Sofia Tablet 10mg (Atorvastatin Calcium Hydrate)
Atorvastatin Calcium Hydrate
Prescription medication
Korea PMG Pharmaceutical Co., Ltd.
MFDS item code 201307918 · Approved 2013.06.28
This product's status changed to Approval withdrawn on 2023.04.13. It may no longer be sold, so consult a doctor or pharmacist before taking it.
Reduction of risks of myocardial infarction and stroke, and improvement of hypercholesterolemia
This medication is used to treat various cardiovascular diseases and hyperlipidemia. Firstly, it effectively reduces the risks of myocardial infarction and stroke in adults with multiple risk factors or in patients with type 2 diabetes. Additionally, it helps improve heart health by lowering the risks of myocardial infarction, stroke, angioplasty, and angina in patients with coronary artery disease and decreases the risk of hospitalization due to congestive heart failure. Regarding hyperlipidemia, it decreases LDL cholesterol and total cholesterol while increasing HDL cholesterol to regulate blood lipid levels. It also acts effectively as an adjunct to dietary therapy in patients with familial hypercholesterolemia or among pediatric patients who meet specific criteria. Thus, this medication is used to reduce the risks associated with cardiovascular diseases and improve dyslipidemia.
For hyperlipidemia treatment, the recommended initial dosage is 10 mg once a day. If greater LDL cholesterol reduction is needed, the initial dosage can be 20 mg or 40 mg once a day. Dosages should be administered within the range of 10 to 80 mg once a day, and personalized based on the therapeutic goals and patient response. Lipid levels should be monitored within 2 to 4 weeks of starting treatment or making dosage adjustments to adjust the dosage accordingly. The goal of the treatment is to reduce LDL cholesterol levels, so monitoring LDL cholesterol levels is recommended when assessing treatment response. If LDL cholesterol levels cannot be used, total cholesterol levels should be used for monitoring treatment responses. For patients with homozygous familial hypercholesterolemia, the recommended dosage is 10 to 80 mg once a day, used in conjunction with other lipid-lowering treatments (e.g., LDL apheresis) or when such treatments are not feasible. For pediatric patients (ages 10 to 17) with heterozygous familial hypercholesterolemia, the recommended initial dosage is 10 mg once a day, and the maximum recommended dosage is 20 mg once a day (clinical data on doses higher than 20 mg in this age group is not available). The dosage should be appropriately adjusted based on the recommended therapeutic goals for individual patients. Dosage adjustments should be made at intervals of 4 weeks or more. ○ For patients with renal impairment: Renal disease does not influence atorvastatin's plasma concentrations or LDL cholesterol lowering effect, so dosage adjustments are not necessary. ○ For elderly patients: The efficacy and safety for patients aged 70 years and older are comparable to those for adult patients.
For pediatric patients (ages 10 to 17) with heterozygous familial hypercholesterolemia, the recommended initial dosage is 10 mg once a day, and the maximum recommended dosage is 20 mg once a day. The dosage should be adjusted based on the therapeutic goals for the patient.
This medication may cause muscle-related symptoms, so if there is severe muscle pain or weakness, or a significant increase in creatine kinase levels, discontinue use immediately and consult a doctor. Patients with impaired liver function should not take this medication and should undergo regular liver function tests. Women who are pregnant, may become pregnant, or are nursing should not take this medication. Patients with a history of alcohol abuse or liver disease should use this medication with caution and adjust the dose under medical supervision if necessary. This medication may interact with other drugs, so it is essential to consult a doctor or pharmacist before taking it with certain antibiotics, antifungals, antivirals, some heart medications, antihypertensives, and antidiabetics. Children and individuals under the age of 10 should not take this medication, and long-term safety in adolescents under 18 is not established. Elderly patients are at higher risk for myopathy, so caution is needed during use, and any symptoms should be reported to healthcare providers immediately. In case of overdose, there is no specific antidote, and treatment should be symptomatic while closely monitoring for liver function and muscle damage. Taking this medication with grapefruit juice may increase blood levels of the drug, so it is advisable to avoid grapefruit juice. If symptoms such as muscle pain, weakness, fatigue, or fever occur during use, contact a doctor immediately for evaluation. This medication contains lactose, so patients with lactose intolerance should not take it. Keep this medication out of the reach of children and store it securely in its original container.
Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweats, pallor, severe allergic reactions, severe rash with high fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, severe skin reactions, shortness of breath or difficulty breathing, asthma attacks, respiratory distress accompanied by cough and fever, respiratory issues, yellowing of skin or eyes (jaundice), extreme lethargy, liver abnormalities (jaundice), sudden and
Not everyone experiences these, and they can vary from person to person.
This medication should be stored in a tightly closed container to protect it from air and moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius. Doing so will help preserve the medication's effectiveness and prevent degradation.
White, round film-coated tablets
30 tablets/bottle, 100 tablets/bottle
Even with the same ingredient, strength, dosage form and how it is taken can differ.
Atorvastatin Calcium Hydrate
Prescription medication
Korea PMG Pharmaceutical Co., Ltd.

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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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For anything that needs medical judgment, consult a doctor or pharmacist.
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.