Medication info
Newtor 20 mg (Atorvastatin Calcium Trihydrate)

Newtor 20 mg (Atorvastatin Calcium Trihydrate)

Prescription medicationTablet경구
Ingredient · strength
Atorvastatin Calcium Trihydrate›21.7mg / 1 tablet
Manufacturer / importer
대한뉴팜(주)
Appearance
White oval film-coated tablet
Packaging
For domestic use - 30 tablets/bottle, for domestic use - 100 tablets/bottle
Approval status
Active

MFDS item code 201403432 · Approved 2014.07.28 · Insurance code 669906010

Summary

Main use
Reduction of risks for myocardial infarction and stroke, improvement of hypercholesterolemia
Who takes it
Adults · Children
Adult dose
For hyperlipidemia, the recommended initial dose is 10 mg once daily, but for patients requiring greater LDL-cholesterol reduction, starting doses may be 20 mg or 40 mg once daily. The dosing range is from 10 to 80 mg once daily. Dosage should be individualized based on treatment goals and patient characteristics, and lipid levels should be analyzed for dosage adjustment 2-4 weeks after starting the treatment.
Child dose
For pediatric patients with heterozygous familial hypercholesterolemia (ages 10-17), the recommended initial dosage is 10 mg once daily, with a maximum dosage of 20 mg once daily. Dosages should be adjusted at intervals of at least 4 weeks based on treatment goals.

Ingredients

Manufacturer
대한뉴팜(주)

Efficacy & effects

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

  • Myocardial infarction
  • stroke
  • revascularization
  • chronic stable angina
  • retinopathy
  • albuminuria
  • congestive heart failure
  • angina
  • hypercholesterolemia
  • dyslipidemia
  • dysbetalipoproteinemia
  • elevated serum triglycerides
View approved original text

This medication helps reduce the risk of cardiovascular diseases. In particular, it decreases the risk of myocardial infarction and stroke in adults with risk factors for coronary artery disease and in patients with type 2 diabetes, and also lowers the risks of revascularization procedures and chronic stable angina. For patients already diagnosed with coronary artery disease, it has effects in reducing the risks of non-fatal myocardial infarction, stroke, revascularization, hospitalization for congestive heart failure, and angina. Furthermore, this medication lowers total cholesterol, LDL-cholesterol, Apo-B protein, and triglyceride levels in patients with hyperlipidemia while increasing levels of HDL-cholesterol, the 'good' cholesterol. It is particularly beneficial for patients with familial hypercholesterolemia and those with dyslipidemia that is not controlled solely by diet. It is used not only for adults but also for patients aged 10-17 years who meet the criteria for hypercholesterolemia to control their cholesterol levels.

How to take

Adult dose

For hyperlipidemia, the recommended initial dose is 10 mg once daily, but for patients requiring greater LDL-cholesterol reduction, starting doses may be 20 mg or 40 mg once daily. The dosing range is from 10 to 80 mg once daily. Dosage should be individualized based on treatment goals and patient characteristics, and lipid levels should be analyzed for dosage adjustment 2-4 weeks after starting the treatment.

Child dose

For pediatric patients with heterozygous familial hypercholesterolemia (ages 10-17), the recommended initial dosage is 10 mg once daily, with a maximum dosage of 20 mg once daily. Dosages should be adjusted at intervals of at least 4 weeks based on treatment goals.

Precautions

This medication may cause muscle-related symptoms, so if muscle pain, weakness, or cramping occurs, consult a doctor immediately. In particular, it should be discontinued if there is a significant increase in muscle enzyme levels or suspicion of myopathy. Caution is required if there is liver disease or if liver function test results are abnormally high as this medication may affect liver function. Women who are pregnant or may become pregnant should not take this medication, and adequate contraception should be used during treatment. Nursing women should also avoid taking this medication. This medication may interact with certain drugs, so inform your doctor or pharmacist if you are taking other medications. Elderly patients or those with impaired kidney function should use caution due to a higher risk of muscle problems. If symptoms such as malaise, fever, or muscle pain appear during treatment, notify healthcare personnel immediately. This medication contains lactose, so patients with lactose intolerance should not take it. Children, especially those under the age of 10, should not use this medication. Always follow the prescribed dosage and administration method, and do not arbitrarily stop or change the dose. Store the medication out of reach of children and keep it in its original container.

Side effects and when to seek care immediately

Serious side effects

Hives, angioedema, chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reactions, severe rashes with high fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, severe skin reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory issues accompanied by cough+fever, breathing problems, yellowing of skin or eyes (jaundice), severe lethargy, liver abnormalities (jaundice), sudden and unusual

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/laryngeal pain
  • nosebleeds
  • insomnia
  • nightmares
  • headache
  • dizziness
  • paresthesia
  • sensory loss
  • taste changes
  • 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 should be stored in a tightly closed container to protect it from air and moisture. It is also advisable to store the medication at room temperature between 1 and 30 degrees Celsius. This way of storage will help maintain the medication’s efficacy and allow safe usage.

Appearance and packaging

Appearance

White oval film-coated tablet

Package unit

For domestic use - 30 tablets/bottle, for domestic use - 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.