Sildenafil Accord 50 Mg Film-coated Tablets

Although specific interaction studies were not conducted for all medicinal products, population pharmacokinetic sildfnafil showed no effect of concomitant medication on sildenafil pharmacokinetics when grouped as CYP2C9 inhibitors such as tolbutamide, warfarin, phenytoinCYP2D6 inhibitors such as selective serotonin reuptake inhibitors, tricyclic antidepressantsthiazide and related diuretics, loop and potassium sparing diuretics, angiotensin converting enzyme inhibitors, calcium channel blockers, beta-adrenoreceptor antagonists or inducers of Sildenafik metabolism such as rifampicin, barbiturates. A sildenafil, placebo-controlled exercise stress trial evaluated patients with erectile dysfunction and chronic stable angina who regularly received anti-anginal tablet products except nitrates. Cardiovascular risk factors 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. 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 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. The following groups were not well ,g or excluded from clinical trials: If your doctor believes treatment is appropriate, they can prescribe a tablet such as s ildenafilwhich tablet as we have seen — comes in three different dosages, the two most popular being sildenafil 50mg and sildenafil mg. If 50mg sildenafil very effective the dose can be reduced to 25mg. Concomitant use of riociguat with PDE5 inhibitors, including sildenafil, is contraindicated see section 4. Do not use this service. Legal Category POM: Penile haemorrhage. Studies with human platelets indicate that sildenafil potentiates the antiaggregatory effect of sodium nitroprusside in vitro. Pharmaceutical particulars 6. Sildenafil tablets is contraindicated in patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy NAIONregardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure see section 4. For the full list of excipients, see section 6. Reproductive system and breast disorders. There are no adequate and well-controlled studies in pregnant or breast-feeding women. 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 addition, tablet of sildenafil at a dose of 25 sildenafiil should be considered see sections 4.

With the exception of ritonavir for which co-administration with sildenafil is not advised see section 4. In the natural setting, i. Dry eye, Lacrimal disorder and Lacrimation increased Reporting of suspected adverse reactions. The following groups were not well represented or excluded from clinical trials: The safety profile of Sildenafil Pfizer tablet based on 9, patients in 74 double-blind placebo-controlled clinical studies. Effects of other medicinal products on sildenafil In vitro studies: Sildehafil The mean steady state volume of distribution V d for sildenafil is l, indicating tablet into the tissues. Stronger CYP3A4 inhibitors such as ketoconazole and itraconazole would be expected to have greater effects. Pack sizes: However, due to high inter-subject variability, these differences were not statistically significant. Changes in functional scores from baseline were not statistically significant with the mg dose compared with the mg dose in the DBPC. Assess the tolerability jg efficacy of sildenafil initiated at the mg dose in men with ED. In order for Tabelt to be effective, sildenafil stimulation is required. If you have a medical emergency, call sildenafil NHS 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. To bookmark a medicine you must sign up and log in. In three specific drug-drug interaction studies, my alpha-blocker doxazosin 4 mg and 8 mg and sildenafil 25 mg, 50 mg, or mg silldenafil administered simultaneously to patients with benign prostatic hyperplasia BPH stabilized on doxazosin therapy. 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. By continuing to browse the site you are agreeing to our policy on the use of cookies. It is skldenafil possible to determine whether these events are related directly to these factors or to other factors. Sildennafil additional blood pressure reductions were of a similar magnitude to those seen when sildenafil was administered alone to healthy volunteers see section 5. Hypersensitivity to the active substance or to any of the excipients listed in section 6. For the full list of excipients, tabblet section 6. Your first prescription will usually be for 50mg, which is the recommended starting dose. Since sildenafil clearance is reduced in patients with hepatic impairment e.

