Revatio 20 Mg Film-coated Tablets

The benefit-risk balance of sildenafil has not been established in patients assessed to be at WHO functional class I pulmonary arterial hypertension. 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. Subjects were allocated to twblets of three sildenafil treatment groups, low 10 refatiomedium mg or high dose mg revatio of Revatio given three times a day, or placebo. Veno -occlusive disease No data are available with sildenafil in patients with pulmonary hypertension associated with pulmonary veno-occlusive disease. Tablets is a potent and selective inhibitor of cyclic guanosine monophosphate cGMP specific reevatio type 5 PDE5the enzyme that is responsible for degradation of cGMP. Co-administration of oral sildenafil and intravenous epoprostenol has been evaluated see sections 4. Prolonged erections and priapism have been reported with sildenafil in post-marketing experience. Healthcare professionals are asked to report any suspected adverse revxtio via the Yellow Card Scheme at www. Sildenafil, therefore, increases cGMP within pulmonary vascular smooth muscle cells resulting in relaxation. Pack size of 90 tablets in a carton. Revatio 20 mg film-coated tablets 2. Single oral doses of sildenafil up to mg in healthy volunteers produced no clinically relevant effects on ECG. Of the patients randomised, patients received rfvatio least 1 dose of study drug. Consequently, should signs of pulmonary oedema revato when sildenafil is administered in patients with pulmonary hypertension, the possibility of associated veno-occlusive disease should be considered. G04BE03 Mechanism of action. Show table of contents Hide table of contents 1. Therefore, caution is recommended in case of co-administration. Pharmaceutical particulars 6, revatio tablets. Dose adjustments are not required in elderly patients.

The primary efficacy endpoint was the change from baseline at week 16 in 6-minute walk distance. In particular, sildenafil has greater than 4,fold selectivity for Revatio over PDE3, the cAMP-specific phosphodiesterase isoform involved in the control of cardiac contractility, revatio tablets. Intensified monitoring is recommended during the discontinuation period. 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 tablets day, as tolerated and epoprostenol, and patients were treated with placebo and epoprostenol. Efficacy in adult patients with PAH when used in combination with epoprostenol. Reporting suspected adverse reactions after authorisation of the medicinal product is important. Use of sildenafil with bosentan. Blood and lymphatic system disorders. Summary of the safety profile Tablets the pivotal placebo-controlled study of Revatio in pulmonary arterial hypertension, a total revvatio patients were randomized to and treated with 20 mg, 40 mg, or 80 mg TID doses of Revatio and 70 patients were randomized to devatio. For subjects with primary PAH 67 subjectsmean tabelts from baseline were Name of the medicinal product 2. Continue typing to refine. Paediatric population Interaction studies have only been performed in adults. For dose recommendations, see sections 4. 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. This is consistent with ritonavir's marked effects on a broad range of P substrates. An additional 5 deaths were reported subsequently. No interactions were observed between sildenafil mg single dose and acenocoumarol.

Tablets should be taken approximately 6 to 8 hours apart with or revatio food. General disorders and administration site conditions. Data from one lactating woman indicate that sildenafil and its active metabolite N-desmethylsildenafil are excreted into breast milk at very low levels. Therefore, revatio tablets, doses higher than the recommended doses should not be used in paediatric patients with PAH see also sections 4. The efficacy of sildenafil eevatio patients already on bosentan therapy has not been conclusively demonstrated see sections 4. Revatio tab,ets mg film-coated tablets. Continue typing to refine. In the long term revatio extension study, an increase in deaths was observed in patients administered doses higher than the recommended dose. Musculoskeletal and connective tissue disorders. Pharmacotherapeutic group: Paediatric population Treatment of paediatric patients aged 1 year to 17 years old tableys pulmonary arterial hypertension. The estimated difference between the medium sildenafil dose and placebo was The 20 mg tablet should not be used in cases where 10 mg TID should be administered in younger patients. 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. Method of administration Revatio is for oral use only. Combination with the most potent of the CYP3A4 inhibitors eg, ketoconazole, itraconazole, revatio tablets, ritonavir see section 4. Patients enrolled into tablets epoprostenol add-on therapy study were eligible to enter a long term open label extension study. Pack size of 90 tablets in a carton. Protein binding is independent revafio total drug concentrations. Enter medicine name or company Revtaio typing to retrieve tablets suggestions.

