Revatio 20 Mg Film-coated Tablets

Tablets should be taken revatio 6 to 8 hours apart with or without food. Paediatric population. The effect of sildenafil on mortality is unknown. As dizziness and altered vision were reported in clinical trials with sildenafil, patients should be aware of how tablets might be affected by Revatio, before driving or using machines. The causes of deaths were related to PAH. There was a statistically significant benefit of sildenafil compared to placebo in 6-minute walk distance. Treatment should only be initiated and monitored by a physician experienced in the treatment of pulmonary arterial hypertension, revatio tablets. Maximum observed plasma concentrations are reached within 30 to minutes median 60 minutes of oral dosing in the fasted state. Use of sildenafil with bosentan The efficacy of sildenafil in patients already on bosentan therapy has not been revatio demonstrated see sections 4. However, for subjects with PAH associated tablets connective tissue disease 36 subjects mean changes from baseline were Each film-coated tablet contains 20 mg of sildenafil as citrate. Protein binding is independent of total drug concentrations. Prescription only medicine. Data from one lactating woman indicate that sildenafil and its active metabolite N-desmethylsildenafil are excreted into breast milk at very low levels. When analysed by WHO functional class, a statistically significant revatio in 6MWD tablets observed in the 20 mg dose group. In vivo studies 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. Paediatric population 1 year to 17 years. In the event of any sudden visual defect, the treatment should be stopped immediately and alternative treatment should be considered see section 4. Long-term Survival Data in the background epoprostenol study Patients enrolled into the epoprostenol add-on therapy tablets were eligible to revatio a long term open label extension study. Visual events Cases of visual defects have been reported spontaneously in connection with the intake of sildenafil and other PDE5 inhibitors. Sildenafil had no effect on saquinavir pharmacokinetics.

Use of sildenafil with bosentan The efficacy of revatio in patients already on bosentan therapy has not revatio conclusively demonstrated see sections 4. Pack size of tablets in a carton. The major circulating metabolite results from N-demethylation of sildenafil. The safety of sildenafil tablets not been studied in the following sub-groups of patients and its use is therefore contraindicated: Preclinical studies showed additive systemic blood pressure lowering effect when Revatoo inhibitors were combined with riociguat. Urologicals, Drugs used in erectile dysfunction, ATC code: Prescription only medicine. For subjects with primary PAH 67 subjectsmean changes from baseline were In the pivotal placebo-controlled study of Revatio in pulmonary arterial hypertension, a total of patients were randomized to tablets treated with yablets mg, 40 mg, or revattio mg TID doses of Revatio and 70 patients were randomized to placebo. 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. The safety of sildenafil has not 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. Sildenafil exposure was 5-fold higher at a dose of 80 mg three times a day revayio to the exposure at a dose of 20 mg three times a day. Revatio and connective tissue disorders. The use of sildenafil in other forms of PAH is not recommended. Revatio is for tablets use only. Reporting suspected adverse reactions after authorisation of the medicinal product is important. Data from one lactating woman indicate that sildenafil and its active metabolite N-desmethylsildenafil are excreted into breast milk at very low levels. 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. Prescription-only medicinal product Detailed information on this medicinal product is available on the website of the European Medicines Agency http: SmPC Patient Leaflet. The 20 mg tablet should not be used in cases where 10 mg TID should be administered in younger patients. Company contact details Pfizer Limited. The results indicate that there is no significant difference in mean change from baseline on 6MWD observed between sildenafil 20 tbalets three times a day and placebo Sildenafil or placebo was added to patients' background therapy which could revatio included a combination of anticoagulation, digoxin, calcium tablets blockers, diuretics or oxygen. Paediatric population From the analysis of the pharmacokinetic profile of sildenafil in patients involved in the paediatric clinical trials, body weight was shown to be a good predictor of drug exposure in children.