Sildenafil potentiates the hypotensive effect of nitrates see Section 4. The physiological mechanism responsible for erection of the penis involves the release of nitric oxide NO in the corpus cavernosum during sexual stimulation. Table 1: Women Sildenafil Tablets are not indicated for use by women. Summary of sildeenafil safety profile The safety profile of Sildenafil Pfizer is based on 9, patients in tahlet double-blind placebo-controlled clinical studies. Enter medicine name or company Start typing to retrieve search suggestions. Cellulose microcrystalline Calcium hydrogen phosphate anhydrous Croscarmellose sodium Hypromellose 5 cp E Magnesium stearate Film coat: Prescription only sildenafi. Hypersensitivity to the active substance or to any of the excipients listed in section 6. Use in adults The recommended dose is 50 mg taken as needed approximately one hour before sexual activity, sildenafil 50 mg tablet. Though the mg effects do not last longer than a lower dosage, the higher concentration does have a more profound effect. In sildenacil trials sildenafil was talbet to more than patients aged The maximum recommended dosing frequency is once per day. There is no safety information on the administration of sildenafil to patients with bleeding disorders or active peptic ulceration. Reproductive system and breast disorders. Effects of sildenafil on other medicinal products In vitro studies: Priaprism 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 diseaseor in patients who have conditions which may predispose them to priapism such as sickle cell anaemia, multiple myeloma or leukaemia. 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. Date of revision of the text. Concomitant silsenafil of sildenafil to patients taking alpha-blocker therapy may lead to symptomatic hypotension in a few susceptible individuals. 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 System Organ Class. It is recommended that several attempts are made using the recommended starting dose before adjusting. Sildenafil citrate 50 mg is the recommended starting dose sildenafil men with erectile dysfunction ED ; tablet, mmg men are later titrated to sildenafil mg for improved efficacy. Use in patients txblet impaired hepatic function: Distribution The mean steady state volume of distribution Vd for sildenafil is l, indicating distribution into the tissues.

Sildenafil has a peripheral site 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. Therefore, inhibitors of these isoenzymes may reduce sildenafil clearance and inducers of these isoenzymes may increase sildenafil tablet. Pharmacotherapeutic group: Concomitant use with alpha-blockers Caution is advised when sildenafil is administered to patients taking an alpha-blocker, as the coadministration may lead to symptomatic hypotension in a few susceptible individuals see section 4. Due to the nitrate component it has the potential to result in aserious interaction with sildenafil. Already a patient? Cardiovascular risk factors 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. There are no data on the interaction of sildenafil and non-specific phosphodiesterase inhibitors such as theophylline or dipyridamole. Enter medicine name or company Start typing to retrieve search suggestions. The postulated mechanism for this change in colour discrimination is related to inhibition of PDE6, which is involved in the sildenafil cascade of the retina. The major circulating metabolite results from N-demethylation of sildenafil. If you have a medical emergency, call or NHS When a single mg sildenafkl of sildenafil was administered with erythromycin, a moderate CYP3A4 inhibitor, at steady state mg twice daily. Therefore, tabket administration of strong CYP3A4 inducers, such as rifampin, is mmg to cause greater decreases in plasma concentrations of sildenafil. Concomitant use with alpha-blockers Caution is advised when sildenafil is administered to patients taking an alpha-blocker, as the coadministration may lead to symptomatic hypotension in a few susceptible individuals see Section 4. Though the mg effects do not sildenafil longer than a lower dosage, the higher concentration does have a more profound effect. Use in patients taking tablet medicinal products With the exception of ritonavir for which co-administration with sildenafil is not taboet see Section 4. Studies in vitro have shown that sildenafil is selective for PDE5, which is involved in the erection process. Tablet core: Hepatic impairment Since sildenafil clearance is reduced in patients with hepatic impairment e. Since sildenafil clearance is reduced in patients with hepatic impairment e. Prolonged erections and priapism have been reported with sildenafil in post-marketing experience.

Sildenafil 50 mg tablet

The following patient groups were represented: Sildenafil mg is the highest safe dosage you can take — if it is ineffective, you should try another ED treatment. Sildenafil tablets potentiates the hypotensive effect of nitrates see section 4. Sildenafil had no effect on saquinavir pharmacokinetics see Section 4. Concomitant use with alpha-blockers 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. Siodenafil 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 diseaseor in patients who have conditions which may predispose them to priapism such as sickle cell anaemia, multiple myeloma or leukaemia. Posology Use in adults Tablet recommended dose is 50mg taken as needed approximately one hour before sexual activity. In clinical trials sildenafil was administered to more than patients aged Sildenafil is an oral therapy for sildenafil dysfunction. In healthy volunteers receiving sildenafil mg single doseless than 0. Effects of sildenafil on other medicinal products In vitro studies: White to off-white, rounded diamond-shaped tablets, of dimensions Use in the elderly: Renal insufficiency. Sildenafil causes mild and transient decreases in blood pressure which, in the majority of cases, do not translate into clinical effects. 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 Sildenafil should never alter the dosage of your sildenafil without talking to your doctor. There was no effect on sperm motility or morphology after single mg oral doses of sidenafil in healthy volunteers see section 5. They will probably encourage you to try it a few more times before you sildemafil onto something else. Tableet anxiety. Tablet each frequency grouping, undesirable effects are presented in order of decreasing seriousness.

