Iqnyde Special Precautions

A medical history and physical examination should be undertaken to diagnose erectile dysfunction and determine potential underlying causes, before pharmacological treatment is considered.
Prior to initiating any treatment for erectile dysfunction, physicians should consider the cardiovascular status of their patients, since there is a degree of cardiac risk associated with sexual activity. Sildenafil has vasodilator properties, resulting in mild and transient decreases in blood pressure. Prior to prescribing sildenafil, physicians should carefully consider whether their patients with certain underlying conditions could be adversely affected by such vasodilatory effects, especially in combination with sexual activity. Patients with increased susceptibility to vasodilators include those with left ventricular outflow obstruction (eg, aortic stenosis, hypertrophic obstructive cardiomyopathy), or those with the rare syndrome of multiple system atrophy manifesting as severely impaired autonomic control of blood pressure.
Iqnyde potentiates the hypotensive effect of nitrates. Serious cardiovascular events, including myocardial infarction, unstable angina, sudden cardiac death, ventricular arrhythmia, cerebrovascular haemorrhage, transient ischaemic attack, hypertension and hypotension have been reported post-marketing in temporal association with the use of Iqnyde. Most, but not all, of these patients had preexisting 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 Iqnyde without sexual activity. It is not possible to determine whether these events are related directly to these factors or to other factors. Agents for the treatment of erectile dysfunction, including 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).
The safety and efficacy of combinations of sildenafil with other treatments for erectile dysfunction have not been studied.
Therefore, the use of such combinations is not recommended. Visual defects and cases of non-arteritic anterior ischaemic optic neuropathy have been reported in connection with the intake of sildenafil and other PDE5 inhibitors. The patient should be advised that in case of sudden visual defect, he should stop taking Iqnyde and consult a physician immediately.
Caution is advised when sildenafil is administered to patients taking an alpha-blocker, as the co-administration may lead to symptomatic hypotension in a few susceptible individuals. This is most likely to occur within 4 hours post sildenafil dosing. In order to minimise the potential for developing postural hypotension, patients should be hemodynamically stable on alpha-blocker therapy prior to initiating sildenafil treatment. Initiation of sildenafil at a dose of 25 mg should be considered. In addition, physicians should advise patients what to do in the event of postural hypotensive symptoms.
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.
Iqnyde is not indicated for use by women.
Caution is required in patient with hepatic or severe renal impairment, and dosage reduction of sildenafil may be necessary. Care is also needed in patients with anatomical deformation of the penis or haematological disorders that may predispose them to priapism. In the events of prolonged erection (for more than 4 hours), patients should seek medical assistance, as penile tissue damage and permanent loss of potency can occur. Patient is also advised to stop taking sildenafil and seek medical advice in cases of sudden visual or hearing loss. Sildenafil should not be given to those with loss of vision in one eye caused by non-arteritic anterior ischaemic optic neuropathy (NAIO), regardless of whether this was in connection with previous phosphodiesterase type 5 inhibitors or not. Patient who experience dizziness or visual disturbances should not drive or operate hazardous machinery.
The safety of sildenafil is uncertain in patients with severe hepatic impairment, bleeding disorders, active peptic ulceration, hypotension, hypertension, a recent history of stroke, myocardial infarction, or life-threatening arrhythmia, unstable angina, heart failure, or retinal disorders such as retinitis pigmentosa a majority of whom have genetic disorders of retinal phosphodiesterases). Licensed product information advises that it should not be used in these groups.
Cardiovascular Disease: For mention of a consensus statement on the use of sildenafil in patients with cardiovascular disease, see previously mentioned text.