Medication info

Y2 Ator Tablet 10 mg (Atorvastatin Calcium Trihydrate)

Prescription medicationTablet
Ingredient · strength
Atorvastatin Calcium Trihydrate›10.845mg / 1 tablet
Manufacturer / importer
성이바이오제약주식회사
Appearance
White oval film-coated tablet
Packaging
30 tablets/bottle, 120 tablets/bottle
Approval status
Active

MFDS item code 202106949 · Approved 2021.10.15

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 dosage for hyperlipidemia is 10 mg of atorvastatin once daily, but in cases requiring greater reduction of LDL cholesterol levels, it may be initiated at 20 mg or 40 mg once daily. This medication is administered at a dosage range of 10-80 mg once daily. Initial and maintenance dosages should be individualized based on therapeutic goals and responses, and lipid levels should be analyzed within 2-4 weeks after initiation and/or dosage adjustment.
Children's dosage
The recommended initial dosage for pediatric patients (10-17 years) with heterozygous familial hypercholesterolemia is 10 mg once daily, with a recommended maximum dosage of 20 mg once daily. The dosage should be adjusted based on therapeutic goals for individual patients.

Ingredients

Manufacturer
성이바이오제약주식회사

Efficacy & effects

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

  • Coronary artery disease
  • myocardial infarction
  • stroke
  • revascularization
  • chronic stable angina
  • retinopathy
  • albuminuria
  • hypertension
  • congestive heart failure
  • angina
  • hyperlipidemia
  • primary hypercholesterolemia
View approved original text

This medication helps reduce the risk of cardiovascular diseases. It particularly decreases the risk of myocardial infarction and stroke in adult patients over 55 years old or those with risk factors such as smoking, hypertension, or low HDL cholesterol. It also reduces the risk of revascularization and chronic stable angina. Additionally, it shows a reduction in the risk of myocardial infarction and stroke in patients with type 2 diabetes. For patients with existing coronary artery disease, it reduces the risks of non-fatal myocardial infarction, stroke, revascularization, hospitalization for congestive heart failure, and angina. In patients with hyperlipidemia, it is effective in lowering total cholesterol, LDL cholesterol, and triglyceride levels, while increasing HDL cholesterol levels when used in conjunction with a dietary regimen. It is also used in pediatric patients aged 10 to 17 with specific hypercholesterolemia. Thus, it is effectively used for preventing cardiovascular diseases and treating hyperlipidemia.

Dosage and Administration

Adult dosage

The recommended initial dosage for hyperlipidemia is 10 mg of atorvastatin once daily, but in cases requiring greater reduction of LDL cholesterol levels, it may be initiated at 20 mg or 40 mg once daily. This medication is administered at a dosage range of 10-80 mg once daily. Initial and maintenance dosages should be individualized based on therapeutic goals and responses, and lipid levels should be analyzed within 2-4 weeks after initiation and/or dosage adjustment.

Children's dosage

The recommended initial dosage for pediatric patients (10-17 years) with heterozygous familial hypercholesterolemia is 10 mg once daily, with a recommended maximum dosage of 20 mg once daily. The dosage should be adjusted based on therapeutic goals for individual patients.

Precautions

This medication may cause issues with muscles, so if symptoms such as muscle pain or weakness occur, the medication should be discontinued immediately, and a physician should be consulted. When taking this medication, liver function may be affected. Therefore, it should not be administered to patients with liver disease or elevated liver enzyme levels. Women who are pregnant, may become pregnant, or are breastfeeding should not take this medication. This medication is not to be used in children, especially those under 10 years of age. Alcoholics or patients with a history of liver disease should take caution when using this medication and should undergo regular liver function tests. This medication may interact with other drugs, so it is essential to inform the doctor or pharmacist, particularly if taking specific antibiotics, antifungals, HIV treatments, certain antihypertensives, or hypoglycemic agents. Serious muscle diseases such as myopathy or rhabdomyolysis can occur rarely, so if symptoms like muscle pain, weakness, or fever arise, it is crucial to notify medical staff immediately. It is advisable to avoid excessive consumption of grapefruit juice while taking this medication, as it can increase drug concentration, raising the risk of side effects. Symptoms such as liver dysfunction, skin rash, allergic reactions, indigestion, headaches, and fatigue may occur. If abnormal symptoms persist, please consult medical personnel. Elderly patients or those with impaired kidney function are at a higher risk for muscle-related side effects and should be monitored more closely.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (angioedema), chest tightness, difficulty breathing, cold sweat, pallor, severe rash with fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory distress associated with cough and fever, jaundice (yellowing of skin or eyes), extreme lethargy, sudden and severe headaches, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urine changes

Mild side effects

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

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

Storage

This medication can be sensitive to air and moisture, so it should be stored in a tightly sealed container. Optimal storage temperature is between 1 degree and 30 degrees Celsius at room temperature to maintain the medication’s effectiveness for an extended period.

Appearance and packaging

Appearance

White oval film-coated tablet

Package unit

30 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.