Caliberi Special Precautions

Cardiovascular: Underlying cardiovascular disease may be aggravated due to sexual activity or vasodilatory effects of tadalafil.
Patients with severely impaired autonomic control of blood pressure or left ventricular outflow obstruction (e.g., aortic stenosis, idiopathic hypertrophic subaortic stenosis) may have an increased sensitivity to vasodilators.
Not recommended in patients with veno-occlusive disease.
Not recommended in patients with angina occurring during sexual intercourse or unstable angina, uncontrolled arrhythmias, hypotension (less than 90/50 mmHg), uncontrolled hypertension, heart failure (NYHA Class 2 or greater) in the last 6 months, or myocardial infarction within the last 90 days.
Hematologic: Patients with bleeding disorders or active peptic ulceration may experience increased bleeding times.
Hepatic: Mild or moderate hepatic impairment (Child Pugh Class A or B); dose adjustment may be necessary.
Severe hepatic impairment (Child Pugh Class C); avoid use.
Neurologic: Not recommended for patients who experienced a stroke within the last 6 months.
Ophthalmic: Sudden vision loss has been reported with phosphodiesterase type 5 (PDE5) inhibitors; drug discontinuation recommended.
Not recommended in patients with hereditary degenerative retinal disorders, including retinitis pigmentosa.
Otic: Sudden hearing decrease or loss has been reported; drug discontinuation recommended.
Renal: Mild or moderate renal impairment (CrCl 31 and 80 mL/min); dose adjustment recommended.
Severe renal impairment (CrCl less than 30 mL/min or on hemodialysis); avoid use.
CrCl less than 50 mL/min or ESRD on hemodialysis; dose adjustment recommended for on-demand use.
CrCl 30 to 50 mL/min; dose adjustment recommended for daily use.
Reproductive: Priapism or prolonged erections lasting greater than 4 hours have been rarely reported; use caution in patients with conditions that predispose them to priapism (e.g., sickle cell anemia, multiple myeloma, or leukemia) or with anatomical deformation of the penis (e.g., angulation, cavernosal fibrosis, or Peyronie's disease).
Concomitant Use: Avoid use when initiating ritonavir.
Avoid use with potent CYP3A inhibitors (e.g., itraconazole, ketoconazole) or potent CYP3A inducers (e.g., rifampin).
Use with other phosphodiesterase type 5 (PDE5) inhibitors or erectile dysfunction therapies not recommended.
Use with alpha blockers not recommended.