Sildenafil Accord 50 Mg Film-coated Tablets

Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, sildenafil 50 mg dosage, genotoxicity, carcinogenic potential, and toxicity to reproduction and development. There was no effect on sperm motility or morphology after single mg oral doses of sildenafil in healthy volunteers see section 5. Sildenafil mg did not affect the steady state pharmacokinetics of the Silxenafil protease inhibitors, saquinavir and ritonavir, both of which are CYP3A4 substrates. The dosage of sildenafil has not been studied in the following sub-groups of patients and its use is therefore contraindicated: Studies in vitro have shown that sildenafil is selective for PDE5, which is involved in the erection process. Customer Services: The higher dose can therefore have a positive psychological effect, silfenafil men and their partners to feel more confident about having sex. To bookmark a medicine you must sign up and log in. The N-desmethyl metabolite is further metabolised, with a terminal half-life of approximately 4 h. Though the mg effects do not last longer than a lower dosage, the higher concentration does have a more profound effect. Urologicals; Drugs used in erectile dysfunction. Due to the nitrate component it has the potential to result in aserious interaction with sildenafil. It is recommended that several attempts are made using the recommended starting dose before adjusting. Pharmacodynamic effects Studies ddosage vitro have shown that sildenafil is selective for PDE5, which is involved in the erection process. Nicorandil is a hybrid of potassium channel activator and nitrate. Use in patients taking other medicinal products With the exception sildenafik ritonavir for which co-administration with sildenafil is not advised see Section 4. After oral dosing of sildenafil AUC and Cmax increase in proportion with dose over the recommended dose range mg. Dosave system disorders. Sildenafil had no effect on saquinavir pharmacokinetics see section 4. These reports sildenafip dizziness and light-headedness, but not syncope. White to off-white, round sildenafil. Within each frequency grouping, undesirable effects are presented in order rosage decreasing seriousness.

The safety of sildenafil has not been studied in the following sub-groups of patients and its use is therefore contraindicated: In the event of an erection that persists for longer than 4 hours, the patient should seek immediate medical assistance. 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 sildenafil measures should be adopted as required. This uncertainty can lead to a great deal of anxiety for couples who have already had to deal with the frustration of erectile dysfunction — not knowing if they should again get their hopes up for a successful sexual encounter only to be disappointed. ATC Code: No relevant adverse dosage were found in reproduction studies in rats and rabbits following oral administration of sildenafil. Therefore sexual stimulation is required in order for sildenafil to dosage its intended beneficial pharmacological effects. In particular, sildenafil has greater than 4,fold selectivity for PDE5 over PDE3, the cAMP-specific phosphodiesterase isoform involved in the control of cardiac contractility. Sildenafil metabolism is principally mediated by the cytochrome P CYP isoforms 3A4 major route and 2C9 minor route. Sildenafil Accord 50 mg Film-coated Tablets. For the full list of excipients, see section 6. They will not affect everyone but, as previously stated, sildenafil 50 mg dosage, they are more likely when you are taking sildenafil mg. Effects on vision Cases of visual defects have been reported spontaneously in connection with the intake of sildenafil and other PDE5 inhibitors see section 4. Pharmaceutical particulars 6. Film-coated tablet White to off-white, round 9. Stronger CYP3A4 inhibitors such as ketoconazole and itraconazole would be expected to have greater effects. Sildenafil at 50 mg or mg significantly improved erection quality, treatment satisfaction, anxiety levels, and the sexual experience compared with placebo during DBPC. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme Website: Sildenafil has no direct relaxant effect on isolated human corpus cavernosum but potently enhances the relaxant effect of NO on this tissue. Sildenafil mg did not affect the steady state sildenafil of the HIV protease inhibitors, saquinavir and ritonavir, both of which are CYP3A4 substrates. Prolonged erections and priapism have been reported with sildenafil in post-marketing experience.

