Supervisor : Prof. Dr.Hekma Coordinator : Ph.Fatmah Bakhder Umm Al-Qura University Faculty of pharmacology department

OBJECTIVES Trade and generic names Mechanism of action Clinical use Side effects Drug interactions Life style

Therapeutic class : Lipid-Lowering Agents Pharmacological class : HMG-CoA Reductase Inhibitors

Trade name : Inegy generic name: Simvastatin & Ezetimibe

Uses of Inegy: The main effects that produce from this drug are: lower levels of total cholesterol, (LDL cholesterol) and triglycerides in the blood. Raises levels of (HDL cholesterol). Hypercholesterolaemia

So. It can use if patient has: Homozygous Familial Hypercholesterolaemia (HoFH) patients not appropriately controlled with a statin alone patients treated with a statin and ezetimibe

Side effect Headache. Fatigue Constipation Abdominal pain Indigestion Diarrhea Nausea,vomiting. Hot flushes. Myopathy and Rhabdomyolysis. Myoglobinuria and acute renal failure. Photosensitivity, purpura, and alopecia.

Drug - drug interaction Mainly for Simvastatin Warfarin Aspirin Niacin Fibrate Erythromycin Verapamil

Drug interaction classification Major Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit. Moderate Moderately clinically significant. Usually avoid combinations; use it only under special circumstances. Minor Minimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan.

Simvastatin ↔ Warfarin It acts by affecting hepatic/intestinal enzyme CYP3A4 metabolism that lead to: Reversible Rhabdomyolysis. Acute renal failure

Simvastatin&ezetimibe ↔ cholestyramine cholestyramine decreases levels of ezetimibe and simvastatin by inhibition of GI absorption.

Simvastatin ↔ Niacin Either increases toxcity of the other by pharmacodynamic synergism that increase risk of : (Rhabdomyolysis ) for Both

simvastatin ↔ fibrate E.g. Gemfibrozil. Either increases effects of the other by pharmacodynamic synergism lead to : Liver damaged. Severe myopathy and Rhabdomyolysis – renal failure secondary to Myoglobinuria and may result in death. increased risk of musculoskeletal toxicity.

simvastatin ↔ verapamil Simvastatin ↔ erythromycin Verapamil hypertension angina pectoris cardiac arrhythmia hypertension angina pectoris cardiac arrhythmia erythromycin Anti-biotic – infections Anti-biotic – infections

simvastatin ↔ verapamil Simvastatin ↔ erythromycin They will increase the level or effect of simvastatin by affecting hepatic/intestinal enzyme CYP3A4 metabolism that lead to : myopathy and Rhabdomyolysis – renal failure secondary to Myoglobinuria and may result in death. increased risk of musculoskeletal toxicity.

simvastatin level Bosentan – (pulmonary artery hypertension) Carbamazepine – (seizure disorders and neuropathic pain.) Efavirenz – ( human immunodeficiency virus (HIV) infection. ) Rifampicin – (tuberculosis )

DONE BY Afraa 3esa Anan fatani Anmah Kinsarah Ghofran Rawas Lamiaa alsalmy Lujain Andargiri Maram Kafyah Nazmeyah alkyyal Razan basalman Waad alhajjaje

REFERENCE Textbooks: Anand Ramachandran, Pharmacology recall, 2 nd edition, Medical Website : SharePractice. Featured Dx: Hyperlipidemia. 04/02/ hyperlipidemia/ (Accessed 30 Mar 2014). hyperlipidemia/ University of Maryland medical center. 06/04/2012. Familial combined Hyperlipidemia. May 31, combined-hyperlipidemia (Accessed 30 Mar 2014). combined-hyperlipidemia

SIU School of Medicine. Hyperlipidemia. pidemia.html (Accessed 30 Mar 2014). pidemia.html Medscape. When Do Triglycerides Matter? (Accessed 30 Mar 2014). Anupama Kizhakkeveettil, Parla S. Jayagopal and Kevin Rose. June 30, Hypercholesterolemia and Ayurvedic Medicine: A Case Report. mia-and-Ayurvedic-Medicine-A-Case- Report.aspx?id= (Accessed 30 Mar 2014). mia-and-Ayurvedic-Medicine-A-Case- Report.aspx?id=