Ristrol Tablet 20 Milligrams (Atorvastatin Calcium Hydrate)

Adult dose

For the treatment of hyperlipidemia, the recommended initial dose is 10 mg once daily. For those requiring more significant LDL cholesterol reduction, the dosage may be started at 20 mg or 40 mg once daily. The drug is administered in a range from 10 to 80 mg once daily. The dosage should be individualized based on treatment goals and response, with lipid levels being analyzed and adjusted 2 to 4 weeks after initiation and/or dosage adjustment. The goal of treatment is to lower LDL cholesterol levels; therefore, it is recommended to use LDL cholesterol for evaluating treatment initiation and response. However, if LDL cholesterol levels cannot be used, total cholesterol levels may be used to monitor treatment response. For patients with homozygous familial hypercholesterolemia, the dosing is 10 to 80 mg once daily, either used in conjunction with other lipid-lowering treatments (e.g., LDL apheresis) or when such therapies are not feasible. 2. For pediatric patients (ages 10 to 17) with heterozygous familial hypercholesterolemia, the recommended initial dose is 10 mg once daily, and the recommended maximum dose is 20 mg once daily (there are no clinical data for doses higher than 20 mg in this age group). The dosage should be appropriately adjusted according to the recommended treatment goals for individual patients. Dosage adjustments should be made at intervals of 4 weeks or longer. ○ For patients with renal impairment: Renal disease does not affect the plasma concentration or LDL cholesterol-lowering effect of atorvastatin, so there is no need to adjust the dosage. ○ For elderly patients: The efficacy and safety for patients aged 70 and older are similar to those for the general adult population.

Child dose

For pediatric patients (ages 10-17) with heterozygous familial hypercholesterolemia, the recommended initial dose is 10 mg once daily, and the recommended maximum dose is 20 mg once daily. Dosage adjustments are made at intervals of more than 4 weeks.

This medication may cause muscle-related issues; therefore, if symptoms such as muscle pain, muscle weakness, or muscle cramps occur, discontinue use immediately and consult a physician. Treatment should be stopped if creatine kinase (CK) levels are abnormally high or if myopathy is suspected. This drug may affect liver function; therefore, it should not be used in cases of liver disease or when liver function test results are elevated, and regular liver function tests must be performed during treatment. Pregnant or potentially pregnant women and breastfeeding women should not take this medication. Patients with a history of alcohol abuse or liver disease should use this product with caution, and it is also not recommended for children under 10 years of age. This medication may interact with other drugs, especially certain antibiotics, antifungals, HIV treatments, and some lipid-lowering agents, so care should be taken when used in conjunction with them. If symptoms such as muscle pain, weakness, fever, or malaise occur during treatment, inform a doctor immediately, and blood tests may be needed to check for muscle damage. This medication may affect blood sugar levels, so patients at risk for diabetes should manage their blood sugar levels closely. Older adults or patients with decreased kidney function are at higher risk for myopathy and should use this drug with increased caution. There is no specific antidote for overdose, so treatment should be symptomatic, with monitoring of liver function and muscle status. This medication should be stored out of the reach of children and kept in its original container for safety.

Serious side effects

Hives, severe swelling (edema), severe allergic reactions, angioedema, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, severe skin adverse reactions, difficulty breathing, respiratory distress, asthma, asthma attacks, severe rash with high fever, blisters, skin peeling, pain in mucous membranes of the mouth/eyes, liver abnormalities (jaundice), yellowing of skin or eyes (jaundice), profound fatigue, sudden and severe headache.

Mild side effects

• Weakness
• malaise
• chest pain
• peripheral edema
• fatigue
• fever
• rhinitis
• hyperglycemia
• hypoglycemia
• weight gain

This medication may be sensitive to air and moisture; therefore, it must be stored in a tightly sealed container. Additionally, it is best to keep the medication at room temperature between 1 to 30 degrees Celsius, away from extreme heat or cold.

Appearance

For domestic use: white oval film-coated tablet For export: white round film-coated tablet

Package unit

For domestic use - 30 tablets/bottle, For domestic use - 100 tablets/bottle, For export - 30 tablets/ptp