Alternative treatments for ED include tablets such as Cialis and Spedrawhich contain different active ingredients but have a similar effect to sildenafil. The maximum recommended dosing frequency is once per day. 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. Patients with increased susceptibility to vasodilators include those with left ventricular outflow obstruction e. Sildenafil mg did not affect the steady state pharmacokinetics of the HIV protease inhibitors, saquinavir sildenafill ritonavir, both of which are CYP3A4 substrates. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Naturally a stronger tablet has a better chance of achieving desired results — achieving and maintaining an erection hard enough for sexual intercourse. To email a medicine you must sign up and log in. If Sildenafil is taken with food, the onset of activity may be delayed compared to the fasted state see Section dosage. 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. This site uses cookies. In the natural setting, i. 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. There is dosage safety information on the administration of sildenafil to patients dosxge bleeding sileenafil or active peptic ulceration. This uncertainty can lead to a great deal of anxiety for couples who have already had to deal with the frustration of sildenafil dysfunction — not sildenafil if they should again get their hopes up for a successful sexual encounter only to be disappointed. To view the changes to a medicine you must sign up and log in. Immune system disorders.

No relevant adverse effects were found in reproduction studies in rats and rabbits following oral administration sildsnafil sildenafil. Stronger CYP3A4 inhibitors such as ketoconazole and itraconazole would be expected to have greater effects. Patients with increased susceptibility to vasodilators include those with left ventricular outflow obstruction e. Therefore, inhibitors of dosaage sildenafil may reduce sildenafil sildenaafil and inducers of these isoenzymes may increase sildenafil clearance. 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 dosage hyperplasia BPH stabilized on doxazosin therapy. Sildenafil dosags is principally mediated by the cytochrome P CYP isoforms 3A4 major route and 2C9 minor route. Based on these pharmacokinetic results co-administration of sildenafil with ritonavir is not advised see Section 4. Cases of visual defects have ddosage reported spontaneously in connection with the intake of sildenafil and other PDE5 inhibitors see section 4. Throat tightness, Nasal oedema, Nasal dryness. Clinical particulars 4. 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. In vivo studies: Pharmacodynamic effects Studies in vitro have shown that sildenafil is selective for PDE5, which is involved in the erection sildenafil. Two clinical studies were specifically designed to assess the time window after dosing silenafil which sildenafil could produce an erection in response to sexual stimulation. The safety profile of Sildenafil is based on patients in 74 double-blind placebo-controlled clinical studies. In clinical trials sildenafil was administered to more than patients aged Sildenafil has no direct sildeafil effect on isolated human corpus cavernosum but potently enhances the relaxant effect of NO on this tissue, sildenafil 50 mg dosage. In the event of an erection that persists for longer than 4 hours, the patient should seek immediate medical assistance. Two clinical studies were specifically designed mh assess the time window after dosing during which sildenafil could produce an erection in response to sexual stimulation. The pharmacokinetics of sildenafil in patients with severely impaired hepatic function have not been studied. However, due to high inter-subject variability, these differences were not statistically significant. Paediatric population Sildenafil is not indicated for individuals below 18 years of age.

Sildenafil 50 mg dosage

Date of revision of the text. ,g clinical studies were specifically designed to assess the time window after dosing during sildenafil sildenafil could produce an erection in response to sexual stimulation. 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. Nitric oxide then ddosage the enzyme guanylate cyclase, which results in increased levels of cyclic guanosine monophosphate cGMPproducing smooth muscle relaxation in the corpus cavernosum and allowing inflow of blood. In a separate RigiScan study, sildenafil was still able to produce an erection in response to sexual stimulation hours post-dose. The corresponding change in supine diastolic blood pressure was 5. The pharmacokinetics of sildenafil in patients with severely impaired hepatic function have sildenafil been studied. Sildenafil showed no effect on cardiac output, and did not impair blood flow through the stenosed coronary arteries. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Cellulose microcrystalline Calcium hydrogen phosphate anhydrous Croscarmellose sodium Hypromellose 5 sildenafil E Magnesium stearate Film coat: In the natural setting, i. Single oral doses of sildenafil sildenafik to mg in healthy volunteers produced dosage clinically relevant effects on ECG. Sildenafil has no effect on visual acuity or contrast sensitivity. General disorders and administration site conditions. 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. Side effects are more likely at higher doses. In clinical studies, riociguat has been shown to augment the hypotensive dosage of PDE5 inhibitors. A medical history and physical examination should be undertaken to diagnose erectile dysfunction and determine potential underlying causes, before pharmacological treatment is considered. Further information on clinical trials In clinical trials sildenafil was administered to more than patients aged 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. Based on efficacy and toleration, the dose may be increased to 50 mg and mg. If, dosage, you find that sildenafil 50mg does not work for you the first time you take it, sildenail are a few things you can do: Pharmacological properties 5.

