DAWNRAYS ANWEINING Atorvastatin Calcium Tablets For Hypercholesterolemia 10mg*14

[Drug Name]
Generic Name: Atorvastatin Calcium Tablets
Trade Name: Anweining Atorvastatin Calcium Tablets 10mg x 14 Tablets

[Main Ingredients]
Atorvastatin calcium, chemical name: [R-(R*, R*]-2-(4-fluorophenyl)-β,&-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(anilino)carbonyl]-1H-pyrrole-1-heptanoic acid calcium salt (2:1) trihydrate.

[Properties]
This product is a white oval Round film-coated tablets.

[Indications/Main Functions]
This product is indicated for the treatment of elevated total cholesterol, low-density lipoprotein cholesterol, apolipoprotein B, and triglycerides in patients with primary hypercholesterolemia, including familial hypercholesterolemia (heterozygous type) or mixed hyperlipidemia (equivalent to types I and IIb in the Fredrickson classification) who have not responded satisfactorily to dietary therapy and other non-drug treatments. For patients with hyperlipidemia, atorvastatin calcium can be used in combination with other lipid-lowering therapies or alone (when other treatment options are unavailable) to lower total cholesterol and LDL cholesterol.

[Specifications]
10mg*14 tablets

[Dosage and Administration]
Patients should follow a standard low-cholesterol diet before starting treatment with this product and maintain a healthy diet throughout treatment. The dose should be individually adjusted based on baseline LDL cholesterol levels, treatment goals, and the patient's response to treatment. The usual starting dose is 10 mg once daily. Dose adjustments should be made every four weeks or longer. The maximum dose of atorvastatin calcium tablets is 80 mg once daily. The daily dose of atorvastatin can be taken at any time of day, regardless of mealtime. For patients with established coronary artery disease or other patients at increased risk of ischemic events, the treatment goal is an LDL-C <3 mmol/L (or <115 mg/dL) and a total cholesterol <5 mmol/L. /L (or <190mg/dL). Excerpted from "Prevention and Treatment of Coronary Heart Disease in Clinical Practice: The Second Joint Recommendation for the Prevention of Coronary Artery Disease in Europe" in the Journal of Atherosclerosis, Issue 140, 1998, pp. 199-270. Treatment of primary hypercholesterolemia and mixed hyperlipidemia Most patients take atorvastatin calcium 10mg once daily, and their blood lipid levels can be controlled. Significant therapeutic effects can be seen within 2 weeks of treatment, and maximum therapeutic effects can be seen within 4 weeks of treatment. Long-term treatment can maintain therapeutic effects. The initial dose for patients with heterozygous familial hypercholesterolemia is 10mg per day. The principle of individualized dosage should be followed and the dose should be gradually adjusted to 40mg per day at intervals of 4 weeks. If satisfactory therapeutic effects are still not achieved, the dose can be adjusted to a maximum dose of 8mg per day. 0 mg or 40 mg daily of this product in combination with a bile acid sequestrant. In a charitable study of 64 patients, 46 of whom had LDL receptor information, the average LDL-C reduction in these 46 patients was 21%. The dose of this product can be increased to 80 mg daily. For patients with homozygous familial hypercholesterolemia, the recommended dose is 10-80 mg daily. Atorvastatin calcium should be used as an adjunct to other lipid-lowering therapies (such as LDL plasma dialysis). Alternatively, this product can be used alone when these treatments are unavailable. Dosage in Patients with Renal Insufficiency: Renal disease does not affect the plasma concentration of this product or its lipid-lowering effect, so no dose adjustment is required.

