Medication info
New Atorvastatin Tablets 20 mg (Atorvastatin Calcium Trihydrate)

New Atorvastatin Tablets 20 mg (Atorvastatin Calcium Trihydrate)

Prescription medicationTablet
Ingredient · strength
Atorvastatin Calcium Trihydrate›21.7mg / 1 tablet
Manufacturer / importer
안국뉴팜(주)
Appearance
White round film-coated tablets
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201602763 · Approved 2016.05.19 · Insurance code 053600310

Summary

Main use
Reduction of the risk of myocardial infarction and stroke and improvement of hyperlipidemia
Who uses it
Adults · Children
Adult dosage
For the treatment of hyperlipidemia, the recommended initial dosage is 10 mg once daily. In cases needing greater LDL cholesterol reduction, treatment may begin at 20 mg or 40 mg once daily. The recommended dosage range is 10 to 80 mg once daily, individualized based on treatment goals and patient characteristics. Lipid levels should be analyzed 2 to 4 weeks after starting treatment to adjust dosages accordingly. Homozygous familial hypercholesterolemia.
Children's dosage
The recommended initial dosage for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) is 10 mg once daily, with a maximum dosage of 20 mg per day. Dosages should be adjusted based on individual treatment goals, spaced intervals of four weeks or more.

Ingredients

Manufacturer
안국뉴팜(주)

Efficacy & effects

Reduction of the risk of myocardial infarction and stroke and improvement of 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 is used to reduce the risk of cardiovascular diseases and improve blood lipid levels. It lowers the risks of myocardial infarction, stroke, the necessity for vascular surgeries, and angina in adults with multiple risk factors or in patients with type 2 diabetes. Additionally, it decreases the hospitalization risk, including fatal risks, in patients with confirmed risk of myocardial infarction and stroke. In the treatment of hyperlipidemia, it reduces total cholesterol and LDL cholesterol, apolipoprotein B, and triglyceride levels, while increasing the level of good cholesterol, HDL cholesterol. It is effectively used in conjunction with dietary therapy for specific conditions like familial hypercholesterolemia. In certain pediatric patients who meet specific criteria, this medication helps in lowering blood lipid levels. It effectively improves various cardiovascular risk factors and lipid abnormalities.

Dosage and Administration

Adult dosage

For the treatment of hyperlipidemia, the recommended initial dosage is 10 mg once daily. In cases needing greater LDL cholesterol reduction, treatment may begin at 20 mg or 40 mg once daily. The recommended dosage range is 10 to 80 mg once daily, individualized based on treatment goals and patient characteristics. Lipid levels should be analyzed 2 to 4 weeks after starting treatment to adjust dosages accordingly. Homozygous familial hypercholesterolemia.

Children's dosage

The recommended initial dosage for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) is 10 mg once daily, with a maximum dosage of 20 mg per day. Dosages should be adjusted based on individual treatment goals, spaced intervals of four weeks or more.

Precautions

This medication requires caution if any symptoms related to muscle abnormalities appear. If there are severe or persistent symptoms such as muscle pain, weakness, or cramps, it is crucial to consult a physician immediately. This medication may affect liver function, so patients with liver disease or abnormally high liver enzyme levels must consult a physician before taking it. If symptoms of hepatitis such as nausea, vomiting, or malaise occur, discontinue the medication and inform medical staff. Women who are pregnant or may become pregnant should not take this medication and must use appropriate contraceptive methods during treatment. Additionally, nursing mothers should also refrain from taking this medication. This medication can interact with certain drugs, so it's important to inform the physician or pharmacist about any other medications currently being taken, particularly if any antibiotics, antifungals, HIV treatments, or specific hyperlipidemia treatments are being used concurrently. Elderly patients or those with impaired kidney function are at a higher risk of muscle adverse reactions, so they must be more cautious when taking this medication, and regular monitoring is recommended. There is no specific antidote for overdose, so symptomatic treatment must be provided, and liver function along with muscle-related tests should be conducted to assess the condition. This medication should not be administered to children, especially those under 10 years old. Patients aged 10 to 17 years should only use it under a physician's guidance. If symptoms such as muscle pain, fever, or malaise occur during treatment, medical staff should be informed immediately, and the medication may be discontinued if these symptoms worsen. Taking this medication with grapefruit juice may increase blood concentration, so it is advisable to avoid grapefruit juice.

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, skin peeling, pain in oral/ocular mucosa, shortness of breath or difficulty in breathing, asthma attacks, breathing difficulties accompanied by cough and fever, jaundice (yellowing of the skin or eyes), extreme malaise, sudden and severe headache, thunderclap headache, seizures, confusion, vision problems, paralysis, urination issues.

Mild side effects

  • Weakness
  • malaise
  • chest pain
  • peripheral edema
  • fatigue
  • fever
  • pharyngitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
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  • loss of appetite
  • constipation
  • abdominal bloating
  • dyspepsia
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • burping
  • pancreatitis
  • pain in the pharynx and larynx
  • epistaxis
  • insomnia
  • nightmares
  • headache
  • dizziness
  • paresthesia
  • sensory loss
  • dysgeusia
  • memory loss
  • peripheral neuropathy
  • myalgia
  • arthralgia
  • limb pain
  • musculoskeletal pain
  • muscle cramps
  • arthritis.

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

Storage

This medication must be stored in a tightly sealed container to protect it from air or moisture. It is advisable to store it at room temperature, between 1 degree and 30 degrees Celsius. This helps maintain the effectiveness of the medication.

Appearance and packaging

Appearance

White round film-coated tablets

Package unit

30 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.