Talafil Special Precautions

Assess the cardiovascular status of the patient prior to initiating tadalafil therapy.
Serious cardiovascular event, including myocardial infarction, sudden cardiac death, unstable angina, ventricular arrhythmia, stroke, transient ischemic attacks, chest pain, palpitations, and tachycardia, have been reported in temporal association with tadalafil during postmarketing experience. In addition hypertension were also reported. Most of the patients had pre-existing cardiovascular risk factors. However, it is not possible to definitively determine whether these events are related directly to these risk factors, to tadalafil, to sexual activity, or to a combination of these or other factors.
Non-arteritic anterior ischemic optic neuropathy (NAION) is a cause of decreased vision, including permanent vision loss that has been reported rarely postmarketing in temporal association with the use of all PDE5 inhibitors. It is not possible to determine if these events are related directly to the use of PDE5 inhibitors or other factors. Instruct patients to seek medical assistance for sudden loss of vision. Clinicians should discuss the increased risk of NAION with patients who have already experienced NAION.
Combined use of tadalafil and other PDE5 inhibitors have not been studied. Therefore, the use of such combination is not recommended.
There is insufficient data available in patients with severe hepatic impairment (Child-Pugh class C).
Patients who experience erections lasting 4 hours or more should be instructed to seek immediate medical assistance. If priapism is not treated immediately, penile tissue damage and permanent loss of potency may result.
Should be used with caution in patients with anatomical deformation of the penis (angulation, cavernosal fibrosis, or Peyronie's disease), or who have conditions which may predispose them to priapism (such as sickle cell anemia, multiple myeloma, leukemia).
Caution should be exercised when prescribing tadalafil to patients who are taking alpha-blockers. In some patients, concomitant use of both drug class may lead to symptomatic hypotension in some patient.
Caution should be exercised when prescribing tadalafil to patients using potent CYP3A4 inhibitors (such as protease inhibitors, ketoconazole, itraconazole) as increase plasma concentration (AUC) for tadalafil.
Combined use of tadalafil and other therapies for erectile dysfunction currently is not recommended because safety and efficacy of such combinations have not been studied.