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In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance.REVATIO has vasodilator properties, resulting in mild and transient decreases in blood pressure (see PRECAUTIONS ).

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Sildenafil and its major circulating N-desmethyl metabolite are both approximately 96% bound to plasma proteins.Age, gender, race, and renal and hepatic function were included as factors assessed in the population pharmacokinetic model to evaluate sildenafil pharmacokinetics in pulmonary arterial hypertension patients.What should I tell my doctor before taking REVATIO (sildenafil citrate).By using this site, you agree to the Terms of Use and Privacy Policy.

In addition to the active ingredient, sildenafil citrate, each tablet contains the following inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide, lactose monohydrate, and triacetin.It is not known if REVATIO passes into your breast milk or if it could harm your baby.The combination of both drugs did not lead to clinically significant changes in blood pressure (supine or standing).Sildenafil Citrate Tablets Cenforce a profitable business demands much more than good business sense.In the pivotal placebo-controlled trial in pulmonary arterial hypertension, the adverse drug reactions that were reported by at least 3% of REVATIO patients treated at the recommended dosage (20 mg t.i.d.) and were more frequent in REVATIO patients than placebo patients, are shown in Table 2.In a study of healthy volunteers, sildenafil (100 mg) did not affect the steady-state pharmacokinetics of the HIV protease inhibitors saquinavir and ritonavir, both of which are CYP3A4 substrates.

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The improvement in walk distance was apparent after 4 weeks of treatment and was maintained at week 8 and week 12.Studies in vitro have shown that sildenafil is selective for PDE5.

REVATIO is indicated for the treatment of pulmonary arterial hypertension (WHO Group I) to improve exercise ability.Sildenafil protects cyclic guanosine monophosphate (cGMP) from degradation by cGMP-specific phosphodiesterase type 5 (PDE5) in the corpus cavernosum.Similar effects on blood pressure were noted with 25 mg, 50 mg and 100 mg doses of sildenafil, therefore the effects are not related to dose or plasma levels within this dosage range.

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Renal dialysis is not expected to accelerate clearance as sildenafil is highly bound to plasma proteins and it is not eliminated in the urine.The overall frequency of discontinuation in REVATIO-treated patients at the recommended dose of 20 mg t.i.d. was low (3%) and the same as placebo (3%).Pre-defined subpopulations in the pivotal study were also evaluated for efficacy, including patient differences in baseline walk distance, disease etiology, functional class, gender, age, and secondary hemodynamic parameters (Figure 2).If priapism (painful erections greater than 6 hours in duration) is not treated immediately, penile tissue damage and permanent loss of potency could result.

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If it is close to your next dose, skip the missed dose, and take your next dose at the regular time.Both sildenafil and the active metabolite have terminal half-lives of about 4 hours.Concomitant administration of potent CYP3A4 inducers is expected to cause greater decreases in plasma levels of sildenafil.An evaluation of visual function at doses up to 200 mg revealed no effects of REVATIO on visual acuity, intraocular pressure, or pupillometry.The patients experiencing these events had risk factors for hemorrhage including concurrent anticoagulant therapy.

In drug-drug interaction studies, sildenafil (25 mg, 50 mg, or 100 mg) and the alpha-blocker doxazosin (4 mg or 8 mg) were administered simultaneously to patients with benign prostatic hyperplasia (BPH) stabilized on doxazosin therapy.Therefore, inhibitors of these isoenzymes may reduce sildenafil clearance and inducers of these isoenzymes may increase sildenafil clearance.Data from other hemodynamic parameters can be found in Table 1.The most common side effects are nosebleed, headache, upset stomach, getting red or hot in the face (flushing), and trouble sleeping.

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The inhibition of PDE5 in these tissues by sildenafil may be the basis for the enhanced platelet anti-aggregatory activity of nitric oxide observed in vitro, and the mild peripheral arterial-venous dilatation in vivo.Tell your doctor about all of your medical conditions, including if you.Larger effects were recorded among patients receiving concomitant nitrates (see CONTRAINDICATIONS ).Sildenafil, therefore, increases cGMP within pulmonary vascular smooth muscle cells resulting in relaxation.None of these factors had a statistically significant impact on sildenafil pharmacokinetics in patients with pulmonary hypertension.