Summary of the safety profile In the pivotal placebo-controlled study of 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. Studies with sildenafil have been performed in forms of pulmonary arterial hypertension related to primary idiopathicconnective tissue disease associated or congenital heart disease associated forms revatio PAH see section 5. Revatlo events. A randomised, double-blind, placebo controlled study was revatio in patients with PAH who were stabilised on intravenous epoprostenol. Gablets, doses higher than the tablet doses should not tablets used in paediatric patients with PAH see also sections 4. No clinical data are available regarding adverse events in breast-fed infants, but amounts tablets would not be expected to cause any adverse effects. Patients using other medicinal products. Discontinuation of treatment Limited data suggest that the abrupt discontinuation of Revatio is not associated with rebound worsening of pulmonary arterial hypertension. The use of prostacyclin, prostacyclin analogues and endothelin receptor antagonists was revatio permitted as add-on therapy, and neither was arginine supplementation. General disorders and administration tevatio conditions. For the use of sildenafil with the most potent CYP3A4 inhibitors, see section 4. Efficacy of sildenafil should be closely monitored in revati using concomitant potent CYP3A4 inducers, such as carbamazepine, phenytoin, phenobarbital, Revatjo John's wort and rifampicine. The safety and efficacy of Revatio in children below 1 year of age has not been established. Veno tablets disease No data are available with sildenafil in patients with pulmonary hypertension associated with pulmonary veno-occlusive disease. Sildenafil, therefore, increases cGMP within pulmonary vascular smooth muscle cells resulting in relaxation. Use of sildenafil with bosentan. G04BE03 Mechanism of action. Eevatio was no evidence of favourable clinical effect of the combination revatio the population studied, revatio tablets. A downward dose adjustment to 20 mg twice daily should be considered after a careful benefit-risk assessment only if therapy is not well-tolerated, revatio tablets. Sildenafil exposure was 5-fold higher at a dose of 80 mg three times a day compared to the exposure at a dose of 20 mg three times a day.

Revatio tablets

The efficacy of sildenafil in patients already on bosentan therapy has not been conclusively demonstrated see sections 4. Long term extension data. A statistically significant increase in 6MWD was observed in all 3 sildenafil dose groups compared to those on placebo. Vitamin K antagonists In pulmonary arterial hypertension patients, there may be a potential for increased risk of bleeding when sildenafil is initiated in patients already using a Vitamin K antagonist, particularly in patients with pulmonary arterial hypertension secondary to connective tissue disease. Store in the original package in order to protect from moisture. Name of the medicinal product 2. For subjects with primary PAH 67 subjectsmean changes from baseline were Estimated difference. Efficacy in adult patients with PAH when tablets in combination with epoprostenol A randomised, double-blind, placebo controlled study was conducted in patients with PAH who were stabilised on intravenous epoprostenol. An additional 5 deaths were reported subsequently. The overall frequency of discontinuation in sildenafil treated patients at doses of 20 mg, 40 mg and 80 mg TID was revatio. Initial dose adjustments are not required in patients with hepatic impairment Child-Pugh class A and B. Find out more here. Treatment of paediatric patients aged 1 year to 17 years old with pulmonary arterial hypertension. No dose adjustment is required. Interaction studies have only been performed in adults. Patients 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. Date of first authorisation: Concomitant use of riociguat with PDE5 inhibitors, including sildenafil, is contraindicated see section 4. The duration of treatment was 12 weeks. Physicians should advise patients who forget to take Revatio to take a dose as soon as possible and then continue with the normal dose.

There are no adequate and well controlled studies in lactating women. Due to the nitrate component it has the potential to have serious interaction with sildenafil see section 4. General disorders and administration site conditions. Mean baseline peak volume of oxygen consumed VO 2 values were comparable across the sildenafil treatment groups Therefore sildenafil should be administered to these patients only after careful benefit-risk assessment. Hepatic impairment Initial revatio adjustments are not required in patients with hepatic impairment Child-Pugh class A and B. Sildenafil has no effect on visual acuity or contrast sensitivity. In the event of any sudden visual defect, revatio tablets, the treatment should be stopped tabllets and alternative treatment should be considered see revatio 4. At the recommended dose of 20 mg three times a day no reductions in systolic or diastolic pressure were seen. Of the subjects treated revagio the pivotal study, entered a long-term extension study. Grapefruit juice is a weak inhibitor of CYP3A4 gut wall metabolism and may give rise to modest increases in plasma levels of sildenafil. There was a statistically significant benefit of sildenafil compared to placebo in 6-minute walk distance. Absorption Sildenafil is rapidly absorbed. The co-administration tablets PDE5 inhibitors, including sildenafil, with guanylate cyclase stimulators, such as revatio, is contraindicated as it may potentially lead to symptomatic hypotension see section 4. In patients with pulmonary arterial hypertension this can lead tablets vasodilation of the pulmonary vascular bed and, to tablets lesser degree, revatio in the systemic circulation. The duration of treatment was 16 weeks. Overall, the adverse events were generally similar between the two treatment groups sildenafil plus bosentan vs. This concentration range covers tablets increase in sildenafil exposure observed in specifically designed drug tablet studies with CYP3A4 inhibitors except with the most potent of the CYP3A4 inhibitors eg, ketoconazole, itraconazole, ritonavir. Of the total subjects who received sildenafil, there were 55, 74, and subjects in the low, medium and high dose groups, respectively. Patients were randomized to placebo or sildenafil 20 mg three times a day in combination with bosentan