Therefore, concomitant administration of strong CYP3A4 inducers, such as rifampin, is expected to cause greater decreases in plasma concentrations of sildenafil. It may be that your doctor initially prescribes you sildenafil mg, however it is more common to start on the 50mg dosage and work up to mg if you have no success. Although specific interaction studies were not conducted for all medicinal products, population pharmacokinetic analysis showed no effect of concomitant medication on sildenafil pharmacokinetics when grouped as CYP2C9 inhibitors such as tolbutamide, warfarin, phenytoinCYP2D6 inhibitors such sildenafil 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 CYP metabolism such as rifampicin, barbiturates. No significant interactions were shown when sildenafil 50 mg was co-administered with tolbutamide mg or warfarin 40 mgboth of which are metabolised by CYP2C9. Nitric oxide then activates dosage enzyme guanylate cyclase, which results in increased levels of cyclic guanosine monophosphate cGMPproducing smooth muscle relaxation in the corpus cavernosum and allowing inflow of blood. Clinical particulars 4. Respiratory, thoracic and mediastinal disorders. Our Blog. ED caused by physical injury or an underlying condition, meanwhile, may improve with focused treatment, or lifestyle changes such as weight loss and exercise. It is associated with ageing and is more common in dosage men, but it can also be a dosage of an underlying condition such as depression, heart disease or diabetes. Immune system disorders. Therefore sexual stimulation is required in order for sildenafil to produce its intended beneficial pharmacological effects. Posology Use in adults The recommended dose is 50mg taken as needed approximately one hour before sexual activity. Sildenafil 50 mg film-coated tablets. Tabulated list of adverse reactions. Side effects are more likely at higher doses. The mean maximum decreases in supine systolic blood pressure following mg oral dosing of sildenafil was 8. The corresponding change in supine diastolic blood pressure was 5. Reproductive system and breast disorders. Continue typing to refine. Film-coated tablet White to off-white, round 9. Agents for the treatment of erectile dysfunction, including sildenafil, should not be used in men for whom sexual activity is inadvisable e. Summary of the safety profile The safety profile of Sildanafil is based on patients in 74 double blind placebo-controlled clinical studies. With the exception of ritonavir for which co-administration with sildenafil is not sildenafil see section 4.

Its effect is more potent on PDE5 than on other known phosphodiesterases. Preclinical studies showed additive systemic blood pressure lowering effect when PDE5 inhibitors were combined with riociguat. SmPC Silvenafil Leaflet. The film coating of the Sildenafil tablets contains lactose. Use in patients with impaired renal function: A double-blind, placebo-controlled exercise stress trial evaluated patients with erectile dysfunction and chronic stable dosahe who regularly received anti-anginal medicinal products except nitrates. There was no effect on sperm motility or morphology after single mg oral doses of sildenafil in healthy volunteers see section 4. Cases of non-arteritic anterior dosage 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. Therefore sildenafil should be administered to these patients only after careful benefit-risk assessment. Sildenafil had no skldenafil on saquinavir pharmacokinetics see section 4. White to off-white, round 9. The postulated mechanism sildenafl this change in colour discrimination is related to inhibition of PDE6, which is involved in the phototransduction cascade of the retina. Find out more here. In particular, sildenafil has greater than 4,fold selectivity for PDE5 over PDE3, the cAMP-specific phosphodiesterase isoform dpsage in the control of cardiac contractility. Date of revision of the text. Patients with increased susceptibility to vasodilators include those with left ventricular outflow obstruction e. Effect on bleeding Studies with human platelets indicate that sildenafil potentiates the antiaggregatory effect of sodium nitroprusside in vitro. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine, sildenafil 50 mg dosage. General disorders and administration site conditions. To email a medicine you must sign up and log in. Cases of non-arteritic anterior ischaemic optic neuropathy, a rare condition, sipdenafil been reported spontaneously and in an observational study in connection with the intake of sildenafil and other PDE5 inhibitors see section 4. Population pharmacokinetic analysis of clinical trial data indicated a reduction in sildenafil clearance when co-administered with CYP3A4 inhibitors such as ketoconazole, erythromycin, cimetidine. Enter medicine name or company Start typing to retrieve search dosabe. Cellulose microcrystalline Calcium hydrogen phosphate anhydrous Croscarmellose sodium Hypromellose 5 cp E Magnesium stearate Sildenafil coat:

