Revatio POS

Revatio POS Special Precautions



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Full Prescribing Info
Special Precautions
No clinical data are available for sildenafil intravenous administration in patients who are clinically or hemodynamically unstable. Its use is accordingly not recommended in these patients.
In the long term pediatric extension study, an increase in deaths was observed in patients administered doses higher than the recommended dose. Therefore, doses higher than the recommended doses should not be used in pediatric patients with PAH.
Vasodilatory action: Sildenafil has vasodilator properties, resulting in mild and transient decreases in blood pressure (see Pharmacology: Pharmacodynamics under Actions). Prior to prescribing sildenafil, physicians should carefully consider whether their patients with certain underlying conditions could be adversely affected by such vasodilatory effects, for example, patients with resting hypotension (blood pressure <90/50 mmHg), patients with fluid depletion, severe left ventricular outflow obstruction or autonomic dysfunction.
Cardiovascular risk factors: Serious cardiovascular events, including myocardial infarction, unstable angina, sudden cardiac death, ventricular arrhythmia, cerebrovascular hemorrhage, transient ischemic attack, hypertension and hypotension have been reported postmarketing in temporal association with the use of sildenafil for erectile dysfunction. Most, but not all, of these patients had preexisting cardiovascular risk factors. Many of these events were reported to occur during or shortly after sexual activity, and a few were reported to occur shortly after the use of sildenafil without sexual activity. Others were reported to have occurred hours to days after the use of sildenafil and sexual activity. It is not possible to determine whether these events are related directly to sildenafil, to sexual activity, to the patient's underlying cardiovascular disease, to a combination of these factors, or to other factors.
Visual events: Non-arteritic anterior ischemic optic neuropathy (NAION), a rare condition and a cause of decreased vision or loss of vision, has been reported rarely post-marketing with the use of all phosphodiesterase type 5 (PDE5) inhibitors, including sildenafil. Most of these patients had risk factors such as low cup to disc ratio ("crowded disc"), age over 50, diabetes, hypertension, coronary artery disease, hyperlipidemia and smoking. An observational study evaluated whether recent, episodic use of PDE5 inhibitors (as a class), typical of erectile dysfunction treatment, was associated with acute onset of NAION. The results suggest an approximately 2-fold increase in the risk of NAION within 5 half-lives of PDE5 inhibitor use. Based on published literature, the annual incidence of NAION is 2.5-11.8 cases per 100,000 males aged ≥50 per year in the general population. In case of sudden visual loss, patients should be advised to stop taking sildenafil and consult a physician immediately.
Individuals who have already experienced NAION are at increased risk of NAION recurrence. Therefore physicians should discuss this risk with these patients and whether they could be adversely affected by use of PDE5 inhibitors. PDE5 inhibitors, including sildenafil should be used with caution in these patients and only when the anticipated benefits outweigh the risks.
Alpha-blockers: Concomitant administration of sildenafil to patients taking alpha-blocker therapy may lead to symptomatic hypotension in a few susceptible individuals (see Interactions). In order to minimize the potential for developing postural hypotension, patients should be hemodynamically stable on alpha-blocker therapy prior to initiating sildenafil treatment. Physicians should advise patients what to do in the event of postural hypotensive symptoms.
Veno-occlusive disease: Pulmonary vasodilators may significantly worsen the cardiovascular status of patients with pulmonary veno-occlusive disease. Since there are no clinical data on administration of Revatio to patients with pulmonary veno-occlusive disease, administration of Revatio to such patients 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.
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 with caution to these patients.
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. If priapism is not treated immediately, penile tissue damage and permanent loss of potency could result.
Vitamin K antagonists: The incidence of epistaxis was higher in patients with PAH secondary to connective tissue disease (CTD) (sildenafil 12.9%, placebo 0%) than in primary pulmonary hypertension patients (sildenafil 3.0%, placebo 2.4%) and was higher in sildenafil-treated patients treated with concomitant oral vitamin K antagonist (8.8% versus 1.7% not treated with concomitant vitamin K antagonist).
Hearing impairment: Sudden decrease or loss of hearing has been reported in a small number of post-marketing and clinical trials cases with the use of all PDE5 inhibitors, including sildenafil. Most of these patients had risk factors for sudden decrease or loss of hearing. No causal relationship has been made between the use of PDE5 inhibitors and sudden decrease or loss of hearing. In case of sudden decrease or loss of hearing patients should be advised to consult a physician promptly.
Use of sildenafil with bosentan: In a study of PAH patients (primary PAH and secondary PAH associated with CTD) on background bosentan therapy, no incremental benefit (6-minute walk distance (6MWD)) of sildenafil co-administered with bosentan was demonstrated over bosentan alone. The results of the 6MWD were different between primary PAH and PAH associated with CTD. The mean result of the combination of sildenafil and bosentan was numerically worse than bosentan alone in patients with PAH associated with CTD but numerically better than bosentan alone in patients with primary PAH. Therefore, healthcare professionals should use their medical judgment to assess the clinical response when sildenafil is co-administered with bosentan in primary PAH. The combined use of sildenafil and bosentan in patients with PAH associated with CTD is not recommended (see Pharmacology: Pharmacodynamics under Actions).
Concomitant use with other PDE5 inhibitors: The safety and efficacy of sildenafil when co-administered with other PDE5 inhibitor products, including Viagra, has not been studied in PAH patients and such concomitant use is not recommended.
Effects on ability to drive and use machine: 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 operating machinery.
The effect of sildenafil on the ability to drive and use machinery has not been studied.
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