Sildenafil 100 Mg Film-coated Tablets

In the event of an erection that persists sildenafip longer than 4 hours, the patient should seek immediate medical assistance. Medically important adverse reactions reported at an incidence greater than placebo in sildenafip clinical studies and medically important adverse reactions reported through post-marketing surveillance. Concomitant use with ritonavir Co-administration of sildenafil with ritonavir is not advised sildenafol 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. Gastro oesophageal reflux disease, Vomiting, Abdominal pain upper, Dry mouth. 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. Sildenafil has no effect on visual acuity or contrast sensitivity. Patients with increased susceptibility to vasodilators include those with left ventricular outflow obstruction e. Sildfnafil sildenafil of sildenafil has not been studied in the following sub-groups of patients and its use sildenqfil therefore contraindicated: In three specific drug-drug interaction studies, the alpha-blocker doxazosin 4 mg and 8 mg and sildenafil 25 mg, 50 mg, sildenafil citrate 100mg, or mg were administered simultaneously to patients with benign prostatic hyperplasia BPH stabilized on doxazosin therapy. Paediatric population Sildenafil is xildenafil indicated for individuals below 18 sildenafil of 100mg. Based on these pharmacokinetic results co-administration of sildenafil with ritonavir is not advised see Section 4. Citrate effect is more potent citrste PDE5 than on other known phosphodiesterases. Date of revision of the text. For the full list of excipients, see section 6. If priapism is not treated immediately, penile 100mg damage and permanent loss of potency could result. Although no increased incidence of adverse events 100mg observed in these patients, when sildenafil is administered concomitantly with CYP3A4 inhibitors, a starting dose of 25mg should be considered. Sildenafil is most likely to occur within sildrnafil hours post sildenafil dosing see Sections 4. Agents for the treatment of erectile dysfunction, including sildenafil, should be used with caution in patients with anatomical deformation of the penis such as citrate, cavernosal fibrosis or Peyronie's diseaseor in patients citrate have conditions which may predispose them to priapism such as sickle cell anaemia, multiple myeloma or leukaemia. To view the changes to 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. This information is intended for use by health professionals.

Date 100mg revision of the text. Nicorandil is a hybrid of potassium channel activator and nitrate. A medical history and physical examination should be undertaken to diagnose erectile dysfunction and determine potential underlying causes, before pharmacological treatment is considered. The co-administration 100mg PDE5 inhibitors, including sildenafil, with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension see sildenafil 4. White to off-white, round However, due to high inter-subject variability, these differences were not statistically significant. Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. In the natural setting, i. Sildenafil has a peripheral site of action on erections. Therefore, concomitant administration of strong CYP3A4 inducers, such as rifampin, is expected to cause greater decreases in plasma concentrations of sildenafil. Last updated on eMC: Reproductive system and breast disorders. Grapefruit juice is a weak inhibitor of CYP3A4 gut wall metabolism and may citrate rise to modest increases in plasma levels of sildenafil. Effects of sildenafil on other medicinal products In vitro studies: The pharmacokinetics of sildenafil in patients with severely impaired hepatic function have not been studied. This is most likely to occur within 4 hours post sildenafil dosing see Sections 4. Cases of visual defects have been reported spontaneously in connection with the intake of sildenafil and other PDE5 inhibitors see section 4. In clinical trials sildenafil was administered to more than patients aged Sildenafil metabolism is principally mediated by the cytochrome P CYP isoforms 3A4 major route and 2C9 minor route. In order to minimise the potential for developing postural hypotension, patients should be hemodynamically stable on alpha-blocker therapy prior to sildenafil sildenafil treatment. Therefore sexual stimulation is required in order for sildenafil to produce its intended beneficial pharmacological effects, sildenafil citrate 100mg. Measures of treatment satisfaction and sexual experience significantly favored the mg dose compared with the mg citrate in the DBPC. Doses of mg did not result in increased efficacy but the incidence of 100mg reactions headache, flushing, dizziness, dyspepsia, nasal congestion, altered vision was increased. Sildenafil citrate 50 mg is the recommended starting citrate for men with erectile dysfunction ED ; however, most men are later titrated to sildenafil mg for improved efficacy.

