Use of Sildenafil oral jelly is contraindicated in patients with a known hypersensitivity to any component of the jelly. Consistent with its known effects on the nitric oxide/ cyclic guanosine monophosphate (cGMP) pathway, Sildenafil oral jelly was shown to potentiate the hypotensive effects of nitrates, and its administration to patients who are concurrently using organic nitrates in any form is therefore contraindicated.
The usual dose for most patients is 50mg, as needed, approximately about one hour before sexual intercourse. The dose may be increased or decreased depending on response. The maximum recommended dose is 100mg, and Sildenafil should not be taken more often than once in 24 hours.
Directions for Use: Open sachet and consume entire contents. One sachet for one-time-use only. Use strictly under Medical supervision
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 (e.g., aortic stenosis, hypertrophic obstructive cardiomyopathy), or those with the rare syndrome of multiple system atrophy manifesting as severely impaired autonomic control of blood pressure.
The cardiovascular risks of sexual activity should be considered before beginning therapy with Sildenafil; in some patients, sexual activity may be inadvisable. Caution is required in patients with hepatic or severe renal impairment, and dosage reduction may be necessary. Care is also needed in patients with anatomical and hematological disorders which may predispose them to priapism. Patients 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, a recent history of stroke, myocardial infarction, or life-threatening arrhythmia, unstable angina, heart failure or retinal disorders such as retinitis pigmentosa (a minority of whom have genetic disorders of retinal phosphodiesterases). The manufacturers advise that it should not be used in these groups.
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 minimize 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 25mg 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.
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