Atorvastatin Calcium Trihydrate 10 mg Tablets

Adult dose

For the treatment of hyperlipidemia, the recommended initial dose is 10 mg once daily. If greater LDL cholesterol reduction is required, dosing can be initiated at 20 mg or 40 mg once daily. The dosing should be individualized within the range of 10 to 80 mg once daily based on treatment goals and patient characteristics. Lipid levels should be analyzed within 2 to 4 weeks post-initiation for dose adjustment. The objective of therapy is to reduce LDL cholesterol levels, therefore LDL cholesterol should be used for evaluating the initiation and response to treatment. If LDL cholesterol is not available, total cholesterol should be monitored for treatment response. For patients with heterozygous familial hypercholesterolemia, the dosing is 10 to 80 mg once daily, either in conjunction with or when alternative lipid-lowering therapies (e.g., LDL apheresis) are not feasible. For pediatric patients (ages 10-17) with heterozygous familial hypercholesterolemia, the recommended initial dose is 10 mg once daily, with a maximum recommended dose of 20 mg once daily (there is no clinical data for doses greater than 20 mg in this age group). The dose should be adjusted appropriately according to the recommended treatment goals for individual patients at intervals of 4 weeks or more. ○ Patients with kidney impairment: Kidney disease does not affect atorvastatin plasma concentrations or its LDL cholesterol-lowering effects, so there is no need to adjust the dose. ○ Elderly patients: The efficacy and safety in patients aged 70 years and older are similar to that of the general adult patient population.

Child dose

The recommended initial dose for pediatric patients (ages 10-17) with heterozygous familial hypercholesterolemia is 10 mg once daily, with a maximum dose of 20 mg daily. Dosage should be adjusted based on treatment goals at intervals of 4 weeks or more.

This medication should be discontinued immediately if serious muscle-related adverse effects appear, especially if there is muscle pain, weakness, or a significant increase in muscle enzyme levels. It should not be used by patients with certain diseases or those taking specific medications. For example, patients with severely impaired liver function, women who are pregnant or breastfeeding, children under 10 years of age, and individuals with hypersensitivity to this drug should not take it. Patients with a history of liver disease or alcohol addiction should use this medication with more caution, and those with a history of muscle disease should also be careful. Elderly patients or those with impaired kidney function are at higher risk of muscle-related adverse effects and should be closely monitored. This drug can affect liver function; therefore, regular liver function tests should be conducted before and during treatment. If symptoms of hepatitis or jaundice appear, consult a doctor immediately. This medication may interact with other drugs, so patients should inform their doctor or pharmacist of all medications they are currently taking. Caution is especially needed when co-administering with certain antibiotics, antifungals, antivirals, and some cardiovascular medications. Women planning to become pregnant or of childbearing age should use adequate contraceptive methods while taking this medication and discontinue its use immediately upon confirmation of pregnancy. Breastfeeding women should not take this medication. If symptoms such as muscle pain, weakness, or fever occur while taking this medication, inform medical personnel immediately and undergo testing, as these symptoms could indicate severe muscle damage. There is no specific antidote for overdose; therefore, appropriate treatment should be administered depending on the symptoms, and liver function and muscle enzyme levels should be closely monitored. Finally, keep this medication out of the reach of children and store it in its original container, as transferring it to another container may pose a risk of misuse or deterioration of quality.

Serious side effects

Hives, severe swelling (edema), chest tightness, difficulty breathing, cold sweat, paleness, severe rash with high fever, blisters, peeling skin, pain in mucous membranes of the mouth/eyes, severe skin reactions, wheezing or difficulty breathing, asthma attacks, respiratory abnormalities accompanied by cough and fever, yellowing of the skin or eyes (jaundice), profound lethargy, liver dysfunction (jaundice), sudden and intense headaches, thunderclap headaches, seizures

Mild side effects

• Weakness
• fatigue
• chest pain
• peripheral edema
• fever
• nasopharyngitis
• hyperglycemia
• hypoglycemia
• weight gain
• loss of appetite

This medication must be stored in a tightly closed container to prevent exposure to air or moisture. It is important to maintain a storage temperature between 1 and 30 degrees Celsius. This will help preserve the medication's effectiveness over time.

Appearance

White, round, film-coated tablets

Package unit

30 tablets/bottle, 100 tablets/bottle