This is consistent with ritonavir's marked effects on citrate broad range of P substrates. Excipient with known effect: If Sildenafil is taken with food, the onset of activity may be delayed compared to the fasted state see Section 5. Assess the tolerability and efficacy of sildenafil initiated at the mg dose in men with ED. Active ingredient 100mg citrate. Pooling of the following classes of antihypertensive medication; diuretics, beta-blockers, ACE inhibitors, angiotensin II antagonists, antihypertensive medicinal products vasodilator and centrally-actingadrenergic 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. 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. The corresponding additional reduction in supine diastolic blood pressure was 7 mmHg. Gastro oesophageal reflux disease, Vomiting, Abdominal pain upper, Dry mouth. Sildenafil is an oral therapy for erectile dysfunction. Therefore sexual stimulation is required in order for sildenafil to produce its intended beneficial pharmacological effects. 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, sildenafil citrate 100mg, or subsequent half-life of sildenafil or its principal circulating metabolite. In addition, initiation of sildenafil at a dose of 25 mg should be considered see Sections 4. Improvements in DBPC patient-reported outcomes from baseline were statistically significant for both sildenafil 50 and mg compared with placebo. Therefore, inhibitors of these isoenzymes may reduce sildenafil clearance and inducers of these sildenafil may increase sildenafil clearance. Continue typing to refine. The N-desmethyl metabolite is further metabolised, with a terminal half life of approximately 4 h. The major circulating metabolite results from N-demethylation of sildenafil. Each film-coated tablet contains mg Sildenafil as sildenafil citrate. 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.

Film-coated tablet White to off-white, round Most, but not all, of these patients had pre-existing cardiovascular risk factors. Last updated on eMC: Sildenafil is an oral therapy citrate erectile dysfunction. Preclinical studies showed additive systemic blood pressure lowering effect when PDE5 inhibitors were combined with riociguat. Sildenafil at 50 mg or mg significantly improved erection quality, treatment satisfaction, anxiety levels, and the sexual experience compared with placebo during DBPC. Continue typing to refine. Protein binding is independent of total drug concentrations. Patients with increased susceptibility to vasodilators include those with left ventricular outflow obstruction e. Maximum observed plasma concentrations are reached within 30 to minutes median 60 minutes of oral dosing in the fasted state. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Sign Up Log In Cancel. There was no effect on sperm motility or morphology after single mg oral doses of sildenafil in healthy volunteers see section 4. Concomitant administration of sildenafil to patients taking alpha-blocker therapy may lead to symptomatic hypotension in a few susceptible individuals. These decreases in blood pressure are consistent with the vasodilatory effects of sildenafil, probably due to increased cGMP levels in vascular smooth muscle. Date of revision of the text. Based citrate efficacy and tolerability, the dose may be increased to sildenafil or decreased to 25mg. The mean maximum decreases in supine systolic blood pressure following mg oral dosing of sildenafil was 8, sildenafil citrate 100mg. Absorption Sildenafil is rapidly absorbed. After oral dosing of sildenafil AUC and 100mg increase in proportion with dose over the recommended dose range mg. 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. Single oral doses of sildenafil up to mg in healthy volunteers produced no clinically relevant effects on ECG. Across all trials, the proportion of patients reporting improvement on sildenafil were as sildenafil Measures of treatment satisfaction and sexual experience significantly favored 100mg mg dose compared with the mg dose in the DBPC.

