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Tadalafil Tablets are phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of: erectile dysfunction (ED) ( 1.1 ) the signs and symptoms of benign prostatic hyperplasia (BPH) ( 1.2 ) ED and the signs and symptoms of BPH (ED/BPH) ( 1.3 ) If Tadalafil Tablets are used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks ( 1.4 ). 1.1 Erectile Dysfunction Tadalafil Tablets are indicated for the treatment of erectile dysfunction (ED). 1.2 Benign Prostatic Hyperplasia Tadalafil Tablets are indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). 1.3 Erectile Dysfunction and Benign Prostatic Hyperplasia Tadalafil Tablets are indicated for the treatment of ED and the signs and symptoms of BPH (ED/BPH). 1.4 Limitation of Use If Tadalafil Tablets are used with finasteride to initiate BPH treatment, such use is recommended for up to 26 weeks because the incremental benefit of Tadalafil Tablets decreases from 4 weeks until 26 weeks, and the incremental benefit of Tadalafil Tablets beyond 26 weeks is unknown [see Clinical Studies ( 14.3 )] .

Administration of Tadalafil Tablets to patients using any form of organic nitrate is contraindicated. Tadalafil Tablets was shown to potentiate the hypotensive effect of nitrates ( 4.1 ). History of known serious hypersensitivity reaction to tadalafil tablets or ADCIRCA ® ( 4.2 ). Administration with guanylate cyclase (GC) stimulators, such as riociguat ( 4.3 ). 4.1 Nitrates Administration of Tadalafil Tablets to patients who are using any form of organic nitrate, either regularly and/or intermittently, is contraindicated. In clinical pharmacology studies, Tadalafil Tablets was shown to potentiate the hypotensive effect of nitrates [see Clinical Pharmacology ( 12.2 )] . 4.2 Hypersensitivity Reactions Tadalafil Tablets are contraindicated in patients with a known serious hypersensitivity to tadalafil (Tadalafil Tablets or ADCIRCA®). Hypersensitivity reactions have been reported, including Stevens-Johnson syndrome and exfoliative dermatitis [see Adverse Reactions ( 6.2 )] . 4.3 …

Evaluation of erectile dysfunction and BPH should include an appropriate medical assessment to identify potential underlying causes, as well as treatment options. Before prescribing Tadalafil, it is important to note the following: Patients should not use Tadalafil if sex is inadvisable due to cardiovascular status ( 5.1 ). Use of Tadalafil with alpha-blockers, antihypertensives or substantial amounts of alcohol (≥5 units) may lead to hypotension ( 5.6 , 5.9 ). Tadalafil is not recommended in combination with alpha-blockers for the treatment of BPH because efficacy of the combination has not been adequately studied and because of the risk of blood pressure lowering. Caution is advised when Tadalafil is used as a treatment for ED in men taking alpha-blockers. ( 2.7 , 5.6 , 7.1 , 12.2 ) Patients should seek emergency treatment if an erection lasts >4 hours. Use Tadalafil with caution in patients predisposed to priapism ( 5.3 ). Patients should stop Tadalafil and seek medical care if a sudden loss of vision occurs in one or both eyes, which could be a sign of non-arteritic anterior ischemic optic neuropathy (NAION). Tadalafil should be used with caution, and only when the anticipated benefits outweigh the risks, in patients with a history of NAION. Patients with a "crowded" optic disc may also be at an increased risk of NAION ( 5.4 , 6.2 ). Patients should stop Tadalafil and seek prompt medical attention in the event of sudden decrease or loss of hearing ( 5.5 ). Prior to …

Hepatic Impairment ( 2.6 , 5.8 , 8.6 ): Mild or Moderate: Dosage adjustment may be needed. Severe: Use is not recommended. Renal Impairment ( 2.6 , 5.7 , 8.7 ): Patients with creatinine clearance 30 to 50 mL/min: Dosage adjustment may be needed. Patients with creatinine clearance less than 30 mL/min or on hemodialysis: For use as needed: Dose should not exceed 5 mg every 72 hours. Once daily use is not recommended. 8.1 Pregnancy Risk Summary Tadalafil is not indicated for use in females. There are no data with the use of Tadalafil in pregnant women to inform any drug-associated risks for adverse developmental outcomes. In animal reproduction studies, no adverse developmental effects were …