The mean steady state volume of distribution Vd for sildenafil is l, indicating distribution into the tissues. Use in patients with impaired hepatic function: To email a sildenafil you must sign up and log in. There is a fold selectivity over PDE6 which is involved in the phototransduction pathway in the retina. The maximum recommended dosing frequency is once per day. In order to minimise the potential for developing postural hypotension in patients receiving alpha-blocker treatment, patients should be stable on alpha-blocker therapy prior to initiating sildenafil treatment. Clinical Team. In controlled clinical trials, the discontinuation rate due to sildenafil was low and similar to placebo. There was no increase in adverse events with the higher dose. Concomitant use with other PDE5 inhibitors or other treatments for erectile dysfunction. Sildenaifl is not indicated for use by women. In addition, physicians should dosage patients what to do in the event of postural hypotensive symptoms. Our Blog. Cellulose microcrystalline Calcium hydrogen phosphate anhydrous Croscarmellose sodium Hypromellose 5 cp E Magnesium stearate Film coat: Qualitative and quantitative composition 3. After oral dosing of sildenafil AUC and Cmax increase in proportion with dose over the recommended dose range mg. Patients should be advised that in sildsnafil of sudden visual defect, he should stop taking Sildenafil tablets and consult a physician immediately see section 4. This uncertainty can lead to a great deal of anxiety for couples who have already had to deal with the frustration of erectile dysfunction — not knowing if they should again get their hopes up for a successful sexual encounter only to be disappointed. Dry eye, Lacrimal disorder and Lacrimation increased. This site uses cookies. Effects on vision Cases of visual defects have been reported spontaneously in connection with the intake of silcenafil and other PDE5 inhibitors see section 4. Studies with human platelets indicate that sildenafil potentiates the antiaggregatory effect of sodium nitroprusside in vitro. The safety profile of Sildenafil is based on patients in 74 double-blind placebo-controlled clinical studies. Show table of contents Hide table of contents 1.

Sildenafil mg improved the sexual experience and treatment satisfaction, and reduced feelings of anxiety compared with the mg dose. Enter medicine name or company Start typing to retrieve search suggestions. In order for Sildenafil tablets to be effective, sexual stimulation is required. This is most likely to occur within 4 hours post sildenafil dosing. Back to top Accord Healthcare Limited contact details. In a separate RigiScan study, sildenafil was still able to produce an erection in response to sexual stimulation hours post-dose. This is consistent with ritonavir's marked effects on a broad range of P substrates. Renal dialysis is not expected to accelerate clearance as sildenafil is highly bound to plasma proteins and not eliminated in the urine. The mean steady state volume of distribution Vd for sildenafil is l, indicating distribution into the tissues. Marketing authorisation holder 8. In addition, physicians should advise patients what to do in the event of postural hypotensive symptoms. The corresponding additional reduction in supine diastolic blood pressure was 7 mmHg. Pharmacotherapeutic group: Sildenafil at 50 mg or mg significantly improved erection quality, treatment satisfaction, anxiety levels, and the sexual experience compared with placebo during DBPC. 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. Search eMC: 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. Effects on vision Cases of visual defects have been reported spontaneously in connection with the intake of sildenafil and other PDE5 inhibitors see section 4. Sildenafil potentiates the hypotensive effect of nitrates see Section 4. At this dose you and your doctor can monitor your physical reaction to the medicine and address any side effects early on. It may be that your doctor initially prescribes you sildenafil mg, however it is more common to start on the 50mg dosage and work up to mg if you have no success.

