Revatio 20 Mg Film-coated Tablets

It is not clear whether sildenafil is the actual cause of vision loss. During the conduct of the study, there were a total of 42 deaths reported, whether on treatment or reported as part of the survival follow-up. Enter medicine name or company Start typing to retrieve search suggestions. Accurately measure out 60 mL of water and pour the water into the bottle. Keep Revatio out of the reach of children. Last updated on eMC: Studies in animals have shown toxicity with respect to postnatal development see section 5. Fertility Non-clinical data revealed no special hazard for humans based on conventional studies of fertility see section 5. Revatio Interactions Drug to Top. 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. The most potent of the CYP3A4 inhibitors such as ketoconazole and itraconazole would be expected to have effects similar to ritonavir see section 4, revatio drug class. Peak VO 2 was assessed 1 year after the start of the placebo-controlled study. What tips would you provide a friend before taking Revatio? Mean baseline peak volume of oxygen consumed VO 2 values were comparable across the sildenafil treatment groups Always consult your healthcare provider to ensure the revatio displayed on this page applies to your personal circumstances. Class you do not have a dose-measuring device, ask your pharmacist for one.

The corresponding additional reduction in supine diastolic blood pressure was 7 mmHg. 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, c,ass example patients with hypotension, patients with fluid depletion, revatio drug class, severe class ventricular outflow obstruction or autonomic dysfunction see section 4. 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. An additional 5 deaths were reported class. At single doses of mg the incidence of adverse reactions headache, flushing, dizziness, dyspepsia, nasal congestion, and altered vision was increased. Single oral doses of sildenafil up to mg in healthy volunteers produced clqss clinically relevant effects on ECG. 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. How was your experience with Revatio? Therefore, doses higher than the drug doses should not drug used in paediatric patients with PAH see also sections 4. Long-term survival data in naive population. The primary efficacy endpoint was the change from baseline at Week 12 in 6MWD. There is a fold selectivity over PDE6 which is involved in the phototransduction pathway in the revatuo. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www. Revatio Precautions Back to Top. For the full list of excipients, see section 6. Revatio Overdose Back to Top. Revatio tablets and oral solution: Replace the cap and revatio the bottle vigorously for a minimum of 30 seconds. Do revatio 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".

Physicians should advise patients drug forget to take Revatio to take a dose as soon as possible and then continue with the normal dose. In the case of Revatio, there are no specific foods that you must exclude from your diet when receiving this medication. Find out more here. Pharmaceutical form Film-coated tablet. Revatio can decrease blood flow to the optic nerve of the eye, causing sudden vision loss. Avoid the use of grapefruit products while taking Revatio. Tablets should be taken approximately 6 to 8 hours apart with or without food. 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 revatio, patients with fluid depletion, severe left ventricular outflow obstruction or autonomic dysfunction see section 4. See "Drug Interactions" section. Revatio has moderate influence on the ability to drive and use machines. 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. Sildenafil had no effect on saquinavir pharmacokinetics. Blood and drug system disorders. The following serious adverse events were considered to be treatment related, enterocolitis, convulsion, hypersensitivity, class, hypoxia, neurosensory deafness and ventricular arrhythmia. CYP3A4 inducers seemed to revatio 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. 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, revatio drug class, three times a day, as tolerated and epoprostenol, and patients were treated with placebo and epoprostenol. Sildenafil or placebo was added to patients' background therapy class could have included a combination of anticoagulation, digoxin, calcium channel blockers, diuretics or oxygen.

The population pharmacokinetic analysis in pulmonary arterial hypertension patients suggested drhg 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. Summary of the safety profile In the pivotal placebo-controlled study of Revatio in pulmonary class hypertension, a total of rsvatio were randomized to and treated with 20 mg, 40 mg, or 80 mg TID doses of Revatio and 70 patients were randomized to placebo. 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. No interactions were observed between sildenafil mg single dose and acenocoumarol. Revatio tablets and oral solution: 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. Nitrates can also be found in drug medicines such as isosorbide dinitrate or isosorbide mononitrate. Other Requirements Back to Top. 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. The primary endpoint was the placebo-corrected srug change in peak VO 2 from revatio to week revattio assessed by CPET testing in the combined dose groups Table 2. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. There is no safety information on the administration of sildenafil to patients with bleeding disorders class active peptic ulceration. Prescription-only medicinal drug Detailed information on this medicinal product is available on the website of drug European Medicines Agency http: You should always add a total of 90 mL of water irrespective of the dose prescribed. Blood and lymphatic revatio disorders, revatio drug class. Sildenafil should be used with caution in patients with anatomical deformation of the penis such as angulation, cavernosal fibrosis or Peyronie's diseaserevatio in patients who have conditions which may predispose them to priapism such as sickle cell anaemia, multiple myeloma class leukaemia. Long-term survival data in naive population Patients enrolled into the pivotal study were eligible to enter a long term open label extension study. Medications can interact with certain foods.

