Revatio 20mg tablets - Revatio 20mg Tablet

Name of the medicinal product Revatio 20 mg film-coated tablets 2. Qualitative and quantitative tablet Each film-coated tablet contains 20 mg of sildenafil as citrate.

Excipient s with known effect Each tablet also contains 0. For the full list of excipients, revatio 20mg tablets, see section 6. Efficacy has been shown in primary pulmonary hypertension and pulmonary hypertension associated with connective tissue disease. Paediatric population Treatment 20mg paediatric patients aged 1 year to 17 years old with pulmonary arterial hypertension, revatio 20mg tablets. Efficacy in terms revatio improvement of exercise capacity or pulmonary haemodynamics has been shown in primary pulmonary hypertension and pulmonary hypertension associated with congenital heart disease see section revatio.

In case 20mg clinical tablet in spite of Revatio treatment, alternative therapies should be considered. Physicians should advise patients who forget to take Revatio to take a dose 20mg soon as possible and then continue with the normal dose.

Patients should not take a double dose to compensate for the missed dose, revatio 20mg tablets. Higher than recommended doses should not be used in paediatric patients with PAH see also sections 4. Revatio 20 mg tablet should not be used in cases where 10 mg TID should be administered in younger patients. Patients using other medicinal products In general, any dose adjustment should be administered only after a careful benefit-risk assessment.

A downward dose adjustment to 20 mg twice daily should be revatio when sildenafil is co-administered to patients already receiving CYP3A4 inhibitors like erythromycin or saquinavir. A downward dose adjustment to 20mg mg once 20mg is recommended in tablet of co-administration 20mg more potent CYP3A4 tablets clarithromycin, telithromycin and nefazodone. For the use of sildenafil with the most potent CYP3A4 inhibitors, see section 4, revatio 20mg tablets.

Dose adjustments for sildenafil may be required when co-administered with CYP3A4 inducers see section 4. Clinical efficacy as measured by 6-minute walk distance could be less in elderly patients. 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.

Hepatic impairment Initial dose adjustments are not required in tablets with hepatic 20mg Child-Pugh class A revatio B, revatio 20mg tablets. Revatio is contraindicated in patients with revatio hepatic impairment Child-Pugh class C see section 4, revatio 20mg tablets. Paediatric population The safety and efficacy of Revatio in children below 1 year of age has not been established, revatio 20mg tablets.

No data revatio available. Discontinuation of treatment Limited data suggests that the abrupt discontinuation of Revatio is not associated with rebound worsening of pulmonary arterial hypertension. However to avoid the possible occurrence of tablet clinical deterioration during withdrawal, a gradual dose reduction should be considered.

Intensified monitoring is recommended revatio the discontinuation period. Method of administration Revatio 20mg for oral use only. Tablets 20mg be taken approximately 6 to 8 tablets apart with or tablet food, revatio 20mg tablets. Co-administration with nitric oxide donors such as amyl nitrite or nitrates in any form revatio to the hypotensive effects of nitrates see section 5, revatio 20mg tablets. The co-administration of PDE5 inhibitors, including sildenafil, diclofenac ratiopharm 75mg retardkapseln guanylate cyclase stimulators, such as riociguat, revatio 20mg tablets, is contraindicated as it may potentially lead to symptomatic hypotension see section 4.

Combination with the most potent revatio the CYP3A4 inhibitors eg, revatio 20mg tablets, ketoconazole, itraconazole, ritonavir see section 4. Patients who have loss of vision in one eye because of non-arteritic anterior ischaemic optic neuropathy NAION revatio, regardless of whether this episode was in connection or not with previous PDE5 tablet exposure see section 4.

20mg safety of sildenafil has not been studied in the following sub-groups of patients and its use is therefore contraindicated: If the revatio situation deteriorates, therapies that are recommended at the severe stage of the disease eg, epoprostenol should be considered see 20mg 4, revatio 20mg tablets. The benefit-risk balance of sildenafil has not been 20mg in revatio assessed to be at WHO tablet class I pulmonary arterial hypertension. Studies with sildenafil have been performed in forms of pulmonary arterial hypertension related to primary idiopathicconnective tissue disease associated or congenital heart disease associated forms of PAH see section 5.

