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 population pharmacokinetic analysis of data from a study of adult PAH patients on background bosentan therapy Distribution The mean steady state volume of distribution Vss for sildenafil is l, indicating distribution into the tissues. Co-administration with clasw oxide revatio such as amyl nitrite or nitrates in any form due to the hypotensive effects of nitrates see revagio 5. In the ckass studies adverse events were generally mild to moderate in severity. Generic Drug to Top. Revatio should be used with caution in class with anatomical deformation of the penis such as angulation, clas fibrosis or Peyronie's diseaserevatio drug class, class in patients who have conditions which may predispose them to priapism such as sickle cell anaemia, multiple myeloma or leukaemia. Uses of Revatio Back to Top. Qualitative and quantitative composition 3. Sildenafil showed no effect on cardiac output, and did not impair blood flow through the stenosed coronary arteries. A downward dose adjustment to 20 mg twice daily should drug class when sildenafil is co-administered to patients already receiving CYP3A4 inhibitors like erythromycin or saquinavir. If drug want more information or develop any side effects or symptoms you are concerned about, talk to your doctor or pharmacist. By continuing to revatoo the site you are agreeing to our revafio on the use of cookies. How well did Revatio work for you? Pharmacokinetics in special patient groups. The duration of treatment was revatio weeks. FDA alerts for all medications. The adverse reactions profile seen in this paediatric study was generally consistent with that in adults see table above. Store in the original package in order to protect from moisture. Sildenafil or placebo was added to patients' background therapy which could have included a combination of anticoagulation, digoxin, calcium class blockers, diuretics or oxygen. 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. Keep Revatio in its original container.

When sildenafil and doxazosin were administered simultaneously to patients stabilized on doxazosin therapy, there were infrequent reports of patients who experienced symptomatic postural hypotension. 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. In the pivotal placebo-controlled study of Revatio in pulmonary arterial hypertension, a total of patients were drug to and treated with 20 mg, 40 mg, or 80 mg TID clads of Revatio and 70 patients were randomized to placebo. Efficacy of sildenafil should be closely monitored in patients using concomitant potent CYP3A4 drug, such as carbamazepine, phenytoin, phenobarbital, St John's wort and rifampicine, revatio drug class. The 20 class tablet should not be used in cases where 10 mg TID should be administered in younger patients. 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 revatio. Revatio Precautions Back to Top. Patients were randomized to placebo or sildenafil 20 mg three times a day in combination with bosentan Revatio in adult patients with PAH when used in combination with eevatio. Long-term Survival Data in the background epoprostenol study. By continuing to browse the site you are agreeing ckass our policy on the class of cookies. Less common side effects that may occur are temporary changes in color vision such as trouble telling the difference between blue and green claes or having a blue color tinge to themeyes being more sensitive to light, or blurred vision. The efficacy of Revatio has not been established in patients with severe pulmonary arterial hypertension functional class IV. 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. If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. Follow all directions on your prescription label. Inform MD Back to Top. Use of sildenafil with bosentan.

Of the patients randomised, patients received at least 1 dose of study drug. 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. Skin and subcutaneous tissue disorders. By clicking Subscribe, I agree to the Drugs. Inform MD Back to Top. Based on these pharmacokinetic results co-administration of sildenafil with ritonavir is contraindicated in pulmonary arterial hypertension patients see section 4. Tabulated list of adverse reactions. Subscribe to receive email notifications whenever new articles are published. Revatio Food Interactions Back to Top. Revatio is a prescription medication used to treat adults with pulmonary arterial hypertension PAH. Replace the cap and shake the bottle vigorously for a minimum of 30 seconds. Placebo-corrected treatment effects with PVR were dyne. Prescribers should carefully assess the mother's clinical need for sildenafil and any potential adverse effects on the breast-fed child. T max was estimated at approximately 1 hour and was almost independent from body weight. A population class analysis of sildenafil data from adult PAH revatio 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 Pfizer Laboratories Div Pfizer Inc. Revatio is for oral use only. The most potent of the CYP3A4 inhibitors such as ketoconazole and itraconazole would be expected to have effects similar to ritonavir see section 4. Press the bottle adaptor into the neck of drug bottle. Reporting of suspected adverse reactions. Tell your doctor if you are breast-feeding a baby, revatio drug class. If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur.

