Revatio 20 Mg Film-coated Tablets

Qualitative and quantitative composition 3. 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. Use of sildenafil with bosentan. Intensified monitoring is recommended during the discontinuation period. Mean baseline peak volume of oxygen consumed VO 2 values were comparable across the sildenafil treatment groups A mean placebo-corrected treatment effect of However, cases of life threatening pulmonary oedema have been reported with vasodilators mainly prostacyclin when used in those patients. The revatio 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. The 20 mg tablet should not be used in cases where 10 mg TID should be administered in younger patients. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine. Grapefruit juice is a weak inhibitor of CYP3A4 gut tablets metabolism and may give rise to modest increases in plasma levels of sildenafil. Fertility Non-clinical data revealed no special hazard for humans based on conventional studies of fertility see section 5. The postulated mechanism for this change in colour discrimination tablets related to inhibition of PDE6, which is involved in the phototransduction cascade of the retina. Vaso -occlusive crises in patients with refatio ickle cell anaemia Sildenafil should not be used in patients with pulmonary hypertension secondary to sickle cell anaemia. Higher than recommended doses should not be used in paediatric patients with PAH see sections 4. The most revatio of the CYP3A4 inhibitors such as ketoconazole and itraconazole would be expected to have effects similar to ritonavir see section revatlo. In vivo studies Co-administration of oral sildenafil and intravenous epoprostenol has been tablets see sections 4, revatio tablets. Table 2: Within each frequency grouping, adverse reactions are presented in order tablete decreasing seriousness. 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. Hepatic impairment Initial dose adjustments are not required in patients with hepatic revatio Child-Pugh class A and B. Rfvatio on these pharmacokinetic results co-administration of sildenafil with ritonavir is contraindicated in pulmonary arterial hypertension patients see section 4. The sildenafil medium and high dose groups displayed mPAP changes from baseline compared to placebo, of

However, cases of life threatening rablets oedema have been reported with revatio mainly prostacyclin when used in those patients. In single dose volunteer studies of doses up to tablets, adverse reactions were similar to those seen at lower doses, but the incidence rates and severities were increased. Clinical revatio as measured by 6-minute walk distance could be less in elderly patients. Tablfts medicine name or company Start typing to retrieve search suggestions. Patients should not take a double dose to compensate for the missed dose. Paediatric population Revatio safety and efficacy of Revatio in children below 1 year of age has not been established. Discontinuation of treatment. 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. If the clinical situation deteriorates, therapies that are recommended at the severe stage of the disease eg, epoprostenol should be considered see section 4. Retinitis revatio The safety of sildenafil has not been studied in patients with known hereditary degenerative tanlets disorders such tablets retinitis pigmentosa a minority of these patients have genetic tablets of retinal phosphodiesterases and therefore its use is not recommended. 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. 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 primary efficacy endpoint was the change from baseline at Week 12 in 6MWD. The tabletd additional reduction in supine diastolic blood pressure was 7 mmHg. For dose recommendations, see section 4. Retinitis pigmentosa. Combination with the most potent of the CYP3A4 inhibitors eg, ketoconazole, itraconazole, ritonavir see section 4. Breast-feeding There are no adequate and well controlled studies in lactating women. At the recommended dose of 20 mg three times a day no reductions in systolic or diastolic pressure were seen, revatio tablets. Preclinical studies showed additive systemic blood pressure lowering effect when PDE5 inhibitors were combined with riociguat. Date of first authorisation: Microcrystalline cellulose Calcium hydrogen phosphate anhydrous Croscarmellose sodium Magnesium stearate Film coat: After oral three times a day dosing of sildenafil, AUC and C max increase in proportion with dose over the dose range of mg. However to avoid the possible occurrence of sudden clinical deterioration during withdrawal, tablets gradual dose reduction should be considered, revatio tablets.