Sildenafil citrate 100mg

Film-coated tablet White sikdenafil off-white, round Therefore, inhibitors of these isoenzymes may reduce sildenafil clearance and inducers of these isoenzymes citrahe increase sildenafil clearance. Caution is advised when sildenafil is citrate to patients taking an alpha-blocker, as the coadministration may lead to symptomatic hypotension in a citrate susceptible individuals see Section 4. Marketing authorisation holder 8. Sildenafil mg improved the sexual experience and treatment satisfaction, and reduced feelings of anxiety compared with the mg dose. Clinical efficacy and safety Two clinical studies sildenafil specifically designed to assess the time window after dosing during which sildenafil could produce an erection in response to sexual stimulation. Prolonged erections and priapism have been reported with sildenafil in post-marketing experience. Date of revision of the text. In single dose volunteer studies of doses 10mg to mg, adverse reactions were similar to those seen at lower doses, citrate the incidence rates and severities were increased. At maximum recommended doses, there is an fold selectivity over PDE1, and over fold over PDE 2, 3, 4, 7, 8, 9, 10 and The corresponding additional reduction in supine diastolic blood pressure was 7 mmHg. Posology Use in adults The recommended dose is sildenafil taken as needed approximately one hour before sexual activity. Studies with human platelets indicate that sildenafil potentiates the antiaggregatory effect of sodium nitroprusside in vitro. Calcium hydrogen phosphate anhydrous Cellulose microcrystalline Croscarmellose sodium Silica colloidal anhydrous Magnesium stearate 100mg coat: Nitric oxide then activates 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. Based on efficacy and tolerability, the dose may be increased to mg or decreased to 25mg. To email a medicine you must sign up and log in. Sildenafil causes mild and transient decreases in blood pressure which, in the majority of cases, do not translate into clinical effects. In healthy 100mg receiving sildenafil mg single doseless than 0. In clinical studies, riociguat has been shown to augment the hypotensive effects of PDE5 inhibitors. Initiation of sildenafil at a dose of 25 mg should be considered see Section 4. Therefore, concomitant administration of strong CYP3A4 inducers, such as rifampin, is expected 100mg cause greater decreases in plasma concentrations of sildenafil. Therefore sexual stimulation is required in sildenafjl for sildenafil to produce its intended beneficial pharmacological effects. These additional blood pressure reductions were of a similar magnitude to those seen when sildenafil was administered alone to healthy volunteers see Sildenafil 5.

Therefore the use of citrate combinations is not recommended. Use in patients 100mg other medicinal products With the exception of ritonavir for which co-administration with sildenafil is not advised see Section 4. Sildenafil 50mg did not potentiate the increase in bleeding time caused by acetyl salicylic acid mg. Cases of visual defects have been reported sildenafil in connection with the intake of sildenafil and other PDE5 inhibitors see section 4. Dry eye, Lacrimal disorder and Lacrimation sildenafil. At maximum recommended doses, there is an fold selectivity over PDE1, and over fold over PDE 2, 3, 4, 7, 8, 9, 10 and Citrate in DBPC patient-reported outcomes from baseline were statistically significant for both sildenafil 50 and citrate compared with placebo. Protein binding is independent of total drug concentrations. These decreases in blood pressure are consistent with the vasodilatory effects of sildenafil, probably due to increased cGMP levels in vascular smooth muscle. Gastro oesophageal reflux disease, Vomiting, Abdominal pain upper, Dry mouth. Concomitant use with other PDE5 100mg 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 REVATIOor other treatments for erectile 100mg have not been studied. Although no increased incidence of adverse events was observed in these patients, when sildenafil is administered concomitantly with CYP3A4 inhibitors, a starting dose of 25mg should be considered. Musculoskeletal and connective tissue disorders. 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. Absorption Sildenafil is rapidly absorbed. Cardiovascular risk factors Prior to initiating any treatment for erectile dysfunction, physicians should consider the cardiovascular status of their patients, 100mg there is a degree of cardiac risk associated with sexual activity. Sildenafil had no effect on saquinavir pharmacokinetics see Section silednafil. Therefore sexual stimulation is required in sildenafil for sildenafil to 1100mg its intended beneficial pharmacological effects. The pharmacokinetics sildnafil sildenafil in patients with severely impaired hepatic function have not been citrate. Concomitant administration of sildenafil to patients sildenafil alpha-blocker therapy may lead to symptomatic hypotension in a few susceptible citrat. 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 safety of sildenafil has not been studied in the following sub-groups of citrate and its use is therefore contraindicated: Improvements in DBPC patient-reported outcomes from baseline were statistically significant for both sildenafil 50 and mg compared with placebo. Population pharmacokinetic analysis of clinical trial data indicated a reduction in sildenafil clearance when co-administered with CYP3A4 inhibitors such as ketoconazole, erythromycin, sildenafil. Two clinical citrate were specifically designed to assess the time window after dosing during which sildenafil could produce an erection in response to sexual stimulation. This is most likely to occur within 4 hours post sildenafil dosing. Single oral doses of sildenafil up to mg in healthy volunteers produced citrate clinically relevant effects on ECG. Sign Up Log In Cancel, sildenafil citrate 100mg. Concomitant use of riociguat with 100mg inhibitors, including sildenafil, is contraindicated see section 4. Pooling of the following classes of antihypertensive medication; diuretics, beta-blockers, ACE inhibitors, angiotensin II antagonists, antihypertensive medicinal products vasodilator and centrally-actingadrenergic 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. Across all trials, the proportion of patients reporting improvement on sildenafil were as follows: Sildenafil is not indicated for 100mg by women. Dry eye, Lacrimal disorder and Lacrimation increased. This information is intended for use by health professionals. However, due to high inter-subject variability, these differences were not statistically significant. Enter medicine name or company Start typing to retrieve search suggestions. The mean maximum decreases in supine systolic blood pressure following mg oral dosing of sildenafil was 8. Each 50 mg film-coated tablet contains 7. Its effect sildenafil more potent on PDE5 than on other known phosphodiesterases. Hepatic impairment 100mg sildenafil clearance sildenafil reduced in patients with hepatic impairment e. Maximum observed plasma concentrations are reached within 30 to minutes median 60 minutes of oral dosing in the fasted state. Date of revision of the text. Sildenafil citrate 50 mg is the recommended starting dose for men with erectile dysfunction ED ; however, most men are later titrated to sildenafil mg for improved efficacy.

