DAWNRAYS SHUMAITONG Atorvastatin Calcium Tablets For Hypercholesterolemia 10mg*28

[Drug Name]
Generic Name: Atorvastatin Calcium Tablets
Trade Name: Shumaitong Atorvastatin Calcium Tablets 10mg x 28 Tablets

[Main Ingredient]
Atorvastatin calcium, chemical name: [R-(R*,R*)]-2-(4-fluorophenyl)-β,8-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, film-coated tablet.

[Indications/Main Function]
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 combined hyperlipidemia (equivalent to types 1a and 1b in the Fredrickson classification), who have not responded satisfactorily to dietary therapy and other non-drug treatments. In patients with homozygous familial hypercholesterolemia, 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 x 28 tablets

[Dosage and Administration]
Patients should follow a standard low-cholesterol diet before starting treatment with this drug 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. Atorvastatin can be taken once daily 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 goals are LDL-C <3 mmol/L (or <115 mg/dL) and total cholesterol <5 mmol/L (or <190 mg/dL). Excerpted from "Prevention and Treatment of Coronary Heart Disease in Clinical Practice: Second European Joint Recommendation for the Prevention of Coronary Artery Disease," Journal of Atherosclerosis, 1998, pp. 199-270. For the treatment of primary hypercholesterolemia and mixed hyperlipidemia, most patients can achieve lipid control with atorvastatin calcium 10 mg once daily. Significant efficacy is seen within 2 weeks of treatment, with maximal efficacy seen within 4 weeks. Efficacy is maintained with long-term treatment. For patients with heterozygous familial hypercholesterolemia, the initial dose is 10 mg daily. Dosage should be individualized and titrated to 40 mg daily at 4-week intervals. If satisfactory efficacy is still not achieved, the dose can be increased to a maximum of 80 mg daily or combined with a bile acid sequestrant at 40 mg daily. For the treatment of homozygous familial hypercholesterolemia, 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 (e.g., LDL-C plasma dialysis). Alternatively, when these treatments are unavailable, this product can be used alone. 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 to this product are constipation, flatulence, dyspepsia, and abdominal pain, which generally resolve with continued treatment. In clinical trials, less than 2% of patients 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 described below. By convention, 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 reaction. Very rare: anaphylaxis. 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: Angioneurotic edema, 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 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, transaminase elevations 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 are contraindicated in patients with hypersensitivity to any of the ingredients. This product is contraindicated in patients with active liver disease, persistent elevations in serum transaminases greater than 3 times the upper limit of normal for unknown reasons, myopathy, and during pregnancy, lactation, or women of childbearing age who are not using adequate contraceptive measures.

[Precautions]
Liver effects: Liver function tests should be performed before starting treatment and regularly reviewed. Liver function tests should be performed if any patient develops any symptoms or signs suggestive of liver damage. Patients with elevated transaminase levels should be monitored until they return to normal. If transaminase levels persist, exceeding 3 times the normal value, dose reduction or discontinuation of Lipitor is recommended (see Adverse Reactions). This product should be used with caution in patients who consume alcohol excessively and/or have a history of liver disease. Skeletal muscle effects: As with other HMG-CoA reductase inhibitors, atorvastatin may rarely affect skeletal muscle, causing myalgia, myositis, and myopathy, which may progress to life-threatening rhabdomyolysis, manifested 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 testing should be performed 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 old, the necessity of this test may be determined by the presence of other predisposing factors for rhabdomyolysis. In these situations, the risk-benefit ratio of treatment should be weighed, and clinical monitoring is recommended. If the baseline CPK level is significantly elevated (exceeding 5 times the upper limit of normal), treatment should not be initiated. Creatine phosphokinase testing should not be performed 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 (exceeding 5 times the upper limit of normal), the result should be repeated within 57 days for verification. During treatment, patients should promptly report muscle pain, cramping, or weakness (preferably when accompanied by malaise or fever). If any of the above symptoms occur while taking medication, CPK testing should be performed. If a significant elevation (exceeding 5 times the upper limit of normal) is detected, treatment should be discontinued. If muscle symptoms are severe and cause frequent discomfort, discontinuation of treatment should be considered, even if the CPK level is <5 times the upper limit of normal. If symptoms resolve and the CPK level returns to normal, atorvastatin may be resumed or switched to another statin under close monitoring, starting at the lowest dose. If the CPK level exceeds 10 times the upper limit of normal or rhabdomyolysis is confirmed or suspected, atorvastatin must be discontinued. Concomitant use of atorvastatin with the following medications increases 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]).

