Tadalafil

Patients experiencing anginal chest pain after tadalafil administration should seek immediate medical attention.

May cause dose-related impairment of color discrimination. Use caution in patients with retinitis pigmentosa; a minority have genetic disorders of retinal phosphodiesterases (no safety information available).

Sudden decrease or loss of hearing has been reported rarely; hearing changes may be accompanied by tinnitus and dizziness. Instruct patients to seek medical assistance for sudden decrease in hearing or loss of hearing. A direct relationship between therapy and hearing loss has not been determined.

Decreases in blood pressure may occur due to vasodilator effects; use with caution in patients with left ventricular outflow obstruction (aortic stenosis or hypertrophic obstructive cardiomyopathy); may be more sensitive to hypotensive actions. Concurrent use with alpha-adrenergic antagonist therapy may cause symptomatic hypotension; patients should be hemodynamically stable prior to initiating therapy at the lowest possible dose. Patients should avoid or limit concurrent substantial ethanol consumption as this may increase the risk of symptomatic hypotension.

Painful erection >6 hours in duration has been reported (rarely). Instruct patient to seek medical assistance for erection lasting >4 hours. Use with caution in patients who have conditions which may predispose them to priapism (eg, sickle cell anemia, multiple myeloma, leukemia).

Vision loss (rare) may be a sign of nonarteritic anterior ischemic optic neuropathy (NAION); causal relationship to PDE5 inhibitors not established. Instruct patients to discontinue therapy and seek medical assistance for sudden loss of vision in one or both eyes. Patients who have already experienced NAION are at an increased risk of recurrence. Other risk factors for NAION include low cup-to-disc ratio ("crowded disc"), CAD, diabetes, hypertension, hyperlipidemia, smoking, and >50 years of age. Use with caution in these patients and only when the benefits outweigh the risks. Safety has not been evaluated in patients with known hereditary degenerative retinal disorders (eg, retinitis pigmentosa); use is not recommended. Disease-related concerns:

Use with caution in patients with anatomical deformation of the penis (angulation, cavernosal fibrosis, or Peyronie disease).

Use with caution in patients with bleeding disorders; safety and efficacy have not been established. In vitro studies have suggested a decreased effect on platelet aggregation.

Use is not recommended in patients with hypotension (170/100 mm Hg), NYHA class II-IV heart failure within the last 6 months, uncontrolled arrhythmias, stroke within the last 6 months, MI within the last 3 months, unstable angina or angina during sexual intercourse; safety and efficacy have not been evaluated in these patients. Safety and efficacy in PAH have not been evaluated in patients with clinically significant aortic and/or mitral valve disease, life-threatening arrhythmias, hypotension (• Hepatic impairment: Use with caution in patients with mild to moderate hepatic impairment; dosage adjustment/limitation is needed. Use is not recommended in patients with severe hepatic impairment or cirrhosis.

Use with caution in patients with active peptic ulcer disease because of effect on platelets (bleeding); safety and efficacy have not been established.

Pulmonary vasodilators may exacerbate the cardiovascular status in patients with PVOD. Use is not recommended; no clinical data exists in patients with PVOD. In patients with unrecognized PVOD, signs of pulmonary edema should prompt investigation into this diagnosis.

Use with caution in patients with renal impairment; dosage adjustment/limitation is needed. Concurrent drug therapy issues:

Potentially significant interactions may exist, requiring dose or frequency adjustment, additional monitoring, and/or selection of alternative therapy. Consult drug interactions database for more detailed information.

Concomitant use (regularly/intermittently) with all forms of nitrates is contraindicated. Nitrate-mediated vasodilation is markedly exaggerated and prolonged in the presence of PDE-5 inhibitors. When tadalafil is used for BPH, erectile dysfunction, or PAH and nitrate administration is medically necessary (eg, chest pain refractory to other treatments) following the use of tadalafil, at least 48 hours should elapse after the tadalafil dose and nitrate administration. When used for PAH, per the manufacturer, nitrate may be administered within 48 hours of tadalafil. For both situations, administration of nitrates should only be done under close medical supervision with hemodynamic monitoring. Other warnings/precautions:

Potential underlying causes of erectile dysfunction or BPH should be evaluated prior to treatment.