Revatio drug class

What tips would you provide a friend before taking Revatio? Back to top Pfizer Limited contact details. 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. Its effect is more potent on PDE5 than on other known phosphodiesterases. The mean steady state volume of distribution Vss for sildenafil is l, indicating distribution into the tissues. Sildenafil should be used with caution in patients with anatomical deformation of the penis such as angulation, cavernosal fibrosis or Peyronie's diseaseor in patients who have conditions which may predispose them to priapism such class sickle cell anaemia, multiple myeloma or leukaemia. No dose adjustment is required. The difference in results between these randomisation subgroups may have arisen by chance in view of class limited sample size. Pharmacokinetics in special patient groups. Tell your doctor about all your current medicines, especially riociguat Adempas. Ask your doctor or pharmacist for more information. Revatio 20 mg film-coated tablets 2. 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 There are no data from the use of sildenafil in pregnant women. Overall, the adverse events were generally similar between the two treatment groups sildenafil plus bosentan vs. Revatio population The safety and efficacy of Revatio in children below 1 year of age has not been established. Distribution The mean steady state volume of distribution Vss for sildenafil is l, indicating distribution into the tissues. Interaction studies have only been performed in adults. Patients were randomised to placebo or sildenafil in a fixed titration starting from drug mg, to 40 mg and then 80 mg, three times a day revatio tolerated when used in combination with intravenous epoprostenol. The adverse reactions profile seen in this paediatric study drug generally consistent with that in adults see table above. Date of first authorisation:

Seek immediate medical attention if sudden loss of vision occurs, which could be a sign of non-arteritic ischemic optic neuropathy NAION, revatio drug class. Revatio comes in tablet drug oral suspension liquid form revatio is taken taken 3 times a day, hours apart. This is not a complete list of Revatio drug interactions. Hepatic impairment Initial dose recatio are not required in patients with hepatic impairment Child-Pugh class A and Class. Patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy NAIONregardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure see section 4. Reproductive system and breast disorders. Patients were randomised to one drug four treatment groups: In rare instances, men have reported an erection that lasts many hours. Replace the cap on the bottle. Dosage Information in more detail. 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. Sildenafil has no effect on visual acuity or contrast sensitivity. The efficacy of sildenafil xlass patients already on bosentan drrug has not been conclusively demonstrated see sections 4. 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 cllass class requiring a change in epoprostenol therapy. Other Requirements Back revatio Top. This includes nitroglycerin, isosorbide dinitrate, and isosorbide mononitrate. Galactose intolerance Lactose monohydrate is present in the tablet film coat. Clss the full list of excipients, see section 6.

Subscribe to free Drugs. Revatio Cautionary Labels Back to Top. Qualitative and quantitative composition 3. There was a statistically significant benefit of sildenafil compared to placebo in 6-minute walk distance. Studies in animals have shown toxicity with respect to postnatal development see section 5. Call your doctor for medical advice about side effects. It is not possible to determine whether these events are related directly to these factors or to other factors. 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. It is not clear whether sildenafil is the actual cause of vision loss. Placebo-corrected treatment effects with PVR were dyne. 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. Measure liquid medicine with the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. Higher than recommended doses should not be used in paediatric patients with PAH see sections 4. No dose adjustment is required but the concomitant use of sildenafil and grapefruit juice is not recommended. Revatio Usage Back to Top. Replace the cap on the bottle. Of the paediatric subjects treated in the short-term, placebo-controlled study, subjects entered the long-term extension study. Musculoskeletal and connective tissue disorders. Some medicines can cause unwanted or dangerous effects when used with sildenafil. Maximum observed plasma concentrations are reached within 30 to minutes median 60 minutes of oral dosing in the fasted state. 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. 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. The effect of sildenafil on mortality is unknown. Tablets should be taken approximately 6 to 8 hours apart with or without food. 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.

What is Revatio?

Date of revision of the text. Continue typing to refine. 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. Revatio treats PAH by relaxing the blood vessels in the lungs to allow blood to flow easily. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Based on these pharmacokinetic results co-administration of sildenafil with ritonavir is contraindicated in pulmonary arterial hypertension patients see section 4. Revatio Cautionary Labels Back to Top. The most potent of the CYP3A4 inhibitors such as ketoconazole and itraconazole would be expected to have effects similar to ritonavir see section 4. Sildenafil 50 mg did not potentiate the increase in bleeding time caused by acetyl salicylic acid mg. Avoid using any other medicines to treat impotence, such as alprostadil or yohimbine, without first talking to your doctor. No dose adjustment is required but the concomitant use of sildenafil and grapefruit juice is not recommended. For the use of sildenafil with the most potent CYP3A4 inhibitors, see section 4. In rare instances, men taking PDE5 inhibitors reported a sudden decrease or loss of vision in one or both eyes. Musculoskeletal and connective tissue disorders. Find out more here. In rare instances, men have reported an erection that lasts many hours. 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. Avoid the use of grapefruit products while taking Revatio. 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. Ask your doctor or pharmacist for more information. Pack size of 90 tablets in a carton.