Improvements in DBPC patient-reported outcomes from baseline were statistically significant for both sildenafil 50 and mg compared with placebo. 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, 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. The film coating of the Sildenafil tablet contains lactose. These additional blood pressure reductions were of a similar magnitude to those seen when sildenafil was administered alone to healthy volunteers see Section 5. 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 pharmacokinetics of sildenafil in patients with severely impaired hepatic function have not been studied. Sildenafil potentiates the hypotensive effect of nitrates see Section 4. The mean maximum decreases in supine systolic blood pressure following mg oral dosing of sildenafil was 8. Effects of other medicinal products on sildenafil In vitro studies: Grapefruit juice is a weak inhibitor of CYP3A4 gut wall metabolism and may give rise to modest increases in plasma levels of sildenafil. Concomitant use with ritonavir Co-administration of sildenafil with ritonavir is not advised see Section 4. No relevant adverse effects were found in reproduction studies in rats and rabbits following oral administration of sildenafil. Absorption Sildenafil is rapidly absorbed. This is most likely to occur within 4 hours post sildenafil dosing see Sections 4. 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. 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. Chest pain, Fatigue, Feeling hot. 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. It is not possible to determine whether these events are related directly to these factors or to other factors. There was no increase in adverse events with the higher dose. In order for Sildenafil to be effective, sexual stimulation is required. This site uses cookies. There is no safety information on the administration of sildenafil to patients with bleeding disorders or active peptic ulceration. 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. 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. Therefore, inhibitors of these isoenzymes may reduce sildenafil clearance and inducers of these isoenzymes may increase sildenafil clearance.

Pharmacodynamic effects Studies in vitro have shown that sildenafil is selective for PDE5, which is involved in the erection process. The maximum recommended dose is mg. 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. Therefore the use of such combinations is not recommended. The major circulating metabolite results from N-demethylation of sildenafil. In clinical studies, riociguat has been shown to augment the hypotensive effects of PDE5 inhibitors. The N-desmethyl metabolite is further metabolised, with a terminal half life of approximately 4 h. Active ingredient sildenafil citrate. In cases of overdose, standard supportive measures should be adopted as required. The following patient groups were represented: However, due to high inter-subject variability, these differences were not statistically significant. 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. Marketing authorisation holder 8. Qualitative and quantitative composition 3. White to off-white, round There was no evidence of favourable clinical effect of the combination in the population studied. In addition, initiation of sildenafil at a dose of 25 mg should be considered see Sections 4. Urologicals; Drugs used in erectile dysfunction. 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. There is a fold selectivity over PDE6 which is involved in the phototransduction pathway in the retina. 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. 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. This is most likely to occur within 4 hours post sildenafil dosing see Sections 4. In the natural setting, i. Date of revision of the text. This information is intended for use by health professionals.