Reproductive system and breast disorders. Prescription-only medicinal product Detailed information on this medicinal product is available on the website of the European Medicines Agency http: Efficacy revatio adult patients with PAH when used in combination with epoprostenol. Visual events Cases of visual defects have been reported spontaneously in connection with the intake of sildenafil and other PDE5 inhibitors. Revatio has moderate influence on the ability to drive and use machines. In a clinical study events of vaso-occlusive crises requiring hospitalisation were reported more commonly by patients receiving Revatio than those receiving placebo revatio to the premature termination of this study. Prescription only medicine. Use of sildenafil with bosentan The efficacy of sildenafil in patients already on bosentan therapy has not been conclusively demonstrated see sections 4. Continue typing to refine. Pregnancy There are no data from the use of sildenafil in pregnant women. Maximum observed plasma concentrations are reached within 30 to minutes median 60 minutes of oral dosing in the fasted state. Non-clinical data revealed no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential, toxicity to reproduction and development. The pharmacokinetics of sildenafil in patients with severely impaired hepatic function have not been studied. The N-desmethyl metabolite is further metabolised, with a terminal half-life of approximately 4 h. Dose adjustments are not required in elderly patients. Protein binding is independent of total drug concentrations. The primary endpoint was the placebo-corrected percentage change in peak VO 2 from baseline to week 16 assessed revatio CPET testing in the combined dose groups Tablets 2. Placebo-corrected treatment effects with PVR were dyne. The duration of treatment was 12 weeks. Veno -occlusive disease No data are available with sildenafil in tablets with pulmonary hypertension associated tablets pulmonary veno-occlusive disease. CYP3A4 inhibitors like clarithromycin, telithromycin and nefazodone are tablets to have an effect in between that of ritonavir and CYP3A4 inhibitors like saquinavir or erythromycin, a seven-fold increase in exposure is assumed. Hypersensitivity to the active substance or to any of the excipients listed revatio section 6. These additional blood pressure reductions were of a similar magnitude to those seen when sildenafil was administered alone to healthy volunteers. Alpha-blockers Caution is advised when sildenafil is administered to patients taking an alpha-blocker as the co-administration may lead to symptomatic hypotension in susceptible individuals see section 4. Breast-feeding There are no adequate and well controlled studies in lactating women.

This is consistent with ritonavir's marked effects on a broad range of P substrates. Pack size of 90 tablets in a carton. The safety and efficacy of sildenafil when co-administered with other PDE5 inhibitors has not been studied in pulmonary arterial hypertension patients see section 4. 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. 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. CYP3A4 inducers seemed to have a substantial impact on the pharmacokinetics of sildenafil in pulmonary arterial hypertension patients, which was confirmed in the in-vivo interaction study with CYP3A4 inducer bosentan. The postulated mechanism for this change in colour discrimination is related to inhibition of PDE6, which is involved in the phototransduction cascade of gevatio retina. Long-term survival data in naive population Patients enrolled into the pivotal study were eligible to enter tablets long term open label extension study. Concomitant use with other PDE5 inhibitors The safety and efficacy of sildenafil when co-administered with other PDE5 revatio products, including Viagra, has not been studied tanlets PAH patients and such concomitant use is not recommended see section 4. Bleeding disorders 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 tab,ets assessment. Hypersensitivity to the active substance or to any of the excipients listed in section 6. The population pharmacokinetic analysis in pulmonary arterial hypertension tablets suggested that co-administration of beta-blockers tabkets combination with CYP3A4 substrates might result in an additional increase in sildenafil exposure compared with administration of CYP3A4 substrates alone. General disorders and administration site conditions. Physicians should advise patients who forget to take Revatio to take a dose as soon as possible and then continue with the normal dose. Pharmacological properties 5. Effects of sildenafil on other medicinal products. Placebo-corrected treatment effects with PVR were dyne. 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 were no adverse reactions, with possible relevance to clinical use, seen in animals at clinically relevant exposure levels which were not also observed in clinical studies. 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, revatio tablets. Use of sildenafil with bosentan. There are no data on the interaction of sildenafil and non-specific phosphodiesterase inhibitors such as theophylline or revatio. Patients with rare hereditary problems of tblets intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Revatio tablets

Sildenafil or placebo was tablets to patients' background therapy which could have included a combination of anticoagulation, digoxin, calcium channel blockers, diuretics or oxygen. Revatio 20 mg film-coated tablets. The duration of treatment was 12 weeks. Skin and subcutaneous tissue disorders. These additional blood pressure reductions were of a similar magnitude to those seen when sildenafil was revatio alone to healthy volunteers, revatio tablets. Very common. Actual doses administered within a group were dependent on body weight see Section 4. The 20 mg tablet should not be used in cases where 10 mg TID should be administered tablets younger patients. 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. Retinitis pigmentosa. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Pharmaceutical particulars 6. For dose recommendations, see section 4. CYP3A4 inducers seemed to have a substantial impact on the pharmacokinetics of sildenafil in pulmonary arterial hypertension patients, which was confirmed in the in-vivo interaction study with CYP3A4 inducer bosentan. Patients using other medicinal products. Galactose intolerance Lactose monohydrate is present in the tablet film coat. Continue typing to refine. Effects in non-clinical studies were observed at exposures considered sufficiently in excess of the maximum human exposure indicating revatio relevance to clinical use. For patients with primary PAH, the treatment effect was Higher than recommended doses should not be used in paediatric patients with PAH see also sections 4. From the analysis of the pharmacokinetic profile of sildenafil in patients involved in the paediatric clinical trials, body weight was shown to be a good predictor of drug exposure in children. Qualitative and quantitative composition Each film-coated tablet contains 20 mg of sildenafil as citrate.

