Medication info
Atorvastatin Calcium Hydrate Tablets 20 mg

Atorvastatin Calcium Hydrate Tablets 20 mg

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

MFDS item code 201602876 · Approved 2016.05.23 · Insurance code 073001450

Summary

Main use
Reduction of the risk of myocardial infarction and stroke, improvement of hyperlipidemia
Who uses it
Adults · Children
Adult dosage
For the treatment of hyperlipidemia, the recommended initial dose is 10 mg once daily, which may be increased to 20 mg or 40 mg as needed. The medication can be administered within a dose range of 10 to 80 mg once daily, individualized based on treatment goals and patient response. Lipid levels should be analyzed within 2 to 4 weeks after starting treatment to adjust the dose. The treatment goal is to reduce LDL cholesterol levels, and it is recommended to monitor LDL cholesterol levels for evaluation of treatment response. However, if LDL cholesterol levels cannot be assessed, total cholesterol levels may be used for response monitoring. For patients with homozygous familial hypercholesterolemia, the dose of this medication is 10 to 80 mg once daily, either in conjunction with other lipid-lowering therapies (e.g., LDL apheresis) or when these therapies are not possible.
Children's dosage
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the recommended initial dose is 10 mg once daily, and the maximum dose is 20 mg once daily. Doses should be adjusted according to treatment goals at intervals of 4 weeks or longer.

Ingredients

Manufacturer
건일바이오팜주식회사

Efficacy & effects

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

  • Myocardial infarction
  • stroke
  • 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 risk of cardiovascular diseases. It is used to lower the risk of myocardial infarction and stroke in adults with multiple risk factors such as hypertension, smoking, hyperlipidemia, and in patients with type 2 diabetes. Additionally, it helps reduce the risk of various heart-related issues such as myocardial infarction, stroke, angina, and congestive heart failure in patients with pre-existing coronary heart disease. Furthermore, it is effective in lowering LDL cholesterol and total cholesterol while increasing HDL cholesterol in patients with hyperlipidemia, thus improving blood lipid levels. It is also effective in children with familial hypercholesterolemia and is used as an adjunct to dietary therapy. Overall, this drug is used to improve cardiovascular health and reduce the risk of major heart diseases.

Dosage and Administration

Adult dosage

For the treatment of hyperlipidemia, the recommended initial dose is 10 mg once daily, which may be increased to 20 mg or 40 mg as needed. The medication can be administered within a dose range of 10 to 80 mg once daily, individualized based on treatment goals and patient response. Lipid levels should be analyzed within 2 to 4 weeks after starting treatment to adjust the dose. The treatment goal is to reduce LDL cholesterol levels, and it is recommended to monitor LDL cholesterol levels for evaluation of treatment response. However, if LDL cholesterol levels cannot be assessed, total cholesterol levels may be used for response monitoring. For patients with homozygous familial hypercholesterolemia, the dose of this medication is 10 to 80 mg once daily, either in conjunction with other lipid-lowering therapies (e.g., LDL apheresis) or when these therapies are not possible.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the recommended initial dose is 10 mg once daily, and the maximum dose is 20 mg once daily. Doses should be adjusted according to treatment goals at intervals of 4 weeks or longer.

Precautions

This medication may pose a risk of muscle problems; therefore, if you experience severe muscle pain or weakness or a significant increase in creatine kinase levels, you should stop taking it immediately. This medication should not be used in patients with specific liver diseases or severely impaired liver function, muscle diseases, pregnant or potentially pregnant women, breastfeeding women, or children under 10 years of age. Patients with a history of alcohol abuse or liver disease, poor kidney function, hypothyroidism, the elderly, or others at high risk of myopathy should consult their doctor before using and exercise caution. While this medication is generally well tolerated, side effects such as headache, myalgia, dyspepsia, fatigue, and rash may occur, so consult your doctor if symptoms persist. Regular liver function tests should be performed as this medication may affect liver function, and if symptoms of hepatitis (nausea, vomiting, fatigue, etc.) arise, inform your doctor immediately. This drug may interact with several medications that can affect its blood concentration, so inform your doctor or pharmacist if you are taking other drugs. Particular caution is required when taken with certain antibiotics, antifungals, antivirals, immunosuppressants, and grapefruit juice. While taking this medication, proper contraceptive methods should be used to avoid pregnancy, and it should not be taken during pregnancy or while breastfeeding. Elderly patients or those with kidney impairment are at increased risk of myopathy and should exercise extra caution while taking this medication and report any unusual symptoms immediately. There is no specific antidote in case of overdose; treatment should be symptomatic and periodic monitoring of liver function and muscle status is necessary. This medication should be stored out of reach of children and kept in its original container for safety.

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 the mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory distress with cough + fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination changes

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
  • throat and larynx pain
  • nosebleed
  • insomnia
  • nightmares
  • headache
  • dizziness
  • paresthesia
  • sensory loss
  • taste disorder
  • 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 protect it from air and moisture, and it is recommended to keep it at a temperature between 1 to 30 degrees Celsius. Proper storage will help maintain the drug's effectiveness for a longer period.

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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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.