Medication info
Neoato Tablets 20 mg (Atorvastatin Calcium Hydrate)

Neoato Tablets 20 mg (Atorvastatin Calcium Hydrate)

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

MFDS item code 201701635 · Approved 2017.04.04 · Insurance code 643605350

Summary

Main use
Reduction of risks of myocardial infarction and stroke, improvement of hypercholesterolemia, treatment of familial hypercholesterolemia
Who uses it
Adults · Children
Adult dosage
For the treatment of hyperlipidemia, the recommended starting dose is 10 mg once daily; if a greater reduction in LDL-cholesterol is needed, it may be initiated at 20 mg or 40 mg once daily.Usually, doses are administered within the range of 10-80 mg once daily. Dosing should be individualized based on treatment goals and patient characteristics, and lipid levels should be analyzed within 2-4 weeks after starting or adjusting the dose.
Children's dosage
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10-17), the recommended starting dose is 10 mg daily, with a maximum dose of 20 mg daily. Doses should be adjusted based on the treatment target at intervals of at least 4 weeks.

Ingredients

Manufacturer
(주)녹십자

Efficacy & effects

Reduction of risks of myocardial infarction and stroke, improvement of hypercholesterolemia, treatment of familial hypercholesterolemia

  • Coronary artery disease
  • myocardial infarction
  • stroke
  • vascular surgery
  • chronic stable angina
  • retinopathy
  • albuminuria
  • hypertension
  • congestive heart failure
  • angina
  • hyperlipidemia
  • primary hypercholesterolemia
View approved original text

This medication helps reduce the risk of myocardial infarction, stroke, vascular surgeries, and angina in adults with various cardiovascular disease risk factors and in patients with type 2 diabetes. In addition, it lowers the risks of myocardial infarction and stroke in patients with clinical evidence of heart disease and also decreases the likelihood of hospitalization due to congestive heart failure and the occurrence of angina. It effectively reduces total cholesterol, LDL-cholesterol, Apo-B, and triglyceride levels in patients with primary hypercholesterolemia and mixed dyslipidemia, while increasing HDL-cholesterol levels. Moreover, it is effective in patients with dysbetalipoproteinemia and elevated triglycerides when dietary adjustments alone are insufficient. In pediatric patients aged 10 to 17 with heterozygous familial hypercholesterolemia, it effectively lowers total cholesterol and LDL-cholesterol levels, thereby reducing the risk of cardiovascular diseases. Thus, this medication is widely used to improve cardiovascular health and manage hyperlipidemia.

Dosage and Administration

Adult dosage

For the treatment of hyperlipidemia, the recommended starting dose is 10 mg once daily; if a greater reduction in LDL-cholesterol is needed, it may be initiated at 20 mg or 40 mg once daily.Usually, doses are administered within the range of 10-80 mg once daily. Dosing should be individualized based on treatment goals and patient characteristics, and lipid levels should be analyzed within 2-4 weeks after starting or adjusting the dose.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10-17), the recommended starting dose is 10 mg daily, with a maximum dose of 20 mg daily. Doses should be adjusted based on the treatment target at intervals of at least 4 weeks.

Precautions

This medication may cause unusual symptoms in muscles, so if there is severe muscle pain or weakness, or a significant increase in creatine kinase levels, it should be discontinued immediately and consult a doctor. Patients with impaired liver function or active liver disease should not take this medication and should undergo regular liver function tests. This drug should not be used during pregnancy or by women who may become pregnant, and by breastfeeding women. Children under 10 years of age or patients with muscle disorders should also not take this medication. Patients with a history of alcohol dependence, liver disease, or kidney dysfunction should take this medication with special caution. This medication may interact with other drugs; therefore, consultation with a physician or pharmacist is particularly advised when taken with certain antibiotics, antifungals, HIV treatments, antacids, antihypertensive drugs, antidiabetic agents, or oral contraceptives. Grapefruit juice can increase the blood concentration of this drug, so excessive intake should be avoided. If symptoms such as muscle pain, weakness, or fever occur during treatment, report to a doctor immediately for testing. If symptoms like hepatitis, jaundice, nausea, vomiting, or fatigue appear, discontinue use and consult a healthcare professional. Regular liver function and muscle status tests are essential during the course of this medication. This medication should not be administered to patients with specific genetic lactose intolerance, and it should be kept out of the reach of children. There is no specific antidote for overdose, so treatment should be based on symptoms, while monitoring liver function and muscle enzyme levels. Elderly patients or those with reduced kidney function should be carefully monitored for muscle abnormalities and other side effects. Appropriate contraceptive measures should be used during treatment, and consultation with a healthcare professional is necessary if planning pregnancy or if already pregnant.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe allergic reaction, severe rashes with high fever, blisters, skin peeling, mucosal pain in the mouth or eyes, severe skin adverse reactions, difficulty breathing or dyspnea, asthma attack, respiratory distress with cough and fever, yellowing of the skin or eyes (jaundice), extreme lethargy, liver dysfunction (jaundice), sudden and

Mild side effects

  • Weakness
  • fatigue
  • chest pain
  • peripheral edema
  • tiredness
  • fever
  • nasopharyngitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
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  • anorexia
  • constipation
  • abdominal distension
  • indigestion
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • throat and laryngeal pain
  • nosebleed
  • insomnia
  • nightmares
  • headache
  • dizziness
  • paresthesia
  • sensory loss
  • taste disturbance
  • 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 may be sensitive to air or moisture, so it must be stored in a tightly sealed container. The recommended storage temperature is room temperature between 1 and 30 degrees Celsius. Proper storage will help maintain the medication's potency 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.