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LEVITRA 5mg, 10mg, 20mg tablets. Each tablet contains vardenafil 5.926mg, 11.852mg, and 23.705mg respectively. INDICATIONS: Treatment of erectile dysfunction. CONTRAINDICATIONS: Contraindicated in patients with hypersensitivity to any of the drug's components. In patients who are concomitantly treated with nitrates or nitric oxide donors. Concomitant use of Vardenafil with HIV Protease inhibitors such as indinavir or ritonavir is contraindicated, as they are potent inhibitors of CYP 3 A 4. In men for whom sexual activity is not recommendable because of their underlying cardiovascular status, agents for the treatment of erectile dysfunction should generally not be used (New York Heart Association III or IV). The safety of Levitra has not been studied in the following sub- groups of patients and its use is therefore not recommended until further information is available: severe hepatic impairment, endstage renal disease requiring dialysis, hypotension, recent history of stroke or myocardial infarction, unstable angina, and known hereditary degenerative retinal disorders such as retinitis pigmentosa. ADVERSE DRUG REACTION: Very common: Headache, flushing. Common: Dizziness, nasal congestion, dyspepsia nausea. Uncommon: Somnolence, lacrimation increased, visual disturbance, hypertension, orthostatic hypotension, dyspnoea epistaxis, abnormal liver function tests, GGTP increased, face oedema, photosensitivity reaction, back pain, myalgia, blood creatine phosphokinase increased. Rare: Hypersinsitivity, anxiety, syncope, intraocular pressure increased, angina pectoris myocadial ischemia, laryngreal oedema, muscle rigidity, erection increased, priapism. L.IL.GM.11.2010.0034

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Associated Nephrotoxicity and Fewer Associated Costs. Pharmacotherapy. 2001, 21, 443-45121. Dager W.E.; Alberson T.E. Impact of Therapeutic Drug Monitoring of Intravenous Theophylline Regimens on Serum Theophylline Concentrations in the Medical Intensive Care Unit. Ann Pharmacotherapy. 1992, 26, 1287-1291 22. Klem C.; Dasta J.F. Efforts of Pharmacy to Reduce Antibiotic Resistance. New Horiz. 1996, 4, 377-384 23. Ibrahim K.H.; Gunderson B.; Rotschafer J.C. Intensive Care Unit Antimicrobial Resistance and the Role of the Pharmacist. Crit. Care Med. 2001, 29 [Suppl], N108-N11324. Rudis M.I,; Brandl K.M; SCCM/ACCP Task Force, Position Paper on Critical Care Pharmacy Services. Crit Care Med, 2000, 28, 3746-375025. Society of Critical Care Medicine and American College of Clinical Pharmacy, Position Paper on Critical Care Pharmacy Services. Pharmacotherapy, 2000, 20, 1400-1406 26. Devlin J.W.; Boleski G.; Mlynarek M.; Nerenx D.R.; Peterson E.; Jankowski M,; Horst H.M.; Zarowitz B.J. Motor Activity Assessment Scale: a Valid and Reliable Sedation Scale for use with Mechanically Ventilated Patients in a Surgical Intensive Care Unit. Crit Care Med, 1999, 27, 1271-1275

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1. Devlin J.W.; Holbrook A.M.; Fuller H.D. The Effect of ICU Sedation Guidelines and Pharmacist Interventions on Clinical Outcomes and Drug Cost. Ann Pharmacotherapy 1997, 31, 689-6952. Hatton J.; Lu W.Y.; Rhoney D.H.; Tibbs P.A, Dempsey R.J.; Young B. A Step-Wise Protocol for Stress Ulcer Prophylaxis in the Neurosurgical Intensive Care Unit. Surgical Neurology, 1996, 46(5(, 493-499 3. Broyles J.E.; Brown R.O.; Vehe K.L.; Nolly R.J.; Luther W. Pharmacist Interventions Impove Fluid balance in Fluid-restricted Patients Requiring Parenteral Nutrition. DICP, 1991, 25, 119-1224. Leape L.L.; Cullen D.J.; Dempsey Clapp M.; Burdick M.; Demonaco H.J.; Erickson J.I.; Bates D.W. Pharmacist Participation on Physician Rounds and Adverse Events in the Intensive Care Unit. JAMA. 1999, 282, 267-270 5. Cullen D.J.; Sweitzer B.J.; Bates D.W.; Burdick E.; Edmondson A.; Leape L.L. Preventable Adverse Drug Events in Hospitalized Patients: A Comparative Study of Intensive Care and General Units. Crit Care Med, 1997, 25, 1289-12976. Lazarou J.; Pomeranz B.H,; Corey P.N. Incidence of Adverse Drug Reactions in Hospitalized Patients. JAMA, 1998, 279, 1200-12057. Calabrese A.D.; Erstad B.L.; Brandl

