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Additional Information
DescriptionTadalafil 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 UsageTadalafil Tablets are indicated for the treatment of erectile dysfunction (ED).
Important Safety InformationContraindications: 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.
Dosage and Administration
Patient Counselling Information
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