Medication info
Iritor Tablet 10 mg (Atorvastatin Calcium Trihydrate)

Iritor Tablet 10 mg (Atorvastatin Calcium Trihydrate)

Prescription medicationTablet
Ingredient · strength
Atorvastatin Calcium Trihydrate›10.85mg / 1 tablet
Manufacturer / importer
(주)인트로바이오파마
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 202003394 · Approved 2020.05.11 · Insurance code 052401750

Summary

Main use
Reduction of risk for myocardial infarction and stroke, improvement of hyperlipidemia, treatment of familial hypercholesterolemia
Who uses it
Adults · Children
Adult dosage
For the treatment of hyperlipidemia, the recommended initial dose is 10 mg once daily; for patients requiring greater reduction in LDL-cholesterol, it may start at 20 mg or 40 mg. The dosing may be adjusted within the range of 10 to 80 mg once daily, individualized based on treatment goals and patient response, with lipid levels analyzed and the dose adjusted at intervals of 2 to 4 weeks. Homozygous familial hypercholesterolemia.
Children's dosage
The recommended initial dose for pediatric patients (ages 10 to 17) with heterozygous familial hypercholesterolemia is 10 mg once daily, with a maximum dose of 20 mg per day. The dosage should be adjusted based on the individual patient's treatment over intervals of more than 4 weeks.

Ingredients

Manufacturer
(주)인트로바이오파마

Efficacy & effects

Reduction of risk for myocardial infarction and stroke, improvement of hyperlipidemia, treatment of familial hypercholesterolemia

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

This medication helps reduce the risk of cardiovascular diseases. In particular, it lowers the risk of myocardial infarction and stroke and reduces the risk associated with vascular interventions and stable angina. It is also effective in adult patients with type 2 diabetes and coronary artery disease, reducing the risk of hospitalization due to congestive heart failure. Moreover, in patients with hyperlipidemia, it decreases cholesterol and triglycerides while increasing HDL-cholesterol, improving blood lipid levels. It is also used for treating familial hypercholesterolemia in children, contributing to the reduction of total cholesterol and LDL-cholesterol levels. This medication is used to reduce the risk of cardiovascular diseases and improve blood lipid levels.

Dosage and Administration

Adult dosage

For the treatment of hyperlipidemia, the recommended initial dose is 10 mg once daily; for patients requiring greater reduction in LDL-cholesterol, it may start at 20 mg or 40 mg. The dosing may be adjusted within the range of 10 to 80 mg once daily, individualized based on treatment goals and patient response, with lipid levels analyzed and the dose adjusted at intervals of 2 to 4 weeks. Homozygous familial hypercholesterolemia.

Children's dosage

The recommended initial dose for pediatric patients (ages 10 to 17) with heterozygous familial hypercholesterolemia is 10 mg once daily, with a maximum dose of 20 mg per day. The dosage should be adjusted based on the individual patient's treatment over intervals of more than 4 weeks.

Precautions

This medication may cause muscle-related symptoms; therefore, if severe muscle pain or weakness is felt or if creatine kinase levels rise significantly, stop taking the drug immediately and consult a doctor. It is safe not to use this medication in patients with impaired liver function or liver disease, and regular liver function tests should be performed. Women who are pregnant or may become pregnant, as well as nursing mothers, should not take this medication, and women of childbearing age should use appropriate contraception while on this medication. This medication should not be administered to children, especially those under the age of 10. Patients with a history of alcohol abuse or liver disease, those with impaired kidney function, and elderly patients should be cautious when taking this medication, closely monitoring for muscle-related side effects. Interactions may occur when combined with other medications, so inform the doctor or pharmacist, especially when taking specific antibiotics, antifungals, HIV treatments, some antihypertensives, and oral contraceptives; dosage adjustments or discontinuation may be necessary. This medication contains lactose, so lactose-intolerant patients should not take it. If allergic reactions such as sudden skin rash, itching, difficulty breathing, or swelling of the face or neck occur while taking this medication, it should be discontinued immediately, and medical personnel should be consulted. There is no specific antidote for overdose, so appropriate treatment should be received based on symptoms, and liver function and muscle condition should be monitored periodically. This medication should be kept out of reach of children and stored in the original container for safety.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweat, pallor, severe rashes accompanied by high fever, blisters, peeling skin, pain in mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attack, coughing with accompanying fever and respiratory issues, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, altered consciousness, visual disturbances, paralysis, urination.

Mild side effects

  • Lethargy
  • malaise
  • chest pain
  • peripheral edema
  • fatigue
  • fever
  • rhinitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
Show 27 more
  • loss of appetite
  • constipation
  • abdominal bloating
  • dyspepsia
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • pharyngeal or laryngeal pain
  • nosebleeds
  • 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 or moisture, so it should be stored in a tightly sealed container. It is safe to store at room temperature, ideally between 1 and 30 degrees Celsius, away from extremes of heat or cold.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle, 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.