Revatio 20 Mg Film-coated Tablets

Sildenafil rvatio no effect on saquinavir pharmacokinetics. Pharmaceutical form 4. Tablet core: The safety and efficacy of Revatio in children below 1 year of age has not been established. Studies with human platelets indicate that sildenafil potentiates the antiaggregatory effect of sodium nitroprusside in vitro. Patients using other medicinal products In general, any dose adjustment should be administered only after a careful benefit-risk assessment. However to avoid the possible occurrence of sudden clinical revatio during withdrawal, revario revatio dose reduction should be considered. Higher than recommended doses should not be used in paediatric patients with PAH see sections 4. Significant improvements in functional class were demonstrated only in subjects on sildenafil high dose compared to placebo. Peak VO 2 was assessed 1 year after the start of the placebo-controlled study. Physicians should advise patients what to do in the revattio of postural hypotensive symptoms. To bookmark a medicine you must sign up and log tsblets. The duration of treatment was 16 weeks. Cardiovascular risk factors. Hypromellose Titanium dioxide E Lactose monohydrate Glycerol triacetate 6. Patients who previously failed bosentan therapy were excluded from the study. Hepatic tablets. Active ingredient sildenafil citrate. Prescription-only medicinal product Detailed information on tablets medicinal product is available on the website of the European Medicines Agency http:

Long term extension data. The primary efficacy endpoint was the change from baseline at week 16 in 6-minute walk distance. Revatio exposure was 5-fold higher at a dose of 80 mg three times tablets day compared to the exposure at a dose of 20 mg three times a day. Clinical efficacy and safety, revatio tablets. Date of first authorisation: Revtio on all sildenafil doses achieved a statistically significant reduction in mean pulmonary arterial pressure mPAP and pulmonary vascular resistance PVR compared to those on placebo. There is no safety information on the administration of sildenafil to patients with bleeding disorders or active peptic ulceration. Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with revatlo tissue disease. Studies in animals have shown toxicity with respect to postnatal development see section 5. Absorption Sildenafil is rapidly absorbed. Its effect is more potent on PDE5 than on other known phosphodiesterases. In healthy male volunteers, there was no evidence of an effect of azithromycin mg daily for 3 days on the Tablets, C maxT maxelimination rate constant, or subsequent half-life of sildenafil or its principal circulating metabolite. Back to top Pfizer Limited contact details. Continue typing to refine. Bleeding disorders Studies with human platelets indicate that sildenafil potentiates the antiaggregatory effect of sodium nitroprusside in vitro. A downward dose adjustment to 20 mg twice daily should be considered when sildenafil is co-administered to patients already receiving CYP3A4 inhibitors like tabltes or saquinavir. Based on these pharmacokinetic results co-administration of sildenafil with ritonavir is contraindicated in pulmonary arterial hypertension patients see section 4. A downward dose adjustment to 20 mg once daily tablets recommended revatio case of co-administration with more potent CYP3A4 inhibitors revatio, telithromycin and nefazodone. Patients enrolled into the epoprostenol add-on therapy study were eligible to enter a long term open label extension study. 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. Musculoskeletal and connective tissue disorders.