[Adverse Reactions]
The most common adverse reactions with this product are constipation, flatulence, dyspepsia, and abdominal pain, which generally resolve with continued treatment. Fewer than 2% of patients in clinical trials discontinued treatment due to adverse reactions related to this product. Based on clinical study data and extensive postmarketing experience, the adverse events associated with Lipitor are listed below. Conventionally, the estimated frequency of adverse events is ranked as follows: common (<1/100, 1/1000, <1/100); rare (<1/10,000, <1/1000); and very rare (<1/10,000). Gastrointestinal Disorders: Common: constipation, flatulence, dyspepsia, nausea, diarrhea. Uncommon: anorexia, vomiting. Blood and Lymphatic System Disorders: Uncommon: thrombocytopenia. Immune System Disorders: Common: allergic reactions. Very rare: anaphylactic reactions. Endocrine Disorders: Uncommon: alopecia, hyperglycemia, hypoglycemia, pancreatitis. Psychiatric Disorders: Common: insomnia. Uncommon: amnesia. Nervous System Disorders: Common: Headache, dizziness, paresthesia, dysesthesia. Uncommon: Peripheral neuropathy. Hepatobiliary Disorders: Rare: Hepatitis, cholestatic jaundice. Skin/Extremities: Common: Rash, pruritus. Uncommon: Urticaria. Very Rare: Angioedema, bullous rash (including erythema multiforme, Stevens-Johnson syndrome, and toxic epidermolysis). Oto-Labyrinthine Disorders: Uncommon: Tinnitus. Musculoskeletal Disorders: Common: Myalgia, arthralgia. Uncommon: Myopathy. Rare: Myositis, rhabdomyolysis. Reproductive System Disorders: Uncommon: Impotence. General Disorders: Common: Asthenia, chest pain, back pain, peripheral edema. Uncommon: Malaise, weight gain. Studies: As with other HMG-CoA reductase inhibitors, elevations in transaminases have been reported in patients taking this drug. However, these changes are generally mild, transient, and do not require treatment interruption. Clinically significant elevations in serum transaminases (>3 times the upper limit of normal) occurred in 0.08% of patients treated with this drug. These changes were dose-related and reversible in all patients. Similar to other HMG-COA reductase inhibitors in clinical trials, 2.5% of patients taking this drug experienced elevations in serum creatine phosphokinase (CPK) greater than 3 times the upper limit of normal. 0.4% of patients taking this drug experienced elevations greater than 10 times the upper limit of normal. (See [Precautions])

[Contraindications]
Atorvastatin calcium tablets should be used in patients with hypersensitivity to any of the ingredients. This drug is contraindicated in patients with active liver disease, persistent elevations in serum transaminases greater than 3 times the upper limit of normal, myopathy, and during pregnancy, lactation, or any woman of childbearing potential who is not using adequate contraceptive measures.

[Precautions: Liver effects]
Liver function tests should be performed before starting treatment and periodically. Liver function tests should be performed if any symptoms or signs suggestive of liver damage occur. Patients with elevated transaminase levels should be monitored until they return to normal. If transaminase levels persist, exceeding three times the normal value, a dose reduction or discontinuation of Lipitor is recommended (see Adverse Reactions). This drug should be used with caution in patients who consume alcohol excessively and/or have a history of liver disease. Skeletal muscle effects: Like other HMG-CoA reductase inhibitors, atorvastatin may rarely affect skeletal muscle, causing myalgia, myositis, and myopathy, potentially progressing to life-threatening rhabdomyolysis, characterized by markedly elevated CPK (greater than 10 times the upper limit of normal), myosinemia, myoglobulinuria, and renal failure. Atorvastatin should be used with caution in patients susceptible to rhabdomyolysis before treatment. CPK should be measured before treatment in the following situations: - Abnormal renal function - Hypothyroidism - Personal or family history of hereditary myopathy - Previous history of muscle damage from statins or fibrates - Previous history of liver disease and/or heavy alcohol consumption. For patients over 70 years of age, the necessity of this test may be determined by the presence of other predisposing factors for rhabdomyolysis. In these situations, the risks and benefits of treatment should be weighed against the benefits of treatment, and clinical monitoring is recommended. If the baseline CPK level is significantly elevated (over 5 times the upper limit of normal), treatment should not be initiated. CPK should not be measured during strenuous exercise or in the presence of any factors that may increase CPK, as this can complicate interpretation of the results. If the baseline CPK level is significantly elevated (over 5 times the upper limit of normal), the result should be rechecked within 5 to 7 days to verify the results. During treatment: Patients should promptly report muscle pain, cramping, or weakness (preferably when accompanied by malaise or fever). If any of these symptoms occur while taking this medication, CPK levels should be measured. If a significant elevation (greater than 5 times the upper limit of normal) is detected, treatment should be discontinued. If muscle symptoms are severe and cause significant discomfort, even if the CPK level is < 5 times the upper limit of normal, discontinuation of treatment should be considered. If symptoms resolve and the CPK level returns to normal, atorvastatin may be restarted or switched to another statin under close monitoring, starting at the lowest dose. If a CPK level exceeds 10 times the upper limit of normal or rhabdomyolysis is confirmed/suspected, atorvastatin must be discontinued. Concomitant use of atorvastatin with the following drugs may increase the risk of rhabdomyolysis: cyclosporine, erythromycin, clarithromycin, itraconazole, ketoconazole, nefazodone, niacin, gemfibrozil, other fibric acid biologics, or HIV protease inhibitors (see [Drug Interactions] and [Adverse Reactions]).

