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The efficacy of Sildenafil has not been established in patients with severe pulmonary arterial hypertension (functional class IV). If the clinical situation deteriorates, therapies that are recommended at the severe stage of the disease (e.g. Epoprostenol) should be considered.
The benefit-risk balance of Sildenafil has not been established in patients assessed to be at WHO functional class I pulmonary arterial hypertension.
Retinitis pigmentosa: The safety of Sildenafil has not been studied in patients with known hereditary degenerative retinal disorders, such as Retinitis pigmentosa (minorities of these patients have genetic disorders of retinal phosphodiesterases) and therefore, its use is not recommended.
Vasodilatory action: When prescribing Sildenafil, physicians should carefully consider whether patients with certain underlying conditions could be adversely affected by Sildenafil's mild to moderate vasodilatory effects, for example patients with hypotension, 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 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 anemia, multiple myeloma or leukemia).
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.
Vaso-occlusive crises in patients with sickle cell anemia: Sildenafil should not be used in patients with pulmonary hypertension secondary to sickle cell anemia.
Visual events: In the event of any sudden visual defect, the treatment should be stopped immediately and alternative treatment should be considered.
Alpha-blockers: Caution is advised when Sildenafil is administered to patients taking an alpha-blocker as the co-administration may lead to symptomatic hypotension in 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.
Bleeding disorders: 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 edema have been reported with vasodilators (mainly Prostacyclin) when used in those patients. Consequently, should signs of pulmonary edema occur when Sildenafil is administered in patients with pulmonary hypertension, the possibility of associated veno-occlusive disease should be considered.
Galactose intolerance: Lactose monohydrate is present in the tablet. Patients with rare hereditary problems of galactose intolerance, the Lapp-lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Source of LUDIPRESS: Lactose monohydrate in Ludipress is a by-product.
Use of Sildenafil with Bosentan: The efficacy of Sildenafil in patients already on Bosentan therapy has not been conclusively demonstrated.
Concomitant use with other PDE5 inhibitors: The safety and efficacy of Sildenafil when co-administered with other PDE5 inhibitor products has not been studied in PAH patients and such concomitant use is not recommended.
Effects on Ability to Drive and Use Machine: Sildenafil has moderate influence on the ability to drive and use machines.
As dizziness and altered vision were reported with Sildenafil, patients should be aware of how they might be affected by Sildenafil, before driving or using machines.