Across the short-term and long-term studies, the overall duration of treatment from start of double-blind for individual subjects ranged from 3 to days. Absorption Sildenafil is rapidly absorbed. In the pivotal placebo-controlled study tqblets Revatio in pulmonary arterial hypertension, a total of patients were randomized to and treated with 20 mg, 40 mg, or 80 mg TID doses of Revatio and 70 patients were randomized to placebo. If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result see section 4. Of the patients revatip, patients received at least 1 dose of study drug. Blood and lymphatic system disorders. Fertility Non-clinical data revealed no special hazard for humans based on conventional studies of fertility see section 5. Paediatric population A total of subjects aged 1 to 17 years were treated in a randomized, double-blind, multi-centre, placebo controlled parallel group, revatio ranging study. Peak VO 2 rvatio assessed 1 year after the start of the placebo-controlled study. Efficacy in adult patients with PAH when used in combination with epoprostenol A randomised, double-blind, placebo controlled study was conducted in patients with PAH who were stabilised on intravenous epoprostenol. Clinical particulars 4. The primary efficacy endpoint was the change from baseline at week 16 in 6-minute walk distance. Sildenafil metabolism is principally mediated by the cytochrome P CYP isoforms 3A4 major route and 2C9 minor route. Revatio is for oral use only. Sign Up Log In Cancel, revatio tablets. The most potent of the CYP3A4 inhibitors such as ketoconazole and itraconazole would be expected to have effects rablets to ritonavir see section tabletss. Placebo-corrected treatment effects tablets PVR were dyne. No dose adjustment is required. Patients using other medicinal products In tablets, any dose adjustment should be administered only after a careful benefit-risk assessment. At talbets doses of mg the incidence of adverse reactions headache, revatio, dizziness, dyspepsia, nasal congestion, and altered vision was increased. Efficacy has tabkets shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease. Name of the medicinal product 2. By continuing to browse the site you are agreeing to our policy on the use of cookies. Pharmacokinetics in special patient groups.

However, for subjects with PAH associated with connective tissue disease 36 subjects mean changes from baseline were This revatio range covers the increase in sildenafil exposure observed in specifically designed drug interaction studies with CYP3A4 inhibitors except taglets the most potent of the CYP3A4 inhibitors eg, ketoconazole, itraconazole, ritonavir. The population pharmacokinetic analysis in pulmonary arterial hypertension patients suggested that co-administration of beta-blockers in combination with CYP3A4 substrates might result in an additional increase in sildenafil exposure compared with administration of CYP3A4 substrates alone. The use of sildenafil tablets other forms of PAH is not recommended. This site uses cookies. To view the changes to a medicine you must sign up and log in, revatio tablets. The primary efficacy endpoint was reavtio change from baseline at week 12 in 6-minute walk distance 6MWD. This is consistent with ritonavir's marked effects on a broad range of P substrates. The effect of sildenafil on mortality is unknown. Paediatric population Reatio of paediatric patients aged 1 year to 17 years old with pulmonary arterial hypertension. In the pivotal placebo-controlled study of Revatio in pulmonary revatio hypertension, a total of patients were randomized to and treated with 20 mg, 40 mg, or 80 mg Rdvatio doses of Revatio and 70 patients were randomized to placebo. In pulmonary arterial hypertension patients, there may be a potential for increased risk revaio bleeding when sildenafil is initiated in patients already tablets a Vitamin K antagonist, particularly in patients with pulmonary arterial hypertension secondary to connective tissue disease. Its effect is more potent on PDE5 than on other known phosphodiesterases. Sildenafil, therefore, increases cGMP within pulmonary vascular smooth muscle cells resulting revatioo relaxation. However to avoid the possible occurrence of sudden clinical deterioration during withdrawal, a gradual dose reduction should be considered.

Revatio tablets

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. Hepatic insufficiency. In vivo studies No significant interactions were shown when sildenafil 50 mg was co-administered with tolbutamide mg or warfarin 40 mgrevatio tablets, both of which are metabolised by CYP2C9. This site uses cookies. In a placebo-controlled study of Revatio as an adjunct to intravenous epoprostenol tab,ets pulmonary arterial hypertension, a total of patients were treated with Revatio in a fixed titration starting from 20 mg, to 40 mg and then 80 mg, three times a day, as revatio and epoprostenol, and patients were treated with placebo and epoprostenol. In the long term paediatric extension study, an increase in deaths was observed in patients administered doses higher than the recommended dose. It is not possible to determine whether revatio events are related directly to these factors or to other factors. Patients who previously failed bosentan therapy were excluded from the study. Hepatic impairment. Store in the original package in order to protect from moisture. Concomitant use with other PDE5 inhibitors The safety and efficacy of sildenafil when co-administered with other PDE5 inhibitor products, including Viagra, has tzblets been studied in PAH patients and such concomitant use is not recommended see section 4. Tablets safety of sildenafil has not been studied in the tablets sub-groups of patients and its use is therefore contraindicated: Paediatric population 1 year to 17 years. Pregnancy There are no data from the use of sildenafil in pregnant women. Non-clinical data revealed no special hazard for humans based on conventional studies of fertility see section 5. Reporting of suspected adverse reactions. The efficacy of sildenafil in patients already on bosentan therapy has taablets been conclusively demonstrated see sections 4.

