Medication info
Neoato 10 mg (Atorvastatin Calcium Hydrate)

Neoato 10 mg (Atorvastatin Calcium Hydrate)

Prescription medicationTablet
Ingredient · strength
Atorvastatin Calcium Hydrate›10.85mg / 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 201701634 · Approved 2017.04.04 · Insurance code 643605340

Summary

Main use
Reduction of the risk of myocardial infarction and stroke, improvement of hypercholesterolemia
Who uses it
Adults · Children
Adult dosage
For hyperlipidemia, the recommended initial dose is 10 mg once daily of atorvastatin, whereas patients requiring a greater reduction in LDL cholesterol levels may begin with 20 mg or 40 mg once a day. This medication can be administered in a dosage range of 10 to 80 mg once daily. Lipid levels should be monitored and adjusted within 2 to 4 weeks after initiation and/or dose adjustment. In patients with homozygous familial hypercholesterolemia, the dosage is 10 to 80 mg once daily, either in conjunction with other lipid-lowering treatments (e.g., LDL apheresis) or when such treatments are not available.
Children's dosage
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10-17), the recommended initial dose is 10 mg once daily, with a maximum dose of 20 mg per day. The dosage should be adjusted based on the individual patient's treatment.

Ingredients

Manufacturer
(주)녹십자

Efficacy & effects

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

  • Coronary heart disease
  • myocardial infarction
  • stroke
  • vascular surgery
  • chronic stable angina
  • retinopathy
  • albuminuria
  • hypertension
  • type 2 diabetes
  • congestive heart failure
  • angina
  • hyperlipidemia
View approved original text

This medication helps to reduce the risk of cardiovascular disease. It lowers the risk of myocardial infarction and stroke in adult patients with various risk factors for coronary heart disease or patients with type 2 diabetes. It also reduces the risk of various cardiovascular problems, such as myocardial infarction, stroke, angina, and congestive heart failure, thus improving cardiovascular health. Additionally, it is used as an adjunct to diet in patients with hyperlipidemia to lower cholesterol and triglyceride levels while increasing good HDL cholesterol levels. It particularly contributes to reducing the risk of heart disease in certain patients with familial hypercholesterolemia and in pediatric patients. Therefore, this drug is used to reduce the risk of hyperlipidemia and cardiovascular disease.

Dosage and Administration

Adult dosage

For hyperlipidemia, the recommended initial dose is 10 mg once daily of atorvastatin, whereas patients requiring a greater reduction in LDL cholesterol levels may begin with 20 mg or 40 mg once a day. This medication can be administered in a dosage range of 10 to 80 mg once daily. Lipid levels should be monitored and adjusted within 2 to 4 weeks after initiation and/or dose adjustment. In patients with homozygous familial hypercholesterolemia, the dosage is 10 to 80 mg once daily, either in conjunction with other lipid-lowering treatments (e.g., LDL apheresis) or when such treatments are not available.

Children's dosage

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10-17), the recommended initial dose is 10 mg once daily, with a maximum dose of 20 mg per day. The dosage should be adjusted based on the individual patient's treatment.

Precautions

This medication may cause muscle-related issues; therefore, if symptoms such as muscle pain or weakness occur, you should stop taking it immediately and consult a doctor. This medication should not be used in patients with certain liver diseases, muscle diseases, pregnant or potentially pregnant women, breastfeeding women, and children under 10 years old. Patients with impaired liver function, alcohol dependence, renal impairment, and elderly individuals should take special care while using this medication, and liver function and muscle condition should be regularly monitored. This medication may interact with other drugs; therefore, especially when taking certain antibiotics, antifungals, HIV treatments, some blood pressure medications, contraceptives, and grapefruit juice, you should consult a doctor or pharmacist. Pregnant or breastfeeding women should avoid this medication as it can harm the fetus or infant. During the course of treatment, it is important to regularly check liver function and serum creatine kinase (CK) levels, and to notify medical staff immediately if any unusual symptoms occur. If excessive muscle pain, muscle weakness, fever, fatigue, or other symptoms appear, you should inform your doctor immediately, and discontinue the medication if necessary. Keep this medicine out of the reach of children and store it in its original container to prevent misuse or degradation of quality.

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, oral/ocular mucosal pain, jaundice (yellowing of skin or eyes), excessive lethargy, sudden and severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, markedly reduced urine output, severe swelling throughout the body with hypertension occurring, anaphylaxis

Mild side effects

  • Weakness
  • fatigue
  • chest pain
  • peripheral edema
  • tiredness
  • fever
  • nasopharyngitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
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  • loss of appetite
  • constipation
  • abdominal distension
  • dyspepsia
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • throat and larynx pain
  • nosebleed
  • insomnia
  • nightmares
  • headache
  • dizziness
  • sensory disturbances
  • numbness
  • taste disturbance
  • amnesia
  • 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 is sensitive to air and moisture, so it must be stored in a tightly sealed container. It is recommended to keep the storage temperature between 1 and 30 degrees Celsius. This helps maintain the effectiveness of the medication for a long 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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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.