Medication info
BC Atorvastatin Tablets 20 mg (Atorvastatin Calcium Hydrate)

BC Atorvastatin Tablets 20 mg (Atorvastatin Calcium Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Atorvastatin Calcium Hydrate›21.69mg / 1 tablet
Manufacturer / importer
(주)비씨월드제약
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 200712032 · Approved 2007.11.02 · Insurance code 653100610

Summary

Main use
Reduction of risks for myocardial infarction and stroke and improvement of hyperlipidemia
Who takes it
Adults · Children
Adult dose
For the treatment of hyperlipidemia, the recommended initial dose is 10 mg once a day, and patients requiring more LDL cholesterol reduction may start at 20 mg or 40 mg once a day. The total dose range is from 10 mg to 80 mg once a day. Dosage should be individualized based on treatment goals and patient response, with lipid levels analyzed and adjusted 2 to 4 weeks after initiation and/or dose adjustment. The goal of treatment is to reduce LDL cholesterol levels, so it is recommended to use LDL cholesterol for evaluating treatment response. However, if LDL cholesterol levels cannot be utilized, total cholesterol levels may be employed for monitoring treatment response. For patients with homozygous familial hypercholesterolemia, the dosing range of this drug is 10 mg to 80 mg once a day, either in conjunction with other lipid-lowering treatments (e.g., LDL apheresis) or when such treatments are not feasible. 2. For pediatric patients (ages 10 to 17) with heterozygous familial hypercholesterolemia, the recommended starting dose is 10 mg once a day, and the maximum recommended dose is 20 mg once a day (there is no clinical data for doses higher than 20 mg in this pediatric population). The dose should be appropriately adjusted based on the recommended treatment targets for each individual patient. Dosage should be adjusted at intervals of 4 weeks or longer. ○ For patients with renal impairment: Renal disease does not affect the plasma concentration or LDL cholesterol-lowering effect of atorvastatin, so no dosage adjustment is necessary. ○ For elderly patients: Efficacy and safety in patients aged 70 years or older are similar to those in the general adult population.
Child dose
The recommended initial dose for pediatric patients (ages 10 to 17) with heterozygous familial hypercholesterolemia is 10 mg once a day, and the maximum dose is 20 mg once a day. The dosage should be adjusted based on the treatment goals with intervals of 4 weeks or longer.

Ingredients

Manufacturer
(주)비씨월드제약

Efficacy & effects

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

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

This medication helps reduce the risk of cardiovascular diseases. It specifically lowers the risk of myocardial infarction and stroke in adults with multiple risk factors and patients with type 2 diabetes. Additionally, in patients who already have coronary heart disease, it reduces the risk of non-fatal myocardial infarction, stroke, revascularization, congestive heart failure hospitalization, and angina. It is also used in the treatment of hyperlipidemia, improving cholesterol and triglyceride levels in patients with primary hypercholesterolemia and mixed dyslipidemia. It is effective in pediatric patients with familial hypercholesterolemia. This drug is used for the prevention of cardiovascular diseases and improvement of hyperlipidemia.

How to take

Adult dose

For the treatment of hyperlipidemia, the recommended initial dose is 10 mg once a day, and patients requiring more LDL cholesterol reduction may start at 20 mg or 40 mg once a day. The total dose range is from 10 mg to 80 mg once a day. Dosage should be individualized based on treatment goals and patient response, with lipid levels analyzed and adjusted 2 to 4 weeks after initiation and/or dose adjustment. The goal of treatment is to reduce LDL cholesterol levels, so it is recommended to use LDL cholesterol for evaluating treatment response. However, if LDL cholesterol levels cannot be utilized, total cholesterol levels may be employed for monitoring treatment response. For patients with homozygous familial hypercholesterolemia, the dosing range of this drug is 10 mg to 80 mg once a day, either in conjunction with other lipid-lowering treatments (e.g., LDL apheresis) or when such treatments are not feasible. 2. For pediatric patients (ages 10 to 17) with heterozygous familial hypercholesterolemia, the recommended starting dose is 10 mg once a day, and the maximum recommended dose is 20 mg once a day (there is no clinical data for doses higher than 20 mg in this pediatric population). The dose should be appropriately adjusted based on the recommended treatment targets for each individual patient. Dosage should be adjusted at intervals of 4 weeks or longer. ○ For patients with renal impairment: Renal disease does not affect the plasma concentration or LDL cholesterol-lowering effect of atorvastatin, so no dosage adjustment is necessary. ○ For elderly patients: Efficacy and safety in patients aged 70 years or older are similar to those in the general adult population.

Child dose

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

Precautions

This drug may cause muscle problems, so if symptoms of muscle pain or weakness occur, you should immediately stop taking it and consult a doctor. This drug may affect liver function and should not be used in patients with liver disease or elevated liver enzymes. Women who are pregnant or may become pregnant, as well as nursing mothers, should not take this medication. It should not be administered to children, especially those under 10 years old. Alcoholics or patients with a history of liver disease should use this drug cautiously and undergo regular liver function tests. This drug may interact with other medications, so you must inform your doctor or pharmacist if you are taking other medications. Particular caution is needed when taken with certain antibiotics, antifungals, and HIV treatments. During the use of this drug, it is advisable to avoid excessive consumption of grapefruit juice. If symptoms like muscle pain, weakness, fever, or fatigue occur, report immediately to your physician for examination. This drug may increase blood glucose levels, so patients at risk for diabetes should manage their blood sugar carefully. Elderly patients or those with impaired kidney function face a higher risk of muscle-related side effects and should be monitored more closely. In cases of overdose, there is no specific antidote, so immediate hospitalization is required for symptomatic treatment. Keep this medication out of the reach of children and store it in its original container.

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, mucosal pain in mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough and fever, yellowing of skin or eyes (jaundice), profound lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urination

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
  • pharyngitis/laryngitis pain
  • nosebleeds
  • insomnia
  • nightmares
  • headache
  • dizziness
  • paresthesia
  • sensation 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 should be stored in a tightly closed container to prevent exposure to air and moisture. It is important 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.

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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.