By sildenafil treatment group, median duration of sildenafil treatment was days excluding the 5 subjects who received placebo in double-blind and were not treated in the long-term extension study. A downward dose adjustment to 20 mg twice daily tablets be considered after a careful benefit-risk assessment only if therapy is not well-tolerated. When analysed by WHO functional class, a statistically significant increase in 6MWD was observed in the 20 mg dose group. Of the subjects treated in the pivotal study, entered a long-term extension study. Sildenafil, therefore, increases cGMP within pulmonary vascular smooth muscle cells resulting in relaxation. However, cases of life threatening pulmonary oedema have been reported with vasodilators mainly prostacyclin when used in those patients. Clinical efficacy revatio safety Efficacy in adult patients with pulmonary arterial hypertension PAH A randomised, double-blind, placebo-controlled study was conducted in patients with primary pulmonary hypertension, PAH associated with connective tissue disease, revatio tablets, and PAH following surgical repair of congenital heart lesions. These reports included dizziness and lightheadedness, but not syncope. Hepatic impairment. The results indicate that there is no significant difference in mean change from baseline on 6MWD observed between sildenafil 20 mg three times a day and placebo In a placebo-controlled study of Revatio as an adjunct to intravenous epoprostenol in pulmonary arterial hypertension, a total of patients were treated with Revatio in a fixed titration starting from 20 mg, to 40 mg and then 80 mg, three times a day, as tolerated and epoprostenol, and patients were treated tablets placebo and epoprostenol. The safety of sildenafil has revatio been studied in patients with known hereditary degenerative retinal disorders such as retinitis pigmentosa a minority of these patients have genetic disorders of retinal phosphodiesterases and therefore its use is not recommended. The adverse reactions profile seen in this paediatric study revatio generally consistent with that in adults see table above. Dose adjustments for sildenafil may be required when co-administered with CYP3A4 inducers see section 4. 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. A downward dose adjustment to 20 mg once daily is recommended in case of co-administration with more potent CYP3A4 inhibitors clarithromycin, telithromycin and nefazodone. Tablets using other medicinal products. By continuing to browse the site you are agreeing to our policy on the use of cookies. As dizziness and altered vision were reported in clinical trials with sildenafil, patients should be aware of how they might be affected by Revatio, before driving or using machines. After oral doses of 80 mg three times a day a more than dose proportional increase in sildenafil plasma levels has been observed. In healthy male volunteers, there was no evidence of an effect of azithromycin mg daily for 3 days on the AUC, C maxT maxelimination rate constant, or subsequent half-life of sildenafil or its principal circulating metabolite. Reports from post-marketing experience are included in italics. 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. Cases of visual defects have been reported spontaneously in connection with the intake of sildenafil and other PDE5 inhibitors, revatio tablets.

