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 Effect on bleeding Tadalafil is a selective PDE5 inhibitor; PDE5 is found in platelets When administered in combination with aspirin, tadalafil 20 mg did not prolong bleeding time relative to aspirin alone Finasteride/tadalafil has not been administered to patients with bleeding disorders or significant active peptic ulceration in clinical trials Although tadalafil has not been shown to increase bleeding times in healthy subjects, use caution in patients with bleeding disorders or significant active peptic ulceration after a careful risk-benefit assessment Ocular adverse reactions Stop PDE5 inhibitors and seek medical attention if sudden vision loss occurs in 1 or both eyes May be a sign of nonarteritic anterior ischemic optic neuropathy (NAION), a rare condition and a cause of decreased vision, including permanent loss of vision, reported rarely postmarketing in temporal association with the use of PDE5 inhibitors The prescribing information lists the annual incidence of NAION as 2.5-11.8 cases/100,000 in men aged ≥50 yr Patients with known hereditary degenerative retinal disorders, including retinitis pigmentosa, were not included in clinical trials; finasteride/tadalafil is not recommended in these patients Prostate-specific antigen Finasteride reduces serum prostate-specific antigen (PSA) concentration by ~50% within 6 months of treatment This decrease is predictable over entire range of PSA values in patients with symptomatic BPH For interpretation of serial PSAs in men taking finasteride/tadalafil, establish new PSA baseline at least 6 months after starting treatment, with PSA monitored periodically thereafter Cardiovascular risks Patients with left ventricular outflow obstruction (eg, aortic stenosis, idiopathic hypertrophic subaortic stenosis) can be sensitive to vasodilator actions, including PDE5 inhibitors Patients not included in safety/efficacy trials Until further information is available, not recommended for the following patients Myocardial infarction within last 90 days Unstable angina or angina occurring during sexual intercourse NYHA class 2 or greater heart failure in last 6 months Uncontrolled arrhythmias, hypotension (<90/50 mm Hg), or uncontrolled hypertension Stroke within last 6 months Drug interaction overview Organic nitrates Contraindicated Do not use finasteride/tadalafil in patients taking any form of organic nitrate or nitric oxide donors, either regularly and/or intermittently PDE5 inhibitors may potentiate the hypotensive effects of nitrates Discuss with patients if they experience anginal chest pain requiring nitroglycerin following intake of finasteride/tadalafil If medically necessary for a life-threatening situation, at least 48 hr should have elapsed after last dose of finasteride/tadalafil before nitrate administration considered; should still be administered under close medical supervision with appropriate hemodynamic monitoring Guanylate cyclase stimulators Contraindicated Tadalafil may potentiate hypotensive effects of guanylate cyclase stimulators Alpha-blockers or antihypertensives Not recommended Coadministration with other vasodilators may have additive and significant blood pressure–lowering effect, which may lead to symptomatic hypotension Discontinue alpha-blockers at least 1 day before starting finasteride/tadalafil Alcohol Caution Alcohol and tadalafil act as mild vasodilators Substantial alcohol consumption (eg, ≥5 units) with tadalafil may cause orthostatic signs and symptoms, including increase in heart rate, decreased standing blood pressure, dizziness, and headache Strong CYP3A4 inhibitors Not recommended Tadalafil is metabolized primarily by CYP3A4; coadministration with strong CYP3A4 inhibitors may increase tadalafil systemic absorption and increase risk for adverse effects Pregnancy Contraindicated in pregnant females and not indicated for use in females Based on animal studies and finasteride mechanism of action, may cause abnormal development of external genitalia in a male fetus if administered to pregnant females Pregnant females should not handle crushed or open capsules owing to possible absorption of finasteride and subsequent potential risk to a male fetus If contact with crushed or broken capsules occurs, wash contact area immediately with soap and water Lactation Not indicated for use in femalesPregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action Finasteride: Selective inhibitor of type1 and type 2 isoforms of 5-alpha-reductase, which results in inhibiting conversion of testosterone to dihydrotestosterone by alpha receptors located in stromal muscle cells;, this decreases prostate volume and improves voiding symptoms Tadalafil: Phosphodiesterase-5 (PDE5) enzyme inhibitor; inhibits PDE5, thereby increasing cyclic guanosine monophosphate (cGMP) to allow smooth muscle relaxation of the corpus cavernosum, prostate, and bladder The combination of tadalafil and finasteride has the greatest benefit in patients with large prostates, owing to the mechanism of tadalafil relaxing smooth muscle of the prostate and finasteride shrinking the prostate; this allows for alleviation of urinary symptoms Absorption Bioavailability Finasteride: 63% Tadalafil: Not determined Peak plasma time Finasteride: 2 hr Tadalafil: 3 hr Peak plasma concentration Finasteride: 43.22 ng/mL Tadalafil: 106.75 ng/mL AUC Finasteride: 335.8 ng⋅h/mL Tadalafil: 2,507.5 ng⋅h/mL Effect of food High-fat, high-calorie meal (ie, 1,011 calorie meal [53% fat]): Decreased peak plasma concentration of finasteride and tadalafil by 29% and 23%; no effect on AUC Distribution Vd Finasteride: 76 L Tadalafil: 63 L Protein bound Finasteride: ~90% Tadalafil: 94% Metabolism Finasteride: Extensive liver metabolism, primarily via CYP3A4; 2 metabolites identified with ≤20% of finasteride’s activity Tadalafil: Metabolized by CYP3A4 to catechol metabolite, which then undergoes methylation and glucuronidation; not expected to be pharmacologically active Elimination Half-life Finasteride: 6.63 hr Tadalafil: 22.33 hr Excretion Finasteride: Urine 39% as metabolites; feces 57% Tadalafil: Urine 36% as metabolites; feces 61% as metabolites Oral Administration Take on empty stomach without food at about the same time each day Storage Store at 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF) No images available for this drug. No images available for this drug.A Patient Handout is not currently available for this monograph.Print FormularyPatient DiscountsAdding plans allows you to compare formulary status to other drugs in the same class.To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.Create Your List of PlansAdding plans allows you to:View the formulary and any restrictions for each plan.Manage and view all your plans together – even plans in different states.Compare formulary status to other drugs in the same class.Access your plan list on any device – mobile or desktop. The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information. View explanations for tiers and restrictions Tier Description 1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs. 2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs. 3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs. 4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. 5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. 6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. NC NOT COVERED – Drugs that are not covered by the plan. Code Definition PA Prior Authorization Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription. 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