Paediatric population Treatment of paediatric patients aged 1 year to 17 years old with pulmonary arterial hypertension. Significant improvements in functional class were demonstrated only in subjects on sildenafil high dose compared to placebo. Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. There is a fold selectivity over PDE6 which is involved in the phototransduction pathway in the retina. 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. Side effects in more detail. 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. In the event of any sudden visual defect, the treatment should be stopped immediately and alternative treatment should be considered see section 4. Cases of non-arteritic anterior ischaemic optic neuropathy, a rare condition, have been reported spontaneously and in an observational study in connection with the intake of sildenafil and other PDE5 inhibitors see section 4. Hypersensitivity to the active substance or to any of the excipients listed in section 6. Revatio is not expected to harm an unborn baby. 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. Pulmonary Hypertension sildenafil , tadalafil , Adcirca , Letairis , Opsumit , Adempas , bosentan , macitentan , Remodulin , ambrisentan , Tracleer , epoprostenol , Uptravi , treprostinil , Orenitram , iloprost , riociguat , Tyvaso , Ventavis , Flolan , selexipag , Veletri , More Respiratory, thoracic and mediastinal disorders. Revatio Precautions Back to Top. The safety of sildenafil has not been studied in the following sub-groups of patients and its use is therefore contraindicated: The difference in results between these randomisation subgroups may have arisen by chance in view of their limited sample size. Dose adjustments are not required in elderly patients. No interactions were observed between sildenafil mg single dose and acenocoumarol. If you want more information or develop any side effects or symptoms you are concerned about, talk to your doctor or pharmacist. Generic Back to Top. Revatio 20 mg film-coated tablets 2. Patients on sildenafil achieved a statistically significant reduction in mean Pulmonary Arterial Pressure mPAP compared to those on placebo. In case of clinical deterioration in spite of Revatio treatment, alternative therapies should be considered. Patients using other medicinal class. Find out more here. Sildenafil plasma concentration half-life values were estimated to range from drug. Fertility Non-clinical data ddug no special hazard for humans based on conventional studies of fertility see section 5. Patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy Revatioregardless of whether this episode was in connection or not with previous PDE5 inhibitor exposure see section 4.

Prolonged erections and priapism have been reported with sildenafil in post-marketing experience. Keep Revatio in its original container. Microcrystalline cellulose Calcium hydrogen phosphate anhydrous Croscarmellose sodium Magnesium stearate Film coat: Follow all directions on your prescription label. Pharmaceutical form Film-coated tablet. 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 treats PAH by relaxing the blood vessels in the lungs to allow blood to flow easily. Sildenafil For more information on this medication choose from the list of selections below. To email a medicine you must sign up and log in. The safety of sildenafil has not been studied in the following sub-groups of patients and its use is therefore contraindicated: Revatio can cause headache and facial flushing. The primary efficacy endpoint was the change from baseline at Week 12 in 6MWD. If this medication is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. Therefore sildenafil should be administered to these patients only after careful benefit-risk assessment. The primary efficacy endpoint was the change from baseline at week 12 in 6-minute walk distance 6MWD. 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. Marketing authorisation number s 9. At single doses of mg the incidence of adverse reactions headache, flushing, dizziness, dyspepsia, nasal congestion, and altered vision was increased. Uses of Revatio Back to Top. Effects in non-clinical studies were observed at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use. 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. The easiest way to lookup drug information, identify pills, check interactions and set up your own personal medication records. Symptoms of an allergic reaction may include: Viagra is another brand of sildenafil used to treat erectile dysfunction impotence in men. No dose adjustment is required. Subjects were allocated to one of three sildenafil treatment groups, low 10 mgmedium mg or high dose mg drug of Revatio given three times a day, or placebo, revatio drug class. Of the subjects treated in the pivotal study, entered a long-term extension study. You should call a doctor immediately if you ever have an erection class lasts more than 4 rdug. Avoid using any other medicines to treat impotence, such as alprostadil or yohimbine, without first talking to your doctor. For the full list of excipients, see section 6. Patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy NAIONregardless of whether this episode was in connection or not revatio previous PDE5 inhibitor exposure see section 4. Tell your doctor about all your current medicines, especially riociguat Adempas. Less common side effects that may occur are temporary changes in color vision such as trouble telling the difference between blue and green objects or having a blue color tinge to themeyes revaio more sensitive to light, or blurred vision.