Medication info
Bieltova Tablet 20mg (Atorvastatin Calcium Hydrate)

Bieltova Tablet 20mg (Atorvastatin Calcium Hydrate)

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

MFDS item code 201602933 · Approved 2016.05.25 · Insurance code 622600510

Summary

Main use
Reduction of the risk of myocardial infarction and stroke, improvement of hypercholesterolemia
Who uses it
Adults · Children
Adult dosage
For hyperlipidemia, the recommended starting dose is 10 mg of atorvastatin once daily; however, for patients requiring a greater reduction in LDL-cholesterol levels, it can be initiated at 20 mg or 40 mg once daily. This medication is administered within a dosage range of 10 to 80 mg once daily, and starting and maintenance doses should be individualized based on treatment goals and response. During the initial treatment and dose adjustment, lipid levels should be evaluated within 2 to 4 weeks, and doses should be adjusted accordingly. The goal of treatment is to reduce LDL-cholesterol levels, so it is recommended to monitor LDL-cholesterol during treatment initiation and evaluation of treatment response. However, if LDL-cholesterol levels cannot be monitored, total cholesterol levels can be used to assess treatment response. For patients with homozygous familial hypercholesterolemia, the dosing is 10 to 80 mg once daily, either in conjunction with other lipid-lowering therapies (e.g., LDL apheresis) or administered when those therapies are not feasible.
Children's dosage
The recommended starting dose for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) is 10 mg daily, with a maximum recommended dose of 20 mg per day. The dosage should be appropriately adjusted based on treatment goals.

Ingredients

Manufacturer
(주)씨엘팜

Efficacy & effects

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

  • Multiple risk factors for coronary heart disease
  • myocardial infarction
  • stroke
  • chronic stable angina
  • retinopathy
  • albuminuria
  • hypertension
  • non-fatal myocardial infarction
  • fatal and non-fatal stroke
  • congestive heart failure
  • angina
  • hypercholesterolemia
View approved original text

This medication helps to reduce the risk of cardiovascular diseases. It lowers the risk of myocardial infarction and stroke in adults with multiple risk factors for coronary heart disease and in patients with type 2 diabetes. Additionally, it is effective in reducing the risk of myocardial infarction, stroke, vascular procedures, congestive heart failure hospitalizations, and angina in patients who already have coronary heart disease. It is also used in the treatment of hyperlipidemia by reducing total cholesterol and LDL-cholesterol levels and increasing HDL-cholesterol levels. It serves as an adjunct therapy for patients with dyslipidemia who do not respond to dietary modifications or familial hypercholesterolemia. It is particularly useful in lowering cholesterol levels among young pediatric patients with heterozygous familial hypercholesterolemia. This medication is used for the prevention and treatment of cardiovascular diseases due to these efficacy ratings.

Dosage and Administration

Adult dosage

For hyperlipidemia, the recommended starting dose is 10 mg of atorvastatin once daily; however, for patients requiring a greater reduction in LDL-cholesterol levels, it can be initiated at 20 mg or 40 mg once daily. This medication is administered within a dosage range of 10 to 80 mg once daily, and starting and maintenance doses should be individualized based on treatment goals and response. During the initial treatment and dose adjustment, lipid levels should be evaluated within 2 to 4 weeks, and doses should be adjusted accordingly. The goal of treatment is to reduce LDL-cholesterol levels, so it is recommended to monitor LDL-cholesterol during treatment initiation and evaluation of treatment response. However, if LDL-cholesterol levels cannot be monitored, total cholesterol levels can be used to assess treatment response. For patients with homozygous familial hypercholesterolemia, the dosing is 10 to 80 mg once daily, either in conjunction with other lipid-lowering therapies (e.g., LDL apheresis) or administered when those therapies are not feasible.

Children's dosage

The recommended starting dose for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) is 10 mg daily, with a maximum recommended dose of 20 mg per day. The dosage should be appropriately adjusted based on treatment goals.

Precautions

This medication may cause severe adverse reactions affecting the muscles; therefore, if symptoms such as muscle pain or weakness occur, treatment should be immediately discontinued, and a physician should be consulted. This medication should not be used in patients with specific liver diseases or severely impaired liver function, and if symptoms of abnormal liver function occur, medical professionals should be notified immediately. Pregnant women, women who may become pregnant, and nursing mothers should not take this medication, and women of childbearing age should use appropriate contraceptive methods while taking this medication. This medication should not be administered to children under 10 years old, and elderly patients over 65 or those with reduced kidney function should use it with caution due to the increased risk of muscle adverse reactions. Interactions may occur when combined with other medications, especially those metabolized by the liver or certain antibiotics, antifungals, or antivirals; therefore, consultation with a physician or pharmacist is advised. This medication contains lactose, so patients with lactose intolerance should not take it. It is essential to undergo regular liver function tests and muscle-related tests during the course of this medication to monitor for adverse reactions. There is no specific antidote for overdose, so treatment should be symptomatic and followed under medical direction. Store this medication out of reach of children and keep it in its original container to prevent misuse or quality degradation.

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, blistering, skin peeling, pain in oral/ocular mucosa, severe allergic reactions, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, respiratory issues, yellowing of the skin or eyes (jaundice), severe overall weakness, liver abnormality (jaundice), sudden...

Mild side effects

  • Weakness
  • fatigue
  • chest pain
  • peripheral edema
  • tiredness
  • fever
  • pharyngitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
Show 27 more
  • decreased appetite
  • constipation
  • abdominal bloating
  • dyspepsia
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • throat and larynx pain
  • nosebleed
  • insomnia
  • nightmares
  • headache
  • dizziness
  • paresthesia
  • sensory loss
  • taste disturbances
  • memory loss
  • peripheral neuropathy
  • muscle pain
  • joint pain
  • 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 sealed container to prevent exposure to air or moisture. Additionally, it is recommended to store it at room temperature between 1°C and 30°C.

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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.