Date of first authorisation/renewal of the authorisation 10.
This information is intended for use by health professionals. Each tablet contains 25 mg, 50 mg or 100 mg of sildenafil (as citrate) Excipient with known effect : Lactose monohydrate. 25 mg: White to off-white, rounded diamond-shaped tablets, of dimensions 9.2 x 6.7 mm, marked ?25? on one side.
50 mg: White to off-white, rounded diamond-shaped tablets, of dimensions 11.2 x 8.1 mm, marked ?50? on one side. 100 mg: White to off-white, rounded diamond-shaped tablets, of dimensions 14.1 x 10.2 mm, marked ?100? on one side.
Treatment of men with erectile cvs sildenafil dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.
In order for Sildenafil to be effective, sexual stimulation is required. The recommended dose is 50 mg taken as needed approximately one hour before sexual activity.
Based on efficacy and tolerability, the dose may be increased to 100 mg or decreased to 25 mg.
The maximum recommended dosing frequency is once per day.
If Sildenafil is taken with food, the onset of activity may be delayed compared to the fasted state (see section 5.2).
Dosage adjustments are not required in elderly patients (? 65 years old). The dosing recommendations described in 'Use in adults' apply to patients with mild to moderate renal impairment (creatinine clearance = 30 - 80 mL/min).
Since sildenafil clearance is reduced in patients with severe renal impairment (creatinine clearance 150 ?M). Given sildenafil peak plasma concentrations of approximately 1 ?M after recommended doses, it is unlikely that Sildenafil will alter the clearance of substrates of these isoenzymes. There are no data on the interaction of sildenafil and non-specific phosphodiesterase inhibitors such as theophylline or dipyridamole.
In vivo studies: Consistent with its known effects on the nitric oxide/cGMP pathway (see section 5.1), sildenafil was shown to potentiate the hypotensive effects of nitrates, and its co-administration with nitric oxide donors or nitrates in any form is therefore contraindicated (see section 4.3). Riociguat: Preclinical studies showed additive systemic blood pressure lowering effect when PDE5 inhibitors were combined with riociguat.
In clinical studies, riociguat has been shown to augment the hypotensive effects of PDE5 inhibitors.
There was no evidence of favourable clinical effect of the combination in the population studied.
Concomitant use of riociguat with PDE5 inhibitors, including sildenafil, is contraindicated (see section 4.3).
Concomitant administration of sildenafil to patients taking alpha-blocker therapy may lead to symptomatic hypotension in a few susceptible individuals. This is most likely to occur within 4 hours post sildenafil dosing (see sections sildenafil rx coupon 4.2 and 4.4). In three specific drug-drug interaction studies, the alpha-blocker doxazosin (4 mg and 8 mg) and sildenafil (25 mg, 50 mg, or 100 mg) were administered simultaneously to patients with benign prostatic hyperplasia (BPH) stabilized on doxazosin therapy.
In these study populations, mean additional reductions of supine blood pressure of 7/7 mmHg, 9/5 mmHg, and 8/4 mmHg, and mean additional reductions of standing blood pressure of 6/6 mmHg, 11/4 mmHg, and 4/5 mmHg, respectively, were observed.
When sildenafil and doxazosin were administered simultaneously to patients stabilized on doxazosin therapy, there were infrequent reports of patients who cvs sildenafil experienced symptomatic postural hypotension.
These reports included dizziness and light-headedness, but not syncope. No significant interactions
were shown when sildenafil (50 mg) was co-administered with tolbutamide (250 mg) or warfarin (40 mg), both of which are metabolised by CYP2C9. Sildenafil (50 mg) did not potentiate the increase in bleeding time caused by acetyl salicylic acid (150 mg). Sildenafil (50 mg) did not potentiate the hypotensive effects of alcohol in healthy volunteers with mean maximum blood alcohol levels of 80 mg/dl.
Pooling of the following classes of antihypertensive medication: diuretics, beta-blockers, ACE inhibitors, angiotensin II antagonists, antihypertensive medicinal products (vasodilator and centrally-acting), adrenergic neurone blockers, calcium channel blockers and alpha-adrenoceptor blockers, showed no difference in the side effect profile in patients taking sildenafil compared to placebo treatment. In a specific interaction study, where sildenafil (100 mg) was co-administered with amlodipine in hypertensive patients, there was an additional reduction on supine systolic blood pressure of 8 mmHg. The corresponding additional reduction in supine diastolic blood pressure was 7 mmHg.