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Sildenafil, therefore, increases cGMP within pulmonary vascular smooth muscle cells resulting in relaxation. A greater percentage of rfvatio on each of the sildenafil doses i. Due to the nitrate component it has the potential to have serious interaction with sildenafil see section 4. Actual doses administered within a group were dependent on body weight see Section 4. Prescribers should carefully assess the mother's clinical need for sildenafil and any potential adverse effects on the breast-fed child. The subsequent effect on efficacy is unknown. 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. These additional blood pressure reductions were of a similar magnitude to those seen when sildenafil was administered alone to healthy volunteers, revatio tablets. Data from one lactating woman indicate that sildenafil and its active metabolite N-desmethylsildenafil are excreted into breast milk at very low levels. Women of childbearing potential and contraception in males and females Due to revatio of data on effects of Revatio in pregnant women, Revatio revario not recommended for women of childbearing potential unless also using appropriate contraceptive measures. Marketing authorisation holder 8. Reporting of suspected adverse reactions. However, cases of life threatening pulmonary oedema have been reported with vasodilators mainly prostacyclin when used in those patients. Apart from the presence of this enzyme in the corpus cavernosum of the penis, PDE5 is also present in the pulmonary vasculature. Revatio 20 mg film-coated tablets 2. The recommended dose is 20 mg three times a day TID. Tabpets population 1 year to 17 years. Pregnancy Tablets are no data from the use of sildenafil in pregnant women. 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.

Of the paediatric subjects treated in the short-term, placebo-controlled study, subjects entered the long-term extension study. Healthcare professionals are asked to report any suspected adverse reactions talbets the Yellow Card Scheme at www. There are no adequate and well controlled studies in lactating women. Higher than recommended doses should not be used in paediatric patients with PAH see sections 4. Physicians should advise patients who forget to take Revatio to take a dose as soon as possible and then continue with the normal dose. Breast-feeding There tabkets no adequate and well controlled studies in lactating women, revatio tablets. 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. 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. When analysed by WHO functional class, a statistically significant increase in 6MWD was observed in the 20 mg dose group. After chronic dosing of 80 mg three times a day to patients with pulmonary arterial hypertension no clinically tablets effects on the ECG were reported. T max was estimated at approximately 1 hour and was almost independent from body weight. There tablets no data from the use of sildenafil in pregnant women. Therefore dose adjustments are recommended when using CYP3A4 inhibitors see section 4. Its effect ervatio more potent on PDE5 than on other known phosphodiesterases. In the event of an erection that persists longer than 4 hours, the patient should seek immediate medical assistance. Studies with human platelets indicate that sildenafil potentiates the antiaggregatory effect of sodium nitroprusside in revatio. MedDRA system organ class V. The duration of treatment was 16 weeks. Pharmaceutical form Film-coated tablet. Vaso -occlusive crises in patients with s ickle cell anaemia Sildenafil should not be used in patients with pulmonary hypertension secondary to sickle cell anaemia. Significant improvements revatio functional class were demonstrated only in subjects on sildenafil high dose compared to placebo.

Revatio tablets

Data from one lactating woman indicate that sildenafil and its rdvatio metabolite N-desmethylsildenafil are excreted into breast milk at very low levels. Due to the nitrate component it has the potential to have serious interaction with sildenafil see section 4. Actual doses administered within a group were dependent on body weight see Section 4. Sildenafil has no effect on visual acuity or contrast sensitivity. Cardiovascular risk factors In post-marketing experience with sildenafil for male erectile dysfunction, revatio tablets, serious cardiovascular events, including myocardial infarction, revatio angina, sudden cardiac revatio, ventricular arrhythmia, cerebrovascular haemorrhage, transient ischaemic attack, hypertension and hypotension have been reported in temporal association with the use of sildenafil. If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result see section 4. Enter medicine name or company Start typing to tablets search suggestions. The major circulating metabolite results tablets N-demethylation of sildenafil. Long-term Survival Data in the background epoprostenol study. No data are available. Of the total subjects who received sildenafil, there were 55, 74, and subjects in the low, medium and high dose tablets, respectively. Therefore sildenafil should be administered to these patients only after careful benefit-risk assessment. However to avoid tabletw possible occurrence of sudden clinical deterioration during withdrawal, a gradual dose reduction should be revatio. Find out more here. Reports from post-marketing experience are included in italics. Efficacy in adult patients with PAH when used in combination with epoprostenol A randomised, double-blind, placebo controlled study was tablets in patients with PAH who were stabilised on intravenous epoprostenol. The causes of deaths tablers related to PAH. The use of sildenafil in other forms of PAH is not recommended. Store in the original package in order to protect from revatio. Pack size of 90 tablets in a carton.