When analysed by WHO functional class, a revatio significant increase in 6MWD was observed in the 20 mg dose group. In patients with pulmonary arterial hypertension this can lead to vasodilation of the pulmonary vascular bed and, to a lesser degree, vasodilatation in the systemic circulation. Prescription only medicine. Single oral doses of sildenafil up to mg in healthy volunteers produced no clinically relevant effects on ECG. In post-marketing experience with revatio for male erectile dysfunction, serious cardiovascular events, including myocardial infarction, unstable angina, sudden cardiac death, ventricular arrhythmia, cerebrovascular haemorrhage, transient ischaemic attack, hypertension and hypotension tablets been reported in temporal association with the use of sildenafil. There was no significant difference in effect between sildenafil doses. The postulated mechanism for this change in colour discrimination is related to inhibition tablets PDE6, which is involved in the phototransduction cascade of the retina. Vasodilatory action When prescribing sildenafil, physicians should carefully consider whether patients with certain underlying conditions could be adversely affected by sildenafil's mild to moderate vasodilatory effects, for example patients with hypotension, patients with fluid depletion, severe left ventricular outflow obstruction or autonomic dysfunction see section 4. Sildenafil plasma concentration half-life values were estimated to range from 4. Prolonged erections and priapism have been reported with sildenafil in post-marketing experience. Reproductive system and breast disorders. Pharmaceutical form Film-coated tablet. A population pharmacokinetic analysis of data from a study of adult PAH patients on background bosentan therapy Most, but not all, of these patients had pre-existing cardiovascular risk factors, revatio tablets. Use of sildenafil with bosentan. Therefore, caution is recommended in case of co-administration. Reports from post-marketing experience are included in italics. Renal dialysis is not expected to accelerate clearance as sildenafil is highly bound to plasma proteins and not eliminated in the urine. In vivo studies No significant interactions were shown when sildenafil revatio mg was co-administered with tolbutamide mg or warfarin 40 mgboth of which are metabolised by CYP2C9. Patients were randomised to placebo or sildenafil in a fixed titration starting from 20 mg, tablets 40 mg and then 80 mg, three times a day as tolerated when used in combination with intravenous epoprostenol. Higher than tablets doses should not be used in paediatric patients with PAH see sections 4. Effects in non-clinical studies were observed at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use. Revatio intolerance Lactose monohydrate is present in the tablet film coat. Actual doses administered within a group were dependent on body weight see Section 4, revatio tablets.

Active ingredient

Long-term Survival Data in the background epoprostenol revatio Patients enrolled into the epoprostenol add-on therapy study were eligible to enter a long term open label extension study. Due to the nitrate component it has the potential to have serious interaction with sildenafil see section 4. There are no data on the interaction of sildenafil and non-specific phosphodiesterase inhibitors such as theophylline or dipyridamole. Each film-coated tablet contains 20 mg of sildenafil as citrate. G04BE03 Mechanism revatii action. Prolonged erections and priapism have been reported with revahio in post-marketing experience. Efficacy in terms of improvement of exercise capacity or pulmonary haemodynamics has been shown in primary pulmonary hypertension and pulmonary hypertension associated with congenital heart disease see section 5. Marketing authorisation holder 8. Talbets is a potent and selective revatuo of cyclic guanosine monophosphate cGMP specific phosphodiesterase type 5 PDE5the enzyme revafio is responsible for degradation of cGMP. Very common, revatio tablets. Enter medicine name or company Start typing to retrieve search suggestions. Prescription-only medicinal product Detailed information tablets this medicinal product is available on the website of the European Medicines Agency http: Revatio Category POM: Continue typing to refine. Sildenafil has no effect on visual acuity or contrast sensitivity. Film-coated tablet. Prescribers should carefully assess the mother's clinical need for sildenafil and any potential adverse effects on the breast-fed child. In the long term paediatric extension study, an increase in tablets was revatio in patients administered doses higher than the recommended dose. For subjects with primary PAH 67 subjectsmean changes from baseline were A downward dose adjustment to rfvatio mg once daily is recommended in case of co-administration with more potent CYP3A4 inhibitors clarithromycin, revatio tablets, telithromycin and nefazodone. Revatio 20 mg film-coated tablets 2. Patients on all sildenafil tablets achieved a statistically significant reduction in mean pulmonary arterial pressure mPAP and pulmonary vascular resistance PVR compared to those on placebo.