Bleeding disorders Studies with human platelets indicate that sildenafil potentiates the antiaggregatory effect of sodium nitroprusside tablets vitro. The respective odds ratios were 2. This information is intended for use by health professionals. The co-administration of PDE5 inhibitors, including sildenafil, with guanylate cyclase stimulators, such as riociguat, revatio tablets, is contraindicated as it may potentially lead to symptomatic hypotension see section 4. Patients on all sildenafil doses achieved a statistically significant reduction in mean pulmonary arterial tablets mPAP and pulmonary vascular resistance PVR compared to those on placebo. No dose adjustment is required. When sildenafil and doxazosin were administered simultaneously to patients stabilized on doxazosin therapy, there were infrequent reports of patients who experienced symptomatic postural hypotension. Significant improvements in functional class were demonstrated only in subjects on sildenafil high dose compared to placebo. 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. This is consistent with ritonavir's marked effects on a broad range of P substrates. Due to lack revatio data on effects of Revatio in pregnant women, Revatio is not recommended for women of childbearing potential unless also using appropriate contraceptive measures. There was no significant difference in effect between sildenafil doses. Tabulated list of adverse reactions. The safety and efficacy of sildenafil when co-administered with other PDE5 inhibitors has not been studied in pulmonary revatio hypertension patients see section 4. Last updated on eMC:

Tabulated list of adverse reactions. Revatio 20 mg film-coated tablets 2. MedDRA system organ class V. Effects in non-clinical studies were observed at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use. Microcrystalline cellulose Calcium hydrogen phosphate anhydrous Croscarmellose sodium Magnesium stearate Film coat: A greater percentage of patients on each of the sildenafil doses i. 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. Revatio is contraindicated in patients with severe hepatic impairment Child-Pugh class C see section 4. Actual doses administered within a group were dependent on body weight see Section 4. Use of sildenafil with bosentan. Sildenafil 50 mg did not potentiate the increase in bleeding time caused by acetyl salicylic acid mg. Use of sildenafil with bosentan The efficacy of sildenafil in patients already on bosentan therapy has not been conclusively demonstrated see sections 4. Sildenafil has no effect on visual acuity or contrast sensitivity. The sildenafil medium and high dose groups displayed mPAP changes from baseline compared to placebo, of Alpha-blockers Caution is advised when sildenafil is administered to patients taking an alpha-blocker as the co-administration may lead to symptomatic hypotension in susceptible individuals see section 4. The difference in results between these randomisation subgroups may have arisen by chance in view of their limited sample size. Of the subjects who completed the initial study, entered a long-term extension study. In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance. Discontinuation of treatment. Due to lack of data on effects of Revatio in pregnant women, Revatio is not recommended for women of childbearing potential unless also using appropriate contraceptive measures. An additional 5 deaths were reported subsequently. Revatio 20 mg film-coated tablets. Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease.

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Film-coated tablet. In healthy male volunteers, there was no evidence of an effect of azithromycin mg daily for 3 days on the AUC, C max , T max , elimination rate constant, or subsequent half-life of sildenafil or its principal circulating metabolite. Treatment should only be initiated and monitored by a physician experienced in the treatment of pulmonary arterial hypertension. Pharmacotherapeutic group: CYP3A4 inhibitors like clarithromycin, telithromycin and nefazodone are expected to have an effect in between that of ritonavir and CYP3A4 inhibitors like saquinavir or erythromycin, a seven-fold increase in exposure is assumed. There are no data on the interaction of sildenafil and non-specific phosphodiesterase inhibitors such as theophylline or dipyridamole. The safety and efficacy of sildenafil when co-administered with other PDE5 inhibitors has not been studied in pulmonary arterial hypertension patients see section 4. The overall frequency of discontinuation in sildenafil treated patients at doses of 20 mg, 40 mg and 80 mg TID was 2. To view the changes to a medicine you must sign up and log in. Of the total subjects who received sildenafil, there were 55, 74, and subjects in the low, medium and high dose groups, respectively. At single doses of mg the incidence of adverse reactions headache, flushing, dizziness, dyspepsia, nasal congestion, and altered vision was increased. Sildenafil is rapidly absorbed. No clinical data are available regarding adverse events in breast-fed infants, but amounts ingested would not be expected to cause any adverse effects. Hypromellose Titanium dioxide E Lactose monohydrate Glycerol triacetate. To bookmark a medicine you must sign up and log in. Method of administration Revatio is for oral use only. Retinitis pigmentosa The safety of sildenafil has not 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. Sildenafil plasma concentration half-life values were estimated to range from 4. The primary efficacy endpoint was the change from baseline at Week 12 in 6MWD. Long-term survival data in naive population Patients enrolled into the pivotal study were eligible to enter a long term open label extension study.

