Medication info
Atovastatin Tablet 10 mg (Atorvastatin Calcium Trihydrate)

Atovastatin Tablet 10 mg (Atorvastatin Calcium Trihydrate)

Prescription medicationTablet
Ingredient · strength
Atorvastatin Calcium Trihydrate›10.85mg / 1 tablet
Manufacturer / importer
익수제약(주)
Appearance
White round film-coated tablet
Packaging
Bottle packaging - 30 tablets/bottle, Bottle packaging - 300 tablets/bottle
Approval status
Active

MFDS item code 201502559 · Approved 2015.04.28 · Insurance code 658501720

Summary

Main use
Reduction of the risk of myocardial infarction and stroke and improvement of hyperlipidemia
Who uses it
Adults · Children
Adult dosage
The recommended initial dose is 10 mg of atorvastatin once daily, but for patients requiring greater reductions in LDL cholesterol levels, 20 mg or 40 mg once daily may be started (only for cases requiring a reduction of over 45% in LDL cholesterol levels). This medication can be administered in a dose range of 10 to 80 mg once daily. Initial and maintenance doses should be individualized based on treatment goals and responses.
Children's dosage
The recommended initial dose for children with heterozygous familial hypercholesterolemia (ages 10 to 17) is 10 mg once daily, with a maximum recommended dose of 20 mg daily. The dosing regimen should be adjusted according to the recommended treatment goals for individual patients.

Ingredients

Manufacturer
익수제약(주)

Efficacy & effects

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

  • Myocardial infarction
  • stroke
  • angina
  • hypercholesterolemia
  • dyslipidemia
  • abnormal beta-lipoproteinemia
  • elevated serum triglycerides
  • hypercholesterolemia
View approved original text

This medication is used to reduce the risk of cardiovascular diseases. In particular, it reduces the risk of myocardial infarction, stroke, revascularization, and angina in adults with risk factors for coronary heart disease and patients with type 2 diabetes. It also helps reduce the risk of nonfatal myocardial infarction, stroke, and heart failure hospitalizations in adults with clinical evidence. Additionally, it is used as an adjunctive treatment to reduce levels of total cholesterol, LDL cholesterol, apolipoprotein B, and triglycerides while increasing HDL cholesterol in patients with hyperlipidemia. It also improves cholesterol levels in children aged 10 to 17 years with heterozygous familial hypercholesterolemia as an adjunct to dietary therapy. This medication is used to improve cardiovascular risk factors and for the treatment of hyperlipidemia.

Dosage and Administration

Adult dosage

The recommended initial dose is 10 mg of atorvastatin once daily, but for patients requiring greater reductions in LDL cholesterol levels, 20 mg or 40 mg once daily may be started (only for cases requiring a reduction of over 45% in LDL cholesterol levels). This medication can be administered in a dose range of 10 to 80 mg once daily. Initial and maintenance doses should be individualized based on treatment goals and responses.

Children's dosage

The recommended initial dose for children with heterozygous familial hypercholesterolemia (ages 10 to 17) is 10 mg once daily, with a maximum recommended dose of 20 mg daily. The dosing regimen should be adjusted according to the recommended treatment goals for individual patients.

Precautions

This medication may cause muscle-related symptoms, so if there is severe muscle pain or weakness, or significantly elevated creatine kinase levels, treatment should be stopped immediately. This medication should not be used in patients with severely impaired liver function or active liver disease, in pregnant or possibly pregnant women, or in breastfeeding women, or in children under 10 years of age. Caution should be taken when using this drug in patients with a history of alcoholism or liver disease, those with impaired kidney function, those with hypothyroidism, and those with a history of muscle disease. Patients taking this medication should undergo regular liver function tests and muscle-related tests, and if symptoms such as nausea, vomiting, fatigue, muscle pain, or fever appear, they should consult a doctor immediately. This medication can interact with several other drugs, so if other medications are being taken, it is essential to inform a doctor or pharmacist, especially when used in conjunction with certain antibiotics, antifungals, antivirals, and immunosuppressants. When taken with grapefruit juice, this medication can increase blood concentration, so excessive intake should be avoided. Women of childbearing potential should use appropriate contraceptive methods while taking this medication and should stop taking it immediately if pregnancy is confirmed. If symptoms such as muscle pain, muscle weakness, fatigue, or fever occur while taking this medication, it is important to notify healthcare personnel and undergo testing. Elderly patients or those with decreased kidney function should be monitored more carefully due to a higher risk of muscle-related side effects. In the case of overdose, there is no specific antidote, so treatment will depend on the symptoms, and liver function and muscle enzyme levels should be monitored. This medication should be kept out of the reach of children and should be stored 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 allergic reactions, severe rash with fever, blisters, skin peeling, pain of oral/eye mucosa, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attack, respiratory distress with cough and fever, respiratory problems, yellowing of skin or eyes (jaundice), extreme lethargy, liver abnormalities (jaundice), sudden onset of

Mild side effects

  • Fatigue
  • malaise
  • chest pain
  • peripheral edema
  • tiredness
  • fever
  • nasopharyngitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
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  • anorexia
  • constipation
  • abdominal bloating
  • indigestion
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • throat and larynx pain
  • nosebleed
  • insomnia
  • nightmares
  • headache
  • dizziness
  • paresthesia
  • sensory loss
  • taste disorder
  • amnesia
  • 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 may be sensitive to air and moisture, so it should be stored in a tightly sealed container. It is recommended to maintain a storage temperature between 1°C and 30°C at room temperature. This storage will help safely maintain the effectiveness of the medication.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

Bottle packaging - 30 tablets/bottle, Bottle packaging - 300 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.