• Benign prostatic hyperplasia/urinary retention

Entadfi Generic Name & Formulations

General Description

Finasteride 5mg, tadalafil 5mg; caps.

Pharmacological Class

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

How Supplied

Caps—30, 90


Generic Availability


Entadfi Indications


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.

Entadfi Dosage and Administration


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


<18yrs: not established.

Entadfi Contraindications


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

Entadfi Boxed Warnings

Not Applicable

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 Pharmacokinetics

See Literature

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.

Entadfi Adverse Reactions

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.

Entadfi Clinical Trials

See Literature

Entadfi Note

Not Applicable

Entadfi Patient Counseling

See Literature