These additional blood pressure reductions were of a similar magnitude to those seen when sildenafil was administered alone to healthy volunteers (see section 5.1).
Sildenafil (cvs sildenafil 100 mg) did not affect the steady state pharmacokinetics of the HIV protease inhibitors, saquinavir and ritonavir, both of which are CYP3A4 substrates.
In healthy male volunteers, sildenafil at steady state (80 mg t.i.d.) resulted in a 49.8% increase in bosentan AUC and a 42% increase in bosentan C max (125 mg b.i.d.).
There are no adequate and well-controlled studies in pregnant or breast-feeding women.
No relevant adverse effects were found in reproduction studies in rats and rabbits following oral administration of sildenafil. There was no effect on sperm motility or morphology after single 100 mg oral doses of sildenafil in healthy volunteers (see section 5.1). Sildenafil Pfizer may have a minor influence on the ability to drive and use machines. As dizziness and altered vision were reported in clinical trials with sildenafil, patients should be aware of how they react to Sildenafil, before driving or operating machinery. The safety profile of Sildenafil Pfizer is based on 9,570 patients in 74 double-blind placebo-controlled clinical studies. The most commonly reported adverse reactions in clinical studies among sildenafil treated patients were headache, flushing, dyspepsia, nasal congestion, dizziness, nausea, hot flush, visual disturbance, cyanopsia and vision blurred. Adverse reactions from post-marketing surveillance has been gathered covering an estimated period >10 years.
Because not all adverse reactions are reported to the Marketing Authorisation Holder
and included in the safety database, the frequencies of these reactions cannot be reliably determined.
In the table below all medically important adverse reactions, which occurred in clinical trials at an incidence greater than placebo are listed by system organ class and frequency (very common (?1/10), common (?1/100 to * Visual colour distortions**, Visual disturbance, Vision blurred.
Non-arteritic anterior ischaemic optic neuropathy (NAION), * Retinal vascular occlusion, * Visual field defect, Visual acuity reduced, Abnormal sensation in eye, Ear and labyrinth disorders. Sudden cardiac death, * Respiratory, thoracic and mediastinal disorders. Gastro oesophagael reflux disease, Abdominal pain upper, Skin and subcutaneous tissue disorders. Stevens-Johnson Syndrome (SJS), * Toxic Epidermal Necrolysis (TEN) * Musculoskeletal and connective tissue disorders. General disorders and administration site conditions. * Reported during post-marketing surveillance only.
**Visual colour distortions: Chloropsia, Chromatopsia, Cyanopsia, Erythropsia and Xanthopsia.
***Lacrimation disorders: Dry eye, Lacrimal disorder and Lacrimation increased.
Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. 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. In single dose volunteer studies of doses up to 800 mg, adverse reactions were similar to those seen at lower doses, but the incidence rates and severities were increased.
Doses of 200 mg did not result in increased efficacy but the incidence of adverse reactions (headache, flushing, dizziness, dyspepsia, nasal congestion, altered vision) was increased.
In cases of overdose, standard supportive measures should be adopted as required. Renal dialysis is not expected to accelerate clearance as sildenafil is highly bound to plasma proteins and not eliminated in the urine. Pharmacotherapeutic group: Urologicals; Drugs used in erectile dysfunction.
Sildenafil is an oral therapy for erectile dysfunction.
with sexual stimulation, it restores impaired erectile function by increasing blood flow to the penis. The physiological mechanism responsible for erection of the penis involves the release of nitric oxide (NO) in the corpus cavernosum during sexual stimulation.
Nitric oxide then activates the enzyme guanylate cyclase, which results in increased levels of cyclic guanosine monophosphate (cGMP), producing smooth muscle relaxation in the corpus cavernosum and allowing inflow of blood.
Sildenafil is a potent and selective inhibitor of cGMP specific phosphodiesterase type 5 (PDE5) in the corpus cavernosum, where PDE5 is responsible for degradation of cGMP. Sildenafil has a peripheral site sildenafil cvs coupon of action on erections.
Sildenafil has no direct relaxant effect on isolated human corpus cavernosum but potently enhances the relaxant effect of NO on this tissue. When the NO/cGMP pathway is activated, as occurs with sexual stimulation, inhibition of PDE5 by sildenafil results in increased corpus cavernosum levels of cGMP.
Therefore sexual stimulation is required in order for sildenafil to produce its intended beneficial pharmacological effects.
