Finasteride/Tadalafil

DEA Class; Rx

Common Brand Names; Entadfi

• Phosphodiesterase Enzyme Inhibitors; 
• 5-Alpha-Reductase Inhibitors

5-alpha reductase inhibitor
Used for symptomatic treatment of BPH and male pattern baldness (i.e., androgenetic alopecia)
May decrease risk of low-grade prostate cancer; but, may increase risk of more serious high-grade prostate cancer

Indicated to initiate treatment for signs and symptoms of benign prostatic hyperplasia (BPH) in men with an enlarged prostate for up to 26 weeks

Known hypersensitivity to finasteride, tadalafil, or capsule components; hypersensitivity reactions have included Stevens-Johnson syndrome, exfoliative dermatitis, pruritus, urticaria, and angioedema

Pregnancy

Coadministration with nitrates or soluble guanylate cyclase (sGC) stimulators (eg, riociguat)

Finasteride

• Impotence (5.1-18.5%)
• Decreased libido (2.6-10%)
• Postural hypotension (9.1%)
• Dizziness (7.4%)
• Abnormal ejaculation (7.2%)
• Asthenia (5.3%)
• Decreased ejaculate volume (1.5-3.7%)
• Sexual function abnormal (2.5%)
• Gynecomastia (2.2%)
• Headache (2%)
• Breast enlargement (0.5-1.8%)
• Somnolence (1.7%)
• Peripheral edema (1.3%)
• Hypotension (1.2%)
• Rhinitis (1%)

Tadalafil

• Headache (4.1%)
• Dyspepsia (2.4%)
• Back pain (2.4%)
• Nasopharyngitis (2.1%)
• Diarrhea (1.4%)
• Pain in extremity (1.4%)
• Myalgia (1.2%)
• Dizziness (1%)

• <2% (uncertain causality)

  • Body as a whole: Asthenia, face edema, fatigue, pain, peripheral edema
  • Cardiovascular: Angina pectoris, chest pain, hypotension, myocardial infarction, postural hypotension, palpitations, syncope, tachycardia
  • Digestive: Abnormal liver function tests, dry mouth, dysphagia, esophagitis, gastritis, gamma-glutamyl transpeptidase (GGTP) increased, loose stools, nausea, upper abdominal pain, vomiting, gastroesophageal reflux disease, hemorrhoidal hemorrhage, rectal hemorrhage
  • Musculoskeletal: Arthralgia, neck pain
  • Nervous: Dizziness, hypoesthesia, insomnia, paresthesia, somnolence, vertigo
  • Renal and urinary: Renal impairment
  • Respiratory: Dyspnea, epistaxis, pharyngitis
  • Skin and appendages: Pruritus, rash, sweating
  • Ophthalmologic: Blurred vision, changes in color vision, conjunctivitis (including conjunctival hyperemia), eye pain, lacrimation increase, swelling of eyelids
  • Otologic: Sudden decrease in or loss of hearing, tinnitus
  • Urogenital: Erection increased, spontaneous penile erection

Hypersensitivity reported; contraindicated with history of hypersensitivity to finasteride, tadalafil, or capsule components; discontinue immediately if hypersensitivity occurs

Before initiating, rule out other urologic conditions that may cause similar symptoms; prostate cancer and BPH may coexist

5-alpha-reductase inhibitors may increase risk of developing high-grade prostate cancer

Carefully monitor patients with large residual urinary volume and/or severely diminished urinary flow for obstructive uropathy; these patients may not be candidates for this therapy

Prolonged erection and priapism may occur; instruct patients who have an erection lasting >4 hr, whether painful or not, to seek emergency medical attention; caution with conditions that may predispose patient to priapism (eg, sickle cell anemia, multiple myeloma, leukemia) or with anatomic deformation of penis (eg, angulation, cavernosal fibrosis, Peyronie disease)

If sudden decrease or loss of hearing occurs, advise patients to stop taking finasteride/tadalafil and seek prompt medical care; these events, which may be accompanied by tinnitus and dizziness, have been reported in temporal association with PDE5 inhibitors

Contraindicated in pregnant females and not indicated for use in females

Not indicated for use in females

Finasteride/tadalafil

capsule

• 5mg/5mg