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The patent on Revatio (indicated for pulmonary arterial hypertension rather than erectile dysfunction) expired in late 2012.This lower selectivity is thought to be the basis for abnormalities related to color vision observed with higher doses or plasma levels (see Pharmacodynamics ).This leaflet does not take the place of talking with your doctor about your medical condition or treatment.In the pivotal study, the incidence of retinal hemorrhage at the recommended sildenafil 20 mg t.i.d. dose was 1.4% versus 0% placebo and for all sildenafil doses studied was 1.9% versus 0% placebo.Figure 1: Change from Baseline in 6-Minute Walk Distance (meters): Mean (95% Confidence Interval).Patients with severe hepatic impairment (Child-Pugh class C) have not been studied.

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PDE5 inhibitors, including sildenafil, and alpha-adrenergic blocking agents are both vasodilators with blood pressure lowering effects.The primary efficacy endpoint was the change from baseline at week 12 in 6-minute walk distance at least 4 hours after the last dose.Rare but serious side effects include prolonged erections, which can lead to damage to the penis, and sudden-onset hearing loss.Our clinicians regularly offer patients the opportunity to take part in trials of new drugs and treatments.Physicians should also discuss with patients the increased risk of NAION in individuals who have already experienced NAION in one eye, including whether such individuals could be adversely affected by use of vasodilators, such as PDE5 inhibitors (see ADVERSE REACTIONS ).Prior to prescribing REVATIO, physicians should carefully consider whether their patients with certain underlying conditions could be adversely affected by such vasodilatory effects, for example patients with resting hypotension (BP.Sildenafil exposure without concomitant medication is shown to be 5-fold higher at a dose of 80 mg t.i.d. compared to its exposure at a dose of 20 mg t.i.d. This concentration range covers the same increased sildenafil exposure observed in specifically-designed drug interaction studies with CYP3A4 inhibitors (except for potent inhibitors such as ketoconazole, itraconazole, and ritonavir).

Inactive ingredients: microcrystalline cellulose, anhydrous dibasic calcium phosphate, croscarmellose sodium, magnesium stearate, hypromellose, titanium dioxide, lactose monohydrate, and triacetin.Sildenafil is a potent and selective inhibitor of cGMP-specific phosphodiesterase type 5 (PDE5), which is responsible for degradation of cGMP in the corpus cavernosum.The data set available for the population pharmacokinetic evaluation contained a wide range of demographic data and laboratory parameters associated with hepatic and renal function.This finding is consistent with the inhibition of PDE6, which is involved in phototransduction in the retina.Physicians should advise patients to seek prompt medical attention in the event of sudden decrease or loss of hearing while taking all PDE5 inhibitors, including REVATIO.In another study in healthy volunteers, co-administration with the HIV protease inhibitor ritonavir, a potent CYP3A4 inhibitor, at steady state (500 mg b.i.d.) with sildenafil (100 mg single dose) resulted in a 300% (4-fold) increase in sildenafil C max and a 1000% (11-fold) increase in sildenafil plasma AUC.

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At doses higher than the recommended 20 mg t.i.d. there was a greater incidence of some adverse events including flushing, diarrhea, myalgia and visual disturbances.

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Help About Wikipedia Community portal Recent changes Contact page.In addition to pulmonary vascular smooth muscle and the corpus cavernosum, PDE5 is also found in other tissues including vascular and visceral smooth muscle and in platelets.Dosage adjustments may be necessary (see PRECAUTIONS: Drug Interactions ).See also: Drugs for erectile dysfunction and premature ejaculation.Treatment with doses higher than 20 mg t.i.d. is not recommended.

Medications used in the management of pulmonary arterial hypertension ( B01, C02 ).

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In a study performed in healthy volunteers, co-administration of the HIV protease inhibitor saquinavir, a CYP3A4 inhibitor, at steady state (1200 mg t.i.d.) with sildenafil (100 mg single dose) resulted in a 140% increase in sildenafil C max and a 210% increase in sildenafil AUC.