholesterol reduction is necessary, it can be started at 20 mg or 40 mg once daily. Generally, it is administered in a range of 10-80 mg once daily. The administration dosage should be individualized based on therapeutic goals and patient response, and lipid levels should be analyzed every 2-4 weeks to adjust the dosage. For patients with homozygous familial hypercholesterolemia, the dosing ranges from 10 to 80 mg once daily and should be used along with other lipid-lowering treatments (e.g., LDL apheresis) or when such therapies are unavailable.
Children's dosage
The recommended initial dose for pediatric patients with heterozygous familial hypercholesterolemia (ages 10-17) is 10 mg once daily, with a maximum recommended dose of 20 mg once daily. The dosage is adjusted according to therapeutic goals.

Ingredients

Manufacturer
(주)씨엘팜

Efficacy & effects

Reduces the risk of myocardial infarction and stroke, and improves hypercholesterolemia

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

This medication helps reduce the risks of cardiovascular diseases. It specifically lowers the risks of myocardial infarction, stroke, vascular procedures, and angina, protecting heart health. It is effective for patients with diabetes or adults with multiple risk factors. Additionally, it helps to reduce the risk of hospitalization due to heart failure and decreases the multifactorial risks of heart disease. For patients with hyperlipidemia, it lowers total cholesterol and LDL-cholesterol levels while increasing HDL-cholesterol levels, thereby improving blood lipid status. It is also used for treating pediatric patients with a family history or other risk factors. This drug is effectively used for the treatment of cardiovascular diseases and hyperlipidemia.

Dosage and Administration

Adult dosage

The recommended initial dose for treating hyperlipidemia is 10 mg once daily; however, if greater LDL-cholesterol reduction is necessary, it can be started at 20 mg or 40 mg once daily. Generally, it is administered in a range of 10-80 mg once daily. The administration dosage should be individualized based on therapeutic goals and patient response, and lipid levels should be analyzed every 2-4 weeks to adjust the dosage. For patients with homozygous familial hypercholesterolemia, the dosing ranges from 10 to 80 mg once daily and should be used along with other lipid-lowering treatments (e.g., LDL apheresis) or when such therapies are unavailable.

Children's dosage

The recommended initial dose for pediatric patients with heterozygous familial hypercholesterolemia (ages 10-17) is 10 mg once daily, with a maximum recommended dose of 20 mg once daily. The dosage is adjusted according to therapeutic goals.

Precautions

This drug may cause muscle-related symptoms, so if there are symptoms such as muscle pain or muscle weakness, or if muscle-related test results significantly increase, the medication should be discontinued immediately and medical consultation should be sought. Additionally, special caution is required in cases of acute infections, hypotension, major surgeries, trauma, severe metabolic disorders, or liver dysfunction. This medication should not be used in individuals with certain liver diseases or muscle disorders, pregnant or breastfeeding women, children under 10 years of age, and patients taking certain medications. Those with a history of alcohol addiction or liver disease, patients with poor kidney function, or those with hypothyroidism should be particularly careful when using this drug. Routine liver function tests should be conducted while taking this medication, and if symptoms of hepatitis, skin rash, or severe allergic reactions occur, immediate medical attention is required. This drug has many potential drug interactions, so it is essential to inform the doctor or pharmacist about concurrent use of antibiotics, antifungals, antivirals, some antihypertensives, and oral contraceptives, as dosage adjustments may be necessary. Pregnant or breastfeeding women should not take this drug, and women of childbearing age should use appropriate contraception while taking it. Elderly patients or those with reduced kidney function may be more prone to muscle-related symptoms, so caution is advised. In the case of overdose, there is no specific antidote, so appropriate treatment should be provided based on symptoms, and it should be kept out of the reach of children.

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 high fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or trouble breathing, asthma attack, respiratory distress with cough and fever, yellowing of skin or eyes (jaundice), severe malaise, sudden and severe headache, thunderclap headache, seizures, disorientation, visual disturbances, paralysis, urination issues

Mild side effects

  • Weakness
  • fatigue
  • chest pain
  • peripheral edema
  • tiredness
  • fever
  • rhinitis
  • 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
  • nosebleed
  • insomnia
  • nightmares
  • headache
  • dizziness
  • paresthesia
  • sensory loss
  • taste disturbances
  • 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 best to maintain a storage temperature between 1 Degree Celsius and 30 Degrees Celsius.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

Bottle packaging - 30 tablets/bottle, Bottle packaging - 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.