Benign prostatic hyperplasia/urinary retention:

Indications for: ENTADFI

Initiate treatment for benign prostatic hyperplasia (BPH) in men with an enlarged prostate for up to 26 weeks.

Limitations of Use:

Not recommended for more than 26 weeks.

Adult Dosage:

Take on an empty stomach. 1 cap once daily (at the same time every day).

Children Dosage:

<18yrs: not established.

ENTADFI Contraindications:

Concomitant nitrates. Concomitant guanylate cyclase (GC) stimulators (eg, riociguat). Pregnancy.

ENTADFI Warnings/Precautions:

Not for use in women. Pregnant females and those of childbearing potential should avoid handling crushed or open caps. Cardiovascular disease (eg, MI within 90 days, unstable angina or angina during intercourse, NYHA Class 2 or greater HF or stroke within 6 months; hypotension [<90/50mmHg], uncontrolled hypertension or arrhythmias, severely impaired autonomic BP regulation, LV outflow obstruction), severe hepatic impairment, renal impairment (CrCl <50mL/min), hemodialysis, hereditary degenerative retinal disorders including retinitis pigmentosa: not recommended. Increased risk of high-grade prostate cancer. Monitor prostate specific antigen (PSA) values; double PSA levels for comparison with normal ranges. Rule out prostate cancer and other urological disorders prior to treatment. Monitor for obstructive uropathy. Anatomical penile deformation. Predisposition to priapism. Underlying non-arteritic anterior ischemic optic neuropathy risk factors. "Crowded" optic disc. Advise patients to discontinue if sudden vision or hearing loss occurs. Patients for whom sexual activity is inadvisable or contraindicated. Mild or moderate hepatic impairment. Bleeding disorders. Active peptic ulcer.

ENTADFI Classification:

Type II 5 alpha-reductase inhibitor + phosphodiesterase type 5 inhibitor (cGMP-specific).

ENTADFI Interactions:

See Contraindications. Allow at least 48hrs to elapse after the last Entadfi dose before nitrate administration; give only under close medical supervision if needed. Hypotension with nitrates, GC stimulators, other antihypertensives, alcohol (≥5 units). Potentiated by strong CYP3A4 inhibitors (eg, ketoconazole); avoid concomitant use. Concomitant α-blockers: not recommended; discontinue at least 1 day prior to therapy. Concomitant other erectile dysfunction treatments: not recommended.

Adverse Reactions:

Impotence, decreased libido, decreased volume of ejaculate, breast enlargement, breast tenderness, rash, headache, dyspepsia, back pain, myalgia, nasal congestion, flushing, limb pain; sudden vision or hearing loss, cardiovascular effects, hypersensitivity reactions (discontinue if occurs); rare: priapism, prolonged erection.

Generic Drug Availability:


How Supplied:

Caps—30, 90