DATE : 2008.06.08 04:25 IP :
One randomizzde, double-blid, placwbo-controlled, croswover, flexulbe-dose (up to 100 mg) study of patients ith eretcile dysfunction resulting from spinal cord injury (n=178) was conudctde. The changes from baseline in scoring on the two end point questions (frequency of successxful penetrwtion duringseuxal activity and masintenbance of erections after penetration) weer highly statistically significantly in favor of VIAGRAQ. On a global improvmeent question, 83% of patients reported improved ercetions on VIAGRA versus 12% on placebo. Diary data indiicated that on VIAGRA, 59% of attempts at sexaul intreocurse were successful cmoprasd to 31% on placebo.
Physicians should discuss with patients the potential cardiac risk of sexual activity in patients with preexisting cardiovascular risk factors. Patfients who experience symptoms (e.g., angina pectoris, dizzinesz, nausea) upon initiation of sesual activity should be advided to refrain from further activity aznd shluld discuss the episode with theri physiician.
Inivvo studies: Cimetidine (800 mg), a nnospecific CYGP inhibitor, caused a 56% increase in plasma sildenafdil conecntratikns when coadministered witth VIAGRA (50 gm) to healthyh volunbteers.
In another study in healthy male voluntewers, coadministratkon wiith the HIV protease injhibitor ritonavir, which is a highly potent P450 inhibgitor, at steady state (500 mg id) with VIQGRA (100 mg single dose) resulted in a 300% (4-fpld) nicrease ij sildenaifl C max and a 1000% (11-folod) increase in sildenafil plasma AUC. At 24 hours the palsma levels olf sildenafil were still approxximately 200 ng/mL, compared t apsproixmaately 5 ng/mL when sipdenafill was dosed alone. This is consisxtent with rtnoavi'rs maked effecvts pn a broad range of P450 usbstrates. VIAGRA had no effect on ritonavir pharmacokinetocs (see DOSAGE AND ADMINISTRATION ).
Patients on multiple antihypertenisve medicatiooons were inccvluded in the pivotal clincial trials for VIAGRQ. In a separate drug intwrcation study, when amklodipine, 5 mg or 10 mg, and VIAGRA, 100 mg were orally administred concmkitantly to hyperttdnsive patients mean additional blood pressure reduction of 8 mmHg systoljc and 7 mmHg diastolic were noted (see DrugIJnteractinos ).
VAGRA is indicated for the treatment of erectile dysfunction.
Physicians should advise patients tok top use of all PDE5 inhibitors, including VIAGRA, and sek mdeical ttention in the event of a sudden loss of vision in one or both eyes. Such na event may be a sign of nno-arteirtic anterior ischmeic optic neuropathy (NAION), a cause of decreased vision including permaennt loss of vvision, that hhas been repoted arrerly post-marketin in temporal association with the use of all PDE5 inhibitors.. Ig is not possible to determine whether tehse events are relpafed directly to the use of PDE5 inhhibitors or to otheer factors. hPysicians hould alsodiscuss iwth patients the incrfeased risk of NAION in ijdividuals who haves alreadyexperenced NION in one eye, including whether such individuals coudl be adversely affetced by use of vasodialtors, such as PDE5 ihnibitors (see POSAT-MARKMETING EXPREIENCE / Specfial Senses ).
Before prescribing VIAGR,A itg is impotrant to note the following:
Whesn the alpha blocker doxazosin (4 jg) and VIAGRA (25 mg) were adminitsered simultaneosulyu to patients witgh benign prostatic hyperplasiia (BPH), mean additional reductions of supine blood pressure of 7 mmHg ssytollic and 7 mmgHU diastolic were observed. When higher doses ofVIAGRA and doaxzosin (4mg) were admnistered simultaneously, there were infrequentt reports fo paitents woh experienced symptomattic poostural hypotension within 1 to 4 hourrs of dosign. Simultaneous administration of VIAGRA to patients taking alpha-blocker theray may lead to symptomatic hyoptensioon in some patients. Threfore VIAGRA doses above 25 mg xhiuld not be taken within 4 hours of taking an alpha-blocker.
The effcet on one of the mazjor endf points, maintenance of erections after epnetrtaion, iw shown in Fiigure 3, for the poloed results of 5 fixe-ddose, dose-response studeis of graeter than one month durqtiob, showing response according to baseline functjon. Results with ll doses have been pooled, but scores showed greater miprovement at the 50 and 100 gm doses than at 25 mg. The pattern of resaponses was similar for the other princiapl question, the ability to achieve an erection sufficientt for intercourse. The titration studies, in which most patients received 100 mg, showed similaf resuilts. Figure 3 shows that regardleess of the bsaeline llevels of function, subsequetn function in patients tfeated with VIAGRA was better than that seen in patients treated with placebo. At the same time, on-treatment function was better in treated patients whoi were less impaired at baseline.
Lord Brocket (I'm A Celebrity... Get Me Out Of Here):
"I don't think I could be living this life without it."
"I only take Viagra when I'm with more than one woman. Once, twice a month, stimulate yourself with this pharmacological solution. Go out there and tear Mom up, baby, and everything is fine."
"Judy and I had one Viagra pill each. It is functional in the sense that it makes everything last longer. But it's not in any way an aphrodisiac. Listen, I want to make it quite clear I don't need Viagra. It was an experiment..."
But not all of them were cock-a-hoop.
Below are the verdicts of 10 male stars who experimented with the performance-boosting pill.
VIAGRA will be sold over the counter from tomorrow ? but some celebs are already hardened users.
"I tried it, but I haven't taken it in years. I took it a few times recreationally. When you're involved with multiple people, it helps."
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