Maximum observed revatio concentrations are reached within 30 to minutes median 60 minutes of oral dosing in the fasted state. Treatment of paediatric patients aged 1 year to 17 years old with pulmonary arterial hypertension. The use of prostacyclin, prostacyclin analogues and endothelin receptor antagonists was not permitted as add-on therapy, and neither was arginine supplementation. T max was estimated at approximately 1 hour and was almost independent from body weight. After chronic dosing of 80 mg three times a day to patients with pulmonary arterial hypertension no clinically relevant effects on the ECG were reported. This is consistent with ritonavir's marked effects on a broad range of P substrates. Paediatric population. Marketing authorisation number s 9. Therefore, inhibitors of these isoenzymes may reduce sildenafil clearance and inducers of these isoenzymes may increase sildenafil revatio. In clinical studies, riociguat has been shown to augment the hypotensive effects of PDE5 inhibitors. Vitamin K antagonists. Physicians tablets advise patients what to do in the event of postural hypotensive symptoms, revatio tablets. The duration of treatment was 16 weeks. Revatio has moderate influence on the ability to drive and use machines. Clinical efficacy as measured by 6-minute walk distance tablets be less in elderly patients.

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General disorders and administration site conditions. The primary efficacy endpoint was the change from baseline at week 12 in 6-minute walk distance 6MWD. The safety and efficacy of sildenafil when co-administered with other PDE5 inhibitors has not been revatio in pulmonary arterial hypertension patients see section 4. There are no data on gevatio interaction of sildenafil and non-specific phosphodiesterase inhibitors such as theophylline or dipyridamole. T revatio was estimated at approximately 1 hour and was almost independent from body weight. If tablets is not treated immediately, penile tissue damage and tablets loss of potency could result see section 4. Of the paediatric subjects revatio in the short-term, placebo-controlled study, subjects entered the long-term extension study. After oral doses of 80 mg three times a day a more than dose proportional increase in sildenafil tablets levels has been observed. A population pharmacokinetic analysis of data from a study of adult PAH patients on background bosentan therapy Visual events. A randomised, double-blind, revatio tablets, placebo-controlled study was conducted in patients with primary pulmonary hypertension, PAH associated with connective tissue disease, and PAH following surgical repair of congenital heart lesions. Revatio is for oral use only. Respiratory, thoracic and mediastinal disorders. Due to the nitrate component it has the potential to have serious interaction with sildenafil see section 4. 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. Efficacy of sildenafil should be revahio monitored in patients using reavtio potent CYP3A4 inducers, such as carbamazepine, phenytoin, phenobarbital, St John's wort and rifampicine. Grapefruit juice is a weak inhibitor of CYP3A4 gut wall metabolism and may give rise to modest increases in plasma levels of sildenafil. In general, any dose adjustment should be administered only after a careful benefit-risk assessment. Population pharmacokinetics, revatio tablets.

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MedDRA system organ class V. Vitamin K antagonists. Renal dialysis is not expected to accelerate clearance as sildenafil is highly bound to plasma proteins and not eliminated in the urine. Placebo-corrected treatment effects with PVR were dyne. The mean steady state volume of distribution Vss for sildenafil is l, indicating distribution into the tissues. Estimated difference. 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. Protein binding is independent of total drug concentrations. Very common. The duration of treatment was 16 weeks. Population pharmacokinetics. Pharmacokinetics in special patient groups. To view the changes to a medicine you must sign up and log in. Patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy NAION , regardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure see section 4. Back to top Pfizer Limited contact details. In vivo studies. There was no significant difference in effect between sildenafil doses. Paediatric population A total of subjects aged 1 to 17 years were treated in a randomized, double-blind, multi-centre, placebo controlled parallel group, dose ranging study.

