1. Indications and Usage
\nHypercholesterolemia:
\nIndicated as an adjunct to diet in adult patients with primary hypercholesterolemia (heterozygous familial or non-familial) or mixed dyslipidemia, whose LDL-C levels have not been adequately controlled on statin monotherapy.
\nHomozygous Familial Hypercholesterolemia (HoFH):
\nIndicated as an adjunct to other lipid-lowering therapies (e.g., LDL apheresis) or as an alternative when such therapies are unavailable, to reduce elevated total cholesterol (TC) and LDL-C levels in patients with HoFH.
\n2. Dosage and Administration
\nRoute of Administration:
\nFor Oral Use ONLY. Can be taken at any time of day, with or without food, and swallowed whole with water.
\nRecommended Dosage:
\nThe recommended dose is one tablet once daily. Patients should continue a low-fat diet during treatment.
\nDosing with Bile Acid Sequestrants:
\nIf co-administered with bile acid sequestrants, this product must be taken at least 2 hours before or at least 4 hours after the bile acid sequestrant.
\nSpecial Populations:
\nHepatic Impairment: No dosage adjustment is required for mild hepatic impairment (Child-Pugh score 5-6). Not recommended for moderate to severe hepatic impairment (Child-Pugh score >6).
\nRenal Impairment: No dosage adjustment is required for mild to moderate renal impairment. Contraindicated in patients with severe renal impairment (creatinine clearance <30 mL\/min).
\nAsian Patients: Due to increased systemic exposure, Asian patients may require a lower starting dose (e.g., rosuvastatin 5 mg\/ezetimibe 10 mg), depending on regional availability and clinical judgment.
\n3. Mechanism of Action
\nDual Complementary Action:
\nThis product combines two lipid-lowering agents with complementary mechanisms:
\nRosuvastatin: A selective, competitive HMG-CoA reductase inhibitor that reduces endogenous cholesterol synthesis in the liver. It increases hepatic LDL receptor expression, enhancing LDL-C uptake and catabolism.
\nEzetimibe: Selectively inhibits the intestinal absorption of dietary and biliary cholesterol by targeting the Niemann-Pick C1-like 1 (NPC1L1) protein at the brush border of the small intestine.
\nPharmacodynamic Effect:
\nThe combination significantly lowers LDL-C, total cholesterol, apolipoprotein B, and triglycerides, while raising HDL-C. Maximal therapeutic response is typically achieved within 4 weeks.
\n4. Safety and Warnings
\nContraindications:
\nActive liver disease, unexplained persistent elevations in serum transaminases (>3x ULN), severe renal impairment, myopathy, pregnancy, lactation, and concomitant use of cyclosporine.
\nSkeletal Muscle Effects:
\nDose-related myalgia, myopathy, and rare rhabdomyolysis with acute renal failure have been reported. Risk is higher in elderly patients (\u226565 years) and those with renal impairment. Discontinue if CK levels exceed 5x ULN or if severe muscle symptoms occur.
\nHepatic Effects:
\nTransient, asymptomatic, dose-related elevations in liver enzymes may occur. Monitor liver function tests periodically.
\nRenal Effects:
\nProteinuria has been observed, mostly tubular in origin, usually transient and resolving spontaneously.
\n5. Adverse Reactions
\nMost Common:
\nHeadache, dizziness, constipation, nausea, abdominal pain, diarrhea, flatulence, and diabetes mellitus.
\nMusculoskeletal:
\nMyalgia, arthralgia, and back pain. Rare cases of immune-mediated necrotizing myopathy.
\nMetabolic & Endocrine:
\nIncreased blood glucose\/HbA1c, leading to new-onset diabetes (especially in patients with risk factors like BMI >30 or impaired fasting glucose).
\nImmune System:
\nRare hypersensitivity reactions, including angioedema.
\n6. Drug Interactions
\nCyclosporine:
\nConcomitant use is contraindicated due to significantly increased rosuvastatin exposure and heightened risk of myopathy\/rhabdomyolysis.
\nBile Acid Sequestrants:
\nMay decrease ezetimibe absorption; requires staggered dosing (2 hours before or 4 hours after).
\nGenetic Polymorphisms:
\nPatients with SLCO1B1 (OATP1B1) c.521CC or ABCG2 (BCRP) c.421AA genotypes exhibit increased rosuvastatin exposure. Lower doses are recommended for these individuals.
\n7. Pharmaceutical Information
\nChemical Composition:
\nEach film-coated tablet contains Rosuvastatin calcium 10 mg (equivalent to rosuvastatin 10 mg) and Ezetimibe 10 mg.
\nExcipients:
\nLactose, croscarmellose sodium, sodium lauryl sulfate, povidone, magnesium stearate, microcrystalline cellulose, colloidal silicon dioxide, hypromellose, macrogol 6000, titanium dioxide, and talc.
\nAppearance:
\nWhite to off-white, round, biconvex, film-coated tablets with a white to pale yellow core upon removal of the coating.
\nStorage:
\nStore in a tightly closed container, protected from moisture and light, at temperatures below 30\u00b0C (86\u00b0F).<\/p>\n","protected":false},"excerpt":{"rendered":"
Brand Name: \u559c\u7acb\u8fbe\u00ae(Zenon\u00ae)
\nGeneric Name: Rosuvastatin Calcium and Ezetimibe
\nStrength: Rosuvastatin Calcium 10mg + Ezetimibe 10mg per tablet\uff0c30 tablets per box
\nManufacturer: Sanofi-Aventis Groupe related overseas pharmaceutical manufacturing site
\nMarketing Authorization Holder: Sanofi (China) Investment Co., Ltd.
\nApproval Date in China: 2021
\nRegistration Number: \u56fd\u836f\u51c6\u5b57 HJ20210045
\nStorage: Seal and store below 30\u2103, protect from moisture; keep out of reach of children<\/p>\n
Price&Cost:Contact Us now for the best price of Rosuvastatin Calcium and Ezetimibe\uff08Zenon\uff09<\/p>\n","protected":false},"featured_media":3715,"comment_status":"open","ping_status":"closed","template":"","meta":[],"product_brand":[77],"product_cat":[27],"product_tag":[],"class_list":["post-3714","product","type-product","status-publish","has-post-thumbnail","product_brand-sanofi","product_cat-tablets","first","instock","shipping-taxable","product-type-simple"],"yoast_head":"\n