K.; Barletta J.; Kane S.L.; Sherman D.S. Medication Administration Errors in Adult Patients in the ICU. Intensive Care Med. 2001, 27, 1592-1598 8. Kaye J.; Ashline V.; Erickson D.; Zeiler K.; Gavigan D.; Gannon L.; Wynne P.; Cooper J.; Kittle W.; Sharma K.; Morton J. Critical Care Bug Team: A Multi-Disciplinary Team Approach to Reducing Ventilator-Associated Pneumonia. Am. J. Infection Control. 2000, 28, 197-2019. Kane, L.K.; Weber R.J.; Dasta J.F. The Impact of Critical Care Pharmacist on Enhancing Patient Outcomes. Intensive Care Med. 2003, 29, 691-69810. Schmock G.T.; Meek P.D.; Ploetz P.A.; Vermeulen L.C. Economic Evaluations of Clinical Pharmacy Services- 1988-1995. Pharmacotherapy. 1996, 16, 1188120811. Montazeri M.; Cook D.J. Impact of a Clinical Pharmacist in a Multidisciplinary Intensive Care Unit. Crit Care Med. 1994, 22, 1044-104812. Miyagawa C.I.; Rivera J.O. Effect of Pharmacist Interventions on Drug Therapy Costs in Surgical Intensive-Care Unit. Am J Hosp Pharm. 1986, 43, 3008301313. Chaung L.C.; Sutton J.D.; Henderson G.T. Impact of a Clinical Pharmacist on Cost Saving and Cost Avoidance in Drug Therapy in an Intensive Care Unit. Hosp Pharm. 1994, 29, 215-218 14. White C.M.; Chow M.S.S. Cost Impact

and Clinical Benefits of Focused Rounding in the Cardiovascular Intensive Care Unit. Hosp Pharm. 1998, 33, 419-42315. Baldinger S.L.; Chow M.S.S.; Gannon R.H; Kelly E.T. Cost Savings from Having a Clinical Pharmacist Work Part-Time in a Medical Intensive Care Unit. Am J Health-Syst Pharm. 1997, 54, 2811-281416. Hadbavny A.M.; Hoyt J.W. Promotion of Cost-Effective Benzodiazepine Sedation. Am J Hosp Pharm. 1993, 50, 60-61 17. Tierney M.; Carter-Snell C.; Cardinal P.; Baxter A. Comparison of Duration of Mechanical Ventilation and Cost Associated with Midazolam and Lorazepam Infusions in Critically Ill Patients. Can J Hosp Pharm. 1996, 49, 211-215 18. Rudis M.I.; Guslits B.J.; Peterson E.L.; Hathaway S.J.; Angus E. Beis S. Zarowitz B.J. Economic impact of prolonged motor weakness complicating neuromuscular blockade in the intensive care unit. Crit Care Med. 1996, 24, 1749-175619. Zarowitz B.J.; Rudis M.I.; Lai K.; Petitta A.; Lulek M. Retrospective Pharmacoeconomic Evaluation of Dosing Vecuronium by Peripheral Nerve Stimulation Versus Standard Clinical Assessment in Critically Ill Patients. Pharmacotherapy. 1997, 17, 327-332 20. Streetman D.S.; Nafziger A.N.; Destache C.J.; Bertino J.S. Individualized Pharmacokinetic Monitoring Results in Less Aminoglycoside-


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1. Cameron M. Gagnier JJ. Little CV. et al. Evidence of effectiveness of herbal medicine products in the treatment of arthritis. Part 1: Osteoarthritis, Phytotherapy Res; 23 (11(: 1497-1515, 20092. Chrubasik JE.Roufogalis BD. Chrubasik S. Evidence of effectiveness of herbal anti-inflammatory drugs in the treatment of painful osteoarthritis and chronic low back pain. Phytotherapy Res; 21(7(: 675-683, 20073. Morelli V. Naquin C. Weaver V. Alterative therapies for traditional disease states: Osteoarthritis. Amer. Fam. Physician;67(2(: 339-344, 20034. Sawitzke AD. Shi H. Finco MF et al. The effect of glucosamine and/or chondriotin sulfate on the progression of knee osteoarthritis: a report from glucosamine/chondrotin arthritis intervention trial. Arthritis Rheum; 2008 5. Sarsaparilla in: The Healing Power of Rainforest Herbs by Leslie Taylor, 2005 Garden City Park NY6. Sarsaparilla in: Bradley PR. British Herbal Compendium Vol. 1, 1992, British Herbal Association, Bournemouth, Dorset, p. 194-1957. Thuja occidentalis, in: PDR for Herbal Medicines 3rd Ed. Thomson PDR, 2004

