Medication info
New Atorva Tablet 10 mg (Atorvastatin Calcium Trihydrate)

New Atorva Tablet 10 mg (Atorvastatin Calcium Trihydrate)

Prescription medicationTablet
Ingredient · strength
Atorvastatin Calcium Trihydrate›10.85mg / 1 tablet
Manufacturer / importer
안국뉴팜(주)
Appearance
White round film-coated tablet
Packaging
30 tablets/bottle
Approval status
Active

MFDS item code 201602765 · Approved 2016.05.19 · Insurance code 053600350

Summary

Main use
Reduction of the risk of myocardial infarction and stroke, improvement of hypercholesterolemia
Who uses it
Adults · Children
Adult dosage
The recommended initial dosage for hyperlipidemia treatment is 10 mg once daily, and for patients requiring greater reduction in LDL-cholesterol levels, it may start at 20 mg or 40 mg once daily. This medication is administered in a dosage range of 10 to 80 mg once daily. Individualize the initial and maintenance doses based on treatment goals and patient characteristics, and analyze lipid levels for adjustment within 2 to 4 weeks after initiation and/or dose adjustment.
Children's dosage
The recommended initial dose for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) is 10 mg once daily, with a maximum dose of 20 mg once daily. Dosing should be adjusted at intervals of no less than 4 weeks, aiming for treatment goals.

Ingredients

Manufacturer
안국뉴팜(주)

Efficacy & effects

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

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

This medication helps reduce the risk of cardiovascular diseases. In particular, it reduces the risk of myocardial infarction and stroke in adults with risk factors for coronary heart disease and in patients with type 2 diabetes. Additionally, it decreases the risk of non-fatal myocardial infarction, stroke, the need for angioplasty, hospitalization for congestive heart failure, and angina in patients who already have heart disease. It is effective in the treatment of hyperlipidemia, particularly improving cholesterol and triglyceride levels in patients with primary hypercholesterolemia and dyslipidemia. It is also used in some pediatric patients to lower total cholesterol and LDL-cholesterol levels. This medication is used to improve cardiovascular health and reduce the risk of related diseases.

Dosage and Administration

Adult dosage

The recommended initial dosage for hyperlipidemia treatment is 10 mg once daily, and for patients requiring greater reduction in LDL-cholesterol levels, it may start at 20 mg or 40 mg once daily. This medication is administered in a dosage range of 10 to 80 mg once daily. Individualize the initial and maintenance doses based on treatment goals and patient characteristics, and analyze lipid levels for adjustment within 2 to 4 weeks after initiation and/or dose adjustment.

Children's dosage

The recommended initial dose for pediatric patients with heterozygous familial hypercholesterolemia (ages 10 to 17) is 10 mg once daily, with a maximum dose of 20 mg once daily. Dosing should be adjusted at intervals of no less than 4 weeks, aiming for treatment goals.

Precautions

This medication can cause muscle problems, so if symptoms such as muscle pain or weakness occur, it is important to notify a physician immediately. Particularly, if there is a significant increase in muscle enzyme levels or severe myopathy is suspected, the medication should be discontinued. It should not be used in individuals with liver dysfunction, and regular liver function tests must be conducted. Women who are pregnant or may become pregnant, as well as breastfeeding women, should not take this medication. Children, particularly those under 10 years old, should not use this medication. Patients with a history of alcoholism or liver disease should use this medication cautiously, and older adults may also be at higher risk for muscle-related reactions, so care is advised. There may be interactions when taken with other medications, particularly certain antibiotics, antifungals, HIV treatments, and some blood pressure medications, so it is essential to consult a physician when taking these in conjunction. This medication contains lactose, so patients with lactose intolerance should avoid it. If symptoms such as muscle pain, fatigue, or fever occur during use, immediate medical attention is required, and occasionally severe skin rashes may occur, so if skin abnormalities develop, discontinuation is advised. There is no specific antidote for overdose, and treatment should be provided according to symptoms; it should be stored out of the reach of children.

Side effects and when to seek care immediately

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe allergic reactions, high fever accompanied by severe rash, blisters, peeling skin, pain in mucous membranes of the mouth/eyes, severe skin reactions, difficulty breathing or shortness of breath, asthma attacks, respiratory irregularities with cough and fever, respiratory issues, yellowing of skin or eyes (jaundice), extreme lethargy, liver abnormalities (jaundice), sudden

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
  • dyspepsia
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • pharyngeal and laryngeal pain
  • nosebleed
  • insomnia
  • nightmares
  • headache
  • dizziness
  • paresthesia
  • sensory disturbance
  • taste disturbance
  • 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 best to maintain storage temperatures between 1 to 30 degrees Celsius at room temperature.

Appearance and packaging

Appearance

White round film-coated tablet

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.