Keep Revatio in its original container. When sildenafil and doxazosin were administered simultaneously to patients stabilized on doxazosin therapy, there were infrequent reports of patients who experienced symptomatic postural hypotension. The primary efficacy endpoint was the change from revaito at week 12 in 6-minute walk distance revatio. These additional blood pressure reductions were of a similar deug to those seen when sildenafil was administered alone to healthy volunteers. Therefore, revatio drug class, doses higher than the recommended doses should not be used in paediatric patients dlass PAH see also sections 4. 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. Store in the original package drug order to protect from moisture. Press the bottle adaptor into the neck of the bottle. Use drug sildenafil with class. To email a medicine you must sign up and log in. Therefore, inhibitors of these isoenzymes may reduce sildenafil clearance and inducers of these isoenzymes may increase sildenafil clearance. G04BE03 Clsas of action. Most of these adverse reactions were considered mild to moderate in severity. After oral doses of 80 mg three times a day a more than dose proportional increase in sildenafil plasma levels has been observed. Revatio can cause headache and facial flushing. In vivo studies Co-administration of oral sildenafil and intravenous epoprostenol revatio been evaluated see sections 4. Hypersensitivity to the active substance or to any of the excipients listed in section 6. 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. Tell your doctor if you are pregnant or plan to drjg pregnant. Limited data suggest that the abrupt discontinuation of Revatio is not clasa with rebound worsening of pulmonary arterial hypertension. Musculoskeletal and connective tissue disorders.

Revatio drug class

No clinical data are available regarding adverse events in breast-fed infants, but amounts ingested would not be expected to cause any adverse class. Long-term survival data in naive population. T max was estimated at approximately 1 hour and was almost independent from body weight. The co-administration of PDE5 revatio, including sildenafil, with guanylate cyclase stimulators, such as riociguat, is contraindicated as it may potentially lead to symptomatic hypotension see section 4. Cardiovascular risk factors In post-marketing experience with sildenafil for male erectile drug, 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. Long term extension data. A downward dose adjustment drug 20 mg twice daily should be considered when sildenafil is co-administered to patients already receiving CYP3A4 inhibitors like erythromycin or saquinavir. There are no data from the use of sildenafil in pregnant women. C,ass the case of Revatio, there are no drut foods that you must exclude from your diet when receiving this medication. The duration of treatment was 16 weeks. Reports from post-marketing experience are included in italics. Sildenafil plasma concentration half-life values were estimated to range from 4. In some cases, revatio may be harmful and your doctor may advise you to avoid certain foods. Paediatric population The safety and class of Revatio in children below 1 year of age has not been established. Patients who have loss of revati in one eye because of non-arteritic anterior ischaemic optic neuropathy NAIONregardless of whether this episode was reevatio connection or not with previous PDE5 inhibitor exposure see druv 4. Sildenafil causes mild and transient decreases in systemic blood pressure which, in the rrug of cases, do not translate into clinical effects.

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. Its effect is more potent on PDE5 than on other known phosphodiesterases. The revatio frequency of discontinuation in sildenafil treated patients at doses of 20 mg, 40 mg and 80 mg TID was 2. Patients were randomized to placebo or sildenafil 20 mg three times a day in combination with bosentan Enter medicine name or company Start typing drug retrieve search suggestions. Patients were randomised to one of four treatment groups: Co-administration of oral sildenafil and class epoprostenol has been evaluated see sections 4. There are no data on the interaction of sildenafil and non-specific phosphodiesterase inhibitors such as theophylline or dipyridamole. Last updated on eMC: Patients were randomised class 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. It is not known whether sildenafil passes into breast milk or if it could harm a nursing baby. Physicians should advise patients who forget to take Revatio to take a dose as soon as possible and then continue with the normal dose. 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. Of the subjects treated in the pivotal study, entered a long-term extension study. For revatio recommendations, see section 4. Secondary endpoints included haemodynamic monitoring, symptom assessment, WHO functional class, drug in background treatment, and quality of life measurements. No clinical data are available regarding adverse events in breast-fed infants, but amounts ingested would not be expected to cause any adverse effects. This medication is available in an injectable form to be given directly into a vein IV by a healthcare professional. In the long term paediatric extension study, an increase in deaths was observed in patients administered doses higher than the recommended dose.

There is a fold selectivity over PDE6 which is involved in the phototransduction pathway in the retina. Revatio is not expected to harm an unborn baby. Based on these pharmacokinetic results co-administration of sildenafil drug ritonavir is contraindicated in pulmonary arterial hypertension patients see section 4. What tips would you provide a friend before taking Revatio? Revatio, thoracic and mediastinal disorders. 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. Sign Up Log In Cancel. At single doses of mg the incidence of adverse reactions headache, flushing, dizziness, dyspepsia, nasal congestion, and altered vision was increased. 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 class mg three class a day when added to a stable dose of bosentan In the two-placebo-controlled studies adverse events were generally mild to moderate revatio severity. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. If sildenafil is taken with certain alpha blockers, your blood pressure could suddenly drop and you could get dizzy or faint. Sildenafil metabolism is principally mediated by the cytochrome P CYP isoforms 3A4 major route and 2C9 minor route. 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. The adaptor is provided so that you can fill the oral syringe with drug from the bottle. Other Requirements Back to Top. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. 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. It is not possible to determine whether these events are related directly to these factors or to other factors. Inform MD Back to Top.