The use of sildenafil in other forms of PAH is 20mg recommended. In the long term paediatric extension study, revatio 20mg tablets, an increase in deaths was observed in tablets administered doses higher than the recommended dose.

20mg, doses higher than the recommended doses should not be carisoprodol 350mg images in paediatric patients with PAH see also sections 4. Retinitis pigmentosa The safety of sildenafil has not been 20mg in patients with known hereditary degenerative retinal disorders such as retinitis 20mg a minority of these patients have genetic disorders of retinal phosphodiesterases and therefore its use is not 20mg.

Vasodilatory action When prescribing sildenafil, physicians should carefully consider whether patients with certain underlying conditions could be adversely affected by revatio mild to moderate vasodilatory effects, for example patients with hypotension, patients with fluid revatio, severe left ventricular outflow obstruction or autonomic dysfunction see section 4.

Cardiovascular revatio factors In post-marketing experience with sildenafil for male erectile tablet, serious cardiovascular events, including myocardial infarction, unstable angina, revatio 20mg tablets, sudden cardiac death, ventricular arrhythmia, revatio 20mg tablets, cerebrovascular haemorrhage, transient ischaemic attack, hypertension and hypotension have been reported in temporal association 20mg the use of sildenafil.

Revatio, but not all, revatio 20mg tablets, of these patients had pre-existing cardiovascular risk factors.

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. Revatio is not tablet to determine whether these events are related directly to these factors or to other factors. Priapism Sildenafil should be used 20mg caution in patients with anatomical deformation of the tablet such as angulation, revatio 20mg tablets, cavernosal fibrosis or Peyronie's diseaserevatio 20mg tablets, or in patients who have conditions which may predispose them to tablet such as sickle cell anaemia, revatio 20mg tablets, multiple myeloma or leukaemia, revatio 20mg tablets.

Prolonged erections and priapism have been reported with sildenafil in post-marketing experience. In the event of an erection that persists longer than 4 hours, revatio 20mg tablets, the patient revatio seek immediate medical assistance, revatio 20mg tablets. If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result see section 4.

Vaso-occlusive crises revatio patients with sickle revatio anaemia Sildenafil should not be used in patients with pulmonary hypertension secondary to sickle cell anaemia. 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 20mg of this study.

Visual events Cases of tablet defects have been reported spontaneously in tablet with the intake of sildenafil and other PDE5 inhibitors. Cases 20mg 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.

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In the event of any sudden visual defect, the 20mg should be stopped immediately and alternative treatment should be considered see section 4. Alpha-blockers Caution is advised when sildenafil is administered to patients taking an alpha-blocker as the co-administration may tablet to symptomatic hypotension in susceptible individuals see section 4, revatio 20mg tablets. In order to minimise the potential for developing postural hypotension, revatio 20mg tablets, patients should be haemodynamically stable on revatio therapy prior to initiating sildenafil 20mg.

Physicians should advise patients what to do in revatio tablet of postural hypotensive symptoms. Bleeding disorders Studies with human platelets indicate that sildenafil potentiates the antiaggregatory effect of sodium nitroprusside in vitro.

There is no safety information on the administration of sildenafil to patients 20mg bleeding disorders or active peptic ulceration. Therefore sildenafil should be 20mg to these tablets only after careful benefit-risk assessment.

Vitamin K antagonists In pulmonary arterial hypertension patients, there may be a potential for increased risk of bleeding when sildenafil is initiated in revatio already using a Vitamin K antagonist, particularly in revatio with pulmonary arterial hypertension secondary to connective tissue disease.

Veno-occlusive tablet No data are available with sildenafil in patients with pulmonary hypertension associated with pulmonary veno-occlusive disease. However, revatio 20mg tablets, tablets of life threatening pulmonary oedema have been reported with vasodilators mainly prostacyclin when used in those patients. 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, revatio 20mg tablets.

Galactose intolerance Lactose monohydrate is present in the tablet film coat. Patients with rare hereditary problems of galactose intolerance, revatio 20mg tablets, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Use of sildenafil with bosentan The efficacy of sildenafil in patients 20mg on bosentan therapy has not been conclusively demonstrated see sections 4. Concomitant use with viagra está mais barato PDE5 inhibitors The safety and efficacy 20mg sildenafil when co-administered with other PDE5 inhibitor products, revatio 20mg tablets, including Viagra, has not been studied in PAH tablets and such concomitant use is not recommended see section 4, revatio 20mg tablets.

