Medication info
Sofia Tablet 10mg (Atorvastatin Calcium Trihydrate)

Sofia Tablet 10mg (Atorvastatin Calcium Trihydrate)

Prescription medicationTablet
Ingredient · strength
Atorvastatin Calcium Trihydrate›10.845mg / 1 tablet
Manufacturer / importer
(주)한국피엠지제약
Appearance
White oval film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Active

MFDS item code 201903325 · Approved 2019.05.22 · Insurance code 697101050

Summary

Main use
Reduction of risk for myocardial infarction and stroke and improvement of hyperlipidemia
Who uses it
Adults · Children
Adult dosage
The recommended initial dose is 10 mg of atorvastatin once daily; however, for patients requiring more substantial reduction in LDL cholesterol, treatment may begin at 20 mg or 40 mg once daily (for cases requiring more than a 45% reduction in LDL cholesterol). This medication can be given in the range of 10 to 80 mg once daily. Initial and maintenance doses should be individualized based on treatment goals and responses.
Children's dosage
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 should be adjusted based on the individual patient's treatment goals.

Ingredients

Manufacturer
(주)한국피엠지제약

Efficacy & effects

Reduction of risk for myocardial infarction and stroke and improvement of hyperlipidemia

  • Multiple risk factors for coronary heart disease
  • myocardial infarction
  • stroke
  • chronic stable angina
  • retinopathy
  • albuminuria
  • hypertension
  • non-fatal myocardial infarction
  • fatal and non-fatal stroke
  • congestive heart failure
  • angina
  • hypercholesterolemia
View approved original text

This medication helps reduce the risk of cardiovascular diseases. It is especially effective for adults with multiple risk factors for coronary heart disease and patients with type 2 diabetes, decreasing the risk of myocardial infarction and stroke, as well as lowering the risk of vascular interventions and stable angina. Additionally, it effectively reduces the risk of myocardial infarction, stroke, hospitalization due to congestive heart failure, and angina in patients already diagnosed with coronary heart disease. Furthermore, it is used in the treatment of hyperlipidemia, lowering cholesterol and triglyceride levels in patients with primary hypercholesterolemia and dyslipidemia, while raising HDL cholesterol levels. It also helps control cholesterol levels in adolescents with familial hypercholesterolemia, particularly when combined with a dietary regimen. Overall, it is effective for the prevention and treatment of cardiovascular diseases.

Dosage and Administration

Adult dosage

The recommended initial dose is 10 mg of atorvastatin once daily; however, for patients requiring more substantial reduction in LDL cholesterol, treatment may begin at 20 mg or 40 mg once daily (for cases requiring more than a 45% reduction in LDL cholesterol). This medication can be given in the range of 10 to 80 mg once daily. Initial and maintenance doses should be individualized based on treatment goals and responses.

Children's dosage

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 should be adjusted based on the individual patient's treatment goals.

Precautions

This medication may cause muscle-related symptoms; if you experience muscle pain, weakness, or cramps that worsen, you should immediately stop taking it and consult your doctor. This medication may affect liver function; therefore, it should not be used in patients with liver disease or elevated liver enzymes, and regular liver function tests should be conducted during treatment. Women who are pregnant or may become pregnant and those who are breastfeeding should not take this medication and should ensure proper contraception before taking it. This medication may interact with certain drugs; therefore, inform your doctor or pharmacist if you are taking other medications. Elderly patients or those with impaired kidney function are at a higher risk for muscle-related side effects and should use caution. Children, particularly those under 10 years of age, should avoid this medication as its safety and efficacy have not been sufficiently established in this age group. If any allergic reactions such as fever, fatigue, skin rash, or difficulty breathing occur, you should stop taking the medication immediately and inform your healthcare provider. There is no specific antidote for overdose, so visit a medical institution promptly and receive appropriate treatment based on symptoms. Store this medication out of reach of children, and keep it in its original container; avoid transferring it to other containers.

Side effects and when to seek care immediately

Serious side effects

Urticaria, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, pallor, severe allergic reaction, severe rash with fever, blisters, skin shedding, pain in mucous membranes of mouth/eyes, severe skin adverse reactions, shortness of breath or difficulty breathing, asthma attack, cough with fever and respiratory abnormalities, respiratory issues, yellowing of skin or eyes (jaundice), profound lethargy, liver dysfunction (jaundice), sudden and

Mild side effects

  • Weakness
  • fatigue
  • chest pain
  • peripheral edema
  • fever
  • pharyngitis
  • hyperglycemia
  • hypoglycemia
  • weight gain
  • loss of appetite
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  • constipation
  • abdominal bloating
  • dyspepsia
  • nausea
  • diarrhea
  • abdominal pain
  • vomiting
  • belching
  • pancreatitis
  • throat and larynx pain
  • nosebleeds
  • insomnia
  • nightmares
  • headache
  • dizziness
  • paresthesia
  • sensory impairment
  • taste disturbance
  • 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

Store this medication in a tightly sealed container to prevent exposure to air or moisture. Additionally, keep the medication at room temperature between 1°C and 30°C, not in places that are too hot or too cold.

Appearance and packaging

Appearance

White oval film-coated tablet

Package unit

30 tablets/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

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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.