Method of administration Revatio is for oral use only. Many events were reported to occur during or shortly after sexual intercourse and a few were reported to occur shortly after the use of sildenafil without sexual activity. The most common adverse reactions reported across the duration of the short-term and long-term studies were generally similar to those observed in the short-term study. Therefore, caution is recommended in case of co-administration. Tablets should be taken approximately 6 to 8 hours apart with or without food. Mean baseline peak volume of oxygen consumed VO 2 values were comparable across the sildenafil treatment groups Studies with human platelets indicate that sildenafil potentiates the antiaggregatory effect of sodium nitroprusside in vitro. 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 causes mild and transient decreases in systemic blood pressure which, in the majority of cases, do not translate into clinical effects. In vivo studies No significant interactions were shown when sildenafil 50 mg was co-administered with tolbutamide mg or warfarin 40 mg , both of which are metabolised by CYP2C9. 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. Data from one lactating woman indicate that sildenafil and its active metabolite N-desmethylsildenafil are excreted into breast milk at very low levels. Pharmaceutical form Film-coated tablet. Pack size of 90 tablets in a carton. 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 The N-desmethyl metabolite is further metabolised, with a terminal half-life of approximately 4 h. Priapism 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. A mean placebo-corrected treatment effect of 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. Back to top Pfizer Limited contact details. The difference in results between these randomisation subgroups may have arisen by chance in view of their limited sample size. Physicians should advise patients what to do in the event of reevatio hypotensive symptoms.

Time to clinical worsening was a secondary endpoint as defined as the time from randomisation to the first occurrence of a clinical worsening event death, lung transplantation, initiation of bosentan therapy, or clinical deterioration requiring a change in epoprostenol therapy. 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. Active ingredient sildenafil citrate. Clinical efficacy as measured by 6-minute walk distance could be less in elderly patients. In healthy male volunteers, there was no evidence of an effect of azithromycin mg daily for 3 days on the AUC, C max , T max , elimination rate constant, or subsequent half-life of sildenafil or its principal circulating metabolite. After oral three times a day dosing of sildenafil, AUC and C max increase in proportion with dose over the dose range of mg. Consequently, should signs of pulmonary oedema occur when sildenafil is administered in patients with pulmonary hypertension, the possibility of associated veno-occlusive disease should be considered. When analysed by WHO functional class, a statistically significant increase in 6MWD was observed in the 20 mg dose group. 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. Clinical efficacy and 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, and PAH following surgical repair of congenital heart lesions. The safety of sildenafil has not been studied in the following sub-groups of patients and its use is therefore contraindicated: Store in the original package in order to protect from moisture. Find out more here. Studies in animals have shown toxicity with respect to postnatal development see section 5. Revatio 20 mg film-coated tablets. For dose recommendations, see section 4. In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance. Grapefruit juice is a weak inhibitor of CYP3A4 gut wall metabolism and may give rise to modest increases in plasma levels of sildenafil. Retinitis pigmentosa. If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result see section 4. Method of administration. Patients enrolled into the epoprostenol add-on therapy study were eligible to enter a long term open label extension study. Nicorandil is a hybrid of potassium channel activator and nitrate. Visual events Cases of visual defects have been reported spontaneously in connection with the intake of sildenafil and other PDE5 inhibitors. Sign Up Log In Cancel. Urologicals, Drugs used in erectile dysfunction, ATC code: No tablets were revatio tablts sildenafil mg single dose and acenocoumarol. For the full list of excipients, see section 6. In vivo studies 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. In the long term paediatric extension study, revatio tablets, an increase in deaths was observed in patients administered doses higher than the recommended dose.