Studies in vitro have shown that sildenafil is selective for PDE5, which is involved in the erection process.
Its effect is more potent on PDE5 than on other known phosphodiesterases.
There is a 10-fold selectivity over PDE6 which is involved in the phototransduction pathway in the retina. At maximum recommended doses, there is an 80-fold selectivity over PDE1, and over 700-fold over PDE2, 3, 4, 7, 8, 9, 10 and 11.
In particular, sildenafil has greater than 4,000-fold selectivity for PDE5 over PDE3, the cAMP-specific phosphodiesterase isoform involved in the control of cardiac contractility.
Two clinical studies were specifically designed to assess the time window after dosing during which sildenafil could produce an erection in response to sexual stimulation.
In a penile plethysmography (RigiScan) study of fasted patients, the median time to onset for those who obtained erections of 60% rigidity (sufficient for sexual intercourse) was 25 minutes (range 12-37 minutes) on sildenafil. In a separate RigiScan study, sildenafil was still able to produce an erection in response to sexual stimulation 4-5 hours post-dose.
Sildenafil causes mild and transient decreases in blood pressure which, in the majority of cases, do not translate into clinical effects.
The mean maximum decreases in supine systolic blood pressure following 100 mg oral dosing of sildenafil was 8.4 mmHg.
The corresponding change in supine diastolic blood pressure was 5.5 mmHg.
These decreases in blood pressure are consistent with the vasodilatory effects of sildenafil, probably due to increased cGMP levels in vascular smooth muscle. Single oral doses of sildenafil up to 100 mg in healthy volunteers produced no clinically relevant effects on ECG.
In a study of the hemodynamic effects of a single oral 100 mg dose of sildenafil in 14 patients with severe coronary artery disease (CAD) (>70% stenosis of at least one coronary artery), the mean resting systolic and diastolic blood pressures decreased by 7% and 6% respectively compared to baseline.
Mean pulmonary systolic blood pressure decreased by 9%. Sildenafil showed no effect on cardiac output, and did not impair blood flow through the stenosed coronary arteries.
A double-blind, placebo-controlled exercise stress trial evaluated 144 patients with erectile dysfunction and chronic stable angina who regularly received anti-anginal medicinal products (except nitrates). The results demonstrated no clinically relevant differences between sildenafil and placebo in time to limiting angina. Mild and transient differences in colour discrimination (blue/green) were detected in some subjects using the Farnsworth-Munsell 100 hue test at 1 hour following a 100 mg dose, with cvs cialis 5mg price no effects evident after 2 hours post-dose. The postulated mechanism for this change in colour discrimination is related to inhibition of PDE6, which is involved in the phototransduction cascade of the retina. Sildenafil has no effect on visual acuity or contrast sensitivity. In a small size placebo-controlled study of patients with documented early age-related macular degeneration (n=9), sildenafil (single dose, 100 mg) demonstrated no significant changes in the visual tests conducted (visual acuity, Amsler grid, colour discrimination simulated traffic light, Humphrey perimeter and photostress). There was no effect on sperm motility or morphology after single 100 mg oral doses of sildenafil in healthy volunteers (see section 4.6).
In clinical trials sildenafil was administered to more than 8000 patients aged 19-87.
The following cvs sildenafil patient groups were represented: elderly (19.9%), patients sildenafil citrate tablets buy online with hypertension (30.9%), diabetes mellitus (20.3%), ischaemic heart disease (5.8%), hyperlipidaemia (19.8%), spinal cord injury (0.6%), depression (5.2%), transurethral resection of the prostate (3.7%), radical prostatectomy (3.3%). The following groups were not well represented or excluded from clinical trials: patients with pelvic surgery, patients post-radiotherapy, patients with severe renal or hepatic impairment and patients with certain cardiovascular conditions (see section 4.3).
In fixed dose studies, the proportions of patients reporting that treatment improved their erections were 62% (25 mg), 74% (50 mg) and 82% (100 mg) compared to 25% on cvs sildenafil placebo.
In controlled clinical trials, the discontinuation rate due to sildenafil was low and similar to placebo.
Across all trials, the proportion of patients reporting improvement on sildenafil were as follows: psychogenic erectile dysfunction (84%), mixed erectile dysfunction (77%), organic erectile dysfunction (68%), elderly (67%), diabetes mellitus (59%), ischaemic heart disease (69%), hypertension (68%), TURP (61%), radical prostatectomy (43%), spinal cord injury (83%), depression (75%).
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