In order for Sildenafil tablets to be effective, sexual stimulation is required. Due to the nitrate component it has the potential to have serious interaction with sildenafil. Nitric oxide then activates the enzyme guanylate cyclase, which results in increased levels of cyclic guanosine monophosphate cGMPproducing smooth muscle relaxation sildenafiil the corpus cavernosum and allowing inflow of blood. Sildenafil 50 mg film-coated tablets. Therefore sexual stimulation is required in order for sildenafil to produce its intended beneficial pharmacological effects. Musculoskeletal and connective tissue disorders. In normal healthy male volunteers, there was no evidence of an effect of azithromycin mg daily for 3 days on the AUC, Cmax, tmax, elimination rate constant, or subsequent half-life of sildenafil or its principal circulating metabolite. Concomitant use with other PDE5 inhibitors or other treatments for erectile dysfunction. In healthy male volunteers, sildenafil at steady state 80 mg t. However, due to high inter-subject variability, these differences were not statistically significant. It may be that your doctor initially prescribes you sildenafil mg, however it is tablet common to start on the 50mg dosage and work up to mg if you have no success. Treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual sildenafil. Each film-coated tablet contains 50 mg Sildenafil as sildenafil sildenafil. Sign Up Log In Cancel. Try sildenafil on seven more occasions, making sure you take it exactly as recommended doctors recommended trying ED tablets eight times before upping the dosage or changing to another treatment If you are still having no success, talk to the doctor who prescribed you about switching to sildenafil mg Consider sildenafkl a different ED tablft such as Cialis. Reduced anxiety. Serious cardiovascular mf, including myocardial infarction, unstable angina, sudden cardiac death, sildenafil 50 mg tablet, ventricular arrhythmia, cerebrovascular haemorrhage, transient ischaemic attack, hypertension and hypotension have tablet reported post-marketing in temporal association with the use of Sildenafil tablets Most, but not all, of these patients had pre-existing cardiovascular risk factors. No studies on the effects on the ability to drive and use machines have been performed. Marketing authorisation holder 8.

Since sildenafil clearance is reduced in patients with hepatic impairment e. 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. Patients should be advised that in the event of any sudden visual defect, they should stop taking sildenafil and consult a physician immediately see section 4. Back to top Aurobindo Pharma - Milpharm Ltd. Visit Lloydspharmacy. Concomitant use with other PDE5 inhibitors or other treatments for erectile dysfunction The safety and sildenafil of combinations of sildenafil with other PDE5 inhibitors, or other pulmonary arterial hypertension PAH treatments containing sildenafil REVATIOor other treatments for erectile dysfunction have not been studied. Studies with human platelets indicate that sildenafil potentiates the antiaggregatory effect of sodium nitroprusside in vitro. Stronger CYP3A4 inhibitors such as ketoconazole and itraconazole would be expected to have greater effects. After oral dosing of sildenafil AUC and Cmax increase in proportion with dose over the recommended dose range mg. Blister pack: Author information: Many events were reported to occur during or shortly after sexual intercourse and a few were reported to occur shortly after the use of Sildenafil without sexual activity. The maximum recommended dose is mg, sildenafil 50 mg tablet. Protein binding is independent of total drug concentrations. The N-desmethyl metabolite is further metabolised, with a terminal half-life of approximately 4 h. Based on these pharmacokinetic sildenafil co-administration of sildenafil with ritonavir is not advised see section 4. Each 50 mg film-coated tablet contains 3. Sildenafil has no effect on visual acuity or contrast sensitivity. Studies in vitro have shown that sildenafil is selective for PDE5, which is involved in the erection process. Due to the nitrate component it has the potential to result in a serious interaction with sildenafil. The safety profile of Sildenafil Pfizer is based on 9, patients in 74 double-blind placebo-controlled clinical studies. The major circulating metabolite results from N-demethylation of sildenafil. Use in the elderly: Patients with increased susceptibility to vasodilators include those with left ventricular outflow obstruction e. A medical history and tablet examination should be undertaken to diagnose erectile tablet and determine potential underlying causes, before pharmacological treatment is considered.

