Usp Monograph Tadalafil

This is in reference to your abbreviated new drug application (ANDA) dated September 27, 2013 submitted pursuant to section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), for Tadalafil Tablets USP, 20 mg.

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).

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. Shankar mahadevan ganesh vandana ekdantay vakratunday song. • Prolonged erection - patients should seek emergency treatment if an erection lasts >4 hours. Use with caution in patients predisposed to priapism. Samjhawan song.

• 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). 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.