Medication info
Newstatin A Tablet 20 mg (Atorvastatin Calcium Trihydrate)

Newstatin A Tablet 20 mg (Atorvastatin Calcium Trihydrate)

Prescription medicationTablet경구
Ingredient · strength
Atorvastatin Calcium Trihydrate›21.7mg / 1 tablet
Manufacturer / importer
삼진제약(주)
Appearance
White oval film-coated tablet
Packaging
30 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 201206318 · Approved 2012.07.30 · Insurance code 647803670

Summary

Main use
Reduction of the risk of myocardial infarction and stroke, improvement of hyperlipidemia
Who takes it
Adults · Children
Adult dose
For hyperlipidemia, the recommended initial dose is 10 mg once daily as atorvastatin, but for patients requiring greater LDL-cholesterol reduction, it can be started at 20 mg or 40 mg once daily. This drug is administered once daily in a dosage range of 10 to 80 mg, individualized based on treatment goals and responses. Patients with homozygous familial hypercholesterolemia are dosed once daily at 10 to 80 mg.
Child dose
The recommended initial dose for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) is 10 mg once daily, and the recommended maximum dose is 20 mg once daily. Dosage adjustment should be made at intervals of 4 weeks or more.

Ingredients

Manufacturer
삼진제약(주)

Efficacy & effects

Reduction of the risk of myocardial infarction and stroke, improvement of hyperlipidemia

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

This drug is primarily used to reduce the risk of cardiovascular diseases. Specifically, it lowers the risk of myocardial infarction and stroke in adults with risk factors for coronary artery disease and patients with type 2 diabetes, and reduces the incidence of cardiovascular-related issues such as vascular surgeries and angina. It also helps patients who have already been diagnosed with coronary artery disease to decrease the risk of non-fatal myocardial infarction, stroke, congestive heart failure, and angina. Additionally, it is used for the treatment of hyperlipidemia, improving blood cholesterol and triglyceride levels in patients with primary and mixed dyslipidemia, and contributing to the increase of good cholesterol, HDL levels. It lowers the cholesterol levels in children and adolescents with hypercholesterolemia or a family history of heart disease, supporting cardiovascular health. This drug is used to reduce the risk of cardiovascular diseases and improve dyslipidemia.

How to take

Adult dose

For hyperlipidemia, the recommended initial dose is 10 mg once daily as atorvastatin, but for patients requiring greater LDL-cholesterol reduction, it can be started at 20 mg or 40 mg once daily. This drug is administered once daily in a dosage range of 10 to 80 mg, individualized based on treatment goals and responses. Patients with homozygous familial hypercholesterolemia are dosed once daily at 10 to 80 mg.

Child dose

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

Precautions

This drug may cause muscle problems, so if symptoms such as muscle pain or weakness appear, you should stop taking it immediately and consult a doctor. This drug can affect liver function and should not be taken if there is a history of liver disease or elevated liver function test results. Women who are pregnant or may become pregnant, as well as nursing mothers, should not take this drug. It should not be administered to children, particularly those under 10 years old. This drug may increase the risk of side effects when taken with certain medications, so if you are taking other medications, be sure to inform your doctor or pharmacist. If you consume alcohol excessively or have a history of liver disease, you should take it with caution and undergo regular liver function tests. There is a risk of serious muscle diseases such as myopathy or rhabdomyolysis, so if symptoms such as muscle pain, weakness, or fever occur, you should inform the medical staff immediately. This medication contains lactose, so patients with lactose intolerance should not take it. Elderly patients or those with reduced kidney function are at higher risk of muscle-related side effects, so extra caution should be taken when administering it. There is no specific antidote in case of overdose, so treatment should be provided based on symptoms, and regular blood tests should be performed to monitor liver function and muscle condition. Keep this medication out of the reach of children, and store it in its original container to prevent misuse or deterioration of quality.

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 high fever, blisters, peeling skin, painful mucous membranes in the mouth/eyes, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough + fever, jaundice (yellowing of skin or eyes), extreme lethargy, hepatic abnormalities (jaundice), sudden and severe headache, thunderclap headache, foot

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 bloating
  • indigestion
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • throat and laryngeal pain
  • nosebleed
  • insomnia
  • nightmares
  • headache
  • dizziness
  • paresthesia
  • sensory loss
  • dysgeusia
  • memory loss
  • peripheral neuropathy
  • muscle pain
  • joint pain
  • limb pain
  • musculoskeletal pain
  • muscle cramps
  • joint

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 important to maintain a storage temperature between 1 and 30 degrees Celsius.

Appearance and packaging

Appearance

White oval film-coated tablet

Package unit

30 tablets/bottle, 300 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.