The primary efficacy endpoint was the change from baseline at Week 12 in 6MWD. Find out more here. Physicians should advise patients who forget to take Revatio to take a dose as soon as possible and then continue with the normal dose. Estimated difference. In vivo studies. Hepatic impairment Initial dose adjustments are not required in patients with hepatic impairment Child-Pugh class A and B. A downward dose adjustment to 20 mg twice daily should be considered when sildenafil is co-administered to patients already receiving CYP3A4 inhibitors like erythromycin or saquinavir. Sildenafil is a potent and selective inhibitor of cyclic guanosine monophosphate cGMP specific phosphodiesterase type 5 PDE5 , the enzyme that is responsible for degradation of cGMP. Sildenafil had no effect on saquinavir pharmacokinetics. There is no safety information on the administration of sildenafil to patients with bleeding disorders or active peptic ulceration. Paediatric population 1 year to 17 years. Patients using other medicinal products In general, any dose adjustment should be administered only after a careful benefit-risk assessment. A population pharmacokinetic analysis of sildenafil data from adult PAH patients in clinical trials including a 12 week study to assess the efficacy and safety of oral sildenafil 20 mg three times a day when added to a stable dose of bosentan A mean placebo-corrected treatment effect of Revatio 20 mg film-coated tablets 2. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 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. There was no evidence of favourable clinical effect of the combination in the population studied. In the two-placebo-controlled studies adverse events were generally mild to moderate in severity. Sildenafil metabolism is principally mediated by the cytochrome P CYP isoforms revatio major route and 2C9 minor route. Pharmaceutical form 4. Actual doses administered within a group were dependent revatio body weight see Section 4. Limited data suggest that the abrupt discontinuation of Revatio is tablets associated tablets rebound worsening of pulmonary arterial hypertension. Its effect is more potent on PDE5 than on other known phosphodiesterases.

However to avoid the possible occurrence of sudden clinical deterioration during withdrawal, a gradual dose reduction should be considered. Prescription-only medicinal product Detailed information on this medicinal product is available on the website of the European Medicines Agency http: Marketing authorisation number s 9. Single oral doses of sildenafil up to mg in healthy volunteers produced no clinically relevant effects on ECG. This site uses cookies. Patients should not take a double dose to compensate for the missed dose. Tabulated list of adverse reactions. There is a fold selectivity over PDE6 which is involved in the phototransduction pathway in the retina. Find out more here. Subjects were allocated to one of three sildenafil treatment groups, low 10 mg , medium mg or high dose mg regimens of Revatio given three times a day, or placebo. After chronic dosing of 80 mg three times a day to patients with systemic hypertension the mean change from baseline in systolic and diastolic blood pressure was a decrease of 9. By sildenafil treatment group, median duration of sildenafil treatment was days excluding the 5 subjects who received placebo in double-blind and were not treated in the long-term extension study. After chronic dosing of 80 mg three times a day to patients with pulmonary arterial hypertension lesser effects in blood pressure reduction were observed a reduction in both systolic and diastolic pressure of 2 mmHg. Very common. Patients who previously failed bosentan therapy were excluded from the study. In a placebo-controlled study of Revatio as an adjunct to intravenous epoprostenol in pulmonary arterial hypertension, a total of patients were treated with Revatio in a fixed titration starting from 20 mg, to 40 mg and then 80 mg, three times a day, as tolerated and epoprostenol, and patients were treated with placebo and epoprostenol. Distribution The mean steady state volume of distribution Vss for sildenafil is l, indicating distribution into the tissues. A statistically significant increase in 6MWD was observed tabldts all 3 sildenafil dose groups compared to those on placebo. A randomised, double-blind, placebo controlled study was conducted in patients with PAH who were stabilised on intravenous epoprostenol, revatio tablets. Each film-coated tablet contains 20 mg of sildenafil as citrate. G04BE03 Mechanism of action. A population pharmacokinetic revatio of sildenafil data from adult PAH patients in clinical trials including a 12 week study to assess the efficacy and safety of oral sildenafil 20 mg three times a day when added to a stable dose of bosentan Data from one lactating woman indicate that sildenafil and its active metabolite N-desmethylsildenafil are excreted into breast milk at very low levels. Patients were randomized to placebo tablets sildenafil 20 mg three times a day in combination with bosentan