Medication info
AtorvaTablets 20mg (Atorvastatin Calcium Trihydrate)

AtorvaTablets 20mg (Atorvastatin Calcium Trihydrate)

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

MFDS item code 202001692 · Approved 2020.03.11 · Insurance code 658502310

Summary

Main use
Reduction of risk of myocardial infarction and stroke, improvement of hypercholesterolemia
Who uses it
Adults · Children
Adult dosage
Start with 10mg once daily, and if a greater reduction in LDL cholesterol is needed, it can be initiated at 20mg or 40mg once daily. Generally, the dosage is adjusted within the range of 10mg to 80mg once daily. Personalized adjustments should be made based on treatment goals and patient responses, with lipid levels analyzed every 2 to 4 weeks to inform dosage adjustments. For patients with homozygous familial hypercholesterolemia, the dosing is 10mg to 80mg once daily, administered either alongside other lipid-lowering treatments (e.g., LDL apheresis) or when such treatments are not possible. For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the recommended initial dose is 10mg once daily, with a maximum recommended dose of 20mg daily (there is no clinical data for doses higher than 20mg in this pediatric population). Doses should be adjusted appropriately based on individual patients' therapeutic goals, with adjustments every 4 weeks or longer if necessary. For patients with renal impairment: Renal disease does not affect atorvastatin plasma concentrations or LDL cholesterol reduction effects, so dose adjustments are not necessary. For elderly patients: The efficacy and safety in patients over 70 years of age are generally similar to those in the adult patient population.
Children's dosage
For pediatric patients aged 10 to 17 with heterozygous familial hypercholesterolemia, the recommended initial dose is 10mg once daily, with a maximum dose of 20mg once daily. Dosage adjustments should be made individually based on therapeutic goals every 4 weeks.

Ingredients

Manufacturer
익수제약(주)

Efficacy & effects

Reduction of risk of myocardial infarction and stroke, improvement of hypercholesterolemia

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

This medication helps reduce the risk of cardiovascular diseases. It particularly lowers the risk of myocardial infarction and stroke in adults with risk factors for coronary heart disease and patients with type 2 diabetes. It also decreases the risk of complications such as vascular revascularization, angina, and congestive heart failure. It is effective in treating hyperlipidemia by lowering levels of total cholesterol, LDL cholesterol, and triglycerides, while increasing good HDL cholesterol levels. It is particularly beneficial in managing the condition of pediatric patients with heterozygous familial hypercholesterolemia. Therefore, it is used as an effective treatment for managing cardiovascular diseases and hyperlipidemia.

Dosage and Administration

Adult dosage

Start with 10mg once daily, and if a greater reduction in LDL cholesterol is needed, it can be initiated at 20mg or 40mg once daily. Generally, the dosage is adjusted within the range of 10mg to 80mg once daily. Personalized adjustments should be made based on treatment goals and patient responses, with lipid levels analyzed every 2 to 4 weeks to inform dosage adjustments. For patients with homozygous familial hypercholesterolemia, the dosing is 10mg to 80mg once daily, administered either alongside other lipid-lowering treatments (e.g., LDL apheresis) or when such treatments are not possible. For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17), the recommended initial dose is 10mg once daily, with a maximum recommended dose of 20mg daily (there is no clinical data for doses higher than 20mg in this pediatric population). Doses should be adjusted appropriately based on individual patients' therapeutic goals, with adjustments every 4 weeks or longer if necessary. For patients with renal impairment: Renal disease does not affect atorvastatin plasma concentrations or LDL cholesterol reduction effects, so dose adjustments are not necessary. For elderly patients: The efficacy and safety in patients over 70 years of age are generally similar to those in the adult patient population.

Children's dosage

For pediatric patients aged 10 to 17 with heterozygous familial hypercholesterolemia, the recommended initial dose is 10mg once daily, with a maximum dose of 20mg once daily. Dosage adjustments should be made individually based on therapeutic goals every 4 weeks.

Precautions

This medication may cause muscle-related symptoms, thus it should be discontinued immediately if muscle pain or weakness worsens or creatine kinase levels rise significantly. Patients with liver function problems or active liver diseases should not take this medication. It should not be administered to women with muscle disorders, those who are pregnant or breastfeeding, and children under 10 years of age. Alcoholics or patients with a history of liver disease should use this medication with caution, particularly elderly patients or those with impaired kidney function should also be monitored carefully. While taking this medication, regular liver function tests and muscle-related tests should be conducted, and if abnormal symptoms appear, consult a physician immediately. Drug interactions may occur when taken with other medications, especially with certain antibiotics, antifungals, antivirals, and grapefruit juice, so attention is needed during co-administration. Appropriate contraceptive methods should be used while taking this medication, and if pregnancy is confirmed, it should be discontinued. This medication can rarely cause serious skin rashes or allergic reactions, so it should be stopped immediately if skin abnormalities occur. There is no specific antidote in case of overdose, so appropriate treatment should be received based on symptoms, and liver function and muscle condition should be monitored through blood tests. It should be stored out of reach of children and kept in its original container for safety.

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, mucosal pain in the mouth/eyes, yellowing of the skin or eyes (jaundice), extreme tiredness all over, sudden and severe headache, lightning headache, seizures, confusion, vision disturbances, paralysis, significantly reduced urine output, severe swelling of the body with elevated blood pressure, anaphylaxis

Mild side effects

  • Fatigue
  • malaise
  • chest pain
  • peripheral edema
  • tiredness
  • fever
  • rhinitis
  • 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
  • nosebleed
  • insomnia
  • nightmares
  • headache
  • dizziness
  • paresthesia
  • sensory reduction
  • taste alteration
  • memory loss
  • peripheral neuropathy
  • myalgia
  • arthralgia
  • limb pain
  • musculoskeletal pain
  • muscle cramps
  • arthritis

Not everyone experiences these, and they can vary from person to person.

Storage

This medication must be stored in a tightly sealed container to protect it from air and moisture. It is best to maintain a storage temperature between 1 degree and 30 degrees Celsius at room temperature. This helps to preserve the drug's efficacy and safety over time.

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.