Medication info
Atorban Tablet 10 mg (Atorvastatin Calcium Hydrate)

Atorban Tablet 10 mg (Atorvastatin Calcium Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Atorvastatin Calcium Hydrate›10.845mg / 1 tablet
Manufacturer / importer
동국제약(주)
Appearance
White oval film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201203607 · Approved 2012.04.30 · Insurance code 653402570

Summary

Main use
Reduction of risk for myocardial infarction and stroke, improvement of hypercholesterolemia
Who takes it
Adults · Children
Adult dose
For treatment of hyperlipidemia, the recommended starting dose is 10 mg of atorvastatin once daily; for patients requiring greater reductions in LDL cholesterol, starting doses may be increased to 20 mg or 40 mg once daily. Doses range from 10 to 80 mg once daily. Lipid levels should be assessed within 2 to 4 weeks following initiation and dose adjustment to determine further dosage modifications. For patients with homozygous familial hypercholesterolemia, doses are typically within the range of 10 to 80 mg once daily, often in conjunction with other lipid-lowering therapies (e.g., LDL apheresis) when this is not feasible. For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years), the recommended starting dose is 10 mg once daily with a maximum recommended dose of 20 mg per day (there is no clinical data for doses over 20 mg in this population). Adjustments should be made based on individual patient response to the recommended treatment goals, with dosage being adjusted at intervals of 4 weeks or more. ○ In patients with renal impairment: Renal disease does not affect the plasma concentration or LDL cholesterol-lowering efficacy of atorvastatin, so no dose adjustment is necessary. ○ In the elderly: Efficacy and safety in patients aged 70 years and older are similar to those in the general adult population.
Child dose
The recommended starting dose for pediatric patients with heterozygous familial hypercholesterolemia (ages 10-17 years) is 10 mg once daily, with a maximum dose of 20 mg per day. Dosage adjustments should be made at intervals of 4 weeks or more.

Ingredients

Manufacturer
동국제약(주)

Efficacy & effects

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

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

This drug is used to reduce the risk of cardiovascular diseases. It lowers the risk of myocardial infarction and stroke in adults with risk factors for coronary heart disease and patients with type 2 diabetes. It also aids in reducing the risk after vascular interventions and in patients with stable angina and congestive heart failure. For patients with hyperlipidemia, it lowers total cholesterol, LDL cholesterol, apo-B protein, and triglyceride levels, while raising HDL cholesterol levels, serving as an adjunct to dietary therapy. It is particularly effective in improving lipid levels in pediatric patients aged 10 to 17 years with heterozygous familial hypercholesterolemia. Overall, it is a medication that aids in the treatment of heart disease and dyslipidemia.

How to take

Adult dose

For treatment of hyperlipidemia, the recommended starting dose is 10 mg of atorvastatin once daily; for patients requiring greater reductions in LDL cholesterol, starting doses may be increased to 20 mg or 40 mg once daily. Doses range from 10 to 80 mg once daily. Lipid levels should be assessed within 2 to 4 weeks following initiation and dose adjustment to determine further dosage modifications. For patients with homozygous familial hypercholesterolemia, doses are typically within the range of 10 to 80 mg once daily, often in conjunction with other lipid-lowering therapies (e.g., LDL apheresis) when this is not feasible. For pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years), the recommended starting dose is 10 mg once daily with a maximum recommended dose of 20 mg per day (there is no clinical data for doses over 20 mg in this population). Adjustments should be made based on individual patient response to the recommended treatment goals, with dosage being adjusted at intervals of 4 weeks or more. ○ In patients with renal impairment: Renal disease does not affect the plasma concentration or LDL cholesterol-lowering efficacy of atorvastatin, so no dose adjustment is necessary. ○ In the elderly: Efficacy and safety in patients aged 70 years and older are similar to those in the general adult population.

Child dose

The recommended starting dose for pediatric patients with heterozygous familial hypercholesterolemia (ages 10-17 years) is 10 mg once daily, with a maximum dose of 20 mg per day. Dosage adjustments should be made at intervals of 4 weeks or more.

Precautions

This medication may pose a risk of muscle problems, so if muscle pain or weakness occurs, consult a doctor immediately. This medication may affect liver function; therefore, it should not be used if there is liver disease or elevated liver enzyme levels. Women who are pregnant or may become pregnant, as well as nursing mothers, should not take this medication. Children, especially those under 10 years old, should not use this medication, and children aged 10 to 17 should use it cautiously under a doctor’s guidance. Patients with a history of alcohol abuse or liver disease need to exercise caution when taking this medication. This medication may interact with other drugs; therefore, inform your doctor or pharmacist about any other medications you are taking. Particularly, there is an increased risk of muscle damage when combined with certain antibiotics, antifungals, and antivirals, so caution is advised. During the course of this medication, it is important to regularly monitor liver function and muscle condition. If severe muscle pain, muscle weakness, fatigue, or fever occurs, inform your healthcare provider and undergo testing immediately. Taking this medication with grapefruit juice can increase blood concentration, so it is best to avoid grapefruit juice. Though this medication is generally safe based on clinical trials and post-marketing studies, rare serious side effects such as allergic reactions, skin rashes, and hepatitis may occur. Store this medication out of the reach of children and keep it in its original container. There is no specific antidote for overdose, so treatment should be provided based on symptoms, and liver function and muscle enzyme tests should be conducted.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • severe swelling (angioedema)
  • chest tightness
  • difficulty breathing
  • cold sweat
  • pallor
  • severe rash with high fever
  • blisters
  • skin peeling
  • pain in oral/ocular mucosa
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  • difficulty breathing
  • asthma attack
  • cough with fever and respiratory issues
  • jaundice (yellowing of skin or eyes)
  • extreme fatigue
  • sudden and severe headache
  • thunderclap headache
  • seizures
  • confusion
  • visual disturbances
  • paralysis
  • urination

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
  • pharyngeal and laryngeal pain
  • nosebleeds
  • insomnia
  • nightmares
  • headaches
  • dizziness
  • paresthesia
  • sensory loss
  • taste distortion
  • 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 can be sensitive to air or moisture, so it must be stored in a tightly closed container. The recommended storage temperature is between 1 and 30 degrees Celsius to ensure the medication's efficacy is maintained safely.

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.