Medication info
Atorcell S Tablets 20 mg (Atorvastatin Calcium Hydrate)

Atorcell S Tablets 20 mg (Atorvastatin Calcium Hydrate)

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

MFDS item code 201907848 · Approved 2019.11.11

Summary

Main use
Reduction of risks of myocardial infarction and stroke and improvement of hyperlipidemia
Who uses it
Adults · Children
Adult dosage
In treating hyperlipidemia, the recommended starting dose is 10 mg once daily. For patients requiring a greater reduction in LDL cholesterol levels, treatment can begin with 20 mg or 40 mg once daily. The dosage range is administered from 10 mg to 80 mg once daily. The initial and maintenance dosages should be individualized considering treatment goals and response, with lipid levels analyzed for dose adjustments within 2 to 4 weeks. The goal of treatment is to lower LDL cholesterol levels, so it is recommended to use LDL cholesterol levels to evaluate treatment initiation and response. However, if LDL cholesterol levels cannot be used, total cholesterol levels should be monitored to evaluate treatment response. For patients with homozygous familial hypercholesterolemia, the administration dose ranges from 10 mg to 80 mg once daily, either alongside other lipid-lowering therapies (e.g., LDL apheresis) or when such therapies are not possible.
Children's dosage
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10–17), the recommended starting dose is 10 mg once daily, and the recommended maximum dose is 20 mg once daily. The dosage should be adjusted appropriately according to treatment goals, with adjustments every 4 weeks.

Ingredients

Manufacturer
(주)텔콘알에프제약

Efficacy & effects

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

  • Myocardial infarction
  • stroke
  • chronic stable angina
  • retinopathy
  • albuminuria
  • congestive heart failure
  • hyperlipidemia
  • hypercholesterolemia
  • dyslipidemia
  • abnormal beta-lipoproteinemia
  • elevated serum triglycerides
  • familial hypercholesterolemia
View approved original text

This medication reduces the risk of cardiovascular events such as myocardial infarction, stroke, the need for vascular surgery, and angina in patients with various risk factors for cardiovascular disease. It is particularly effective in adults with risk factors such as older age, smoking, hypertension, low HDL cholesterol levels, and diabetes, as well as in patients with type 2 diabetes. Additionally, for patients with clinical evidence, it decreases the risk of hospitalization due to not only myocardial infarction and stroke but also congestive heart failure. This drug is also used to treat hyperlipidemia, specifically lowering blood cholesterol and triglycerides in patients with primary hypercholesterolemia and dyslipidemia, while increasing HDL cholesterol. It is used as an adjunct to dietary therapy in children with heterozygous familial hypercholesterolemia at high risk of heart disease. Overall, this medication effectively improves the risk of cardiovascular disease.

Dosage and Administration

Adult dosage

In treating hyperlipidemia, the recommended starting dose is 10 mg once daily. For patients requiring a greater reduction in LDL cholesterol levels, treatment can begin with 20 mg or 40 mg once daily. The dosage range is administered from 10 mg to 80 mg once daily. The initial and maintenance dosages should be individualized considering treatment goals and response, with lipid levels analyzed for dose adjustments within 2 to 4 weeks. The goal of treatment is to lower LDL cholesterol levels, so it is recommended to use LDL cholesterol levels to evaluate treatment initiation and response. However, if LDL cholesterol levels cannot be used, total cholesterol levels should be monitored to evaluate treatment response. For patients with homozygous familial hypercholesterolemia, the administration dose ranges from 10 mg to 80 mg once daily, either alongside other lipid-lowering therapies (e.g., LDL apheresis) or when such therapies are not possible.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10–17), the recommended starting dose is 10 mg once daily, and the recommended maximum dose is 20 mg once daily. The dosage should be adjusted appropriately according to treatment goals, with adjustments every 4 weeks.

Precautions

This medication may present symptoms of muscle abnormalities, so if there is severe muscle pain or weakness or if creatine kinase levels rise significantly, use should be discontinued immediately. Patients at higher risk for severe myopathy or rhabdomyolysis should temporarily discontinue or stop using this medication. This drug should not be used in women who are pregnant or have specific diseases, children under 10 years old, and patients with certain liver diseases. Patients with alcohol dependence or impaired liver function should use this drug cautiously, and it is advised to check muscle enzyme levels before treatment in patients at risk of myopathy. If symptoms such as fatigue, muscle pain, or fever appear during the use of this medication, consult a doctor promptly. Also, as this drug can affect liver function, regular liver function tests are necessary, and if symptoms of hepatitis or jaundice appear, its use should be discontinued. Women of childbearing age should use appropriate contraceptive methods during treatment and should stop taking it if pregnancy occurs. This drug may interact with other medications, particularly specific antibiotics, antifungals, HIV treatments, and grapefruit juice, so caution is advised when used concomitantly. Elderly patients or those with reduced renal function are at increased risk for myopathy and should take extra precautions when using this drug. There is no specific antidote for overdose, thus treatment should be symptomatic, checking liver function and muscle enzyme tests to monitor the condition. Keep this medication out of the reach of children and store it safely in its original container.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe rash with high fever, blisters, skin peeling, pain in oral or ocular mucosa, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough + fever, jaundice (yellowing of skin or eyes), extreme fatigue all over the body, sudden and severe headaches, lightning-type headaches, seizures, confusion of consciousness, visual disturbances, paralysis, urination

Mild side effects

  • Weakness
  • lethargy
  • chest pain
  • peripheral edema
  • fatigue
  • fever
  • rhinitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
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  • loss of appetite
  • constipation
  • abdominal bloating
  • dyspepsia
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • oropharyngeal pain
  • nosebleeds
  • insomnia
  • nightmares
  • headaches
  • dizziness
  • sensory disturbances
  • sensory loss
  • taste disturbances
  • memory loss
  • peripheral neuropathy
  • myalgia
  • arthralgia
  • limb pain
  • musculoskeletal pain
  • muscle cramps
  • joint swelling

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 tightly sealed container. It is best to maintain storage temperatures between 1°C and 30°C.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

100 tablets/bottle, 30 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.

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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.