Medication info
Atorvastatin Tablets 10 mg (Atorvastatin Calcium Trihydrate)

Atorvastatin Tablets 10 mg (Atorvastatin Calcium Trihydrate)

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

MFDS item code 201601146 · Approved 2016.02.29 · Insurance code 661604640

Summary

Main use
Reduction of the risk of myocardial infarction and stroke, improvement of hyperlipidemia
Who uses it
Adults · Children
Adult dosage
The recommended starting dose for hyperlipidemia is 10 mg once daily as atorvastatin, and for patients requiring significant further LDL-cholesterol reduction, it can begin at 20 mg or 40 mg once daily. This drug is administered in a dosage range of 10 to 80 mg once daily. For patients with homozygous familial hypercholesterolemia, the dosage is 10 to 80 mg once daily.
Children's dosage
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the recommended starting dose is 10 mg once daily, and the recommended maximum dose is 20 mg once daily. Dose adjustment should occur at intervals of 4 weeks or longer.

Ingredients

Manufacturer
(주)알피바이오

Efficacy & effects

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

  • Multiple risk factors for coronary artery heart disease
  • myocardial infarction
  • stroke
  • vascular surgery
  • 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 helps reduce the risk of cardiovascular diseases. It lowers the risk of myocardial infarction and stroke in patients with various risk factors such as older age, smoking, hypertension, low HDL cholesterol, and diabetes. It is also effective in preventing heart-related problems such as angina or requiring vascular surgery. In patients with hyperlipidemia, this drug reduces total cholesterol, LDL cholesterol, and triglyceride levels, while increasing HDL cholesterol, thereby improving blood lipid levels. It can especially be used as an adjunctive treatment for patients with familial hypercholesterolemia or when dietary control alone is insufficient. This drug is also effective as an adjunctive treatment in pediatric patients with severe hypercholesterolemia. In summary, this medication is used to reduce the risk of cardiovascular diseases and to improve cardiovascular health by regulating blood lipids.

Dosage and Administration

Adult dosage

The recommended starting dose for hyperlipidemia is 10 mg once daily as atorvastatin, and for patients requiring significant further LDL-cholesterol reduction, it can begin at 20 mg or 40 mg once daily. This drug is administered in a dosage range of 10 to 80 mg once daily. For patients with homozygous familial hypercholesterolemia, the dosage is 10 to 80 mg once daily.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the recommended starting dose is 10 mg once daily, and the recommended maximum dose is 20 mg once daily. Dose adjustment should occur at intervals of 4 weeks or longer.

Precautions

This medication may cause muscle symptoms; therefore, it should be discontinued immediately if there is severe muscle pain or weakness, or if Creatine Kinase levels increase significantly. This medication should not be taken by individuals with certain diseases or allergies, by pregnant women or women who may become pregnant, or by children under 10 years of age. Those with liver or kidney problems or risk factors for myopathy such as alcoholism or hypothyroidism should exercise caution while taking this drug. Various side effects such as liver function abnormalities, skin rash, headache, dyspepsia, and muscle pain may occur while taking this medication; if symptoms arise, consult your doctor. Since this drug is metabolized in the liver, care should be taken when taken with certain antibiotics, antifungals, or antiviral medications, as this may increase blood concentration and the risk of side effects. Women who are pregnant or breastfeeding should not take this medication, and women of childbearing age should use appropriate contraception during treatment. Elderly patients or those with impaired kidney function have a higher risk of myopathy, so muscle condition should be closely monitored during treatment. In cases of overdose, there is no specific antidote, and treatment should be symptomatic; regular monitoring of liver function tests and muscle enzyme levels is necessary. This medication should be stored out of the reach of children and kept in its original container, as transferring to another container may risk degradation of quality or misuse.

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, pain in mucous membranes of the mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough + fever, yellowing of the skin or eyes (jaundice), extreme lethargy, sudden and severe headache, lightning headache, seizures, confusion, visual disturbances, paralysis, urination problems

Mild side effects

  • Weakness
  • malaise
  • chest pain
  • peripheral edema
  • fatigue
  • fever
  • nasopharyngitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
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  • decreased appetite
  • constipation
  • abdominal bloating
  • dyspepsia
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • oropharyngeal pain
  • nosebleeds
  • insomnia
  • nightmares
  • headache
  • dizziness
  • paresthesia
  • sensory loss
  • dysgeusia
  • memory loss
  • peripheral neuropathy
  • myalgia
  • arthralgia
  • 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 or moisture, so it must be stored in a tightly closed container. It is important to maintain the storage temperature between 1 and 30 degrees Celsius. This will ensure the effectiveness is well maintained and safe to use.

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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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.