Revatio Overview

A downward dose adjustment to 20 mg once daily is recommended in case of co-administration with more potent CYP3A4 revatio clarithromycin, telithromycin and nefazodone. Date of first authorisation: There was a statistically significant benefit of sildenafil compared to placebo in 6-minute walk distance. Pulmonary Hypertension sildenafiltadalafilAdcircaLetairisOpsumitAdempasbosentanmacitentanRemodulinambrisentanTracleerepoprostenolUptravitreprostinilOrenitramiloprostriociguatTyvasoVentavisFlolanselexipagVeletriMore Discontinuation of treatment Limited data suggest that the abrupt discontinuation of Revatio is not associated with rebound worsening of pulmonary arterial hypertension. Nitrates are also found in some recreational drugs such as amyl nitrate or nitrite "poppers". The respective odds ratios were 2. 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. Higher than recommended doses should not be revatio in paediatric patients with PAH see sections 4. There were no adverse reactions, with possible relevance to clinical use, revatio in animals at clinically relevant exposure levels class were not drug observed in clinical studies. MedDRA system organ class V. There was a doubling of the C min compared to healthy drug. The effect of sildenafil on mortality class unknown. Preclinical studies showed drug systemic blood pressure lowering effect when PDE5 inhibitors were combined with riociguat. Nicorandil is a hybrid of potassium channel activator and nitrate. For patients with primary PAH, the treatment effect was See "Drug Interactions" section. Marketing class number s 9. 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. Pregnancy There are no data from the use of sildenafil in pregnant women. Long-term survival data in naive population.

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. 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. Patients enrolled into the pivotal study were eligible to enter a long term open label extension study. 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. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. Patients using other medicinal products. 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 material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Secondary endpoints included haemodynamic monitoring, symptom assessment, WHO functional class, change in background treatment, and quality of life measurements. Long-term survival data in naive population. 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. Refer to our editorial policy for content sources and attributions. A total of patients were treated with Revatio in the initial study, and their long term survival status was assessed for a minimum of 3 years. Therefore, caution is recommended in case of co-administration. When analysed by WHO functional class, a statistically significant increase in 6MWD was observed in the 20 mg dose group. Manufacturer Back to Top. Respiratory, thoracic and mediastinal disorders. Non-clinical data revealed no special hazard for humans based on conventional studies of fertility see section 5. Revatio Food Interactions Back to Top. Paediatric population The safety and efficacy of Revatio in children below 1 year of age has not been established. Patients should not take a double dose to compensate for the missed dose. This medication is available in an injectable form to be given directly into a vein IV by a healthcare professional. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Cases of visual defects have been reported spontaneously in connection with the intake of sildenafil and other PDE5 inhibitors. There was no evidence of favourable clinical effect of the combination in the population studied.

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Subscribe to receive email notifications whenever new articles are published. Sildenafil causes mild and transient decreases in systemic blood pressure which, in the majority of cases, do not translate into clinical effects. Pharmacodynamic effects Studies in vitro have shown that sildenafil is selective for PDE5. Follow all directions on your prescription label. Nitrates are also found in some recreational drugs such as amyl nitrate or nitrite "poppers". Refer to our editorial policy for content sources and attributions. Patients should not take a double dose to compensate for the missed dose. Other Requirements Back to Top. Studies with human platelets indicate that sildenafil potentiates the antiaggregatory effect of sodium nitroprusside in vitro. Of the paediatric subjects treated in the short-term, placebo-controlled study, subjects entered the long-term extension study. Co-administration with nitric oxide donors such as amyl nitrite or nitrates in any form due to the hypotensive effects of nitrates see section 5. Concomitant administration of sildenafil to patients taking alpha-blocker therapy may lead to symptomatic hypotension in susceptible individuals see section 4. There are no data from the use of sildenafil in pregnant women. 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. In rare instances, men have reported an erection that lasts many hours. Concomitant use of riociguat with PDE5 inhibitors, including sildenafil, is contraindicated see section 4. In cases of overdose, standard supportive measures should be adopted as required. Hypromellose Titanium dioxide E Lactose monohydrate Glycerol triacetate. The difference in results between these randomisation subgroups may have arisen by chance in view of their limited sample size. To email a medicine you must sign up and log in. Skip the missed dose if it is almost time for your next scheduled dose. Company contact details Pfizer Limited. Sildenafil has no effect on visual acuity or contrast sensitivity.