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1. Arguedas JA, Perez MI, Wright JM. Treatment blood pressure targets for hypertension. Cochrane Database of Systematic reviews 2009, Issue 3. Art No.: CD004349. DOI:10. 1002/14651858.CD004349.pub2 2. Molander L, Lovheim H, Norman T et al. Lower systolic blood pressure is associated with greater mortality in people aged 85 and older. J Am Geriatr Soc; 56: 1853-59, 20083. Ungar A, Pepe G, Lambertucci L et al. Low diastolic ambulatory blood pressure is associated with greater all-cause mortality in older patients with hypertension. J Am Geriatr Soc; 57: 291-296, 20094. Larson EB. Evidence, guidelines, performance incentives, complexity, and old people: clinicians dilemma. J Am Geriatr Soc; 57: 353-354, 20095. Mangin D, Sweeney K, Heath I. Preventive health care in elderly people needs rethinking. Brit Med J; 335:285-287, 20076. U.S. Preventive Service Task Force. Aspirin for the prevention of cardiovascular disease: U.S. Preventive Service Task Force recommendation statement. Ann Intern Med; 150: 396-404, 20097. Monane M, Glynn RJ, Avorn J. The impact of sedative-hypnotic use on sleep symptoms in elderly nursing home residents. Clin Pharmacol Therap; 59: 83, 1996 8. Ersser S, Wiles A, Taylor H, et al. The sleep of older people in hospital and nursing homes. J Clin Nurs; 8: 360-368, 1990 9. King MB. Falls. In: Principles of Geriatric Medicine & Gerontology (Hazzard WR, Blass JP, Halter JB, Ouslander JG, Tinetti ME eds.(,

Fifth edition, McGraw-Hill Companies 2003, Pg. 152110. Garfinkel D, Laudon M, Nof D, Zisapel N. Improvement of sleep quality in elderly people by controlled-release melatonin. LANCET; 346: 541-544, 199511. Garfinkel D, Zisapel N, Wainstein J, Laudon M. Facilitation of benzodiazepine discontinuation by melatonin: A new clinical approach. Arch Int Med; 159: 2456-2460, 1999

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JANUVIA IndicationsMonotherapy and Combination TherapyJANUVIA is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.Important Limitation of UseJANUVIA should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, as it would not be effective in these settings.JANUVIA has not been studied in combination with insulin

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1. Osteoporosis prevention, diagnosis, and therapy. NIH Consens Statement; 17:1-45, 20002. Gordon CM, Baim S, Bianchi ML, et al. Special report on the 2007 Pediatric Position Development Conference of the International Society for Clinical Densitometry. South Med J; 101:740-743, 20083. Bishop N, Braillon P, Burnham J, et al. Dual-energy X-ray aborptiometry assessment in children and adolescents with diseases that may affect the skeleton: the 2007 ISCD Pediatric Official Positions. J Clin Densitom; 11:29-42, 20084. Gafni RI, Baron J. Over diagnosis of osteoporosis in children due to misinterpretension of dual-energy X-ray absorptiometry (DEXA(. J Ped; 144:253-257, 20045. Rizzoli R, Bonjour JP, Ferrari SL. Osteoporosis, genetics and hormones. J Mol Endocrinol; 26:79-94, 20016. Rideout CA, McKay HA, Barr SI. Self-reported lifetime physical activity and areal bone mineral density in healthy postmenopausal women: the importance of teenage activity. Calcif Tissue Int; 79:214-222, 2006


