Medication info
Newpex 10mg Tablet (Atorvastatin Calcium Hydrate)

Newpex 10mg Tablet (Atorvastatin Calcium Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Atorvastatin Calcium Hydrate›10.85mg / 1 tablet
Manufacturer / importer
한국유나이티드제약(주)
Appearance
White round film-coated tablet
Packaging
Bottle - 30 tablets/bottle, Bottle - 100 tablets/bottle
Approval status
Active

MFDS item code 201300047 · Approved 2013.01.04 · Insurance code 644308470

Summary

Main use
Reduces the risk of myocardial infarction and stroke, and improves hyperlipidemia
Who takes it
Adults · Children
Adult dose
For hyperlipidemia, the recommended initial dose is 10 mg once daily. Patients requiring greater LDL cholesterol reduction may start with 20 mg or 40 mg once daily. The dosing range is 10 to 80 mg once daily. Lipid levels should be analyzed to adjust doses within 2 to 4 weeks after initiating treatment. For patients with homozygous familial hypercholesterolemia, the dose is 10 to 80 mg once daily, administered in conjunction with other lipid-lowering therapies (e.g., LDL apheresis) or when such therapies are not possible.
Child dose
The recommended initial dose for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years) is 10 mg once daily, with a maximum dose of 20 mg once daily. Dosage should be adjusted with intervals of 4 weeks or more.

Ingredients

Manufacturer
한국유나이티드제약(주)

Efficacy & effects

Reduces the risk of myocardial infarction and stroke, and improves hyperlipidemia

  • Coronary heart disease
  • myocardial infarction
  • stroke
  • chronic stable angina
  • retinopathy
  • albuminuria
  • congestive heart failure
  • hyperlipidemia
  • hypercholesterolemia
  • dyslipidemia
  • abnormal beta-lipoproteinemia
  • elevated serum triglycerides
View approved original text

This medication reduces the risk of various cardiovascular diseases such as myocardial infarction, stroke, and angina in adults with multiple risk factors for cardiovascular disease and patients with type 2 diabetes. Additionally, for patients with hyperlipidemia, it is used as an adjunct to diet therapy to improve hypercholesterolemia and dyslipidemia, lowering levels of bad cholesterol and triglycerides while raising levels of good cholesterol. Particularly, it helps in lowering total cholesterol and LDL cholesterol for those with a family history or for young pediatric patients with hypercholesterolemia, contributing to the prevention of cardiovascular diseases. In summary, this drug is effectively used to reduce various cardiovascular risks and improve hyperlipidemia.

How to take

Adult dose

For hyperlipidemia, the recommended initial dose is 10 mg once daily. Patients requiring greater LDL cholesterol reduction may start with 20 mg or 40 mg once daily. The dosing range is 10 to 80 mg once daily. Lipid levels should be analyzed to adjust doses within 2 to 4 weeks after initiating treatment. For patients with homozygous familial hypercholesterolemia, the dose is 10 to 80 mg once daily, administered in conjunction with other lipid-lowering therapies (e.g., LDL apheresis) or when such therapies are not possible.

Child dose

The recommended initial dose for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17 years) is 10 mg once daily, with a maximum dose of 20 mg once daily. Dosage should be adjusted with intervals of 4 weeks or more.

Precautions

This medication may cause muscle issues; therefore, if muscle pain or weakness worsens or if creatine kinase levels rise significantly, use should be discontinued immediately. Individuals with an allergy to this medication, those with severe liver dysfunction, those with muscle diseases, pregnant or breastfeeding women, children under 10 years old, and those taking certain other medications should not take this drug. Patients with impaired liver function or a history of alcoholism, those with decreased kidney function, elderly patients, and individuals with hypothyroidism should use this medication with caution and require regular testing. Although this medication is generally well tolerated, various side effects such as liver dysfunction, muscle pain, dyspepsia, headache, and skin rash may rarely occur. If unusual symptoms appear, consult a doctor immediately. This drug is metabolized in the liver, so caution should be taken when used concurrently with specific antibiotics, antifungals, and antivirals, as drug concentration may increase, raising the risk of side effects. Pregnant women or women who may become pregnant must use appropriate contraception while taking this drug, and if pregnancy is confirmed, use should be stopped immediately. Breastfeeding women should not take this medication, and careful observation is required for children and the elderly due to a higher risk of muscle-related side effects. There are no special detoxification methods for overdose; treatment should be symptomatic, and liver function and muscle enzyme levels should be regularly examined. This drug should be stored away from direct sunlight and kept out of reach of children, ideally in its original container.

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 rashes with high fever, blisters, skin peeling, pain in oral/ocular mucosa, severe skin reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities with cough + fever, respiratory issues, jaundice (yellowing of skin or eyes), extreme lethargy, liver abnormalities (jaundice), sudden onset

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 laryngeal pain
  • nosebleed
  • insomnia
  • nightmares
  • headache
  • dizziness
  • sensory disturbances
  • loss of sensation
  • taste disturbances
  • amnesia
  • peripheral neuropathy
  • muscle pain
  • joint pain
  • 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 or moisture, so it should be stored in a tightly sealed container. Additionally, it is recommended to store the drug at room temperature, between 1°C and 30°C. Avoid extremely hot or cold places, and keep it in a cool place away from direct sunlight.

Appearance and packaging

Appearance

White round film-coated tablet

Package unit

Bottle - 30 tablets/bottle, 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.