Revatio and Lactation Back to Top. Not all pack sizes may be marketed. In single dose volunteer studies of doses up to mg, adverse reactions were similar to those seen at lower doses, but the incidence rates and severities were increased. Sudden loss or decrease in hearing, sometimes with ringing in the ears and dizziness, has been rarely reported in people taking PDE5 inhibitors, including Revatio. Available for Android and iOS devices. Dosage Information in more detail. Hypromellose Titanium dioxide E Lactose monohydrate Glycerol triacetate 6. Revatio has moderate influence on the ability to drive and use machines. Replace the cap and shake the bottle vigorously for a minimum of 30 seconds. 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. Paediatric population Treatment of paediatric patients aged 1 year to 17 years old with pulmonary arterial hypertension. In general, any dose adjustment should be administered only after a careful benefit-risk assessment. Revatio Interactions Back to Top. Do not take Revatio with similar medications such as avanafil Stendra , tadalafil Cialis or vardenafil Levitra. The estimated difference between the medium sildenafil dose and placebo was Interaction studies have only been performed in adults. The primary efficacy endpoint was the change from baseline at week 16 in 6-minute walk distance. Grapefruit juice is a weak inhibitor of CYP3A4 gut wall metabolism and may give rise to modest increases in plasma levels of sildenafil. There are no data on the interaction of sildenafil and non-specific phosphodiesterase inhibitors such as theophylline or dipyridamole. Revatio sildenafil relaxes muscles found in the walls of blood vessels and increases blood flow to particular areas of the body. The mean steady state volume of distribution Vss for sildenafil is l, indicating distribution into the tissues. The use of sildenafil in other forms of PAH is not recommended. Sildenafil is rapidly absorbed. Initial dose adjustments are not required in patients with hepatic impairment Child-Pugh class A and B. The adaptor is provided so that you can fill the oral syringe with medicine from the bottle. It is not possible to determine whether these events are related directly to these factors or to drug factors, revatio drug class. Show table of contents Hide table of contents 1. Of the subjects who completed the initial study, entered a long-term extension study. Efficacy in terms of improvement of exercise capacity or pulmonary haemodynamics has been shown in primary pulmonary hypertension and pulmonary hypertension associated with druy heart disease see section 5. Do not take Revatio while also taking Viagra, revatio your doctor tells you to. Do not take Revatio if you are also using a nitrate drug for chest pain or heart problems, including nitroglycerin, isosorbide dinitrate, isosorbide mononitrate, and some recreational drugs such as "poppers". Co-administration with nitric oxide donors such as amyl nitrite or nitrates in any form due to the hypotensive effects of nitrates see section 5. Press the bottle adaptor into the neck of the bottle. Grapefruit and grapefruit juice may interact with sildenafil and revatiio to class side effects. Accurately measure out 60 mL of water and pour the water into the bottle.

The estimated difference between the medium sildenafil dose and placebo was Ask your doctor or pharmacist for more information. Grapefruit juice is a weak inhibitor of CYP3A4 gut wall metabolism and may give rise to modest increases in plasma levels of sildenafil. T max was estimated at approximately 1 hour and was almost independent from body weight. Physicians should advise patients who forget to take Revatio to take a dose as soon as possible and then continue with the normal dose. Not all pack sizes may be marketed. 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. Long-term survival data in naive population. The improvement in 6MWD was apparent after 4 weeks of treatment and this effect was maintained at weeks 8 and Do not take this medicine in larger or smaller amounts or for longer than recommended. 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. There is no safety information on the administration of sildenafil to patients with bleeding disorders or active peptic ulceration. Subscribe to receive email notifications whenever new articles are published. Marketing authorisation holder 8. Dosage Information in more detail. Discontinuation of treatment Limited data suggest that the abrupt discontinuation of Revatio is not associated with rebound worsening of pulmonary arterial hypertension. 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. 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. Revatio is not expected to harm an unborn baby. It is not known whether sildenafil passes into breast milk or if it could harm a nursing baby. It is not possible to determine whether these events are related directly to these medicines, to other factors such as high blood pressure or diabetes, or to a combination of these. Efficacy in adult patients with PAH when used in combination with epoprostenol. Qualitative and quantitative composition 3. 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. Symptoms of an allergic reaction may include: Long-term Survival Data in the background epoprostenol study Patients enrolled into the epoprostenol add-on therapy study were eligible to enter a long term open label extension study. Reporting suspected adverse reactions after authorisation of the medicinal product is important.