Product Overview
[Drug Name]
Generic Name: H Rosuvastatin Calcium Tablets
Trade Name: Chang Le Ding H Rosuvastatin Calcium Tablets 10mg*14 Tablets
Pinyin Code: Chang Le Ding HRui Shu Fa Ta Ting Gai Pian 10mg*14 Tablets
[Main Ingredients]
The active ingredient of this product is rosuvastatin calcium. Chemical Name: Bis-[(E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]-pyrimidin-5-yl](3R,5S)-3,5-dihydroxyhept-6-enoic acid] calcium salt (2:1) Molecular Formula: (C22H27FN3O6S)2Ca Molecular Weight: 1001.14
[Properties]
Rosuvastatin Calcium Tablets 5mg These are pink, round, biconvex film-coated tablets with "5" engraved on one side and "CY" engraved on the other. Rosuvastatin Calcium Tablets 10mg are yellow, round, biconvex film-coated tablets engraved with "10" on one side and "CY" on the other side. Rosuvastatin Calcium Tablets 20mg are yellow, round, biconvex film-coated tablets engraved with "20" on one side and "CY" on the other side.
[Indications/Main Functions]
This product is indicated for patients with primary hypercholesterolemia (type IIa, including heterozygous familial hypercholesterolemia) or mixed dyslipidemia (type IIb), whose dyslipidemia is not adequately controlled with diet and other non-drug therapies (e.g., exercise therapy, weight loss). This product is also indicated for patients with homozygous familial hypercholesterolemia as an adjunct to diet and other lipid-lowering measures (e.g., LDL-density lipoprotein cholesterol removal), or when these measures are inadequate.
[Precautions]
Renal Effects: Proteinuria (as measured by dipstick) has been observed in patients treated with high doses, particularly 40 mg. The protein is primarily derived from the renal tubules and, in most cases, is transient or intermittent. Proteinuria is not considered a precursor to acute or progressive renal disease (see Adverse Reactions).
Skeletal Muscle Effects: Skeletal muscle effects, such as myalgia, myopathy, and, rarely, rhabdomyolysis, have been reported in patients treated with all doses of ezetimibe, particularly in doses greater than 20 mg. Extremely rare cases of rhabdomyolysis have been reported with the concomitant use of ezetimibe and HMG-CoA reductase inhibitors. Drug interactions cannot be ruled out; caution should be exercised when these drugs are used together.
Creatine Kinase Testing: Creatine kinase (CK) should not be measured after strenuous exercise or in the presence of plausible causes of CK elevation, as this can confound interpretation of the results. If baseline CK values are significantly elevated (>5×ULN), confirm the result with a repeat test within 5–7 days. If repeated testing confirms a baseline CK value >5×ULN, treatment should not be initiated. As with other HMG-CoA reductase inhibitors, caution should be exercised when using this product in patients with predisposing factors for myopathy/rhabdomyolysis. These factors include: renal impairment; hypothyroidism; personal or family history of hereditary muscle disorders; a history of muscle toxicity with other HMG-CoA reductase inhibitors or fibrates; alcohol abuse; age >70 years; conditions in which elevated blood levels may occur; concomitant use of fibrates. For these patients, the potential benefits of treatment should be weighed against the potential risks, and clinical monitoring is recommended. If a patient's baseline CK value is significantly elevated (>5×ULN), treatment should not be initiated. During treatment, patients should be instructed to immediately report unexplained muscle pain, weakness, or cramping, particularly if accompanied by malaise and fever. CK levels should be measured in these patients, and treatment should be discontinued if CK values are significantly elevated (>5×ULN) or if muscle symptoms are severe and cause daylong malaise (even if CK is ≤5×ULN). If symptoms resolve and CK levels return to normal, consider restarting levofloxacin or switching to the lowest dose of another HMG-CoA reductase inhibitor with close observation. Regular monitoring of CK levels is not necessary for asymptomatic patients. Rare reports of immune-mediated necrotizing myopathy (IMNM), an autoimmune myopathy, have been associated with statin use. IMNM is characterized by proximal muscle weakness and elevated serum creatine kinase, symptoms that persist despite discontinuation of statin therapy. Muscle biopsy reveals a necrotizing myopathy without significant inflammation; the condition improves with immunosuppressive therapy. In clinical studies, there was no evidence of increased effects on skeletal muscle in the small number of patients receiving levofloxacin concomitantly with other therapies. However, an increased incidence of myositis and myopathy has been observed in patients receiving other HMG-CoA reductase inhibitors concomitantly with fibric acid derivatives (including gemfibrozil), cyclosporine, niacin, azole antifungals, protease inhibitors, or macrolide antibiotics. Concomitant use of gemfibrozil with some HMG-CoA reductase inhibitors can increase the risk of myopathy. Therefore, coadministration of this drug with gemfibrozil is not recommended. The benefits of coadministration of this drug with fibrates or niacin to further improve lipid levels should be carefully weighed against the potential risks of this combination. Coadministration of rosuvastatin with fusidic acid is not recommended. Rhabdomyolysis (including fatalities) has been reported in patients receiving this combination. (See Drug Interactions.) This drug should not be used in any patient with an acute, severe illness suggestive of myopathy or with renal failure that predisposes to rhabdomyolysis (e.g., sepsis, hypotension, major surgery, trauma, severe metabolic, endocrine, or electrolyte abnormalities, or uncontrolled seizures). Effects on the Liver: As with other HMG-CoA reductase inhibitors, this drug should be used with caution in patients who consume excessive alcohol and/or have a history of liver disease. Liver function tests are recommended before and three months after initiation of treatment. If serum transaminases increase more than three times the upper limit of normal, this product should be