Additional Information

Description
Tadalafil Tablets, USP, contain tadalafil, a phosphodiesterase type 5 (PDE5) inhibitor. Tadalafil is chemically described as pyrazino[1',2':1,6]pyrido[3,4-b]indole-1,4-dione, 6-(1,3-benzodioxol-5-yl)-2,3,6,7,12,12a-hexahydro-2-methyl-, (6R,12aR)-. It has a molecular formula of C22H19N3O4 and a molecular weight of 389.41. Each oval, biconvex, film-coated tablet contains 20 mg of tadalafil, USP for oral administration.

Tadalafil is a selective inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). Tadalafil enhances the effect of nitric oxide (NO) by inhibiting PDE5, which is responsible for the degradation of cGMP in the corpus cavernosum. Increased cGMP levels lead to smooth muscle relaxation and inflow of blood to the corpus cavernosum, facilitating an erection in response to sexual stimulation.

Indications and Usage
Tadalafil Tablets are indicated for the treatment of erectile dysfunction (ED).

Important Safety Information
Contraindications: Concomitant use with organic nitrates in any form. Concomitant use with guanylate cyclase stimulators (e.g., riociguat). Known hypersensitivity to tadalafil or any component of the tablet.

Warnings and Precautions

• Cardiovascular Effects: Not for use in men for whom sexual activity is inadvisable due to cardiovascular status. Evaluate cardiovascular status before prescribing. There is a potential for cardiac risk during sexual activity in patients with pre-existing cardiovascular disease.

  Prolonged Erection/Priapism: If an erection lasts >4 hours, seek immediate medical attention to avoid long-term injury.

• Effects on Eye: Non-arteritic anterior ischemic optic neuropathy (NAION) has been reported rarely. Sudden vision loss in one or both eyes requires immediate medical attention. Consider increased risk in patients with a history of NAION.
   
• Hearing Loss: Sudden decrease or loss of hearing has been reported. Seek medical attention if this occurs.
   
• Hypotension: Use with caution in patients on antihypertensive therapy or who have significant underlying cardiovascular disease. Concomitant use with alpha-blockers requires careful dosing consideration.
   
• Renal/Hepatic Impairment: Dosage adjustment is recommended for moderate to severe renal impairment or severe hepatic impairment.

Dosage and Administration

• The recommended dose for most patients is 10 mg taken prior to anticipated sexual activity, with or without food.
• Based on efficacy and tolerability, the dose may be increased to 20 mg or decreased to 5 mg.
• Do not take more than one dose per day.
• See Full Prescribing Information for specific dosing in renal/hepatic impairment and with concomitant medications.

Patient Counselling Information

• Read the FDA-approved patient labeling (Medication Guide).
• Advise patients about contraindications (especially nitrates), potential cardiovascular risks, priapism, sudden vision/hearing loss, and common side effects.
• Advise patients to take Tadalafil Tablets only as prescribed.