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REVATIO is a brand name for Sildenafil. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Revatio solution for injection is for the treatment of adult patients (≥ 18 years) with pulmonary arterial hypertension who are currently prescribed oral Revatio and who are temporarily unable to take oral therapy, but are otherwise clinically and haemodynamically stable. Revatio (oral) is indicated for treatment of…
Verbatim from this product's MHRA label. Tap a section to expand.
Treatment should only be initiated and monitored by a physician experienced in the treatment of pulmonary arterial hypertension. In case of clinical deterioration in spite of Revatio treatment, alternative therapies should be considered.
Revatio solution for injection should be administered to patients already prescribed oral Revatio as a replacement for oral administration under conditions where they are temporarily unable to take oral Revatio therapy. 5 ml (10 mg) TID have not been established.
6). A 10 mg dose of Revatio solution for injection is predicted to provide exposure of sildenafil and its N-desmethyl metabolite and pharmacological effects comparable to those of a 20 mg oral dose. 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 10 mg twice daily should be considered when sildenafil is co-administered to patients already receiving CYP3A4 inhibitors like erythromycin or saquinavir. A downward dose adjustment to 10 mg once daily is recommended in case of co-administration with more potent CYP3A4 inhibitors like clarithromycin, telithromycin and nefazodone.
For the use of sildenafil with the most potent CYP3A4 inhibitors, see section
Adverse reactions that resulted from intravenous Revatio use are similar to those associated with oral Revatio use. Since there are limited data for intravenous Revatio use and since pharmacokinetic models predict that 20 mg oral and 10 mg intravenous formulations will yield similar plasma exposures, the safety information for intravenous Revatio is supported by that of oral Revatio.
Intravenous administration A 10 mg dose of Revatio solution for injection is predicted to provide total exposure of free sildenafil and its N-desmethyl metabolite and their combined pharmacological effects comparable to those of a 20 mg oral dose.
Study A1481262 was a single centre, single dose, open label study to assess the safety, tolerability and pharmacokinetics of a single intravenous dose of sildenafil (10 mg) administered as a bolus injection to patients with Pulmonary Arterial Hypertension (PAH) who were already receiving and stable on oral Revatio 20 mg three times per day.
A total of 10 PAH subjects enrolled and completed the study. The mean postural changes in systolic and diastolic blood pressure over time were small (< 10 mmHg) and returned towards baseline beyond 2 hours. No symptoms of hypotension were associated with these changes.
The mean changes in heart rate were clinically insignificant. Two subjects experienced a total of 3 adverse reactions (flushing, flatulence and hot flush). There was one serious adverse reaction in a subject with severe ischaemic cardiomyopathy who experienced ventricular fibrillation and death 6 days post study.
It was judged to be unrelated to the study medicinal product. Oral administration In the pivotal placebo-controlled study of Revatio in pulmonary arterial hypertension, a total of 207 patients were randomized to and treated with 20 mg, 40 mg or 80 mg TID doses of oral Revatio and 70 patients were randomized to placebo.
No clinical data is available for sildenafil IV administration in patients who are clinically or haemodynamically unstable. Its use is accordingly not recommended in these patients. The efficacy of Revatio has not been established in patients with severe pulmonary arterial hypertension (functional class IV).
2). The benefit-risk balance of sildenafil has not been established in patients assessed to be at WHO functional class I pulmonary arterial hypertension. 1). The use of sildenafil in other forms of PAH is not recommended. 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.
4) Cardiovascular risk factors In post-marketing experience with sildenafil for male erectile dysfunction, serious cardiovascular events, including myocardial infarction, unstable angina, sudden cardiac death, ventricular arrhythmia, cerebrovascular haemorrhage, transient ischaemic attack, hypertension and hypotension have been reported in temporal association with the use of sildenafil.
Most, but not all, 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.
It is not possible to determine whether these events are related directly to these factors or to other factors. 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).
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, the patient should seek immediate medical assistance. 8). Vaso-occlusive crises in patients with sickle cell anaemia Sildenafil should not be used in patients with pulmonary hypertension secondary to sickle cell anaemia.
3. 5). Special populations Elderly (≥ 65 years) Dose adjustments are not required in elderly patients. Clinical efficacy as measured by 6-minute walk distance could be less in elderly patients. Renal impairment Initial dose adjustments are not required in patients with renal impairment, including severe renal impairment (creatinine clearance < 30 ml/min).
A downward dose adjustment to 10 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 patients with hepatic impairment (Child- Pugh class A and B).
A downward dose adjustment to 10 mg twice daily should be considered after a careful benefit-risk assessment only if therapy is not well-tolerated. 3). Paediatric population Revatio solution for injection is not recommended for use in children below 18 years due to insufficient data on safety and efficacy.
