Medication info
Atorvastatin Calcium Trihydrate 10 mg Tablets

Atorvastatin Calcium Trihydrate 10 mg Tablets

Prescription medicationTablet경구
Ingredient · strength
Atorvastatin Calcium Trihydrate›10.85mg / 1 tablet
Manufacturer / importer
한화제약(주)
Appearance
White, round film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle, 300 tablets/bottle
Approval status
Active

MFDS item code 200705817 · Notified 2007.05.21 · Insurance code 651600840

Summary

Main use
Reduction of risk for myocardial infarction and stroke, improved high cholesterol
Who takes it
Adults · Children
Adult dose
Administer 10 to 80 mg once daily at any time without regard to meals. The initial dosage is 10 mg once daily, and if greater reductions in LDL cholesterol are required, it can be started at 20 mg or 40 mg. The dose should be individualized based on treatment goals and response, with dosage adjustments after 2 to 4 weeks.
Child dose
For pediatric patients aged 10 to 17, the recommended initial dosage is 10 mg once daily, with a maximum recommended dosage of 20 mg daily. The dose should be adjusted at intervals of 4 weeks or longer according to treatment goals.

Ingredients

Manufacturer
한화제약(주)

Efficacy & effects

Reduction of risk for myocardial infarction and stroke, improved high cholesterol

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

This medication helps reduce the risk of myocardial infarction, stroke, and vascular complications in adults with cardiovascular disease risk factors and patients with type 2 diabetes. Additionally, it reduces the risk of myocardial infarction, stroke, vascular procedures, hospitalization for congestive heart failure, and angina in patients with coronary artery disease. In the treatment of hyperlipidemia, it is used to lower total cholesterol and LDL cholesterol levels in patients with primary hypercholesterolemia and mixed dyslipidemia, and to increase HDL cholesterol levels. It is also prescribed as an adjunctive treatment in patients with dyslipidemia who do not respond to dietary measures or in severe familial hypercholesterolemia patients. In children, it helps control cholesterol levels in patients aged 10 to 17 with heterozygous familial hypercholesterolemia. This medication is used for improving cardiovascular health and managing hyperlipidemia.

How to take

Adult dose

Administer 10 to 80 mg once daily at any time without regard to meals. The initial dosage is 10 mg once daily, and if greater reductions in LDL cholesterol are required, it can be started at 20 mg or 40 mg. The dose should be individualized based on treatment goals and response, with dosage adjustments after 2 to 4 weeks.

Child dose

For pediatric patients aged 10 to 17, the recommended initial dosage is 10 mg once daily, with a maximum recommended dosage of 20 mg daily. The dose should be adjusted at intervals of 4 weeks or longer according to treatment goals.

Precautions

This medication may cause unusual muscle symptoms, so if you experience severe muscle pain, weakness, or a significant increase in creatine kinase levels, you should immediately stop taking it and consult your doctor. This medication should not be used by individuals with certain medical conditions or allergies to this medication, by pregnant or nursing women, or by children under the age of 10. Patients with impaired liver or kidney function should use this medication with caution, and inform their doctor immediately if they experience symptoms of liver dysfunction. This medication may interact with other drugs, so you must inform your doctor or pharmacist of any other medications you are currently taking. Women should use appropriate contraceptive methods to avoid pregnancy while taking this medication, and if pregnancy is confirmed, they should stop taking it immediately. If you experience symptoms such as muscle pain, fatigue, or fever while taking this medication, you should immediately notify medical personnel and seek testing. Regular liver function tests are necessary while taking this medication, and treatment should be stopped immediately if symptoms such as hepatitis or jaundice occur. It is advisable to avoid grapefruit juice during treatment, and dose adjustments may be necessary when combined with certain antibiotics or antifungals. Elderly patients or those with reduced kidney function are at higher risk of myopathy and should be especially cautious when taking this medication. The long-term safety of this medication in children and adolescents has not been sufficiently studied; therefore, it should be used cautiously in this age group. In case of overdose, there is no specific antidote, so appropriate treatment should be administered based on symptoms, and liver function and muscle condition should be monitored. This medication should be stored out of the reach of children and kept in its original container to maintain quality.

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 rash with fever, blistering, peeling of skin, pain in mucous membranes of mouth/eyes, severe skin reactions, difficulty catching breath, asthma attacks, breathing problems accompanied by cough and fever, jaundice (yellowing of the skin or eyes), profound 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
  • burping
  • pancreatitis
  • oropharyngeal and laryngeal pain
  • nosebleeds
  • insomnia
  • nightmares
  • headaches
  • 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 is 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°C and 30°C.

Appearance and packaging

Appearance

White, round film-coated tablet

Package unit

30 tablets/bottle, 100 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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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.