Medication info
Newpex Tablet 20 mg (Atorvastatin Calcium Hydrate)

Newpex Tablet 20 mg (Atorvastatin Calcium Hydrate)

Prescription medicationTablet경구
Ingredient · strength
Atorvastatin Calcium Hydrate›21.7mg / 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 201208998 · Approved 2012.11.30 · Insurance code 644308440

Summary

Main use
Reduction of myocardial infarction and stroke risk, improvement of hypercholesterolemia
Who takes it
Adults · Children
Adult dose
For the treatment of hyperlipidemia, the recommended initial dose is 10 mg of atorvastatin once daily. If a greater reduction in LDL cholesterol is needed, it can be started at 20 mg or 40 mg once daily. The dosage range is from 10 mg to 80 mg once daily. Lipid levels should be analyzed within 2 to 4 weeks after starting treatment to adjust the dosage. In patients with homozygous familial hypercholesterolemia, the dose is 10 mg once daily.
Child dose
For pediatric patients (ages 10 to 17) with heterozygous familial hypercholesterolemia, the recommended initial dose is 10 mg once daily, and the maximum recommended dose is 20 mg once daily. The dosing may be adjusted according to treatment goals for more than 4 weeks.

Ingredients

Manufacturer
한국유나이티드제약(주)

Efficacy & effects

Reduction of myocardial infarction and stroke risk, improvement of hypercholesterolemia

  • Myocardial infarction
  • stroke
  • vascular interventions
  • chronic stable angina
  • retinopathy
  • albuminuria
  • hypertension
  • congestive heart failure
  • angina
  • hypercholesterolemia
  • dyslipidemia
  • abnormal beta-lipoproteinemia
View approved original text

This medication helps reduce the risk of myocardial infarction, stroke, the need for vascular interventions, angina, and hospitalization due to congestive heart failure in adults with multiple risk factors related to coronary artery heart disease and patients with type 2 diabetes. It is also effective in maintaining cardiovascular health by reducing total cholesterol, LDL cholesterol, apolipoprotein B, and triglycerides, and increasing HDL cholesterol in patients with primary hypercholesterolemia and mixed dyslipidemia. This drug is also used in patients with dyslipidemia not controlled by diet or patients with homozygous familial hypercholesterolemia. In addition, it aids in improving lipid levels to prevent atherosclerosis early in pediatric patients aged 10 to 17 who have heterozygous familial hypercholesterolemia. This medication is used for reducing the risk of cardiovascular disease and improving hyperlipidemia.

How to take

Adult dose

For the treatment of hyperlipidemia, the recommended initial dose is 10 mg of atorvastatin once daily. If a greater reduction in LDL cholesterol is needed, it can be started at 20 mg or 40 mg once daily. The dosage range is from 10 mg to 80 mg once daily. Lipid levels should be analyzed within 2 to 4 weeks after starting treatment to adjust the dosage. In patients with homozygous familial hypercholesterolemia, the dose is 10 mg once daily.

Child dose

For pediatric patients (ages 10 to 17) with heterozygous familial hypercholesterolemia, the recommended initial dose is 10 mg once daily, and the maximum recommended dose is 20 mg once daily. The dosing may be adjusted according to treatment goals for more than 4 weeks.

Precautions

This medication may cause muscle-related symptoms, so if muscle pain or weakness worsens, or creatine kinase levels significantly increase, it should be discontinued immediately. It should not be used in individuals with an allergy to this drug, those with severe liver disease or active liver disease, individuals with muscle disorders, pregnant or nursing women, and children under 10 years old. Patients with a history of alcohol abuse or liver disease, those with impaired kidney function, patients with hypothyroidism, and the elderly should use this medication with caution and closely monitor for muscle-related symptoms. Regular liver function tests and muscle-related tests should be conducted during treatment, and if symptoms of hepatitis or severe muscle pain occur, medical consultation should be sought immediately. Caution is advised regarding drug interactions as the blood concentration of this medication may increase or decrease when taken with certain drugs, especially when combined with antibiotics, antifungals, some antivirals, cyclosporine, grapefruit juice, etc. Women of childbearing age should use adequate contraception while taking this drug and should not use it if pregnant or planning to become pregnant. Nursing mothers should not take this medication and special attention should be paid to monitoring adverse effects in children or the elderly when taking this drug. There is no specific antidote for overdose; treatment is based on symptoms, and it should be stored out of reach of children. Rarely, skin rashes or severe skin reactions may occur, so if abnormal symptoms arise, discontinue use immediately and inform healthcare professionals.

Side effects and when to seek care immediately

Serious side effects

  • Hives
  • angioedema
  • anaphylaxis
  • erythema multiforme
  • Stevens-Johnson syndrome
  • toxic epidermal necrolysis
  • lyell syndrome
  • cholestatic jaundice
  • jaundice
  • generalized edema
Show 13 more
  • severe edema
  • acute liver failure
  • non-alcoholic cirrhosis
  • fulminant hepatitis
  • hepatitis
  • liver failure
  • elevated serum aminotransferase levels
  • severe allergic reactions
  • severe skin reactions
  • shortness of breath
  • asthma attacks
  • respiratory issues
  • difficulty breathing

Mild side effects

  • Weakness
  • fatigue
  • chest pain
  • peripheral edema
  • tiredness
  • fever
  • nasopharyngitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
Show 27 more
  • loss of appetite
  • constipation
  • abdominal bloating
  • dyspepsia
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • pharyngeal and laryngeal pain
  • nosebleed
  • insomnia
  • nightmares
  • headache
  • dizziness
  • paresthesia
  • sensory impairment
  • dysgeusia
  • 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 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 degree and 30 degrees Celsius to ensure the medication's effectiveness is preserved safely over time.

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

No questions yet.

For anything that needs medical judgment, consult a doctor or pharmacist.

Related searches

Search tags

Suggested searches

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.