1). Discontinuation of treatment Limited data suggest that the abrupt discontinuation of oral Revatio is not associated with rebound worsening of pulmonary arterial hypertension. However to avoid the possible occurrence of sudden clinical deterioration during withdrawal, a gradual dose reduction should be considered.
Intensified monitoring is recommended during the discontinuation period. Method of administration Revatio solution for injection is for intravenous use as a bolus injection. 6 for instructions of use. 1. 1). 5). 5). 4). The safety of sildenafil has not been studied in the following sub-groups of patients, and its use is therefore contraindicated: Severe hepatic impairment, Recent history of stroke or myocardial infarction, Severe hypotension (blood pressure < 90/50 mmHg) at initiation.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The duration of treatment was 12 weeks. 9 % with placebo. Of the 277 subjects treated in the pivotal study, 259 entered a long-term extension study. Doses up to 80 mg three times a day (4 times the recommended dose of 20 mg three times a day) were administered and after 3 years 87 % of 183 patients on study treatment were receiving Revatio 80 mg TID.
In a placebo-controlled study of Revatio as an adjunct to intravenous epoprostenol in pulmonary arterial hypertension, a total of 134 patients were treated with oral 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 131 patients were treated with placebo and epoprostenol.
The duration of treatment was 16 weeks. 7 % in the placebo/epoprostenol treated patients. Newly reported adverse drug reactions, which occurred more frequently in the sildenafil/ epoprostenol group, were ocular hyperaemia, vision blurred, nasal congestion, night sweats, back pain and dry mouth.
The known adverse events headache, flushing, pain in extremity and oedema were noted in a higher frequency in sildenafil/epoprostenol treated patients compared to placebo/epoprostenol treated patients. Of the subjects who completed the initial study, 242 entered a long-term extension study.
Doses up to 80 mg TID were administered and after 3 years 68 % of 133 patients on study treatment were receiving Revatio 80 mg TID. In the two placebo-controlled oral Revatio studies adverse events were generally mild to moderate in severity.
The most commonly reported adverse reactions that occurred (greater or equal to 10 %) on Revatio compared to placebo were headache, flushing, dyspepsia, diarrhoea and pain in extremity. In a study to assess the effects of different dose levels of sildenafil the safety data for sildenafil 20 mg TID (recommended dose) and for sildenafil 80 mg TID (4 times the recommended dose), were consistent with the established safety profile of sildenafil in previous adult PAH studies.
Tabulated list of adverse reactions Adverse reactions which occurred in > 1 % of Revatio-treated patients and were more frequent (> 1 % difference) on Revatio in the pivotal study or in the Revatio combined data set of both the placebo-controlled studies in pulmonary arterial hypertension, at oral doses of 20, 40 or 80 mg TID are listed in table 1 below by class and frequency grouping (very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1000 to ≤ 1/100) and not known (cannot be estimated from the available data).
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Reports from post-marketing experience are included in italics. 0) Adverse reaction Infections and infestations Common cellulitis,influenza, bronchitis, sinusitis, rhinitis, gastroenteritis Blood and lymphatic system disorders Common anaemia Metabolism and nutrition disorders Common fluid retention Psychiatric disorders Common insomnia, anxiety Nervous system disorders Very common headache Common migraine, tremor, paraesthesia, burning sensation, hypoaesthesia Eye disorders Common retinal haemorrhage, visual impairment, vision blurred, photophobia, chromatopsia, cyanopsia, eye irritation, ocular hyperaemia Uncommon visual acuity reduced, diplopia, abnormal sensation in eye Not known Non-arteritic anterior ischaemic optic neuropathy (NAION)*, Retinal vascular occlusion*, Visual field defect* Ear and labyrinth disorders Common vertigo Not known sudden hearing loss Vascular disorders Very common flushing Not Known hypotension Respiratory, thoracic and mediastinal disorders Common epistaxis, cough, nasal […]
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. Visual events Cases of visual defects have been reported spontaneously in connection with the intake of sildenafil and other PDE5 inhibitors.
8). 3). 5). In order to minimise the potential for developing postural hypotension, patients should be haemodynamically stable on alpha-blocker therapy prior to initiating sildenafil treatment. Physicians should advise patients what to do in the event 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 with bleeding disorders or active peptic ulceration.
Therefore sildenafil should be administered to these patients 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 patients already using a Vitamin K antagonist, particularly in patients with pulmonary arterial hypertension secondary to connective tissue disease.
Veno-occlusive disease No data are available with sildenafil in patients with pulmonary hypertension associated with pulmonary veno-occlusive disease. However, cases 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. 1). 5).