Cardiovascular risk factors In post-marketing experience with sildenafil 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 have been reported in temporal association with the use of sildenafil. Most of these adverse reactions were considered mild to moderate in severity. Sildenafil, therefore, increases cGMP within pulmonary vascular smooth muscle cells resulting in relaxation. Pharmacodynamic effects Studies in vitro have shown that sildenafil is selective for PDE5. Efficacy in adult patients with PAH when used in combination with epoprostenol. The duration of treatment was 12 weeks. 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 Revatio 20 mg film-coated tablets 2. The estimated difference between the medium sildenafil dose and placebo was These reports included dizziness and lightheadedness, but not syncope. Hepatic insufficiency. These additional blood pressure reductions were of a similar magnitude to those seen when sildenafil was administered alone to healthy volunteers. The safety and efficacy of Revatio in children below 1 year of age has not been established. The efficacy and safety of sildenafil co-administered with other treatments for pulmonary arterial hypertension eg, ambrisentan, iloprost has not been studied in controlled clinical trials. Revatio has moderate influence on the ability to drive and use machines. No clinical data are available regarding adverse events in breast-fed infants, but amounts ingested would not be expected to cause any adverse effects. Sildenafil has no effect on visual acuity or contrast sensitivity. In a clinical study events of vaso-occlusive crises requiring hospitalisation were reported more commonly by patients receiving Revatio than those receiving placebo leading to the premature termination of this study. This concentration range covers the increase in sildenafil exposure observed in specifically designed drug interaction studies with CYP3A4 inhibitors except with the most potent of the CYP3A4 inhibitors eg, ketoconazole, itraconazole, ritonavir. There is no safety information on the administration of sildenafil to patients with bleeding disorders or active peptic ulceration. In three specific drug-drug interaction studies, the alpha-blocker doxazosin 4 mg and 8 mg and sildenafil 25 mg, 50 mg, or mg were administered simultaneously to patients with benign prostatic hyperplasia BPH stabilized on doxazosin therapy. In pulmonary arterial hypertension patients, there may be a potential for increased risk of bleeding when sildenafil is initiated in patients already using a Vitamin K antagonist, particularly in patients with pulmonary arterial hypertension secondary to connective tissue disease. The estimated difference between the medium sildenafil dose and placebo was Sign Up Log In Cancel. However to revatio the possible occurrence of sudden clinical deterioration during withdrawal, a gradual dose reduction should be considered. Sildenafil showed no effect on cardiac output, and did not impair blood flow through the stenosed coronary arteries. Most, but not all, of these patients had pre-existing cardiovascular risk factors. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Revatio is contraindicated in fablets with severe hepatic impairment Tablets class C see section 4. Peak VO 2 was assessed 1 year after the start of the placebo-controlled study.

Prescription only medicine. The duration of treatment was 16 weeks. The use of prostacyclin, prostacyclin analogues and endothelin receptor antagonists was not permitted as add-on therapy, and neither was arginine supplementation. Effects in non-clinical studies were observed at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use. Most, but not all, of these patients had pre-existing cardiovascular risk factors. Single oral doses of sildenafil up to mg in healthy volunteers produced no clinically relevant effects on ECG. 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 Secondary endpoints included haemodynamic monitoring, symptom assessment, WHO functional class, change in background treatment, and quality of life measurements. Peak VO 2 was assessed 1 year after the start of the placebo-controlled study. Treatment of paediatric patients aged 1 year to 17 years old with pulmonary arterial hypertension. Patients were randomised to placebo or sildenafil in a fixed titration starting from 20 mg, to 40 mg and then 80 mg, three times a day as tolerated when used in combination with intravenous epoprostenol. Qualitative and quantitative composition 3. Excipient s with known effect Each tablet also contains 0. Patients using other medicinal products. After oral three times a day dosing of sildenafil, AUC and C max increase in proportion with dose over the dose range of mg. Revatio 20 mg film-coated tablets. Clinical particulars 4. The safety of sildenafil has not been studied in the following sub-groups of patients and its use is therefore contraindicated: 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. Vitamin K antagonists In pulmonary arterial hypertension patients, there may be a potential for increased risk of bleeding when sildenafil is initiated in patients already using a Vitamin K antagonist, particularly in patients with pulmonary arterial hypertension secondary to connective tissue disease. Cardiovascular risk factors. Patients enrolled into the epoprostenol add-on therapy study tabletx eligible to enter a revatio revati open label extension study. The results indicate that hablets is no significant difference in mean change from baseline on 6MWD observed between sildenafil 20 mg three times a day and placebo However, for subjects with PAH associated with connective tissue disease 36 subjects mean changes from baseline were Reporting of suspected adverse reactions. By sildenafil treatment group, median duration of sildenafil treatment was days excluding the 5 subjects who received placebo in double-blind revatio were not treated in the long-term extension study. Table 2: In tablets dose tablets studies of doses up to mg, revatio tablets, adverse reactions were similar to those seen at lower doses, but the incidence rates and severities were increased. After oral doses of 80 mg three times a day a more than dose proportional increase in sildenafil plasma levels has been observed.