Medication info
Aptostatin 20 mg (Atorvastatin Calcium Trihydrate)

Aptostatin 20 mg (Atorvastatin Calcium Trihydrate)

Prescription medicationTablet경구
Ingredient · strength
Atorvastatin Calcium Trihydrate›21.7mg / 1 tablet
Manufacturer / importer
건일제약(주)
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201202396 · Notified 2012.03.30 · Insurance code 646802530

Summary

Main use
Reduction of risks for myocardial infarction and stroke, improvement of hyperlipidemia
Who takes it
Adults · Children
Adult dose
For treating hyperlipidemia, the recommended initial dose is 10 mg once daily. For patients requiring further reduction in LDL cholesterol levels, an initial dose of 20 mg or 40 mg once daily may be started. The dosing should be individualized within the range of 10-80 mg once daily based on patient characteristics. Patients with homozygous familial hypercholesterolemia are prescribed 10-80 mg once daily.
Child dose
The recommended initial dose for pediatric patients (10-17 years) with heterozygous familial hypercholesterolemia is 10 mg once daily, with a maximum dose of 20 mg daily. Doses should be adjusted at intervals of 4 weeks or longer, according to treatment goals.

Ingredients

Manufacturer
건일제약(주)

Efficacy & effects

Reduction of risks for myocardial infarction and stroke, improvement of hyperlipidemia

  • Multiple risk factors for coronary heart disease
  • myocardial infarction
  • stroke
  • revascularization procedures
  • chronic stable angina
  • retinopathy
  • albuminuria
  • hypertension
  • non-fatal myocardial infarction
  • fatal and non-fatal stroke
  • congestive heart failure
  • angina
View approved original text

This medication is used for the treatment of cardiovascular diseases and dyslipidemia. Firstly, it helps to reduce the risks of myocardial infarction, stroke, revascularization procedures, and angina in adults with risk factors for coronary heart disease and in diabetic patients. Additionally, it reduces the risk of non-fatal myocardial infarction, stroke, hospitalization due to congestive heart failure, and angina in patients already diagnosed with coronary heart disease. In the treatment of hyperlipidemia, it lowers cholesterol and triglyceride levels in patients with primary hypercholesterolemia and mixed dyslipidemia, while increasing HDL cholesterol levels. It particularly aids in lipid control in some hypercholesterolemic patients and pediatric patients who are not adequately managed by diet. Thus, it is effectively used for the prevention of cardiovascular diseases and improvement of dyslipidemia.

How to take

Adult dose

For treating hyperlipidemia, the recommended initial dose is 10 mg once daily. For patients requiring further reduction in LDL cholesterol levels, an initial dose of 20 mg or 40 mg once daily may be started. The dosing should be individualized within the range of 10-80 mg once daily based on patient characteristics. Patients with homozygous familial hypercholesterolemia are prescribed 10-80 mg once daily.

Child dose

The recommended initial dose for pediatric patients (10-17 years) with heterozygous familial hypercholesterolemia is 10 mg once daily, with a maximum dose of 20 mg daily. Doses should be adjusted at intervals of 4 weeks or longer, according to treatment goals.

Precautions

This medication may cause muscle-related symptoms; therefore, you should inform your doctor and stop the treatment immediately if you experience muscle pain or weakness, especially if severe. This medication can affect liver function, so it should not be used in individuals with liver disease or elevated liver function tests. Pregnant women, women who may become pregnant, and breastfeeding women should not take this medication. Children, especially those under 10 years of age, are advised against using this medication. This medication may interact with certain drugs; if you are taking other medications, be sure to inform your doctor or pharmacist. Patients who consume excessive alcohol or have a history of liver disease should use this medication cautiously and undergo regular liver function tests. During the treatment, if symptoms such as muscle pain, fatigue, or fever occur, consult healthcare professionals immediately. This medication may affect blood sugar levels, so patients at risk of diabetes should ensure thorough blood sugar management. Elderly patients are at increased risk for muscle abnormalities and other side effects, necessitating caution during treatment and regular health monitoring. It is advisable to avoid grapefruit juice while taking this medication, as it may increase serum concentration. Store this medication out of reach of children and in its original container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty breathing, asthma attack, respiratory abnormalities accompanied by cough and fever, yellowing of skin or eyes (jaundice), severe body weakness, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, urination changes

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
  • dyspepsia
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • pharyngeal and laryngeal pain
  • nosebleeds
  • insomnia
  • nightmares
  • headache
  • dizziness
  • paresthesia
  • sensory loss
  • dysgeusia
  • memory loss
  • peripheral neuropathy
  • myalgia
  • arthralgia
  • limb pain
  • musculoskeletal pain
  • muscle cramps
  • arthralgia

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 important to maintain a room temperature between 1 and 30 degrees Celsius.

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.