7. Tlacuilo-Parra A, Morales-Zambrano R, Tostado-Rabago N, et al. Inactivity is a risk factor for low bone mineral density among haemophilic children. Br J Haematol;140:562-567, 20088. Ausili E, Focarelli B, Tabacco F, et al. Bone mineral density and body composition in a myelomeningocele children population: effects of walking ability and sport activity. Eur Rev Med Pharmacol Sci; 12:349-354, 20089. Alwis G, Linden C, Stenevi-Lundgren S, et al. A school-curriculum-based exercise intervention program for two years in pre-pubertal girls does not influence hip structure. Dyn Med; 7:8, 200810. Rautava E, Lehtonen-Veromaa M, Kautiainen H, et al. The reduction of physical activity reflects on the bone mass among young females: a follow-up study of 142 adolescent girls. Osteoporos Int; 18:915-922, 200711. Chevalley T, Bonjour JP, Ferrari S, et al. High-protein intake enhances the positive impact of physical activity on BMC in prepubertal boys. J Bone Miner Res; 23:131-142, 200812. Greer FR, Krebs NF. Optimizing bone health and calcium intakes of infants, children, and adolescents. Pediatrics; 117:578-585, 200613. Winzenberg T, Shaw K, Fryer J, et al. Effects of calcium supplementation on bone density in healthy children: meta-analysis of randomised controlled trials. BMJ; 333:775, 200614. Seiquer I, Mesias M, Hoyos AM, et al. A Mediterranean dietary style improves calcium utilization in healthy male adolescents. J Am Coll Nutr; 27:454-562, 200815. Wagner CL, Greer FR. Prevention of rickets and vitamin D deficiency in infants, children, and adolescents. Pediatrics; 122:1142-1152, 200816. Bowden SA, Robinson RF, Carr R, et al. Prevalence of vitamin D deficiency and insufficiency in children with osteopenia or osteoporosis referred to a pediatric metabolic bone clinic. Pediatrics; 121:1585-1590, 200817. Marinovic D, Dorgeret S, Lescoeur B, et al. Improvement in bone mineral density and body composition in survivors of childhood

acute lymphoblastic leukemia: a 1-year prospective study. Pediatrics; 116:102-108, 200518. Okumus O, Erguven M, Deveci M, et al. Growth and bone mineralization in patients with juvenile idiopathic arthritis. Indian J Pediatr; 75:239-243, 200819. Bianchi ML, Bardare M, Caraceni MP, et al. Bone metabolism in juvenile rheumatoid arthritis. Bone Miner; 9:153-162, 199020. Maalouf J, Nabulsi M, Vieth R, et al. Short- and long-term safety of weekly high-dose vitamin D3 supplementation in school children. J Clin Endocrinol Metab; 93:2693-2701, 2008 21. Kilpinen-Loisa P, Nenonen H, Pihko H, et al. High-dose vitamin D supplementation in children with cerebral palsy or neuromuscular disorder. Neuropediatrics; 38:167-172, 200722. Misra M, Pacaud D, Petryk A, et al. Drug and Therapeutics Committee of the Lawson Wilkins Pediatric Endocrine Society. Vitamin D deficiency in children and its management: review of current knowledge and recommendations. Pediatrics; 122:398-417, 200823. Fuleihan GEH, Nabulsi M, Tamim H, et al. Effect of Vitamin D Replacement on Musculoskeletal Parameters in School Children: A Randomized Controlled Trial. J Clin Endocrinol Metab; 91:405-412, 200624. Ward L, Tricco AC, Phuong P, et al. Bisphosphonate therapy for children and adolescents with secondary osteoporosis. Cochrane Database Syst Rev; 4:CD005324, 200725. Bachrach LK, Ward LM. Clinical review 1: Bisphosphonate use in childhood osteoporosis. J Clin Endocrinol Metab; 94:400-409, 200926. Poyrazoglu S, Gunoz H, Darendeliler F, et al. Successful results of pamidronate treatment in children with osteogenesis imperfecta with emphasis on the interpretation of bone mineral density for local standards. J Pediatr Orthop; 28:483-487, 200827. Rauch F, Munns C, Land C, et al. Risedronate in the Treatment of Mild Pediatric Osteogenesis Imperfecta: A Randomized Placebo-Controlled Study. J Bone Miner Res; 200928. Streeten EA, McBride D, Puffenberger E,

et al. Osteoporosis-pseudoglioma syndrome: description of 9 new cases and beneficial response to bisphosphonates. Bone; 43:584-590, 200829. Barros ER, as da Silva MR, Kunii IS, et al. Three years follow-up of pamidronate therapy in two brothers with osteoporosis-pseudoglioma syndrome (OPPG( carrying an LRP5 mutation. J Pediatr Endocrinol Metab; 21:811-818, 200830. Apkon S, Coll J. Use of weekly alendronate to treat osteoporosis in boys with muscular dystrophy. Am J Phys Med Rehabil; 87:139-143, 200831. Inoue Y, Shimojo N, Suzuki S, et al. Efficacy of intravenous alendronate for the treatment of glucocorticoid-induced osteoporosis in children with autoimmune diseases. Clin Rheumatol; 27:909-912, 200832. Lethaby C, Wiernikowski J, Sala A, et al. Bisphosphonate therapy for reduced bone mineral density during treatment of acute lymphoblastic leukemia in childhood and adolescence: a report of preliminary experience. J Pediatr Hematol Oncol; 29:613-616, 200733. Papapoulos SE, Cremers SC. Prolonged bisphosphonate release after treatment in children. NEJM; 2007;356:1075-1076, 200734. Munns CF, Rauch F, Ward L, et al. Maternal and fetal outcome after long-term pamidronate treatment before conception: a report of two cases. J Bone Miner Res; 19:1742-1745, 200435. Waterhouse KM, Auron A, Srivastava T, et al. Sustained beneficial effect of intravenous bisphosphonates after their discontinuation in children. Pediatr Nephrol; 22:282-287, 200736. Cimaz R, Biggioggero M, Boncompagni A, et al. Alendronate treatment of pediatric patients with connective tissue disorders. A ten year follow-up study ACR 2007- abstract37. Malmgren B, Astrm E, Sderhll S. No osteonecrosis in jaws of young patients with osteogenesis imperfecta treated with bisphosphonates. J Oral Pathol Med; 37:196-200, 200838. Bilezikian JP. Osteonecrosis of the jaw-do bisphosphonates pose a risk? NEJM; 355:2278-2281, 2006


