Medication info
Atorvastatin Calcium Hydrate Tablets 10 mg

Atorvastatin Calcium Hydrate Tablets 10 mg

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

MFDS item code 201905536 · Approved 2019.08.06

Summary

Main use
Reduces the risk of myocardial infarction and stroke and improves hyperlipidemia
Who uses it
Adults · Children
Adult dosage
For hyperlipidemia, the recommended initial dose is 10 mg of atorvastatin once daily; for patients requiring a greater reduction in LDL cholesterol levels, treatment may be initiated with 20 mg or 40 mg once daily. The dosage range is 10 to 80 mg once daily. The initial and maintenance doses should be individualized based on treatment goals and responses, and lipid levels should be analyzed within 2 to 4 weeks after starting therapy.
Children's dosage
For pediatric patients (10-17 years) with heterozygous familial hypercholesterolemia, the recommended initial dose is 10 mg once daily, and the recommended maximum dose is 20 mg once daily. The dosage should be adjusted every 4 weeks or longer intervals.

Ingredients

Manufacturer
독립바이오제약(주)

Efficacy & effects

Reduces the risk of myocardial infarction and stroke and improves hyperlipidemia

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

This drug helps reduce the risk of cardiovascular disease and improve hyperlipidemia. It decreases the risk of myocardial infarction and stroke in adults with multiple risk factors for coronary heart disease or in patients with type 2 diabetes. In patients with confirmed heart disease, it lowers the risks of myocardial infarction, stroke, vascular surgeries, heart failure admissions, and angina. In treating hyperlipidemia, it is used to lower cholesterol and triglyceride levels in patients with primary and familial hypercholesterolemia and mixed dyslipidemia, and to increase HDL cholesterol levels. It is also helpful for certain types of dyslipidemia that do not respond to diet. It is effective as an adjunct to diet in pediatric patients aged 10 to 17 with familial hypercholesterolemia. This drug effectively improves the management of cardiovascular disease and hyperlipidemia.

Dosage and Administration

Adult dosage

For hyperlipidemia, the recommended initial dose is 10 mg of atorvastatin once daily; for patients requiring a greater reduction in LDL cholesterol levels, treatment may be initiated with 20 mg or 40 mg once daily. The dosage range is 10 to 80 mg once daily. The initial and maintenance doses should be individualized based on treatment goals and responses, and lipid levels should be analyzed within 2 to 4 weeks after starting therapy.

Children's dosage

For pediatric patients (10-17 years) with heterozygous familial hypercholesterolemia, the recommended initial dose is 10 mg once daily, and the recommended maximum dose is 20 mg once daily. The dosage should be adjusted every 4 weeks or longer intervals.

Precautions

This medication carries a risk of muscle problems, so if muscle pain, weakness, or severe muscle pain occurs, you should immediately discontinue the drug and consult a doctor. This drug may affect liver function and should not be used if there are existing liver diseases or significantly elevated liver function tests. Pregnant women or women who could become pregnant, as well as nursing mothers, should not take this drug, and women of childbearing age should use appropriate contraception while taking the medication. This drug is not to be administered to children, especially to those under 10 years of age. Patients with a history of alcoholism or liver disease should use this drug cautiously and undergo regular liver function tests. The risk of side effects may increase when this drug is taken with certain medications, so you must inform your doctor or pharmacist of any other drugs you are taking. Side effects such as muscle pain, fatigue, gastrointestinal discomfort, headache may occur, and rare instances of skin rashes or allergic reactions could happen, so report any unusual symptoms to your healthcare provider immediately. Elderly patients or those with impaired kidney function are at higher risk of muscle problems, so caution is advised during use. While taking this drug, it is advisable to avoid strenuous exercise or activities that may overstrain the muscles. In case of overdose, there is no specific antidote, and treatment should be based on symptoms; liver function and muscle enzyme levels should be regularly checked. This drug should be kept out of reach of children and stored in its original container to prevent quality degradation.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, paleness, severe allergic reactions, severe rash with high fever, blisters, skin peeling, pain in the mucous membranes of mouth/eyes, severe skin reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanying cough and fever, jaundice (yellowing of the skin or eyes), profound lethargy, liver abnormalities (jaundice), sudden and

Mild side effects

  • Weakness
  • fatigue
  • chest pain
  • peripheral edema
  • tiredness
  • fever
  • pharyngitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
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  • loss of appetite
  • constipation
  • abdominal bloating
  • indigestion
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • throat and laryngeal pain
  • nosebleeds
  • insomnia
  • nightmares
  • headache
  • dizziness
  • paresthesia
  • sensory loss
  • taste changes
  • memory loss
  • peripheral neuropathy
  • muscle pain
  • joint pain
  • limb pain
  • musculoskeletal pain
  • muscle cramps
  • joint pain

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

Storage

This drug should be stored in a sealed container to prevent air or moisture from entering, and it is safe to store at a temperature between 1 and 30 degrees Celsius. Storing it this way will help maintain the effectiveness of the medication.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

For domestic use - 30 tablets/bottle, For domestic use - 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.