Pending Monographs. The USP Pending Monograph process allows for development of these proposals in a number of different ways, depending on the type of change that is needed and the amount of time available before the anticipated approval. In any case, these proposals remain in an unofficial status until FDA approval of the market application held by the donor.

Dosing (Adult) General Dosing & Administration Notes: • If used with finasteride to initiate BPH treatment, such use if recommended for up to 26 weeks. • May be taken without regard to food. Do not split tablets; entire dose should be taken. • Once-daily use: take at approximately the same time every day (Cialis).

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Dividing the dose (40 mg) over the course of the day is not recommended (Adcirca) • Erectile Dysfunction (ED): • As needed use: 10 mg by mouth prior to sexual activity. • May increase to 20 mg or decrease to 5 mg, based on individual efficacy and tolerability. Maximum dosing frequency: once daily • Once-daily use: 2.5 mg once daily. May increase to 5 mg once daily based on individual efficacy and tolerability • Benign Prostatic Hyperplasia (BPH; +/- Erectile Dysfunction): • 5 mg by mouth once daily • Note: If initiated with finasteride: 5 mg by mouth once daily for ≤ 26 weeks • Pulmonary Arterial Hypertension (PAH; WHO Group 1): • 40 mg (two 20 mg tablets) by mouth once daily. • Adcirca: Mild (CrCl 51-80 mL/min) or Moderate (CrCl 31-50 mL/min): • 20 mg once daily • Increase to 40 mg once daily based on individual tolerability • Adcirca: Severe (CrCl. • Patients should not use if sex is inadvisable due to cardiovascular status • Use with alpha-blockers, antihypertensives, or substantial amounts of alcohol (≥5 units) may lead to hypotension • 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 used as a treatment for ED in men taking alpha-blockers. • Prolonged erection - patients should seek emergency treatment if an erection lasts >4 hours. Use with caution in patients predisposed to priapism.

• Effects on the eye - patients should stop treatment 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). 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. • Sudden decrease or loss of hearing - patients should stop treatment and seek prompt medical attention • Other urological conditions - prior to initiating treatment for BPH, consideration should be given to other urological conditions that may cause similar symptoms. • Pregnancy: Pregnancy Category B • Labor and Delivery: None • Nursing Mothers: Not indicated for use in women. • Renal Impairment: • CrCl 30 to 50 mL/min: dosage adjustment may be needed. • CrCl 65 and ≥75 years of age) and younger subjects (≤65 years of age).

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Therefore no dose adjustment is warranted based on age alone. However, a greater sensitivity to medications in some older individuals should be considered. • Penile erection during sexual stimulation is caused by increased penile blood flow resulting from the relaxation of penile arteries and corpus cavernosal smooth muscle. This response is mediated by the release of nitric oxide (NO) from nerve terminals and endothelial cells, which stimulates the synthesis of cGMP in smooth muscle cells. Cyclic GMP causes smooth muscle relaxation and increased blood flow into the corpus cavernosum.

The inhibition of phosphodiesterase type 5 (PDE5) enhances erectile function by increasing the amount of cGMP. Tadalafil inhibits PDE5. Because sexual stimulation is required to initiate the local release of nitric oxide, the inhibition of PDE5 by tadalafil has no effect in the absence of sexual stimulation. • The effect of PDE5 inhibition on cGMP concentration in the corpus cavernosum and pulmonary arteries is also observed in the smooth muscle of the prostate, the bladder and their vascular supply. The mechanism for reducing BPH symptoms has not been established. • Studies in vitro have demonstrated that tadalafil is a selective inhibitor of PDE5.

PDE5 is found in the smooth muscle of the corpus cavernosum, prostate, and bladder as well as in vascular and visceral smooth muscle, skeletal muscle, urethra, platelets, kidney, lung, cerebellum, heart, liver, testis, seminal vesicle, and pancreas. • In vitro studies have shown that the effect of tadalafil is more potent on PDE5 than on other phosphodiesterases. These studies have shown that tadalafil is >10,000-fold more potent for PDE5 than for PDE1, PDE2, PDE4, and PDE7 enzymes, which are found in the heart, brain, blood vessels, liver, leukocytes, skeletal muscle, and other organs. Tadalafil is >10,000-fold more potent for PDE5 than for PDE3, an enzyme found in the heart and blood vessels. Additionally, tadalafil is 700-fold more potent for PDE5 than for PDE6, which is found in the retina and is responsible for phototransduction. Tadalafil is >9,000-fold more potent for PDE5 than for PDE8, PDE9, and PDE10.