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Potential For Vidalista To Affect Other Drugs. Patients on alpha-blocker therapy for BPH should discontinue their alpha-blocker at least one day prior to starting Vidalista for once daily use for the treatment of BPH. The dose of Vidalista for use as needed should be limited to 10 mg no more than once every 72 hours in patients taking potent inhibitors of CYP3A4 such as ritonavir, ketoconazole , and itraconazole see DRUG INTERACTIONS In patients taking potent inhibitors of CYP3A4 and Vidalista for once daily use, the maximum recommended dose is 2.5 mg see DOSAGE AND ADMINISTRATION. Therefore, patients who experience anginal chest pain after taking Vidalista should seek immediate medical attention see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS.
Physicians should instruct patients on the appropriate administration of Vidalista to allow optimal use. For Vidalista for once daily use in men with BPH, patients should be instructed to take one tablet at approximately the same time every day. Systemic exposure (based on AUC) at no-observed-adverse-effectlevel (NOAEL) (10 mg/kg/day) for unbound tadalafil was similar to that expected in humans at the MRHD of 20 mg. There were no treatment-related testicular findings in rats or mice treated with doses up to 400 mg/kg/day for 2 years.

Signs of maternal toxicity occurred at doses greater than 16 times the MRHD based on AUC. There are no available data for doses higher than 10 mg of tadalafil in patients with hepatic impairment. In subjects with end-stage renal disease on hemodialysis, there was a two-fold increase in Cmax and 2.7- to 4.8-fold increase in AUC following single-dose administration of 10 or 20 mg tadalafil.
In a clinical pharmacology study (N=28) at a dose of 10 mg, back pain was reported as a limiting adverse event in male patients with creatinine clearance 30 to 50 mL/min. Single doses up to 500 mg have been given to healthy subjects, and multiple daily doses up to 100 mg have been given to patients. Vidalista is contraindicated in patients with a known serious hypersensitivity to tadalafil (Vidalista or ADCIRCA®).
Because sexual stimulation is required to initiate the local release of nitric oxide, the inhibition of PDE5 by tadalafil has no effect in the absence of sexual stimulation. Tadalafil is >10,000-fold more potent for PDE5 than for PDE3, an enzyme found in the heart and blood vessels. Therefore, the use of Vidalista in patients taking any form of nitrates is contraindicated see CONTRAINDICATIONS.
Subjects were administered a single dose of 0.4 mg sublingual nitroglycerin (NTG) at pre-specified timepoints, following their last dose of tadalafil (2, 4, 8, 24, 48, 72, and 96 hours after tadalafil). In this study, a significant interaction between tadalafil and NTG was observed at each timepoint up to and including 24 hours. Figure 1: Mean Maximal Change in Blood Pressure (Tadalafil Minus Placebo, Point Estimate with 90% CI) in Response to Sublingual Nitroglycerin at 2 (Supine Only), 4, 8, 24, 48, 72, and 96 Hours after the Last Dose of Tadalafil 20 mg - https://vidalista.biz/
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