Product Overview
[Drug Name]
Generic Name: Atorvastatin Calcium Tablets
Trade Name: Shan Le Ting
English Name: Atorvastatin Calcium Tablets
Chinese Pinyin: ATuoFaTaTingGaiPian (ShanLeTing)
[Ingredients]
The main ingredient of this product is atorvastatin calcium.
[Properties]
This product is a film-coated tablet that appears white after removal of the film coating.
[Indications/Main Functions]
1. For patients with hyperlipidemia, hypercholesterolemia, primary hypercholesterolemia, including familial hypercholesterolemia (heterozygous type) or combined hyperlipidemia (equivalent to types Ila and IIb in the Fredrickson classification) who have not responded satisfactorily to dietary therapy and other non-drug therapies, this product can be used to treat elevated total cholesterol, low-density lipoprotein cholesterol, apolipoprotein B, and triglycerides. 2. In patients with homozygous familial hypercholesterolemia, atorvastatin calcium can be used in combination with other lipid-lowering therapies (such as LDL plasma dialysis) or alone (when no other treatment options are available) to lower total cholesterol and low-density lipoprotein cholesterol.
[Usage and Dosage]
1 Before starting treatment with this product, patients should follow a standard low-cholesterol diet and maintain a reasonable diet throughout the treatment period. The dose should be adjusted individually based on the baseline low-density lipoprotein cholesterol level, treatment goals, and the patient's treatment effect. The usual starting dose is 10 mg once daily. The dose adjustment interval should be 4 weeks or longer. 2. The maximum dose of this product is 80 mg once daily. The daily dose of atorvastatin can be taken once a day at any time of the day and is not affected by meals. (1) Treatment of primary hypercholesterolemia and mixed hyperlipidemia Most patients can control their blood lipid levels by taking atorvastatin calcium 10 mg once a day. Significant therapeutic effects can be seen within 2 weeks of treatment, and the maximum therapeutic effect can be seen within 4 weeks of treatment. Long-term treatment can maintain the therapeutic effect. (2) The initial dose for patients with heterozygous familial hypercholesterolemia is 10 mg/day. The dose should be individualized and gradually adjusted to 40 mg/day every 4 weeks. If satisfactory efficacy is still not achieved, the dose can be adjusted to a maximum dose of 80 mg/day or 40 mg once daily can be used in combination with bile acid sequestrants. (3) Treatment of homozygous familial hypercholesterolemia In a charitable drug study involving 64 patients, 46 of them had corresponding LDL receptor information. The average LDL-C level of these 46 patients decreased by 21%. The dose of this product can be increased to 80 mg/day. For patients with homozygous familial hypercholesterolemia, the recommended dose of this product is 10-80 mg/day. Atorvastatin calcium should be used as an adjunct to other lipid-lowering treatments (such as LDL plasma dialysis). Or when these treatment conditions are not available, this product can be used alone. (4) Dosage for patients with renal insufficiency Renal disease will not affect the plasma concentration of this product or its lipid-lowering effect, so there is no need to adjust the dose.
[Adverse Reactions]
The most common adverse reactions of this product are constipation, flatulence, indigestion and abdominal pain, which usually improve after continued use. In clinical studies, less than 2% of patients discontinued the study due to adverse reactions related to this product. Gastrointestinal dysfunction is common: constipation, flatulence, indigestion, nausea, diarrhea. Rare: anorexia, vomiting. Blood and lymphatic system dysfunction is rare: thrombocytopenia. Immune system dysfunction is common: allergic reaction. Very rare: allergic reaction. (See inner package insert for details)
[Contraindications]
This product is contraindicated in the following patients: 1. Those who are allergic to any of the ingredients contained in this product. 2. Patients with active liver disease, patients with serum transaminase levels that are continuously elevated by more than 3 times the upper limit of normal and the cause is unknown. 3. Myopathy. 4. This product is contraindicated in pregnant women, lactating women and women of childbearing age who do not take appropriate contraceptive measures.
[Precautions]
Liver effects: Perform liver function tests before starting treatment and review them regularly. Patients should have their liver function checked if they develop any symptoms or signs suggestive of liver damage. Patients with elevated transaminase levels should have their levels monitored until they return to normal. If transaminase levels persist, exceeding three times the normal value, a dose reduction or discontinuation of this drug is recommended. Use this drug with caution in patients with excessive alcohol consumption and/or a history of liver disease. (See inner package insert for details.) Please read the package insert carefully and follow your doctor's instructions.
[Special Use in Special Populations]
Precautions for use in children:
This drug should only be used by a specialist. Pediatric experience with this drug is limited to a small number of patients (aged 4 to 17 years) with severe lipid disorders, such as homozygous familial hypercholesterolemia. The recommended starting dose for this patient population is 10 mg/day. The dose can be increased to 80 mg/day based on the patient's response and tolerance. There are no data on the safety of this drug for growth and development in this population.
Precautions for Pregnancy and Lactation:
Atorvastatin calcium tablets are contraindicated in pregnant and lactating women. Women of childbearing age should take appropriate contraceptive measures. The safety of atorvastatin for pregnant and lactating women has not been confirmed. Animal studies have shown that HMG-CoA reductase inhibitors can affect embryonic and fetal growth and development. Atorvastatin doses exceeding 20 mg/kg/day (equivalent to the clinical human dose) have been associated with developmental delay and decreased postnatal survival in rat offspring. The concentrations of atorvastatin and its active metabolites in rat plasma are comparable to those in rat milk. It is unknown whether atorvastatin and its active metabolites are secreted in human milk.
Precautions for Elderly Patients:
The efficacy and safety of atorvastatin calcium at the recommended dose in adults aged 70 years and older are no different from those in the general population.
[Drug Interactions]
When this product is used in combination with oral contraceptives containing norethindrone and ethinyl estradiol, it increases the AUC of norethindrone and ethinyl estradiol by 30% and 20%, respectively. When used in combination with erythromycin, this product's plasma concentration increases by approximately 40%. When used in combination with digoxin, the steady-state plasma concentration of digoxin increases by approximately 20% after repeated dosing; digoxin concentrations should be monitored. When used in combination with cholestyramine (cholestyramine), this product's plasma concentration decreases by approximately 25%, but the LDL-C lowering effect is greater than that of this product or colestipol alone. The risk of myopathy increases when this product is used in combination with cyclosporine, niacin, erythromycin, and azole antifungals.
[Pharmacological Actions]
This product is a statin, a lipid-regulating drug and an HMG-CoA reductase inhibitor. While inactive, its hydrolysis product, after oral absorption, competitively inhibits hydroxymethylglutaryl-CoA reductase, the rate-limiting enzyme in cholesterol synthesis, reducing cholesterol synthesis and increasing LDL receptor synthesis. Its primary site of action is in the liver, resulting in lower blood cholesterol and LDL cholesterol levels, moderately lowering serum triglyceride levels, and increasing high-density lipoprotein levels. This has a preventive and therapeutic effect on atherosclerosis and coronary heart disease.
[Storage] Sealed.
[Strength] 20mg
[Packaging] 10 tablets/box.
[Expiry Date] 24 months
[Approval Number] National Medicine Standard No. J20140002
