Medication info

Atorbin Tablet 20 mg (Atorvastatin Calcium Trihydrate)

Prescription medicationApproval withdrawn
Ingredient · strength
Atorvastatin Calcium Trihydrate›Strength being verified
Manufacturer / importer
한국노바티스(주)
Appearance
A bright yellow, double-sided, convex, round film-coated tablet
Packaging
30 tablets (10 tablets/PTP x 3)
Approval status
Approval withdrawn

MFDS item code 201505880 · Approved 2015.08.21

This product's status changed to Approval withdrawn on 2023.06.29. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Treatment for reducing the risk of myocardial infarction and stroke and improving hyperlipidemia
Who uses it
Adults · Children
Adult dosage
For the treatment of hyperlipidemia, the recommended starting dose is 10 mg of atorvastatin once daily, and if more LDL cholesterol reduction is needed, it may start at 20 mg or 40 mg once daily. The dosing range is from 10 to 80 mg once daily, individualized based on therapeutic goals and patient response. Assess lipid levels within 2-4 weeks after starting treatment to adjust the dosage. In the case of homozygous familial hypercholesterolemia, the dosing regimen is from 10 to 80 mg once daily, used either in conjunction with other lipid-lowering therapies (e.g., LDL apheresis) or when such therapies are not possible.
Children's dosage
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10-17), the recommended starting dose is 10 mg once daily, and the recommended maximum dose is 20 mg once daily. The dosage should be adjusted according to the patient’s therapeutic goals.

Ingredients

Importer
한국노바티스(주)

Efficacy & effects

Treatment for reducing the risk of myocardial infarction and stroke and improving hyperlipidemia

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

This medication helps reduce the risk of cardiovascular diseases. In particular, it may lower the risks associated with myocardial infarction, stroke, vascular interventions, and angina. These effects are expected to be more significant in patients with type 2 diabetes or in high-risk adults. It also contributes to reducing the risk of hospitalization due to congestive heart failure. It is effective in managing hyperlipidemia and is used to lower total cholesterol and LDL cholesterol levels while increasing HDL cholesterol. It is also used as an adjunct in patients with familial hypercholesterolemia who do not respond sufficiently to dietary therapy. Therefore, it is used for the treatment of cardiovascular diseases and dyslipidemia.

Dosage and Administration

Adult dosage

For the treatment of hyperlipidemia, the recommended starting dose is 10 mg of atorvastatin once daily, and if more LDL cholesterol reduction is needed, it may start at 20 mg or 40 mg once daily. The dosing range is from 10 to 80 mg once daily, individualized based on therapeutic goals and patient response. Assess lipid levels within 2-4 weeks after starting treatment to adjust the dosage. In the case of homozygous familial hypercholesterolemia, the dosing regimen is from 10 to 80 mg once daily, used either in conjunction with other lipid-lowering therapies (e.g., LDL apheresis) or when such therapies are not possible.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10-17), the recommended starting dose is 10 mg once daily, and the recommended maximum dose is 20 mg once daily. The dosage should be adjusted according to the patient’s therapeutic goals.

Precautions

This medication may cause muscle problems, so if symptoms such as muscle pain or weakness occur, discontinue use immediately and consult a physician. Individuals with liver dysfunction or active liver disease should not take this medication and should undergo regular liver function tests. Women who are pregnant or may become pregnant, as well as breastfeeding women, should not take this medication, and fertile women should use appropriate contraceptive methods during treatment. Children under 10 years old or patients with certain genetic diseases should not take this medication. Patients with a history of alcoholism or liver disease should take this medication with caution, and elderly patients are at higher risk for myopathy, so extra care is necessary. Drug interactions may occur when taking this medication with other drugs, so it is advisable to consult a physician when used in combination with specific antibiotics, antifungals, HIV medications, certain antihypertensive drugs, and oral contraceptives. This medication may increase blood sugar levels in some patients, so those at risk of diabetes should strictly manage their blood sugar. If symptoms such as muscle pain, fatigue, or fever occur, inform a physician immediately, and if necessary, blood tests should be done to check for muscle damage. There is no specific antidote for overdose, so treatment should be symptomatic, and liver function and muscle enzyme levels should be checked regularly. This medication should be kept out of the reach of children and stored in its original container to prevent misuse.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), tightness in the chest, difficulty breathing, cold sweats, pallor, anaphylaxis, angioedema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, severe rash with high fever, blisters, skin peeling, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory distress with cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy,

Mild side effects

  • Weakness
  • fatigue
  • chest pain
  • peripheral edema
  • fever
  • nasopharyngitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
  • loss of appetite
Show 26 more
  • constipation
  • abdominal bloating
  • indigestion
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • throat and larynx pain
  • nosebleeds
  • insomnia
  • nightmares
  • headache
  • dizziness
  • paresthesia
  • sensory decrease
  • taste disturbance
  • memory loss
  • peripheral neuropathy
  • muscle pain
  • joint pain
  • limb pain
  • musculoskeletal pain
  • muscle cramps
  • joint

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. Additionally, it should be kept at room temperature between 1°C and 30°C, away from excessive heat or cold.

Appearance and packaging

Appearance

A bright yellow, double-sided, convex, round film-coated tablet

Package unit

30 tablets (10 tablets/PTP x 3)

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.