Medication info

Sofia Tablet 20 mg (Atorvastatin Calcium Trihydrate)

Prescription medicationTabletExpired
Ingredient · strength
Atorvastatin Calcium Trihydrate›21.69mg / 1 tablet
Manufacturer / importer
(주)한국피엠지제약
Appearance
White oval film-coated tablet
Packaging
30 tablets/bottle, 100 tablets/bottle
Approval status
Expired

MFDS item code 201400361 · Approved 2014.01.27

This product's status changed to Expired on 2024.01.27. It may no longer be sold, so consult a doctor or pharmacist before taking it.

Summary

Main use
Reduction of risk of myocardial infarction and stroke, and improvement of hyperlipidemia
Who uses it
Adults · Children
Adult dosage
Start with a dose of 10 mg once daily, and if further reduction in LDL cholesterol levels is needed, it can be increased to 20 mg or 40 mg once daily. The dosage range is from 10 to 80 mg once daily, and it should be individualized based on treatment goals and responses with lipid levels analyzed and dosage adjusted every 2 to 4 weeks. For patients with homozygous familial hypercholesterolemia, the administration dosage is 10 to 80 mg once daily.
Children's dosage
Children aged 10 to 17 with heterozygous familial hypercholesterolemia should receive an initial recommended dose of 10 mg per day, with a maximum dose of 20 mg per day. Dose adjustments should be made after 4 weeks or more.

Ingredients

Manufacturer
(주)한국피엠지제약

Efficacy & effects

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

  • Myocardial infarction
  • stroke
  • chronic stable angina
  • retinopathy
  • albuminuria
  • congestive heart failure
  • hyperlipidemia
  • dyslipidemia
  • abnormal beta-lipoproteinemia
  • elevated serum triglycerides
  • familial hypercholesterolemia
View approved original text

This drug helps reduce the risk of myocardial infarction, stroke, the need for vascular intervention, and the occurrence of angina in adults with risk factors for cardiovascular disease or in patients with type 2 diabetes. It is also effective in reducing the hospitalization risk due to non-fatal myocardial infarction, stroke, and congestive heart failure in patients with clinical evidence of heart disease. In patients with hyperlipidemia, it is used as an adjunct to diet to reduce total cholesterol, LDL cholesterol, apo-B protein, and triglyceride levels, and to increase high-density lipoprotein (HDL) cholesterol levels. Particularly, it helps lower total cholesterol and LDL cholesterol levels in children and adolescents with familial hypercholesterolemia. Thus, this drug is used to improve cardiovascular health and reduce the risk of various heart-related diseases.

Dosage and Administration

Adult dosage

Start with a dose of 10 mg once daily, and if further reduction in LDL cholesterol levels is needed, it can be increased to 20 mg or 40 mg once daily. The dosage range is from 10 to 80 mg once daily, and it should be individualized based on treatment goals and responses with lipid levels analyzed and dosage adjusted every 2 to 4 weeks. For patients with homozygous familial hypercholesterolemia, the administration dosage is 10 to 80 mg once daily.

Children's dosage

Children aged 10 to 17 with heterozygous familial hypercholesterolemia should receive an initial recommended dose of 10 mg per day, with a maximum dose of 20 mg per day. Dose adjustments should be made after 4 weeks or more.

Precautions

This drug may pose a risk of muscle problems, thus if muscle pain, weakness, or a significant increase in creatine kinase (CK) levels occurs, you should stop taking it immediately and consult a physician. Patients with impaired liver function or active liver disease should not take this drug and should undergo regular liver function tests. Women who are pregnant, may become pregnant, or are breastfeeding should not take this drug, and women of childbearing age should use appropriate contraception while on this medication. Children under 10 years old and patients with muscle diseases should not take this drug. Patients with a history of alcoholism, liver disease, reduced kidney function, and hypothyroidism should consult healthcare professionals before use for careful administration. This drug can interact with several other medications, so if you are taking other medications, you must inform your doctor or pharmacist and seek advice. Caution is especially required when taking it together with certain antibiotics, antifungals, HIV treatments, some antihypertensive agents, grapefruit juice, etc. If you experience symptoms such as muscle pain, weakness, fatigue, or fever while taking this medication, inform your doctor immediately and get blood tests to check for muscle damage. Long-term use of this drug may lead to hepatitis, liver function abnormalities, or hepatitis symptoms (nausea, vomiting, fatigue, etc.), so regular monitoring is necessary. Additionally, this drug may slightly increase the risk of diabetes, so patients with diabetes risk factors should routinely check their blood sugar levels. Children, elderly patients, and those with kidney impairment are at a higher risk of side effects when using this drug, so extra caution is warranted. In the case of overdose, there is no specific antidote, so treatment should be symptomatic while monitoring liver function and muscle condition.

Side effects and when to seek care immediately

Serious side effects

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

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
  • pharyngitis/laryngitis
  • epistaxis
  • insomnia
  • nightmares
  • headache
  • dizziness
  • sensory disturbances
  • numbness
  • taste disorders
  • memory loss
  • peripheral neuropathy
  • muscle pain
  • joint pain
  • limb pain
  • musculoskeletal pain
  • muscle cramps
  • joint pain

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

Storage

This drug should be stored in a tightly sealed container to prevent exposure to air or moisture. It is recommended 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, 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.

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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.