Medication info
Apeco Tablet 10 mg (Atorvastatin Calcium Hydrate)

Apeco Tablet 10 mg (Atorvastatin Calcium Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Atorvastatin Calcium Hydrate›10.845mg / 1 tablet
Manufacturer / importer
국제약품(주)
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201300149 · Approved 2013.01.08 · Insurance code 643703590

Summary

Main use
Reduction of risk for myocardial infarction and stroke, and improvement of hyperlipidemia
Who takes it
Adults · Children
Adult dose
For hyperlipidemia, the recommended initial dose is 10 mg once daily. If greater reduction of LDL cholesterol is required, the dose may start at 20 mg or 40 mg once daily. Dosing is typically within the range of 10 to 80 mg once daily, and individual adjustments should be made based on treatment goals and patient characteristics. Lipid levels should be analyzed within 2 to 4 weeks after starting treatment to adjust the dosage accordingly. In patients with homozygous familial hypercholesterolemia, the dosing is 10 to 80 mg once daily, used together with other lipid-lowering therapies, or when those therapies are not feasible.
Child dose
For pediatric patients (ages 10-17) with heterozygous familial hypercholesterolemia, the recommended initial dose is 10 mg once daily, with a maximum dose of 20 mg once daily. The dosing interval should be adjusted based on the patient's cholesterol level and treatment goals with a minimum interval of 4 weeks.

Ingredients

Manufacturer
국제약품(주)

Efficacy & effects

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

  • Coronary heart disease
  • myocardial infarction
  • stroke
  • chronic stable angina
  • retinopathy
  • albuminuria
  • congestive heart failure
  • hyperlipidemia
  • hypercholesterolemia
  • dyslipidemia
  • dysbeta-lipoproteinemia
  • elevated serum triglycerides
View approved original text

This medication helps to reduce various risk factors associated with cardiovascular disease. In particular, it reduces the risk of myocardial infarction and stroke in adults with multiple risk factors and patients with type 2 diabetes. Additionally, it is effective in reducing the risk of non-fatal myocardial infarction, stroke, vascular interventions, and hospitalization for heart failure in patients with clinical evidence of heart disease. In hyperlipidemia patients, it lowers total cholesterol, LDL cholesterol, and triglyceride levels while raising HDL cholesterol levels, thereby supporting dietary therapy. It is particularly helpful in managing cholesterol levels effectively in patients with familial hypercholesterolemia and in pediatric patients. This medication is used for the reduction of cardiovascular disease risk and the improvement of dyslipidemia.

How to take

Adult dose

For hyperlipidemia, the recommended initial dose is 10 mg once daily. If greater reduction of LDL cholesterol is required, the dose may start at 20 mg or 40 mg once daily. Dosing is typically within the range of 10 to 80 mg once daily, and individual adjustments should be made based on treatment goals and patient characteristics. Lipid levels should be analyzed within 2 to 4 weeks after starting treatment to adjust the dosage accordingly. In patients with homozygous familial hypercholesterolemia, the dosing is 10 to 80 mg once daily, used together with other lipid-lowering therapies, or when those therapies are not feasible.

Child dose

For pediatric patients (ages 10-17) with heterozygous familial hypercholesterolemia, the recommended initial dose is 10 mg once daily, with a maximum dose of 20 mg once daily. The dosing interval should be adjusted based on the patient's cholesterol level and treatment goals with a minimum interval of 4 weeks.

Precautions

This medication may cause unusual symptoms in muscles, so if severe muscle pain or muscle weakness occurs, or if creatine kinase levels rise significantly, discontinue use immediately and consult a physician. Patients with liver function issues or active liver disease should not use this medication. Patients with muscle disorders or those who have previously experienced muscle-related side effects should use this medication cautiously and may require regular testing. Women who are pregnant, potentially pregnant, or nursing should not take this medication, and women of childbearing age should use adequate contraception while taking this medication. This medication may interact with certain antibiotics, antifungals, and antivirals, so if taking other medications, be sure to inform your doctor or pharmacist. Elderly patients or those with impaired kidney function are at increased risk for muscle-related side effects, so caution is needed when taking this medication. During treatment with this medication, regular liver function tests and muscle-related tests should be conducted, and it is important to inform healthcare providers of any adverse symptoms. Children, especially those under 10 years of age, should not use this medication, and for children over 10, long-term safety has not been adequately verified. There is no specific antidote for overdose, and treatment should be based on symptoms, requiring regular testing. This medication should be kept out of reach of children and should be stored in its original container to maintain quality.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rash with high fever, blisters, skin peeling, oral/ocular mucosal pain, severe skin reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory distress with cough and fever, breathing problems, yellowing of the skin or eyes (jaundice), severe lethargy, liver abnormalities (jaundice), sudden and

Mild side effects

  • Weakness
  • fatigue
  • chest pain
  • peripheral edema
  • exhaustion
  • 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
  • altered perception
  • sensory loss
  • altered taste
  • amnesia
  • peripheral neuropathy
  • muscle pain
  • joint pain
  • 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 sealed container. It is recommended to maintain a storage temperature between 1 and 30 degrees Celsius at room temperature to safely preserve its efficacy.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

30 tablets/bottle, 100 tablets/bottle, 300 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.