Medication info

Iritor Tablet 20 mg (Atorvastatin Calcium Hydrate)

Prescription medicationTabletExpired
Ingredient · strength
Atorvastatin Calcium Hydrate›21.7mg / 1 tablet
Manufacturer / importer
(주)인트로바이오파마
Appearance
White round film-coated tablets
Packaging
Bottle pack - 30 tablets/bottle, Bottle pack - 100 tablets/bottle
Approval status
Expired

MFDS item code 201900715 · Approved 2019.01.30

This product's status changed to Expired on 2024.01.30. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Reduction of risk of myocardial infarction and stroke, and improvement of hyperlipidemia
Who uses it
Adults · Children
Adult dosage
The recommended starting dose for hyperlipidemia is 10 mg of atorvastatin once daily, but patients requiring greater LDL-C reduction may start at 20 mg or 40 mg once daily. This medication is administered in a dosage range of 10 to 80 mg once daily. The starting and maintenance doses should be individualized based on treatment goals and the patient's response, with lipid levels analyzed within 2 to 4 weeks to adjust the dosage.
Children's dosage
The recommended starting dose for pediatric patients (ages 10-17) with heterozygous familial hypercholesterolemia is 10 mg once daily, and the recommended maximum dose is 20 mg once daily. Dosage should be adjusted at intervals of 4 weeks or more.

Ingredients

Manufacturer
(주)인트로바이오파마

Efficacy & effects

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

  • Multiple risk factors for coronary artery disease
  • myocardial infarction
  • stroke
  • vascular interventions
  • chronic stable angina
  • retinopathy
  • albuminuria
  • hypertension
  • Type 2 diabetes
  • non-fatal myocardial infarction
  • fatal and non-fatal stroke
  • congestive heart failure
View approved original text

This medication helps reduce the risk of myocardial infarction, stroke, the need for vascular interventions, and angina in adults with cardiovascular disease risk factors and in patients with Type 2 diabetes. Especially for patients with coronary artery disease, it effectively reduces the risk of hospitalization due to myocardial infarction, stroke, and congestive heart failure. Additionally, this medication lowers cholesterol and triglyceride levels in patients with primary and mixed hyperlipidemia, while increasing the level of good cholesterol (HDL) to improve blood lipid status. Furthermore, it is used to effectively manage lipid levels in pediatric patients with familial hypercholesterolemia aged 10 and above to control the risk of heart disease. Therefore, this medication is very useful for the prevention of cardiovascular diseases and the treatment of hyperlipidemia.

Dosage and Administration

Adult dosage

The recommended starting dose for hyperlipidemia is 10 mg of atorvastatin once daily, but patients requiring greater LDL-C reduction may start at 20 mg or 40 mg once daily. This medication is administered in a dosage range of 10 to 80 mg once daily. The starting and maintenance doses should be individualized based on treatment goals and the patient's response, with lipid levels analyzed within 2 to 4 weeks to adjust the dosage.

Children's dosage

The recommended starting dose for pediatric patients (ages 10-17) with heterozygous familial hypercholesterolemia is 10 mg once daily, and the recommended maximum dose is 20 mg once daily. Dosage should be adjusted at intervals of 4 weeks or more.

Precautions

This medication may cause muscle-related symptoms, so if there is severe muscle pain or weakness, or significantly elevated creatine kinase levels, the patient should immediately discontinue use and consult a physician. Patients with liver function problems may experience worsened liver function when taking this medication, so it should not be used if there is liver disease or abnormally high liver enzyme levels. Women who are pregnant, capable of becoming pregnant, or breastfeeding should not take this medication, and women of childbearing age should use appropriate contraception while taking it. Children, especially those under 10 years old, should preferably not take this medication, and for children over 10 years old, safety and efficacy during long-term use have not been sufficiently verified. This medication may cause increased or decreased blood concentration when taken with certain drugs, so patients should inform their doctor or pharmacist if they are taking other medications. Particularly, the risk of muscle-related side effects may increase when used with strong CYP3A4 inhibitors, certain antibiotics, antifungal medications, HIV treatments, and some hyperlipidemia treatments. If symptoms of liver dysfunction appear (e.g., jaundice, extreme fatigue, nausea, vomiting), the patient should immediately stop taking this medication and consult healthcare professionals. Elderly patients, patients with renal impairment, and alcoholic patients should be monitored carefully for side effects when taking this medication. During treatment with this medication, if symptoms such as muscle pain, weakness, or fever occur, the patient should immediately seek medical attention, and blood tests may be necessary to check for muscle damage. This medication should be avoided with grapefruit juice as it may increase blood concentration.

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 fever, blisters, skin peeling, pain in the mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities with cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, vision abnormalities, paralysis, urination changes

Mild side effects

  • Weakness
  • fatigue
  • chest pain
  • peripheral edema
  • fever
  • pharyngitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
  • loss of appetite
Show 26 more
  • constipation
  • abdominal bloating
  • indigestion
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • pharyngeal and laryngeal pain
  • nosebleeds
  • insomnia
  • nightmares
  • headache
  • dizziness
  • paresthesia
  • sensory loss
  • dysgeusia
  • 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 should be stored in a tightly sealed container to protect it from air and moisture. It is best to maintain a storage temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

White round film-coated tablets

Package unit

Bottle pack - 30 tablets/bottle, Bottle pack - 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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.