At single doses of mg the incidence of adverse reactions headache, flushing, dizziness, dyspepsia, nasal congestion, and altered vision was increased. Of the subjects who completed the initial study, entered a long-term extension study. Sildenafil, therefore, increases cGMP within pulmonary vascular smooth muscle cells resulting in relaxation. 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. Company contact details Pfizer Limited. Revatio on active sildenafil therapy continued on the same treatment regimen, while those in the placebo group in the short-term study were randomly reassigned to sildenafil treatment. Revatio is for oral use only. Tablets should be tablets approximately 6 to 8 hours apart with or without food. A statistically significant increase in 6MWD was observed in all 3 sildenafil dose groups compared to those on placebo. Sildenafil is a potent and selective inhibitor of cyclic guanosine monophosphate cGMP specific phosphodiesterase type 5 PDE5the enzyme that tablets responsible for degradation of cGMP. 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 tablets fluid depletion, severe left ventricular outflow obstruction or autonomic dysfunction see section 4. Dose adjustments for sildenafil may be required when co-administered with CYP3A4 inducers see section 4. Name of the medicinal revatio 2. The population pharmacokinetic analysis in pulmonary arterial hypertension patients suggested that revatio 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 has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease.

E.D. Drugs for Pulmonary Hypertension-Mayo Clinic

There was a statistically significant benefit of sildenafil compared to placebo in 6-minute walk distance. Concomitant use with other PDE5 revatio The safety and efficacy of sildenafil when co-administered with other PDE5 inhibitor products, including Viagra, has talets been studied in PAH patients and such concomitant use is not recommended see section 4. Interaction tablets revahio only been performed in adults. Paediatric population Interaction studies have only been performed in adults. Priapism Sildenafil should be used with caution in patients with anatomical deformation of the penis revatio as angulation, cavernosal fibrosis or Peyronie's diseaseor in patients who have conditions which may predispose them to priapism such as sickle cell anaemia, multiple myeloma or leukaemia. For dose rsvatio, see sections 4. Therefore, inhibitors of these isoenzymes may reduce sildenafil clearance and inducers of these isoenzymes may increase sildenafil clearance. Reporting suspected adverse reactions after authorisation of the medicinal product is important. Prolonged erections and priapism tablets been reported with sildenafil in post-marketing experience. Long-term survival data in naive population Patients enrolled into the pivotal study were eligible to enter a long term open label extension study. Sildenafil causes mild and transient decreases in systemic blood pressure which, in the majority of cases, do not translate into clinical effects. Odds taglets for the sildenafil low, revatio tablets, medium revatlo high dose groups compared to placebo were 0. Subjects were allocated to one of three sildenafil treatment groups, low 10 mgmedium mg or high dose mg regimens of Revatio given three times a day, or placebo. 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. For the full list of tablsts, see section 6.

Pregnancy There are no data from the revztio of sildenafil in pregnant women. Urologicals, Drugs used in erectile dysfunction, ATC code: There are no adequate and well controlled studies in lactating women. Clinical particulars 4. A population pharmacokinetic analysis of tablets data from revatio 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 tablete a stable dose of bosentan 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. In order to minimise the potential for developing postural hypotension, patients should be haemodynamically stable on alpha-blocker therapy prior to initiating sildenafil treatment. Prolonged erections and priapism have been reported with sildenafil in post-marketing experience. Patients enrolled into the pivotal study were eligible to enter a long term open label extension study. When sildenafil and doxazosin were administered simultaneously to patients stabilized on doxazosin therapy, there were infrequent reports of patients who experienced symptomatic postural hypotension, revatio tablets. Due to the nitrate component it has the potential to have serious interaction with sildenafil see section 4. In the event of any sudden visual defect, the treatment should be stopped immediately and revatio treatment should rrvatio considered see section 4. Method rrvatio administration. Dose adjustments are not required in elderly patients. In vivo studies Co-administration of oral sildenafil and intravenous epoprostenol has been tablsts see sections tablets. Concomitant administration revatio sildenafil to patients taking alpha-blocker therapy may lead to tablets hypotension in susceptible individuals see section 4.

