سعر ليبوكومب 10/10 مجم 30 كبسولة 2024

Lipocomb 10/10 mg 30 capsules (Servier / Pharma Over Seas, Egypt): hard capsules combining rosuvastatin 10 mg and ezetimibe 10 mg.

• Adjunct to diet for primary hypercholesterolaemia as substitution therapy in adults adequately controlled with rosuvastatin and ezetimibe given concurrently at the same dose levels as separate products.Population: AdultsMedicines Evaluation Board (CBG-MEB), Netherlands
• Substitution treatment for prevention of cardiovascular events in adults with coronary heart disease and a history of acute coronary syndrome adequately controlled with the individual substances at the same doses.Population: AdultsMedicines Evaluation Board (CBG-MEB), Netherlands

• Most frequent with the combination (published literature): increased hepatic transaminases, gastrointestinal problems and muscle pain. Common reactions of the components include diabetes mellitus (risk-factor dependent, rosuvastatin), headache, dizziness, constipation, nausea, abdominal pain, diarrhoea, flatulence, myalgia and fatigue/asthenia.International label, same formulation · Medicines Evaluation Board (CBG-MEB), Netherlands

• Hypersensitivity to rosuvastatin, ezetimibe or excipients; active liver disease including unexplained persistent transaminase elevations or any elevation above 3 x ULN; pregnancy, breast-feeding and women of childbearing potential without contraception; severe renal impairment (CrCl < 30 mL/min); myopathy; sofosbuvir/velpatasvir/voxilaprevir; concomitant ciclosporin.International label, same formulation · Medicines Evaluation Board (CBG-MEB), Netherlands

• Severe cutaneous adverse reactions (SJS, DRESS) reported with rosuvastatin: discontinue immediately and never restart. Skeletal muscle effects (myalgia, myopathy, rarely rhabdomyolysis), particularly with rosuvastatin doses above 20 mg; discontinue if myopathy is suspected or confirmed; patients should report unexplained muscle pain, tenderness or weakness promptly.International label, same formulation · Medicines Evaluation Board (CBG-MEB), Netherlands

• CiclosporinContraindicated: rosuvastatin AUC on average 7 times higher with ciclosporin; ezetimibe AUC increased about 3.4-fold in renal transplant patients.Medicines Evaluation Board (CBG-MEB), Netherlands
• Protease inhibitors (e.g. atazanavir/ritonavir)Not recommended: may strongly increase rosuvastatin exposure (about 3-fold AUC, 7-fold Cmax with atazanavir/ritonavir).Medicines Evaluation Board (CBG-MEB), Netherlands
• TicagrelorTicagrelor inhibits BCRP and increases rosuvastatin AUC about 2.6-fold; increased myopathy risk.Medicines Evaluation Board (CBG-MEB), Netherlands

• Contraindicated in pregnancy and breast-feeding; women of childbearing potential should use appropriate contraception; discontinue immediately if pregnancy occurs (cholesterol products are essential for fetal development).International label, same formulation · Medicines Evaluation Board (CBG-MEB), Netherlands
• Rosuvastatin is present in human milk (limited data) and is contraindicated during lactation; ezetimibe is secreted in rat milk, human data unknown.International label, same formulation · Medicines Evaluation Board (CBG-MEB), Netherlands

• Rosuvastatin: Selective, competitive HMG-CoA reductase inhibitor acting mainly in the liver; increases hepatic LDL receptors and reduces VLDL synthesis.
• Ezetimibe: Inhibits intestinal absorption of cholesterol and related phytosterols by binding the sterol transporter NPC1L1 at the small-intestinal brush border.