Medication info
Mega Atova 10 mg (Atorvastatin Calcium Hydrate)

Mega Atova 10 mg (Atorvastatin Calcium Hydrate)

Prescription medicationTablet
Ingredient · strength
Atorvastatin Calcium Trihydrate›10.845mg / 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 201902759 · Approved 2019.04.29 · Insurance code 060500770

Summary

Main use
Reduction of risk of myocardial infarction and stroke, and improvement of hyperlipidemia
Who uses it
Adults · Children
Adult dosage
Atorvastatin is administered once daily at doses between 10 to 80 mg, at any time of day regardless of meals. For hyperlipidemia, the recommended initial dose is 10 mg once daily, but for patients needing greater reductions in LDL-cholesterol, treatment can start at 20 mg or 40 mg. The dose should be individualized based on treatment goals and responses, and lipid levels are assessed 2 to 4 weeks afterwards to make dosage adjustments.
Children's dosage
The recommended initial dose for pediatric patients with heterozygous familial hypercholesterolemia aged 10 to 17 years is 10 mg once daily, with a maximum recommended dose of 20 mg per day. The dosing should be adjusted appropriately according to the treatment goals.

Ingredients

Manufacturer
(주)엘앤씨바이오

Efficacy & effects

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

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

This medication reduces the risk of myocardial infarction and stroke in adults with multiple risk factors for cardiovascular diseases and patients with type 2 diabetes. It also lowers the risk of cardiac complications such as vascular procedures and angina. Additionally, it decreases total cholesterol and LDL-cholesterol levels while increasing HDL-cholesterol levels, thereby improving blood lipid profiles. It is particularly effective for patients with familial hypercholesterolemia who cannot control their condition with diet alone and is safe for use in young pediatric patients. This helps to maintain healthy heart function by reducing overall cardiovascular disease risk and improving blood lipids.

Dosage and Administration

Adult dosage

Atorvastatin is administered once daily at doses between 10 to 80 mg, at any time of day regardless of meals. For hyperlipidemia, the recommended initial dose is 10 mg once daily, but for patients needing greater reductions in LDL-cholesterol, treatment can start at 20 mg or 40 mg. The dose should be individualized based on treatment goals and responses, and lipid levels are assessed 2 to 4 weeks afterwards to make dosage adjustments.

Children's dosage

The recommended initial dose for pediatric patients with heterozygous familial hypercholesterolemia aged 10 to 17 years is 10 mg once daily, with a maximum recommended dose of 20 mg per day. The dosing should be adjusted appropriately according to the treatment goals.

Precautions

This medication may cause muscle problems; if symptoms of muscle pain or weakness occur, discontinue use immediately and inform your doctor. This medication should not be used in patients with certain liver diseases or severely impaired liver function. Women who are pregnant, may become pregnant, or are nursing should not take this medication. Children under the age of 10 should not use this medication. Precautions are necessary for patients with alcoholism, a history of liver disease, decreased kidney function, or hypothyroidism. This medication can interact with other drugs; if you are taking other medications, be sure to inform your doctor or pharmacist. If symptoms such as muscle pain, weakness, fatigue, fever, etc., occur during treatment, seek medical attention immediately and have blood tests if necessary to check for muscle damage. This medication can affect liver function, so regular liver function tests are important. Appropriate contraceptive methods should be used during the course of this medication, and if you plan to become pregnant or are pregnant, it is crucial to consult your doctor. There are no specific antidotes for overdose, so appropriate treatment should be administered based on symptoms, and liver function and muscle condition should be monitored regularly. This medication should be stored out of reach of children and in its original container for safety. Particularly in elderly patients or those with decreased kidney function, careful observation is needed due to the increased risk of muscle disease.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (edema)
  • chest tightness
  • difficulty breathing
  • cold sweat
  • pallor
  • severe allergic reactions
  • severe rash with high fever
  • blisters
  • peeling skin
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  • pain in oral/ocular mucosa
  • severe skin reactions
  • shortness of breath or trouble breathing
  • asthma attacks
  • respiratory problems with cough+fever
  • jaundice (yellowing of skin or eyes)
  • extreme lethargy
  • liver problems (hepatitis)
  • 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
  • indigestion
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • throat/laryngeal pain
  • nosebleeds
  • insomnia
  • nightmares
  • headache
  • dizziness
  • abnormal sensations
  • sensory loss
  • taste disturbance
  • memory loss
  • peripheral neuropathy
  • muscle pain
  • joint pain
  • limb pain
  • musculoskeletal pain
  • muscle cramps
  • joints.

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

Storage

Store this medication in a tightly closed container to protect it from air and moisture. It is important to maintain the storage temperature between 1 to 30 degrees Celsius at room temperature.

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

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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.