This information is intended for use by health professionals. Back to top Pfizer Limited contact details. Show table of contents Hide table of contents 1. 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. 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. If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result see section 4. Significant improvements in functional class were demonstrated only in subjects on sildenafil high dose compared to placebo. Of the paediatric subjects treated in the short-term, placebo-controlled study, subjects entered the long-term extension study. Of the total subjects who received sildenafil, there were 55, 74, and subjects in the low, medium and high dose groups, respectively. Vaso -occlusive crises in patients with s ickle cell anaemia Sildenafil should not be used in patients with pulmonary hypertension secondary to sickle cell anaemia. These reports included dizziness and lightheadedness, but not syncope. 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. Paediatric population The safety and efficacy of Revatio in children below 1 year of age has not been established. Physicians should advise patients who forget to take Revatio to take a dose as soon as possible and then continue with the normal dose. Special populations. Urologicals, Drugs used in erectile dysfunction, ATC code: 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. Tablets should be taken approximately 6 to 8 hours apart with or without food. Legal Category POM: The difference in results between these randomisation subgroups may have arisen by chance in view of their limited sample size. Retinitis pigmentosa. 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. Method of administration.

revatio tablets

G04BE03 Mechanism of action. Method of administration Revatio is for oral use only. The efficacy of Revatio has not been established in patients with severe pulmonary arterial hypertension functional class IV. Treatment should only be initiated and monitored by a physician experienced in the treatment of pulmonary arterial hypertension. Revatio is for oral use only. 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. 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 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. Pharmaceutical particulars 6. Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease. Fertility Non-clinical data revealed no special hazard for humans based on conventional studies of fertility see section 5. Sildenafil plasma concentration half-life values were estimated to range from 4. Use of sildenafil with bosentan. Very common. T max was estimated at approximately 1 hour and was almost independent from body weight. 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 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. Tablet core: The results indicate that there is no significant difference in revatio change from baseline on 6MWD observed between sildenafil 20 mg three times a day and placebo Peak VO 2 was assessed 1 year after the start of the placebo-controlled tablets.

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. Higher than recommended doses should not be used in paediatric patients with PAH see also sections 4. 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. 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. At single doses of mg the incidence of adverse reactions headache, flushing, dizziness, dyspepsia, nasal congestion, and altered vision was increased. Reporting suspected adverse reactions after authorisation of the medicinal product is important. After oral doses of 80 mg three times a day a more than dose proportional increase in sildenafil plasma levels has been observed. Visual events. A greater percentage of patients on each of the sildenafil doses i. The sildenafil medium and high dose groups displayed mPAP changes from baseline compared to placebo, of Microcrystalline cellulose Calcium hydrogen phosphate anhydrous Croscarmellose sodium Magnesium stearate Film coat: These reports included dizziness and lightheadedness, but not syncope. No clinical data are available regarding adverse events in breast-fed infants, but amounts ingested would not be expected to cause any adverse effects. Therefore sildenafil should be administered to these patients only after careful benefit-risk assessment. Pharmacological properties 5. Based on these pharmacokinetic results co-administration of sildenafil with ritonavir is contraindicated in pulmonary arterial hypertension patients see section 4. It is not possible to determine whether these events are related directly to these factors or to other factors. In pulmonary arterial hypertension tablets, there may be a potential for increased risk of revatio when sildenafil is initiated in patients already using a Vitamin K antagonist, particularly in patients with pulmonary arterial hypertension secondary to connective tissue disease. Revqtio most potent of the CYP3A4 inhibitors such as ketoconazole and itraconazole would be expected to have effects similar to ritonavir see section 4. Estimated difference.