They will probably encourage you to try it a few more times before you move onto something else. At maximum recommended doses, there is an fold selectivity over PDE1, and over fold over PDE 2, 3, 4, 7, 8, 9, 10 and 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. Use in patients taking other medicinal products. In addition, initiation of sildenafil at a dose of 25 mg should be considered see Sections 4. Use in adults The recommended dose is 50 mg taken as needed approximately one hour before sexual activity. With the exception of ritonavir for which co-administration with sildenafil is not advised see section 4. Priapism 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. Therefore sexual stimulation is required in order for sildenafil to produce its intended beneficial pharmacological effects. Therefore the use of such combinations is not recommended. In normal healthy male volunteers, there was no evidence of an effect of azithromycin mg daily for 3 days on the AUC, Cmax, Tmax, elimination rate constant, or subsequent half-life of sildenafil or its principal circulating metabolite. Hypersensitivity to the active substance or to any of the excipients in sildenafil tablets see section 6. As dizziness and altered vision were reported in clinical trials with sildenafil, patients should be aware of how they react to Sildenafil tablets, before driving or operating machinery. Since sildenafil clearance is reduced in patients with hepatic impairment e. There are no adequate and well-controlled studies in pregnant or breast-feeding women. They will not affect everyone but, as previously stated, they are more likely when you are taking sildenafil mg. If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result.

Preclinical studies showed additive systemic blood pressure lowering effect when PDE5 inhibitors were combined with riociguat. 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. Studies with human platelets indicate that sildenafil potentiates the antiaggregatory effect of sodium nitroprusside in vitro. The corresponding change in supine diastolic blood pressure was 5. Clinical efficacy and safety 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. Cardiovascular risk factors. Date of first authorisation: No relevant adverse effects were found in reproduction studies in rats and rabbits following oral administration of sildenafil. 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. Clinical particulars 4. Legal Category POM: Nicorandil is a hybrid of potassium channel activator and nitrate. See section 4. Erectile dysfunction is a condition that affects the majority of men at some point during their lives. Therefore sildenafil should be administered to these patients only after careful benefit-risk assessment. Not all pack sizes may be marketed. Blue, almond shaped, biconvex, film coated tablets, debossed with '50' on one side and plain on other side. Cellulose microcrystalline Calcium hydrogen phosphate anhydrous Croscarmellose sodium Hypromellose 5 cp E Magnesium stearate Film coat: Legal Category POM:

Clinical efficacy and safety 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. If Sildenafil tablets is taken with food, the onset of activity may be delayed compared to the fasted state see section 5. Toggle navigation. Last updated on eMC: 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. Pharmacodynamic effects Studies in vitro have shown that sildenafil is selective for PDE5, which is involved in the erection process. This site uses cookies. 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. 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. The effects of sildenafil mg do not last longer than the 50mg dosage, but they tend to be stronger. Stronger CYP3A4 inhibitors such as ketoconazole and itraconazole would be expected to have greater effects. Qualitative and quantitative composition 3. Film-coated tablet. Renal dialysis is not expected to accelerate clearance as sildenafil is highly bound to plasma proteins and not eliminated in the urine. 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. Throat tightness, Nasal oedema, Nasal dryness. In order to minimise the potential for developing postural hypotension, patients should be hemodynamically stable on alpha-blocker therapy prior to initiating sildenafil treatment. 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. Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenic potential, and toxicity to reproduction and development. Posology Use in adults: Concomitant administration of sildenafil to patients taking alpha-blocker therapy may lead to symptomatic hypotension in a few susceptible individuals. Visit Lloydspharmacy. Patients with increased susceptibility to vasodilators include those with left ventricular sildenafil obstruction tablet. Reduced anxiety. Sildenafil 25 mg film-coated tablets Sildenafil 50 mg film-coated tablets Sildenafil mg film-coated tablets.