Medication info

Atoratin Tablet 20 mg (Atorvastatin Calcium Trihydrate)

Prescription medicationTabletExpired
Ingredient · strength
Atorvastatin Calcium Hydrate›21.7mg / 1 tablet
Manufacturer / importer
알파제약(주)
Appearance
White, round, film-coated tablet
Packaging
30 tablets - 30 tablets/bottle, 300 tablets - 300 tablets/bottle
Approval status
Expired

MFDS item code 201904538 · Approved 2019.07.03

This product's status changed to Expired on 2024.07.03. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Reduction of risk for myocardial infarction and stroke, and treatment of hyperlipidemia
Who uses it
Adults · Children
Adult dosage
The recommended starting dose for the treatment of hyperlipidemia is 10 mg of atorvastatin once daily; however, in cases where a greater reduction in LDL cholesterol is needed, it can be initiated at 20 mg or 40 mg. The dosing is individualized and adjusted within a range of 10 to 80 mg once daily based on treatment goals and patient characteristics. Lipid levels should be analyzed within 2 to 4 weeks after initiation and dosage adjustments.
Children's dosage
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the recommended starting dose is 10 mg once daily, and the recommended maximum dose is 20 mg once daily. The dosage should be adjusted based on treatment goals with an interval of 4 weeks or more.

Ingredients

Manufacturer
알파제약(주)

Efficacy & effects

Reduction of risk for myocardial infarction and stroke, and treatment of hyperlipidemia

  • Coronary artery disease
  • myocardial infarction
  • stroke
  • chronic stable angina
  • retinopathy
  • albuminuria
  • congestive heart failure
  • hypercholesterolemia
  • dyslipidemia
  • abnormal beta-lipoproteinemia
  • elevated serum triglycerides
  • homozygous familial hypercholesterolemia
View approved original text

This medication is primarily used to reduce the risk of cardiovascular disease. It decreases the risk of myocardial infarction and stroke in adults aged 55 years or older, or those who smoke, have hypertension, low HDL cholesterol, or a family history of cardiovascular disease. It also lowers the risk of vascular procedures and angina. In patients with type 2 diabetes who have risk factors for heart disease, it helps in the reduction of myocardial infarction and stroke risks. Additionally, in patients with existing coronary artery disease, it reduces the risks of myocardial infarction, stroke, vascular procedures, as well as hospitalizations due to congestive heart failure and angina. For patients with hyperlipidemia, it effectively lowers total cholesterol, LDL cholesterol, apo-B proteins, and triglyceride levels while increasing HDL cholesterol. It also acts as an adjunct to dietary therapy for pediatric patients with familial hypercholesterolemia to help alleviate blood lipid levels. This medication is used to reduce the risk of cardiovascular disease and improve hyperlipidemia.

Dosage and Administration

Adult dosage

The recommended starting dose for the treatment of hyperlipidemia is 10 mg of atorvastatin once daily; however, in cases where a greater reduction in LDL cholesterol is needed, it can be initiated at 20 mg or 40 mg. The dosing is individualized and adjusted within a range of 10 to 80 mg once daily based on treatment goals and patient characteristics. Lipid levels should be analyzed within 2 to 4 weeks after initiation and dosage adjustments.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the recommended starting dose is 10 mg once daily, and the recommended maximum dose is 20 mg once daily. The dosage should be adjusted based on treatment goals with an interval of 4 weeks or more.

Precautions

This medication may cause muscle abnormalities; therefore, if severe muscle pain or weakness occurs, the medication should be immediately discontinued and a doctor should be consulted. If there is a significant increase in muscle enzyme levels or suspicion of myopathy, the use of this medication should be stopped. It should not be used in patients with liver function issues or liver disease, and if liver function tests show abnormalities, medical personnel should be notified immediately. Women who are pregnant, may become pregnant, or are breastfeeding should not take this medication. It is not recommended for children, especially those under 10 years of age. Those with allergic reactions to this medication or hypersensitivity to its components should avoid use. Patients with a history of alcohol addiction or liver disease should use this medication cautiously and undergo regular assessments as directed by their doctor. Elderly patients or those with impaired kidney function are also at increased risk of myopathy and should use caution. There may be interactions when taken with other medications; therefore, inform your doctor about any medications you are currently taking. Special caution is advised when using this medication together with certain antibiotics, antifungals, HIV treatments, specific heart medications, grapefruit juice, etc. If symptoms such as muscle pain, fatigue, fever, etc. arise during treatment, inform medical personnel immediately and undergo testing. Additionally, if serious skin reactions occur such as rash, itching, hives, or in severe cases, Stevens-Johnson syndrome, discontinue use. This medication should be kept out of reach of children and should be stored in its original container. There is no specific antidote for overdose; appropriate treatment should be provided based on symptoms, with regular blood tests and liver function tests being necessary.

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 mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough + fever, yellowing of skin or eyes (jaundice), severe lethargy, sudden and severe headache, lightning-like headache, seizures, confusion, visual disturbances, paralysis, urination issues

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
  • indigestion
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • throat and larynx pain
  • nosebleed
  • insomnia
  • nightmares
  • headache
  • dizziness
  • paresthesia
  • sensory loss
  • dysgeusia
  • memory loss
  • peripheral neuropathy
  • myalgia
  • arthralgia
  • limb pain
  • musculoskeletal pain
  • muscle cramps
  • arthritis

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

Storage

This medication should be stored in a tightly sealed container to protect it from air and moisture, and it is safe to keep it at room temperature between 1°C and 30°C.

Appearance and packaging

Appearance

White, round, film-coated tablet

Package unit

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