Medication info
Arostin 10 mg Tablet (Atorvastatin Calcium Trihydrate)

Arostin 10 mg Tablet (Atorvastatin Calcium Trihydrate)

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

MFDS item code 201207013 · Approved 2012.09.28 · Insurance code 621802290

Summary

Main use
Reduction of the risk of myocardial infarction and stroke, improvement of hyperlipidemia
Who takes it
Adults · Children
Adult dose
1. Hyperlipidemia: The recommended initial dose is 10 mg atorvastatin once daily; however, for patients requiring greater reductions in LDL cholesterol, it may be initiated at 20 mg or 40 mg once daily. The dose range for this medication is 10 to 80 mg once daily. For patients with homozygous familial hypercholesterolemia: The dosing regimen for this medication is once daily at 10 to 80 mg, either in conjunction with other lipid-lowering therapies (e.g., LDL apheresis) or when such therapies are not feasible.
Child dose
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10-17): The recommended initial dose of this medication is 10 mg once daily, and the recommended maximum dose is 20 mg once daily. Dosage adjustments should be made according to individual patient needs.

Ingredients

Manufacturer
(주)한국파비스제약

Efficacy & effects

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

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

This medication helps reduce the risk of cardiovascular diseases. It particularly lowers the risk of myocardial infarction and stroke in high-risk adults and patients with type 2 diabetes. It also reduces the risk of hospitalization due to vascular procedures, chronic stable angina, and congestive heart failure and is effective in preventing angina. In the treatment of hyperlipidemia, it helps to lower total cholesterol, LDL cholesterol, apolipoprotein B, and triglyceride levels while increasing HDL cholesterol levels. It is also used in the treatment of patients with heterozygous familial hypercholesterolemia, especially those with a family history or high cholesterol levels, as well as in pediatric patients. This drug is effective in improving cardiovascular health.

How to take

Adult dose

1. Hyperlipidemia: The recommended initial dose is 10 mg atorvastatin once daily; however, for patients requiring greater reductions in LDL cholesterol, it may be initiated at 20 mg or 40 mg once daily. The dose range for this medication is 10 to 80 mg once daily. For patients with homozygous familial hypercholesterolemia: The dosing regimen for this medication is once daily at 10 to 80 mg, either in conjunction with other lipid-lowering therapies (e.g., LDL apheresis) or when such therapies are not feasible.

Child dose

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10-17): The recommended initial dose of this medication is 10 mg once daily, and the recommended maximum dose is 20 mg once daily. Dosage adjustments should be made according to individual patient needs.

Precautions

This medication carries a risk of muscle problems; therefore, it should be discontinued immediately if there is worsening muscle pain or weakness, or a significant increase in creatine kinase levels. Patients with impaired liver function or a history of liver disease should not use this medication and should undergo regular liver function tests. Women who are pregnant, may become pregnant, or are breastfeeding should not use this medication, and fertile women should take appropriate contraception while on the drug. Children, particularly those under 10 years of age, should not take this medication, and long-term safety in individuals under 18 has not been well studied. This drug should be used with extra caution in patients with a history of alcohol abuse, liver disease, renal impairment, and elderly patients, as there is a higher risk of serious side effects such as myopathy or rhabdomyolysis; careful monitoring is necessary. Due to possible interactions with other medications, special caution is needed, especially when taken with CYP3A4 inhibitors, cyclosporine, some antibiotics, antifungals, HIV protease inhibitors, grapefruit juice, etc. Patients experiencing symptoms such as muscle pain, muscle weakness, fever, or malaise should notify their doctor immediately and undergo examination; in severe cases, the medication should be discontinued. This drug may cause various side effects such as liver function abnormalities, skin rashes, allergic reactions, gastrointestinal symptoms, and neurological symptoms, so consult healthcare professionals if any abnormal signs occur. There is no specific antidote for overdose, so treatment should be symptomatic and liver function and muscle enzyme tests must be conducted to manage the condition. This medication should be kept out of reach of children and stored in its original container tightly closed.

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, oral/ocular mucosal pain, shortness of breath or difficulty breathing, asthma attacks, respiratory distress accompanied by cough and fever, yellowing of skin or eyes (jaundice), extreme lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urinary retention

Mild side effects

  • Weakness
  • malaise
  • chest pain
  • peripheral edema
  • fatigue
  • 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/larynx pain
  • nosebleeds
  • insomnia
  • nightmares
  • headaches
  • dizziness
  • paresthesia
  • sensory loss
  • taste disturbances
  • memory loss
  • peripheral neuropathy
  • muscle pain
  • joint pain
  • limb pain
  • musculoskeletal pain
  • muscle cramps
  • joints

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

Storage

This drug may be sensitive to air and moisture, so it must be stored in a tightly sealed container. It is important to maintain a storage temperature between 1 and 30 degrees Celsius. This will help maintain the medication's effectiveness and safety over time.

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

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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.