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1. Indejeeth CA, Foo AC, Lai MM, et al. Efficacy and safety of pharmacological agents in managing osteoporosis in the old old: Review of the evidence. Bone; 44:744-751, 20092. Pietschmann P, Rauner M, Sipos W, et al. Osteoporosis: an age-related and gender-specific disease A Mini-Review. Gerontology; 55:3-12, 20093. Raisz LG. Pathogenesis of osteoporosis: Concepts, conflicts, and prospects. J Clin Invest; 115:3318-3325, 20054. Duque G, Troen BR. Understanding the mechanisms of senile osteoporosis: new facts for a major geriatric syndrome. J Am Geriatr Soc; 56:935-941, 20085. Gimble JM, Zvonic S, Floyd ZE, et al. Playing with bone and fat. J Cell Biochem 98:251-266, 20066. Ongphiphadhanakul B, Chanprasertyothin S, Chailurkit L, et al. Differential associations of residual estradiol levels with bone mineral density and serum lipids in postmenopausal women with osteoporosis. Maturitas; 48:193-196, 20047. Rubin J, Rubin C, Jacobs CR. Molecular pathways mediating mechanical signaling in bone. Gene; 367:1-16, 20068. David V, Martin A, Lafage-Proust MH, et al. Mechanical loading down-regulates peroxisome proliferator-activated receptor gamma in bone marrow stromal cells and favors osteoblastogenesis at the expense of adipogenesis. Endocrinology; 148:2553-2562, 20079. Karinkanta S, Heinonem A, Sievanen H,

et al. A multi-component exercise regimen to prevent functional decline and bone fragility in home-dwelling elderly women: Randomized, controlled trial. Osteoporos Int; 18:453-462, 200710. Uusi-Rasi K, Kannus P, Cheng S, et al. Effect of alendronate and exercise on bone and physical performance of postmenopausal women: A randomized controlled trial. Bone; 33:132-143, 200311. Bischoff-Ferrari HA, Willet WC, Wong JB, et al. Fracture prevention with vitamin D supplementation: A meta-analysis of randomized controlled trials. JAMA; 293:2257-2264, 200512. Bichoff-Ferrari HA, Dawson-Hughes B, Willett WC, et al. Effect of vitamin D on falls: a meta-analysis. JAMA; 291:1999-2006, 200413. Mann V, Huber C, Kogianni G, et al. The antioxidant effect of estrogen and selective estrogen receptor modulators in the inhibition of osteocyte apoptosis in vitro. Bone 2007; 40:674-68414. Burger HG. Hormone therapy in the WHI era. Aust N Z J Obstet Gynaecol; 46:84-91, 200615. Miller PD. Anti-resorptives in the management of osteoporosis. Best Pract Res Clin Endocrinol Metabol 22:849-868, 200816. Manuele S, Sorbello L, Puglisi N, et al. The teriparatide in the treatment of severe senile osteoporosis. Arch Gerontol Geriatr; 44:249-258, 200717. Bonnen S, Marin F, Mellstrom D, et al. Safety and efficacy of teriparatide in elderly women with established osteoporosis: Bone anabolic therapy from a geriatric perspective. J Am Geriatr Soc; 54:782-789, 200618. Seeman E, Vellas B, Benhamou C, et al. Strontium renelate reduces the risk of vertebral and nonvertebral fractures in women eighty years of age and older. J Bone Miner Res; 21:1113-1120, 200619. Backesjo CM, Li Y, Lindgren U, et al. Activation of Sirt 1 decreases adipocyte formation during osteoblast differentiation of mesenchymal stem cells. J Bone Miner Res; 21:993-1002, 2006 : : ,2009 ,


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גיליון מס' 44 - דצמבר 2010 / ינואר 2011