Medication info

Hator Tablet 20 mg (Atorvastatin Calcium Hydrate)

Prescription medicationTabletApproval withdrawn
Ingredient · strength
Atorvastatin Calcium Hydrate›21.69mg / 1 tablet
Manufacturer / importer
한올바이오파마(주)
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Approval withdrawn

MFDS item code 201310868 · Approved 2013.12.24

This product's status changed to Approval withdrawn on 2023.12.18. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Reduction of the risk of myocardial infarction and stroke and improvement of hyperlipidemia
Who uses it
Adults · Children
Adult dosage
For hyperlipidemia, the recommended starting dose is 10 mg of atorvastatin once daily. Patients who require a greater reduction in LDL cholesterol may start at 20 mg or 40 mg once daily. This medication is administered in a dosage range of 10 to 80 mg once daily. Lipid levels should be analyzed within 2 to 4 weeks of starting treatment to adjust the dosage accordingly. The treatment goal is to lower LDL cholesterol levels, so it is recommended to use LDL cholesterol levels for both initiating treatment and evaluating treatment response. However, if LDL cholesterol levels are not available, total cholesterol levels should be used to monitor treatment response. For patients with homozygous familial hypercholesterolemia, the dose of this medication is 10 to 80 mg once daily, administered either in conjunction with other lipid-lowering treatments (e.g., LDL apheresis) or when such treatments are not feasible.
Children's dosage
The recommended starting dose for pediatric patients with heterozygous familial hypercholesterolemia (ages 10-17) is 10 mg once daily, with a maximum dose of 20 mg once daily. Dosing should be adjusted based on treatment goals at intervals of 4 weeks or more.

Ingredients

Manufacturer
한올바이오파마(주)

Efficacy & effects

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

  • Coronary heart disease
  • myocardial infarction
  • stroke
  • angioplasty
  • chronic stable angina
  • retinopathy
  • albuminuria
  • hypertension
  • congestive heart failure
  • angina
  • hypercholesterolemia
  • dyslipidemia
View approved original text

This medication helps to lower the risk of cardiovascular diseases. It particularly reduces the risks of myocardial infarction, stroke, complications after angioplasty, and angina, and is effective for patients with multiple risk factors such as hypertension or diabetes. It also lowers cholesterol and triglyceride levels in patients with primary hypercholesterolemia and mixed dyslipidemia and increases HDL cholesterol levels to improve vascular health. This medication is also used for the treatment of hyperlipidemia in pediatric patients with a family history or other risk factors, contributing to the prevention of heart disease. Overall, this medication is used to improve health by controlling various risk factors for cardiovascular diseases.

Dosage and Administration

Adult dosage

For hyperlipidemia, the recommended starting dose is 10 mg of atorvastatin once daily. Patients who require a greater reduction in LDL cholesterol may start at 20 mg or 40 mg once daily. This medication is administered in a dosage range of 10 to 80 mg once daily. Lipid levels should be analyzed within 2 to 4 weeks of starting treatment to adjust the dosage accordingly. The treatment goal is to lower LDL cholesterol levels, so it is recommended to use LDL cholesterol levels for both initiating treatment and evaluating treatment response. However, if LDL cholesterol levels are not available, total cholesterol levels should be used to monitor treatment response. For patients with homozygous familial hypercholesterolemia, the dose of this medication is 10 to 80 mg once daily, administered either in conjunction with other lipid-lowering treatments (e.g., LDL apheresis) or when such treatments are not feasible.

Children's dosage

The recommended starting dose for pediatric patients with heterozygous familial hypercholesterolemia (ages 10-17) is 10 mg once daily, with a maximum dose of 20 mg once daily. Dosing should be adjusted based on treatment goals at intervals of 4 weeks or more.

Precautions

This medication may cause muscle problems, so if there is an increase in muscle pain or weakness, or if creatine kinase (CK) levels rise significantly, discontinue use immediately. Patients with impaired liver function or liver disease should not use this medication, and if symptoms of liver dysfunction occur, they should consult a doctor immediately. Use in pregnant women or those who may become pregnant, nursing women, and children under 10 years of age is prohibited. Patients with a history of alcohol abuse or liver disease, decreased kidney function, or hypothyroidism should consult a physician before taking this medication due to an increased risk of muscle-related side effects. This medication may interact with various drugs; therefore, if you are taking other medications, you must inform your doctor or pharmacist. Particularly caution should be taken when used in combination with certain antibiotics, antifungals, HIV medications, some blood pressure medications, antidiabetic medications, and oral contraceptives, as dosage adjustment may be required. If symptoms such as muscle pain, muscle weakness, fever, or malaise occur while taking this medication, inform your doctor immediately, and if necessary, blood tests should be performed to check for muscle damage. While taking this medication, regular liver function tests should be conducted, and if any abnormal symptoms occur, use should be stopped immediately and the healthcare provider consulted. Children and elderly patients may have different risks of side effects, so appropriate dosage adjustment and monitoring according to age are necessary. In case of overdose, there is no specific antidote, so treatment should be symptomatic while closely monitoring liver function and muscle condition. This medication should be kept out of reach of children and stored 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 allergic reactions, severe rash with fever, blisters, skin shedding, oral/ocular mucosal pain, severe skin reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough and fever, respiratory problems, yellowing of the skin or eyes (jaundice), extreme lethargy, liver abnormalities (jaundice), sudden

Mild side effects

  • Weakness
  • malaise
  • chest pain
  • peripheral edema
  • fatigue
  • fever
  • nasopharyngitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
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  • loss of appetite
  • constipation
  • abdominal bloating
  • indigestion
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • throat pain
  • nosebleed
  • insomnia
  • nightmares
  • headache
  • dizziness
  • paresthesia
  • sensory loss
  • taste alteration
  • memory loss
  • peripheral neuropathy
  • myalgia
  • arthralgia
  • limb pain
  • musculoskeletal pain
  • muscle cramps
  • joints

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

Storage

This medication may be sensitive to air and moisture, so it must be stored in a tightly sealed container. It is important to maintain a storage temperature between 1 to 30 degrees Celsius. This helps to preserve the efficacy and safety of the medication.

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.