Medication info
Mega Atova Tablet 20mg (Atorvastatin Calcium Hydrate)

Mega Atova Tablet 20mg (Atorvastatin Calcium Hydrate)

Prescription medicationTablet
Ingredient · strength
Atorvastatin Calcium Trihydrate›21.69mg / 1 tablet
Manufacturer / importer
(주)엘앤씨바이오
Appearance
White oval film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201902753 · Approved 2019.04.29 · Insurance code 060500760

Summary

Main use
Reduction of risk of myocardial infarction and stroke, improvement of hyperlipidemia
Who uses it
Adults · Children
Adult dosage
Atorvastatin is administered once daily at doses ranging from 10 mg to 80 mg, regardless of food intake at any time of the day. The initial dose is 10 mg once daily, but for patients requiring a greater reduction in LDL cholesterol, it may be started at 20 mg or 40 mg once daily. Lipid levels should be analyzed within 2 to 4 weeks after starting treatment, and doses should be adjusted accordingly. For patients with homozygous familial hypercholesterolemia, the dosing range is 10 mg to 80 mg once daily, in conjunction with other lipid-lowering therapies (e.g., LDL apheresis) when applicable or when such treatments are not available. For pediatric patients with heterozygous familial hypercholesterolemia (ages 10-17), the recommended initial dose is 10 mg once daily, with a maximum recommended dose of 20 mg per day (there is no clinical data for doses higher than 20 mg in pediatric patients). The dosage should be adjusted according to individual treatment goals. Adjustments should be made every 4 weeks or more. ○ In patients with renal impairment: Kidney disease does not affect atorvastatin plasma concentration or LDL cholesterol-lowering efficacy; thus, dose adjustments are not necessary. ○ In the elderly: The efficacy and safety for patients aged 70 and older are similar to that of the general adult population.
Children's dosage
For pediatric patients (ages 10-17) with heterozygous familial hypercholesterolemia, a recommended initial dose is 10 mg once daily, with a maximum dose of 20 mg per day. Dosage should be adjusted based on treatment responses every 4 weeks or longer.

Ingredients

Manufacturer
(주)엘앤씨바이오

Efficacy & effects

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

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

This medication reduces the risk of myocardial infarction and stroke in adults with cardiovascular disease risk factors and in patients with type 2 diabetes. It also lowers the need for vascular procedures and the risk of hospitalization due to angina and congestive heart failure. In patients with hyperlipidemia, it helps decrease total cholesterol, LDL cholesterol, apolipoprotein B, and triglyceride levels, while increasing good HDL cholesterol to improve blood lipids. It is particularly effective in children and adolescents with familial hypercholesterolemia and is recommended for patients at high risk of early cardiovascular diseases. This drug is used to protect heart health and improve blood lipid levels.

Dosage and Administration

Adult dosage

Atorvastatin is administered once daily at doses ranging from 10 mg to 80 mg, regardless of food intake at any time of the day. The initial dose is 10 mg once daily, but for patients requiring a greater reduction in LDL cholesterol, it may be started at 20 mg or 40 mg once daily. Lipid levels should be analyzed within 2 to 4 weeks after starting treatment, and doses should be adjusted accordingly. For patients with homozygous familial hypercholesterolemia, the dosing range is 10 mg to 80 mg once daily, in conjunction with other lipid-lowering therapies (e.g., LDL apheresis) when applicable or when such treatments are not available. For pediatric patients with heterozygous familial hypercholesterolemia (ages 10-17), the recommended initial dose is 10 mg once daily, with a maximum recommended dose of 20 mg per day (there is no clinical data for doses higher than 20 mg in pediatric patients). The dosage should be adjusted according to individual treatment goals. Adjustments should be made every 4 weeks or more. ○ In patients with renal impairment: Kidney disease does not affect atorvastatin plasma concentration or LDL cholesterol-lowering efficacy; thus, dose adjustments are not necessary. ○ In the elderly: The efficacy and safety for patients aged 70 and older are similar to that of the general adult population.

Children's dosage

For pediatric patients (ages 10-17) with heterozygous familial hypercholesterolemia, a recommended initial dose is 10 mg once daily, with a maximum dose of 20 mg per day. Dosage should be adjusted based on treatment responses every 4 weeks or longer.

Precautions

This medication may pose a risk of muscle problems; thus, if muscle pain or weakness worsens or if creatine kinase levels rise significantly, stop taking the medication immediately and consult a physician. Individuals with poor liver function or liver disease should not take this medication, and if symptoms of liver dysfunction occur during treatment, they should inform a doctor immediately. Women who are pregnant, may become pregnant, or breastfeeding should not take this medication, and women of childbearing age should use appropriate contraceptive methods while taking it. Children under 10 years of age and patients with muscle disorders should also avoid this medication. Patients with a history of alcohol addiction or liver disease should use this medication cautiously, and elderly patients aged 70 or older are at higher risk of muscle-related side effects and should be monitored closely. This medication can interact with other drugs, so it is essential to inform your physician or pharmacist, especially if you are taking certain antibiotics, antifungals, protease inhibitors, or some cardiovascular drugs. Be cautious if taking this medication with grapefruit juice or certain other drugs, as it may increase the blood concentration of the medication and heighten the risk of side effects. If symptoms such as muscle pain, weakness, fever, or fatigue develop while taking this medication, notify a doctor immediately and get tested, and discontinue use if necessary. Regular monitoring of liver function tests and blood creatine kinase levels is necessary, and immediate action should be taken if abnormalities are found. Store this medication out of reach of children, and keep it in its original container. There is no specific antidote for overdose; treatment should be symptom-based, while closely monitoring liver function and muscle condition.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe allergic reactions, severe rash with high fever, blisters, skin peeling, pain in oral/ocular mucosa, severe skin reactions, shortness of breath or difficulty in breathing, asthma attacks, respiratory problems with cough + fever, jaundice (yellowing of skin or eyes), extreme lethargy, liver disorders (jaundice), sudden and

Mild side effects

  • Weakness
  • fatigue
  • chest pain
  • peripheral edema
  • tiredness
  • fever
  • nasopharyngitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
Show 27 more
  • loss of appetite
  • constipation
  • abdominal bloating
  • dyspepsia
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • pharyngolaryngeal pain
  • nosebleeds
  • insomnia
  • nightmares
  • headache
  • dizziness
  • paresthesia
  • sensory loss
  • taste disturbance
  • memory loss
  • peripheral neuropathy
  • myalgia
  • arthralgia
  • 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 sealed container to prevent exposure to air or moisture. It is best kept at room temperature between 1 to 30 degrees Celsius.

Appearance and packaging

Appearance

White oval 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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.