[Pediatric Use]
The use of atorvastatin calcium tablets in children should be determined by a specialist. Lipitor's experience in children 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 of this drug in this patient population is 10 mg/day. Based on the patient's response and tolerability, the dose can be increased to 80 mg daily. There are no safety data for this drug in this population regarding growth and development.

[Use in Elderly Patients]
The efficacy and safety of atorvastatin calcium at the recommended dose in elderly 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 extremely 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 this product 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, so caution is advised when atorvastatin is coadministered with these drugs (see [Precautions]). P-glycoprotein inhibitors: Atorvastatin and atorvastatin metabolites are substrates for P-glycoprotein. P-glycoprotein inhibitors (such as 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), respectively, increases atorvastatin plasma concentrations. Clarithromycin increases 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 with 200 mg of itraconazole daily results 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. Consumption of 240 mL of grapefruit juice increases the AUC of atorvastatin by 37% and decreases the AUC of the active para-hydroxy metabolite by 20.4%. However, ingestion of large amounts of grapefruit juice (greater than 1.2 liters per day for 5 consecutive days) increases the AUC of atorvastatin and the active HMG-CoA reductase inhibitors (atorvastatin and metabolites) by 2.5-fold and 1.3-fold, respectively. Therefore, patients taking atorvastatin are advised not to consume large amounts of grapefruit juice concurrently. Cytochrome P450 3A4 inducers: The effect of cytochrome P450 3A4 inducers (rifampicin, phenytoin) on this drug is unknown. The potential for interactions between this drug and other substrates of this isoenzyme is unknown, but caution should be exercised with drugs with a narrow therapeutic index, such as Class III 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 lead to elevated atorvastatin plasma levels (see Precautions). Digoxin: Coadministration of 10 mg of this drug with multiple doses of digoxin did not affect steady-state plasma concentrations of digoxin. Coadministration of 80 mg of this drug once daily with digoxin increased digoxin concentrations by approximately 20%. This is due to inhibition of the cell membrane transport protein P-glycoprotein. Patients taking digoxin should be appropriately monitored. Oral contraceptives: When this product is co-administered with oral contraceptives, plasma concentrations of norethindrone and ethinyl estradiol are increased. When using oral contraceptives, be aware of these increased concentrations. Colestipol (cholestyramine): When colestipol is co-administered with this product, plasma concentrations of atorvastatin and its active metabolite decrease by approximately 25%. However, the lipid-lowering effect of the combined drug is greater than that of either drug alone. Antacids: When this product is co-administered with oral antacid suspensions 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 product is co-administered with warfarin, prothrombin time decreases slightly within the first few days, returning to normal after 15 days. Nevertheless, patients taking warfarin should be closely monitored when this product is added to their warfarin regimen. Artipyrine: Multiple doses of this product co-administered with atipyrine have not been shown to affect atipyrine clearance. Cimetidine: Interaction studies with this product have not revealed any interaction between the two. Amlodipine: Coadministration of 80 mg of atorvastatin and 10 mg of amlodipine did not alter the pharmacokinetics of atorvastatin at steady-state concentrations. Other: No clinically significant drug interactions have been observed in clinical trials of this product with antihypertensive or hypoglycemic agents.