Medication info
Daewoong Bio Atorvastatin Tablets 20 mg (Atorvastatin Calcium Trihydrate)

Daewoong Bio Atorvastatin Tablets 20 mg (Atorvastatin Calcium Trihydrate)

Prescription medicationTablet
Ingredient · strength
Atorvastatin Calcium Trihydrate›21.7mg / 1 tablet
Manufacturer / importer
대웅바이오(주)
Appearance
White, round film-coated tablets
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201500979 · Approved 2015.02.25 · Insurance code 694000800

Summary

Main use
Treatment to reduce the risk of myocardial infarction and stroke and improve hyperlipidemia
Who uses it
Adults · Children
Adult dosage
For hyperlipidemia, the recommended starting dose is atorvastatin 10 mg once daily. If a greater reduction in LDL cholesterol is needed, it may start at 20 mg or 40 mg once daily, with administration within the range of 10-80 mg once daily. Dosage should be individualized based on treatment goals and patient characteristics, and lipid levels should be analyzed within 2-4 weeks after starting treatment or adjusting dosage to make further adjustments.
Children's dosage
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10-17), the recommended starting dose is 10 mg once daily and the maximum dose is 20 mg once daily. Dosage should be adjusted appropriately based on the treatment goals.

Ingredients

Manufacturer
대웅바이오(주)

Efficacy & effects

Treatment to reduce the risk of myocardial infarction and stroke and improve hyperlipidemia

  • Coronary heart disease
  • myocardial infarction
  • stroke
  • vascular interventions
  • chronic stable angina
  • retinopathy
  • albuminuria
  • hypertension
  • type 2 diabetes
  • congestive heart failure
  • angina
  • hypercholesterolemia
View approved original text

This medication helps reduce the risk of various cardiovascular diseases. It lowers the risk of major cardiovascular events, including myocardial infarction and stroke, and reduces the risk of vascular interventions and angina. It is particularly effective in adults with multiple risk factors such as hypertension, smoking, and family history, as well as in patients with type 2 diabetes. Additionally, it decreases the possibility of hospitalization due to congestive heart failure. Furthermore, in patients with hyperlipidemia, it supports dietary therapy to lower total cholesterol, LDL cholesterol, apo-B protein, and triglyceride levels, while increasing HDL cholesterol, which is the good cholesterol. It can also be used in pediatric patients with heterozygous familial hypercholesterolemia to effectively control cholesterol levels. Therefore, this drug is used for the reduction of cardiovascular disease risk and the improvement of hyperlipidemia.

Dosage and Administration

Adult dosage

For hyperlipidemia, the recommended starting dose is atorvastatin 10 mg once daily. If a greater reduction in LDL cholesterol is needed, it may start at 20 mg or 40 mg once daily, with administration within the range of 10-80 mg once daily. Dosage should be individualized based on treatment goals and patient characteristics, and lipid levels should be analyzed within 2-4 weeks after starting treatment or adjusting dosage to make further adjustments.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10-17), the recommended starting dose is 10 mg once daily and the maximum dose is 20 mg once daily. Dosage should be adjusted appropriately based on the treatment goals.

Precautions

This medication poses a risk of muscle problems, so if symptoms of muscle pain or weakness occur, treatment should be stopped immediately and a doctor consulted. This medication should not be used in patients with specific liver diseases or severely impaired liver function. Pregnant women, women who may become pregnant, and nursing mothers should not take this medication. Children under 10 years and patients with muscle disorders should also not take this medication. Due to the potential impact on liver function, it is important to have regular liver function tests while taking this medication. If any severe muscle pain, muscle weakness, fever, or fatigue occurs during treatment, the doctor should be informed immediately. Patients with a history of liver disease or high alcohol intake should exercise caution when using this medication. This drug may increase the risk of side effects when taken with certain medications, so if other medications are being taken, it is important to inform the doctor or pharmacist. Grapefruit juice should be avoided as it may increase blood levels of this medication, raising the risk of side effects. Elderly patients may have a higher risk of muscle issues, thus they should be monitored more closely while taking this medication. When storing this medication, keep it out of reach of children and store it in its original container.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in mouth/eye mucosa, shortness of breath or difficulty breathing, asthma attack, cough with fever and breathing difficulties, jaundice (yellowing of skin or eyes), profound lethargy, sudden and severe headache, thunderclap headache, seizures, confusional state, visual disturbances, paralysis, urination changes

Mild side effects

  • Weakness
  • fatigue
  • chest pain
  • peripheral edema
  • exhaustion
  • fever
  • nasopharyngitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
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  • loss of appetite
  • constipation
  • abdominal bloating
  • dyspepsia
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • oropharyngeal/laryngeal pain
  • nosebleeds
  • insomnia
  • nightmares
  • headache
  • dizziness
  • paresthesia
  • sensory loss
  • taste disturbance
  • memory loss
  • peripheral neuropathy
  • myalgia
  • arthralgia
  • limb pain
  • musculoskeletal pain
  • muscle cramps
  • joints

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 air or moisture from entering. The recommended storage temperature is room temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

White, round film-coated tablets

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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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.