discontinued or the dose reduced. For hypercholesterolemia secondary to hypothyroidism or nephrotic syndrome, the underlying disease should be treated before initiating this product. Race: Pharmacokinetic studies have shown that Asian subjects have higher drug exposure than Caucasians. Protease inhibitors: Increased systemic exposure to rosuvastatin has been observed in subjects receiving rosuvastatin concomitantly with various protease inhibitors (combined with ritonavir). The lipid-lowering benefits of this product in HIV patients receiving protease inhibitor therapy and the potential for increased rosuvastatin plasma concentrations with concomitant protease inhibitor therapy should be fully considered. Coadministration with protease inhibitors is not recommended unless the dose of this product is adjusted. Lactose intolerance: Patients with rare hereditary conditions such as galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should not take this product. Interstitial lung disease: Rare cases of interstitial lung disease have been reported with some statin therapy, particularly with long-term treatment. Presenting features include dyspnea, a dry, nonproductive cough, and a decline in overall health (fatigue, weight loss, and fever). Statin therapy should be discontinued in patients suspected of developing interstitial lung disease. Diabetes: Use of 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors, including this product, has been reported to be associated with increases in glycated hemoglobin A1C (HbA1c) and fasting serum glucose levels. Clinical and biochemical monitoring should be performed according to relevant guidelines for at-risk patients (fasting plasma glucose: 5.6-6.9 mmol/L, BMI >30 kg/m2, elevated triglycerides, hypertension). Pediatric Patient Population: For pediatric patients aged 10-17 years who are at the stage of secondary sexual maturity according to Tenner stage, the duration of rosuvastatin use is limited to one year, based on assessment of linear growth (height), weight, and BMI (body mass index). After 52 weeks of study treatment, there were no effects on growth, weight, BMI, or sexual maturation. Clinical trial experience in children and pediatric patients is limited, and the effects of long-term (greater than one year) treatment with rosuvastatin in adolescents are unknown. In 52-week clinical trials, pediatric and adolescent patients treated with rosuvastatin experienced elevations of creatine kinase greater than 10× the upper limit of normal (ULN), as well as muscle symptoms observed with exercise or increased physical activity, at a higher frequency than in adult clinical trials (see Adverse Reactions). Effects on Driving and Operating Machines: Studies have not been conducted to determine the effects of this product on driving and operating machines. However, based on its pharmacodynamic properties, this product is unlikely to affect these abilities. The potential for dizziness during treatment should be considered when driving and operating machines.
[Drug Interactions]
This product is contraindicated in: Patients with hypersensitivity to rosuvastatin or any of its components; Patients with active liver disease, including unexplained persistent elevations of serum transaminases and any elevation of serum transaminases greater than three times the upper limit of normal (ULN). Patients with severe renal impairment (creatinine clearance <30 ml/min). Patients with myopathy. Patients taking cyclosporine concomitantly. Pregnant or lactating women, as well as women who may become pregnant but are not using adequate contraception.
[Specifications]
10mg*14 tablets
[Dosage and Administration]
Before starting treatment, patients should follow a standard cholesterol-lowering diet and maintain this diet during treatment. The use of this product should be individualized, taking into account the patient's cholesterol level, expected cardiovascular risk, and potential risk of adverse reactions. Oral. The usual starting dose of this product is 5 mg once daily. The starting dose should be selected based on the patient's cholesterol level, expected cardiovascular risk, and potential risk of adverse reactions. For patients requiring more intensive low-density lipoprotein cholesterol (LDL-C) lowering, a starting dose of 10 mg once daily can be considered; this dose controls lipid levels in most patients. If necessary, the dose can be adjusted to a higher dose level after 4 weeks of treatment. The maximum daily dose of this product is 20 mg. This product can be taken at any time of day, with or without food. Use in Patients with Renal Impairment: No dose adjustment is required for patients with mild and moderate renal impairment. All doses of this product are contraindicated in patients with severe renal impairment. Use in Patients with Hepatic Impairment: Systemic exposure to rosuvastatin was not increased in subjects with a Child-Pugh score of 7 or less. Increased systemic exposure was observed in subjects with Child-Pugh scores of 8 and 9; an assessment of renal function should be considered in these patients. There is no experience with the use of this product in patients with a Child-Pugh score exceeding 9. This product is contraindicated in patients with active liver disease. Race: Increased systemic exposure has been observed in Asian subjects. This factor should be considered when determining the dose for patients of Asian descent. Dosage in Patients with Predisposing Factors to Myopathy: The recommended starting dose for patients with predisposing factors to myopathy (see [Precautions]) is 5 mg.
[Adverse Reactions]
See the instructions for details.
[Contraindications]
This product is contraindicated in patients with: Hypersensitivity to rosuvastatin or any of its ingredients; Active liver disease, including unexplained persistent elevations in serum transaminases and any elevation in serum transaminases exceeding three times the upper limit of normal (ULN); Severe renal impairment (creatinine clearance <30 ml/min); Myopathy; Concomitant use of cyclosporine; Pregnancy, lactation, or women who may become pregnant without adequate contraception.
