PO (placed on & dissolved on the tongue)Benign prostatic hyperplasia 5 mg once daily at the same time each day; for up to 26 wk when used w/ finasteride for treatment initiation. Benign prostatic hyperplasia-erectile dysfunction 5 mg once daily at the same time each day. Erectile dysfunction 2.5 mg once daily at the same time each day; may increase to 5 mg once daily. As needed use: 10 mg prior to anticipated sexual activity, may increase to 20 mg or decrease to 5 mg. Max frequency: Once daily. Pulmonary HTN 40 mg once daily. Mild to moderate hepatic impairment (Child-Pugh class A or B)/severe renal impairment Max: 10 mg. Renal impairment CrCl 31-50 mL/min Initially 5 mg not more than once daily, max: 10 mg in 48 hr, <30 mL/min or on hemodialysis Max: 5 mg not more than once every 72 hr. Patient stabilized on α-blocker therapy Initially 5 mg. Patient taking potent CYP3A4 inhibitors eg, ketoconazole or ritonavir-boosted HIV-PIs Not to exceed 10 mg once every 72 hr when used as needed; & not to exceed 2.5 mg when used on regular daily basis.
View Caliberi overdosage for action to be taken in the event of an overdose.
Administration
May be taken with or without food: Place tab on the tongue & allow to disintegrate before swallowing w/ or w/o water. Take immediately once taken out from pouch.
Contraindications
Hypersensitivity. Patients using nitrates (any form) regularly or intermittently. Coadministration w/ guanylate cyclase stimulator (eg, riociguat).
Underlying CV disease may be aggravated due to sexual activity or vasodilatory effects; increased sensitivity in patients w/ severely impaired autonomic control of BP or left ventricular outflow obstruction. Not recommended in patients w/ veno-occlusive disease; angina occurring during sexual intercourse or unstable angina, uncontrolled arrhythmias, hypotension (<90/50 mmHg), uncontrolled HTN, heart failure (NYHA class ≥2) in the last 6 mth, or MI w/in the last 90 days. Increased bleeding times in patients w/ bleeding disorders or active peptic ulceration. Not recommended for patients who experienced stroke w/in the last 6 mth. Sudden vision loss; not recommended in patients w/ hereditary degenerative retinal disorders including retinitis pigmentosa. Discontinue if sudden hearing decrease or loss occurs. Predisposition to priapism (eg, sickle cell anemia, multiple myeloma or leukemia) or w/ anatomical deformation of penis (eg, angulation, cavernosal fibrosis or Peyronie's disease). Avoid use when initiating ritonavir; w/ potent CYP3A inhibitors (eg, itraconazole, ketoconazole) or inducers (eg, rifampicin). Not recommended w/ other PDE5 inhibitors or erectile dysfunction therapies; α-blockers. Mild/moderate hepatic (Child-Pugh class A or B) & renal (CrCl 31 & 80 mL/min) impairment. Avoid use in severe hepatic (Child-Pugh class C) & renal (CrCl <30 mL/min or on hemodialysis) impairment. Not indicated for women. Pregnancy & lactation.
May potentiate hypotensive effects of organic nitrates. Additive effect on BP may be anticipated w/ α-blockers. Potentiation of BP lowering effects of amlodipine, ARBs, bendrofluazide, enalapril & metoprolol. May increase potential for orthostatic signs & symptoms, including increase in heart rate, decrease in standing BP, dizziness, & headache w/ substantial consumption of alcohol (eg, ≥5 u).
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