Medication info
Atostatin 10 mg (Atorvastatin Calcium Trihydrate)

Atostatin 10 mg (Atorvastatin Calcium Trihydrate)

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

MFDS item code 200705825 · Notified 2007.05.21 · Insurance code 642702290

Summary

Main use
Reduction of the risk of myocardial infarction and stroke and improvement of hyperlipidemia
Who takes it
Adults · Children
Adult dose
In the treatment of hyperlipidemia, the recommended initial dose is 10 mg once daily; for patients needing more significant reductions in LDL cholesterol, dosing can be initiated at 20 mg or 40 mg once daily. The dose is adjusted within a range of 10 to 80 mg once daily, individualized based on treatment goals and patient response. Lipid levels should be analyzed within 2 to 4 weeks after the initiation of therapy to adjust the dosage accordingly.
Child dose
For pediatric patients (ages 10 to 17 years) with heterozygous familial hypercholesterolemia, the recommended initial dose is 10 mg once daily, and the maximum dose is 20 mg once daily. Adjustments to dosing should be made every 4 weeks or more as per treatment goals.

Ingredients

Manufacturer
동화약품(주)

Efficacy & effects

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

  • Coronary heart disease
  • myocardial infarction
  • stroke
  • revascularization procedures
  • chronic stable angina
  • retinopathy
  • albuminuria
  • hypertension
  • type 2 diabetes
  • congestive heart failure
  • hyperlipidemia
  • primary hypercholesterolemia
View approved original text

This medication helps to reduce the risk of cardiovascular diseases. Specifically, it decreases the risk of myocardial infarction and stroke in adults who are at risk for coronary heart disease or have type 2 diabetes, and lowers the risk of revascularization procedures and angina. Furthermore, in patients with existing coronary heart disease, it is effective in reducing the risk of hospitalization for myocardial infarction, stroke, angina, and congestive heart failure. In the treatment of hyperlipidemia, it is used to manage cholesterol and triglyceride levels in patients with primary and familial hypercholesterolemia, as well as mixed dyslipidemia. It also helps lower cholesterol levels in pediatric patients with heterozygous familial hypercholesterolemia when used in conjunction with dietary modifications. Therefore, this drug is effective in improving significant risk factors for cardiovascular diseases and hyperlipidemia.

How to take

Adult dose

In the treatment of hyperlipidemia, the recommended initial dose is 10 mg once daily; for patients needing more significant reductions in LDL cholesterol, dosing can be initiated at 20 mg or 40 mg once daily. The dose is adjusted within a range of 10 to 80 mg once daily, individualized based on treatment goals and patient response. Lipid levels should be analyzed within 2 to 4 weeks after the initiation of therapy to adjust the dosage accordingly.

Child dose

For pediatric patients (ages 10 to 17 years) with heterozygous familial hypercholesterolemia, the recommended initial dose is 10 mg once daily, and the maximum dose is 20 mg once daily. Adjustments to dosing should be made every 4 weeks or more as per treatment goals.

Precautions

This medication may cause unusual symptoms in muscles, so if severe muscle pain or weakness occurs, or if creatine kinase levels are significantly elevated, the use of this medication should be discontinued immediately. This drug should not be used in patients with certain liver or muscle diseases, women who are pregnant or could become pregnant, children under 10 years of age, and patients taking specific medications. Patients with liver or kidney function problems should be particularly cautious when taking this medication and should monitor liver function and muscle condition regularly. Side effects such as muscle pain, fatigue, malaise, indigestion, headache, and insomnia may occur while taking this medication, so if these symptoms are severe or persistent, consultation with a physician is necessary. Additionally, this medication has a high potential for interactions with other drugs, so if other medications are being taken, it is essential to inform a healthcare provider and not to discontinue or change medication regimens arbitrarily. This medication is contraindicated during pregnancy, and women of childbearing potential should use appropriate contraception while taking it, discontinuing use immediately if pregnancy is confirmed. Lactating women should not take this medication and should either discontinue breastfeeding or consult a healthcare provider. Elderly patients or those with kidney impairment have a higher risk of muscle disease and rhabdomyolysis, so caution is advised, and regular health assessments are recommended. There is no specific antidote for overdose, so treatment should be symptomatic, and liver function and muscle enzyme levels should be monitored periodically. Keep out of reach of children and store the medication in its original container to maintain quality.

Side effects and when to seek care immediately

Serious side effects

Urticaria, angioedema, chest tightness, difficulty breathing, cold sweats, pallor, severe allergic reactions, severe rashes, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, severe dermatological reactions, difficulty breathing, asthma attacks, respiratory irregularities with cough and fever, yellowing of the skin or eyes (jaundice), profound lethargy, liver issues (jaundice), sudden and very severe headaches, thunderclap headaches.

Mild side effects

  • Weakness
  • malaise
  • chest pain
  • peripheral edema
  • fatigue
  • fever
  • pharyngitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
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  • loss of appetite
  • constipation
  • abdominal bloating
  • dyspepsia
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • pain in pharynx/larynx
  • nosebleeds
  • insomnia
  • nightmares
  • headaches
  • dizziness
  • abnormal sensation
  • numbness
  • taste abnormalities
  • memory loss
  • 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 should be stored in a tightly closed container to prevent air or moisture from entering. Ideally, maintain a storage temperature between 1 degree and 30 degrees Celsius.

Appearance and packaging

Appearance

White oval-shaped 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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For anything that needs medical judgment, consult a doctor or pharmacist.

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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.