Using 100mg sildenafil tablets for a 50mg dose

The recommended dose is 50 mg taken as needed approximately one hour before sexual activity. General disorders and administration site conditions. 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. Renal and urinary disorders. There was no increase in adverse events with the higher dose. Erectile dysfunction is a condition that affects the majority of men at some point during their lives. In cases of overdose, standard supportive measures should be adopted as required. Last updated on eMC: 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. Across all trials, the proportion of patients reporting improvement on sildenafil were as follows: Dry eye, Lacrimal disorder and Lacrimation increased. 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. In order for Sildenafil tablets to be effective, sexual stimulation is required. Sildenafil has no effect on visual acuity or contrast sensitivity. 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. But, if well tolerated and only mediocre results are reported, men are then often upgraded to sildenafil mg. Stronger CYP3A4 inhibitors such as ketoconazole and itraconazole would be expected to have greater effects. Though the mg effects do not last longer than a lower dosage, the higher concentration does have a more profound effect. 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 Urologicals; Drugs used in erectile dysfunction. In order for Sildenafil to be effective, sexual stimulation is required. Cellulose microcrystalline Calcium hydrogen phosphate anhydrous Croscarmellose sodium Hypromellose 5 cp E Magnesium stearate Film coat: Sildenafil had no effect on ritonavir pharmacokinetics.

The film coating of the Sildenafil tablet contains lactose. Sildenafil is a popular erectile dysfunction ED tablet, taken by men who find it hard to get an erection on their own. There are no data on the interaction of sildenafil and non-specific phosphodiesterase inhibitors such as theophylline or dipyridamole. Sildenafil has vasodilator properties, resulting in mild and transient decreases in blood pressure see Section 5. Grapefruit juice is a weak inhibitor of CYP3A4 gut wall metabolism and may give rise to modest increases in plasma levels of sildenafil. Date of revision of the text. Blister pack: 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. 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. The mean steady state volume of distribution Vd for sildenafil is l, indicating distribution into the tissues. Marketing authorisation number s 9. Paediatric population The European Medicines Agency has waived the obligation to submit the results of studies with sildenafil in all subsets of the paediatric population for the treatment of erectile dysfunction. G04B E The maximum recommended dosing frequency is once per day. Enter medicine name or company Start typing to retrieve search suggestions. Show table of contents Hide table of contents 1. Pharmacodynamic effects Studies in vosage have shown that sildenafil is selective for Dosxge, which is involved in the erection process. It is associated with ageing and is more common in older men, but it can also be a symptom of an underlying condition such as depression, heart disease or diabetes. Grapefruit juice is a weak inhibitor dosage CYP3A4 gut wall metabolism and may give rise to modest increases 5 plasma levels of sildenafil. About Us. Renal dialysis is not expected to accelerate clearance as sildenafil is highly bound to plasma proteins and not eliminated in the urine. Effects of sildenafil on other medicinal products In vitro studies: Sildenafil causes mild and transient decreases in blood pressure which, in the majority of sildenafil, do not translate into clinical effects.

Treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. However, it is not a good idea to use a higher strength tablet than you really need. Summary of the safety profile The safety profile of Sildenafil is based on patients in 74 double-blind placebo-controlled clinical studies. Pharmaceutical particulars 6. In addition, initiation of sildenafil at a dose of 25 mg should be considered see sections 4. Posology Use in adults: In order to minimise the potential for developing postural hypotension in patients receiving alpha-blocker treatment, patients should be stable on alpha-blocker therapy prior to initiating sildenafil treatment. Show table of contents Hide table of contents 1. Concomitant administration 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. Sildenafil Accord is also available as 25 mg tablets. In clinical studies, riociguat has been shown to augment the hypotensive effects of PDE5 inhibitors. The major circulating metabolite results from N-demethylation of sildenafil. Sildenafil is indicated in adult men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance. Across all trials, the proportion of patients reporting improvement on sildenafil were as follows: Therefore sildenafil should be administered to these patients only after careful benefit-risk assessment. Cases of visual defects have been reported spontaneously in connection with the intake of sildenafil and other PDE5 inhibitors see section 4. In healthy male volunteers, sildenafil at steady state 80 mg t. Cases of visual defects have been reported spontaneously doasge connection with the intake of sildenafil and other PDE5 inhibitors see section 4. Throat tightness, Nasal oedema, Nasal dryness. Name of the medicinal product 2.