[Use in Elderly Patients]
The efficacy and safety of atorvastatin calcium at the recommended dose in patients aged 70 years and older do not differ from those in the general population. [Drug Interactions] The risk of myopathy is increased when statins are coadministered with cyclosporine, fibrates, macrolide antibiotics (including erythromycin), conazole antifungals, or niacin. In rare cases, rhabdomyolysis may occur, accompanied by myoglobulinuria and subsequent renal insufficiency. Therefore, the risk-benefit ratio of coadministration should be carefully considered (see [Precautions]). Cytochrome P450 3A4 Inhibitors: Atorvastatin is metabolized by cytochrome P450 3A4. Drug interactions may occur when atorvastatin is coadministered with cytochrome P450 3A4 inhibitors (cyclosporine, macrolide antibiotics such as erythromycin or clarithromycin, conazole antifungals such as itraconazole, and HIV protease inhibitors). Coadministration of these drugs increases atorvastatin plasma concentrations; therefore, caution should be exercised when atorvastatin is coadministered with the above-mentioned drugs (see Precautions). P-glycoprotein inhibitors: Atorvastatin and its metabolites are P-glycoprotein substrates. P-glycoprotein inhibitors (e.g., cyclosporine) may increase the bioavailability of atorvastatin. Erythromycin and clarithromycin: Coadministration of 10 mg of atorvastatin once daily with the cytochrome P450 3A4 inhibitors erythromycin (500 mg four times daily) or clarithromycin (500 mg twice daily) increased atorvastatin plasma concentrations. Clarithromycin increased the maximum plasma concentration and area under the concentration-time curve of atorvastatin by 56% and 80%, respectively. Itraconazole: Coadministration of 40 mg of atorvastatin and 200 mg of itraconazole daily resulted in a three-fold increase in the AUC of atorvastatin. Protease inhibitors: Protease inhibitors, known inhibitors of cytochrome P450 3A4, increase atorvastatin plasma concentrations when coadministered with atorvastatin. Grapefruit juice: Contains one or more components that inhibit cytochrome P450 3A4, potentially increasing the plasma concentration of drugs metabolized by this enzyme. Ingestion of 240 mL of grapefruit juice increased the AUC of atorvastatin by 37% and decreased the AUC of the active para-hydroxy metabolite by 204%. However, ingestion of large amounts of grapefruit juice (more than 1.2 liters per day for 5 consecutive days) increased the AUC of atorvastatin and the active atorvastatin metabolite (HMG-CoA reductase inhibitor) by 2.5-fold and 1.3-fold, respectively. Therefore, patients taking atorvastatin are advised not to consume large amounts of grapefruit juice concomitantly. Cytochrome P450 3A4 inducers: The effect of cytochrome P450 3A4 inducers (rifampicin, phenytoin) on this drug is unknown. The potential interactions between this product and other substrates of this isoenzyme are unknown, but caution should be exercised with drugs with a narrow therapeutic index, such as antiarrhythmic drugs (amiodarone). Other concomitant therapies: Gemfibrozil/fibric acid biologics: Fibric acid biologics may increase the risk of atorvastatin-induced myopathy. Based on in vitro studies, gemfibrozil inhibits the glucuronidation pathway of atorvastatin, which may result in elevated plasma levels of atorvastatin (see Precautions). Digoxin: Coadministration of 10 mg of this product with multiple doses of digoxin did not affect steady-state plasma concentrations of digoxin. Coadministration of 80 mg of this product once daily with digoxin increased digoxin concentrations by approximately 20%. This is due to inhibition of the cell membrane transporter P-glycoprotein. Patients taking digoxin should be appropriately monitored. Oral contraceptives: Coadministration of this product with oral contraceptives increases plasma concentrations of norethindrone and ethinyl estradiol. Be aware of these elevated concentrations when using oral contraceptives. Colestipol (Cholestyramine): When colestipol is coadministered with this medication, plasma concentrations of atorvastatin and its active metabolite decrease by approximately 25%. However, the lipid-lowering effect of the combined medication is greater than that of either medication alone. Antacids: When this medication is coadministered with an oral antacid suspension containing magnesium hydroxide and aluminum hydroxide, plasma concentrations of atorvastatin and its active metabolite decrease by approximately 35%, but their LDL-cholesterol-lowering effect is unaffected. Warfarin: When this medication is coadministered with warfarin, prothrombin time decreases slightly within the first few days, returning to normal after 15 days. Nevertheless, patients taking this medication should be closely monitored when it is added to warfarin. Artipyrine: Multiple doses of this medication have not been shown to affect the clearance of artipyrine when coadministered with this medication. Cimetidine: Interaction studies with this medication have not revealed any interaction between the two drugs. Amlodipine: Coadministration of atorvastatin 80 mg and amlodipine 10 mg did not alter the pharmacokinetics of atorvastatin at steady-state concentrations. Other: No clinically significant drug interactions were observed in clinical trials of this product with antihypertensive or hypoglycemic agents.