Medication info
Atorvastatin Calcium Hydrate Tablet 20 mg

Atorvastatin Calcium Hydrate Tablet 20 mg

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

MFDS item code 201405524 · Approved 2014.11.26 · Insurance code 657306540

Summary

Main use
Reduces the risk of myocardial infarction and stroke and improves high cholesterol levels
Who takes it
Adults · Children
Adult dose
The recommended starting dose for hyperlipidemia is 10 mg of atorvastatin once daily, and if a greater reduction in LDL cholesterol is required, it may be started at 20 mg or 40 mg once daily. This medication is administered within a dose range of 10 to 80 mg once daily. The initial and maintenance doses should be individualized based on treatment goals and response, with lipid levels analyzed 2 to 4 weeks after therapy initiation and dose adjustment.
Child dose
The recommended starting dose for pediatric patients (10 to 17 years of age) with heterozygous familial hypercholesterolemia is 10 mg once daily, and the recommended maximum dose is 20 mg once daily. The dosage should be adjusted appropriately based on treatment goals.

Ingredients

Manufacturer
(주)동구바이오제약

Efficacy & effects

Reduces the risk of myocardial infarction and stroke and improves high cholesterol levels

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

This medication helps reduce the risk of myocardial infarction, stroke, vascular procedures, and angina in adults with cardiovascular risk factors or type 2 diabetes. It also lowers various complications for patients who already have heart disease, such as the risk of hospitalization due to myocardial infarction, stroke, and congestive heart failure. In patients with hyperlipidemia, it decreases total cholesterol, LDL cholesterol, triglyceride levels, and increases HDL cholesterol levels to improve lipid disorders. It is especially useful for pediatric patients with heterozygous familial hypercholesterolemia. This medication is used to maintain vascular health and effectively reduce the risk of heart disease.

How to take

Adult dose

The recommended starting dose for hyperlipidemia is 10 mg of atorvastatin once daily, and if a greater reduction in LDL cholesterol is required, it may be started at 20 mg or 40 mg once daily. This medication is administered within a dose range of 10 to 80 mg once daily. The initial and maintenance doses should be individualized based on treatment goals and response, with lipid levels analyzed 2 to 4 weeks after therapy initiation and dose adjustment.

Child dose

The recommended starting dose for pediatric patients (10 to 17 years of age) with heterozygous familial hypercholesterolemia is 10 mg once daily, and the recommended maximum dose is 20 mg once daily. The dosage should be adjusted appropriately based on treatment goals.

Precautions

This medication may cause muscle problems, so discontinue immediately if there is severe muscle pain or weakness, or if there is a significant increase in creatine kinase levels. Patients with severe infections, hypotension, major surgery, trauma, metabolic disorders, electrolyte imbalances, or uncontrolled epilepsy should temporarily discontinue this medication. This medication should not be taken by individuals with certain diseases or allergies, women who are pregnant or may become pregnant, children under 10 years old, or individuals with certain liver or muscle diseases. Individuals with a history of alcohol abuse or liver disease, those with poor kidney function, those with hypothyroidism, individuals with a family history of muscle disorders, or those who have previously experienced muscle toxicity reactions, as well as elderly patients over 70 years old should use this medication with caution. Various side effects such as fatigue, muscle pain, indigestion, headache, insomnia, and skin rash may occur during treatment, so consult a doctor if any abnormal symptoms arise. In particular, if severe muscle pain or weakness occurs, seek medical attention promptly, and blood tests should be conducted to check for muscle damage. This medication may affect liver function, so regular liver function tests should be conducted before and during treatment, and if symptoms such as nausea, vomiting, or jaundice occur, discontinue immediately. Women of childbearing age should use appropriate contraception to avoid pregnancy while taking this medication and must discontinue use if pregnant. Breastfeeding women should not take this medication, as it may be passed to the baby through breast milk. This medication may interact with certain other medications, so inform and consult with your doctor or pharmacist if you are taking other medications. Particular caution is required when used with strong CYP3A4 inhibitors, certain antibiotics, antifungals, HIV treatments, certain antihypertensives, and hypoglycemic agents. In the event of an overdose, there is no specific antidote, so treatment should be based on symptoms, with monitoring of liver function and muscle condition. Keep out of reach of children and store in the original container to prevent misuse or degradation.

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, pain in mucous membranes of mouth/eyes, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), severe overall fatigue, sudden and very severe headache, thunderclap headache, seizures, confusion, visual disturbances, paralysis, changes in urination

Mild side effects

  • Weakness
  • fatigue
  • chest pain
  • peripheral edema
  • tiredness
  • fever
  • pharyngitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
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  • loss of appetite
  • constipation
  • abdominal bloating
  • indigestion
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • burping
  • pancreatitis
  • pharyngeal/laryngeal pain
  • nosebleeds
  • insomnia
  • nightmares
  • headache
  • dizziness
  • sensory disturbances
  • sensory loss
  • taste disturbances
  • memory loss
  • peripheral neuropathy
  • muscle pain
  • joint pain
  • limb pain
  • musculoskeletal pain
  • muscle cramps
  • joint pain

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

Storage

This medication should be stored in a sealed container to protect it from air and moisture. It is best to store it at room temperature between 1 to 30 degrees Celsius. This way, the medication's effectiveness can be maintained and safely used.

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.