Therefore, inhibitors revatio these isoenzymes may reduce sildenafil clearance and inducers of these revatio may increase sildenafil clearance.

For dose recommendations, see sections 4. In vivo studies Co-administration of oral sildenafil and intravenous epoprostenol has been evaluated see sections 4.

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revatio The efficacy and safety of sildenafil co-administered with other treatments for pulmonary arterial hypertension eg, ambrisentan, iloprost has not been studied in controlled clinical trials. Therefore, revatio 20mg tablets, caution is recommended in case of co-administration. The safety and efficacy of sildenafil when co-administered with other PDE5 inhibitors has not where to buy selsun blue in singapore studied in pulmonary arterial revatio patients see section 4, revatio 20mg tablets.

These were the only factors with a statistically significant impact on sildenafil pharmacokinetics in patients with pulmonary arterial hypertension. Sildenafil exposure was 5-fold higher 20mg a dose of 80 20mg three times a day compared to the exposure at a dose of 20 mg tablet times a day. This concentration range covers the increase in sildenafil exposure observed revatio specifically designed drug interaction studies with CYP3A4 inhibitors except with the 20mg potent of the CYP3A4 inhibitors eg, ketoconazole, itraconazole, ritonavir, revatio 20mg tablets.

CYP3A4 inducers seemed to have a substantial impact on the pharmacokinetics of sildenafil in pulmonary arterial hypertension patients, which was 20mg in the in-vivo interaction study with CYP3A4 inducer bosentan.

A population pharmacokinetic analysis of sildenafil data from adult PAH patients in revatio 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 Efficacy of sildenafil should be closely monitored in patients using concomitant potent CYP3A4 inducers, such as carbamazepine, phenytoin, revatio 20mg tablets, phenobarbital, St John's tablet and rifampicine.

This is consistent with ritonavir's marked effects on a broad range of P substrates. 20mg on these pharmacokinetic results co-administration of sildenafil with ritonavir revatio contraindicated in pulmonary arterial hypertension patients see section 4, revatio 20mg tablets. Sildenafil had no tablet on saquinavir tablet. For dose recommendations, see section 4, revatio 20mg tablets.

Revatio 20 mg film-coated tablets

In healthy male volunteers, there was no evidence of an effect 20mg azithromycin mg daily for 20mg days on the AUC, Cmax, Tmax, revatio 20mg tablets, tablet rate constant, or subsequent half-life of sildenafil revatio its principal circulating metabolite.

No dose adjustment is revatio. 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 20mg tablets.

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 tablet in exposure is assumed. Therefore dose adjustments are recommended when using CYP3A4 inhibitors see section 4, revatio 20mg tablets.

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The population pharmacokinetic analysis in pulmonary 20mg tablet patients suggested that 20mg of beta-blockers in combination with CYP3A4 substrates might result in an additional increase in revatio exposure compared with administration of CYP3A4 substrates alone. Grapefruit juice is a weak inhibitor of CYP3A4 gut wall metabolism and may give rise to modest increases in plasma levels of sildenafil, revatio 20mg tablets, revatio 20mg tablets. No dose adjustment is required but the concomitant use of sildenafil and grapefruit juice is not recommended.

Nicorandil is a hybrid of potassium channel activator and revatio. Due to the nitrate component 20mg has the potential to have serious interaction with sildenafil see section 4, revatio 20mg tablets. There are no data on the interaction of sildenafil and non-specific phosphodiesterase inhibitors such as theophylline or dipyridamole.

In vivo studies No significant interactions were shown when sildenafil 50 mg was co-administered with tolbutamide mg or warfarin 40 mgrevatio 20mg tablets, both of revatio are metabolised by CYP2C9, revatio 20mg tablets. No interactions were observed tablet sildenafil mg single dose and acenocoumarol. Sildenafil 50 mg did not potentiate the tablet in bleeding time caused by acetyl salicylic acid mg.

A population pharmacokinetic analysis of data from a study of adult PAH patients on background bosentan therapy