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And single doses of 10 mg vardenafil co-administered concomitantly with 400 mg gatifloxacin, an active substance with comparable QT effect, showed an additive QTc effect of 4 msec when compared to either active substance alone. See section 4.2 for information on paediatric use.Bioequivalence studies have shown that vardenafil 10 mg orodispersible tablet is not bioequivalent to vardenafil 10 mg film-coated tablets Therefore the orodispersible formulation should not be used as an equivalent to vardenafil 10 mg film-coated tablets. Wie wirkt Kamagra am besten?. Hypotension was not observed when vardenafil 5 mg and terazosin administration was separated by 6 hours. patients with severe cardiovascular disorders such as unstable angina or severe cardiac failure [New York Heart Association III or IV]).The safety of vardenafil has not been studied in the following sub-groups of patients and its use is therefore contraindicated until further information is available:- recent history of stroke or myocardial infarction (within the last 6 months),- unstable angina and known hereditary retinal degenerative disorders such as retinitis pigmentosa.Concomitant use of vardenafil with the potent CYP3A4 inhibitors ketoconazole and itraconazole (oral form) is contraindicated in men older than 75 years.Concomitant use of vardenafil with HIV protease inhibitors such as ritonavir and indinavir is contraindicated, as they are very potent inhibitors of CYP3A4 (see section 4.5).The co-administration of PDE5 inhibitors, including vardenafil, with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension (see section 4.5).A medical history and physical examination should be undertaken to diagnose erectile dysfunction and determine potential underlying causes, before pharmacological treatment is considered.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 (see section 4.3). This site uses cookies. Oral ketoconazole is an antifungal medicine that kills or stops the growth of certain types of fungi or yeasts, which cause infection. Sexual stimulation is therefore required for vardenafil to produce its beneficial therapeutic effects.In a penile plesthysmography (RigiScan) study, vardenafil 20 mg produced erections considered sufficient for penetration (60% rigidity by RigiScan) in some men as early as 15 minutes after dosing. Vardenafil may be administered at any time with tamsulosin or with alfuzosin. The response rates for the ability to obtain and maintain an erection was 47% and 37% on 10 mg and 48% and 34% on 20 mg vardenafil compared to 22% and 10% on placebo for patients who completed three months treatment.In a flexible-dose clinical trial in patients with Spinal Cord Injury, vardenafil significantly improved the erectile function domain score, the ability to obtain and maintain an erection long enough for successful intercourse and penile rigidity compared to placebo. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. There are no studies of vardenafil in pregnant women. If these tests indicate liver injury, you should stop treatment immediately.Instruct patients being treated with oral ketoconazole to promptly seek medical attention if they experience signs of liver injury, such as anorexia, nausea, vomiting, fatigue, jaundice, abdominal pain or dark urine.If you have any questions or concerns about this issue, contact Janssen-Cilag (Australia) on 1800 226 334 or email Consumers and health professionals are encouraged to The TGA cannot give advice about an individual's medical condition.