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1. Khullar V, Rovner ES, Dmochowski R, Nitti V, Wang J, Guan Z. Fesoterodine dose response in subjects with overactive bladder syndrome. Urology. 2008 May;71(5):839-43. (Erratum in: Urology. 2009 Sep;74(3):716) 2. Chapple C, Van Kerrebroeck P, Tubaro A, Haag-Molkenteller C, Forst HT, Massow U, Wang J, Brodsky M. Clinical Ecacy, Safety,and Tolerability of Once-Daily Fesoterodine in Subjects With Overactive Bladder. Eur Urol. 2007 Oct; 52(4):1204-12. 3. Kelleher CJ, Tubaro A, Wang JT, Kopp Z. Impact of fesoterodine on quality of life: pooled data from two randomized trials. BJU Int. 2008 Jul;102(1):56-61. 4. Toviaz EMEA Scientic discussion. 5.Khullar V. Dose response relationship of fesoterodine 4 mg vs 8 mg and onset of action in subjects with overactive bladder: results from a pooled analysis of 2 randomized trials. ICS 2007, Rotterdam, Netherlands. Abst. 270. 6. Malhotra B, Wood N, Guan Z, Gandelman K. Pharmacokinetic prole of fesoterodine, a novel antimuscarinic treatment for overactive bladder. British Pharmacological Society Winter Meeting. December 17-20, 2007; Brighton, UK. 7. Toviaz Israeli approved Prescribing Information.

Indications: Treatment of symptoms (increased urinary frequency and/or urgency and/or urgency incontinence) that may occur in patients with overactive bladder syndrome. Contraindications: Hypersensitivity to the active substance or soya or any of the excipients; Urinary retention; Gastric retention; Uncontrolled narrow angle glaucoma; Severe hepatic impairment; Concomitant use of potent CYP3A4 inhibitors in subjects with moderate to severe hepatic or renal impairment; Severe ulcerative colitis; Toxic megacolon. Special warnings and precautions: Clinically signicant bladder outow obstruction at risk of urinary retention; Gastrointestinal obstructive disorders; Gastro-oesophageal reux; Patients who are taking medications that can cause or exacerbate oesophagitis; Decreased gastrointestinal motility; Autonomic neuropathy; Controlled narrow angle glaucoma; Myasthenia gravis; Caution should be exercised when prescribing or uptitrating Fesoterodine to patients with hepatic impairment, renal impairment, concomitant administration of potent or moderate CYP3A4 inhibitors or potent CYP2D6 inhibitor; Organic causes must be excluded; Risk for QT prolongation and relevant pre-existing cardiac diseases; Toviaz prolonged-release tablets contain lactose. Undesirable eects: The most common AE were: dizziness, headache, dry eyes, dry throat, dry mouth, abdominal pain, diarrhoea, dyspepsia, constipation, nausea, dysuria, insomnia Post marketing AE urinary retention.

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Abbreviated Prescribing Information:Presentation: Vesicare (Solifenacin Succinate) 5 mg & 10 mg film-coated tablets. Indication: treatment of overactive bladder with symptoms of urgency with or without urge incontinence, frequency of micturition and nocturia.

Dosage: One tablet 5 mg once daily, to be swallowed whole with fluid. If the 5 mg dose is well-tolerated, the dose may be increased to 10 mg once daily. Contra-indications: Hypersensitivity to Solifenacin or any other ingredient of Vesicare, urinary or gastric retention, uncontrolled open-angle glaucoma and severe liver or kidney impairment. Not recommended for children or pregnant or breast-feeding women. Precautions: Prescribe 5 mg once daily only if the patient is concomitantly administering strong CYP3A4 inhibitors, like ketoconazole. Possible adverse events: As an anti-muscarinic, dry mouth, constipation, nausea and/or blurring of vision may occur.

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ODT = Orodispersible TabletsLevitra 5 mg / 10 mg / 20 mg film-coated tablets, Levitra 10 mg Orodispersible Tablets Abbreviated Prescribing Information. Composition: Each tablet contains 5 mg, 10 mg and 20 mg of vardenafil respectively (5.926 mg, 11.852 mg and 23.705 mg of vardenafil monohydrochloride trihydrate respectively) Indication: Treatment of erectile dysfunction (Inability to achieve or maintain penile erection sufficient for satisfactory sexual performance). Contraindications: Contraindicated in patients with hypersensitivity to the active substance or to any of the excipients. Consistent with the effects of PDE inhibition on the nitric oxide / cGMP pathway, PDE5 inhibitors may potentiate the hypotensive effects of nitrates. Levitra is thus contraindicated in patients who are concomitantly treated with nitrates or nitric oxide donors. Concomitant use of Levitra with HIV Protease inhibitors such as indinavir or ritonavir is contraindicated, as they are potent inhibitors of CYP3A4. Special warnings and Precautions for use: Prior to initiating any treatment for erectile dysfunction, physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Levitra has vasodilator properties which may result in mild and transient decreases in blood pressure. The safety of Levitra has not been studied in the following sub-groups of patients and its use is therefore not recommended: severe hepatic impairment, endstage renal disease requiring dialysis, hypotension (resting systolic blood pressure of < 90 mm Hg), recent history of stroke or myocardial infarction (within last 6 months), unstable angina, and known hereditary degenerative retinal disorders such as retinitis pigmentosa. The safety of Levitra 10 mg orodispersible tablets has not been studied in patients with moderate hepatic impairment, therefore use of Levitra 10 mg orodispersible tablets in these patients is not recommended. Transient vision loss and cases of non-arteritic ischemic optic neuropathy have been reported in connection with the intake of Levitra and other PDE5 inhibitors. The patient should be advised that in the case of sudden vision loss, he should stop taking Levitra and consult immediately a physician. Consistent with vasodilatory effects of alpha-blockers and vardenafil, the concomitant use of Levitra with alpha-blockers may lead to symptomatic hypotension in some patients. Concomitant treatment should be initiated only if the patient is stable on his alpha-blocker therapy. In those patients who are stable on alpha-blocker therapy, Levitra should be initiated at the lowest recommended starting dose of 5 mg. Levitra may be administered at any time with tamsulosin. With other alpha-blockers a time separation of dosing should be considered when Levitra is prescribed concomitantly. Undesirable effects: The following adverse drug reactions were reported in patients given Levitra film-coated tablets or Levitra orodispersible tablets in all clinical trials. Very common ( 10%): Headache, Common ( 1% to < 10%): Dizziness, Nasal Congestion, Vaso-dilatation, Dyspepsia. For further details see prescribing information approved by the Ministry of Health in August 2011. Registration Holder: Bayer Israel Ltd. 36 Hacharash St., Hod Hasharon 45240.References: 1. Levitra ODT PI. 2. Sperling H. et al, J Sex Med 2010. 3. Gittelman M. et al, Int J Clin Prac 2010. 4. Heinig R. et al, Clin Drug Investig 2011. 5. Debruyne F.M.J. et al, J Sex Med 2011

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