Medication info

Y2Ator Tablet 20 mg (Atorvastatin Calcium Trihydrate)

Prescription medicationTablet
Ingredient · strength
Atorvastatin Calcium Trihydrate›21.69mg / 1 tablet
Manufacturer / importer
성이바이오제약주식회사
Appearance
White oval film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle, 120 tablets/bottle
Approval status
Active

MFDS item code 202106950 · Approved 2021.10.15

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 initial dose is 10 mg of atorvastatin to be taken once daily, while patients requiring a more significant reduction in LDL cholesterol may start at 20 mg or 40 mg once daily. The dosage range is 10 to 80 mg once daily. The initial dose and maintenance dose should be individualized based on treatment goals and patient characteristics, and lipid levels should be analyzed within 2 - 4 weeks after initiating therapy.
Children's dosage
The recommended initial dose for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 - 17) is 10 mg per day, with a maximum recommended dose of 20 mg per day. The dosage should be adjusted according to the treatment goals and monitored for a duration of 4 weeks.

Ingredients

Manufacturer
성이바이오제약주식회사

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
  • congestive heart failure
  • hyperlipidemia
  • primary hypercholesterolemia
  • mixed dyslipidemia
  • abnormal beta-lipoproteinemia
  • elevated serum triglycerides
View approved original text

This medicine is used to reduce the risk of cardiovascular diseases. Specifically, it reduces the risk of myocardial infarction and stroke in adults with risk factors for coronary heart disease and patients with type 2 diabetes, and lowers the risks associated with revascularization procedures and angina pectoris. It also helps reduce the risk of myocardial infarction, stroke, hospitalization for congestive heart failure, and angina in adults with clinical evidence. Additionally, it is effective in treating hyperlipidemia, helping to lower LDL cholesterol and total cholesterol levels, while increasing HDL cholesterol levels to maintain a healthy blood lipid profile. It is used especially as a dietary adjunct in children with familial hypercholesterolemia to effectively manage risk factors for cardiovascular diseases. Therefore, this medicine is used to improve cardiovascular health and reduce the risk of related diseases.

Dosage and Administration

Adult dosage

For hyperlipidemia, the recommended initial dose is 10 mg of atorvastatin to be taken once daily, while patients requiring a more significant reduction in LDL cholesterol may start at 20 mg or 40 mg once daily. The dosage range is 10 to 80 mg once daily. The initial dose and maintenance dose should be individualized based on treatment goals and patient characteristics, and lipid levels should be analyzed within 2 - 4 weeks after initiating therapy.

Children's dosage

The recommended initial dose for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 - 17) is 10 mg per day, with a maximum recommended dose of 20 mg per day. The dosage should be adjusted according to the treatment goals and monitored for a duration of 4 weeks.

Precautions

This medication may cause muscle issues, so it should be discontinued immediately if there is muscle pain or weakness, or if creatine kinase (CK) levels rise significantly. Patients with impaired liver function or liver disease should not take this medication and should undergo regular liver function tests. Women who are pregnant or may become pregnant, and breastfeeding women should not take this medication. It is not to be used in children, particularly those under 10 years of age. Patients with a history of alcohol abuse or liver disease should use this medication cautiously, and elderly patients are also at higher risk for myopathy, so careful monitoring is needed. This medication may interact with various other drugs, so if you are taking other medications, you must inform your doctor or pharmacist. Caution is particularly needed when used with certain antibiotics, antifungals, HIV treatments, specific cardiac medications, and grapefruit juice. If muscle pain, weakness, fever, or fatigue occurs while taking this medication, notify your healthcare provider immediately. Serious side effects such as interstitial lung disease, skin rash, and allergic reactions may rarely occur; if any of these symptoms develop, discontinue use and consult a healthcare provider immediately. During the course of taking this medication, appropriate contraceptive measures should be employed, and it must be discontinued if pregnancy occurs. In the event of overdose, as there is no specific antidote, treatment must be symptomatic, and liver function and muscle condition should be monitored. Keep this medication out of reach of children and store it in its original container.

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 mucous membranes in the mouth/eyes, severe skin adverse reactions, shortness of breath or difficulty in breathing, asthma attacks, breathing abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, liver abnormalities (jaundice), sudden and severe

Mild side effects

  • Weakness
  • fatigue
  • chest pain
  • peripheral edema
  • fever
  • rhinitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
  • loss of appetite
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  • constipation
  • abdominal bloating
  • dyspepsia
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • sore throat and larynx pain
  • nosebleed
  • insomnia
  • nightmares
  • headache
  • dizziness
  • paresthesia
  • sensory loss
  • taste disturbances
  • memory loss
  • 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 should be stored in a tightly closed container to protect it from air and moisture. Additionally, it is safest to store the medication at room temperature between 1°C and 30°C.

Appearance and packaging

Appearance

White oval film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle, 120 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.