Take Durevolis 10 mg Tablet orally, with or without food. It can be taken at any time of day.

Tadalafil selectively inhibits cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). When sexual stimulation causes local release of nitric oxide, PDE5 inhibition by tadalafil increases cGMP levels in the corpus cavernosum, leading to smooth muscle relaxation and inflow of blood into the penis, resulting in an erection. For BPH, it relaxes smooth muscle cells in the prostate and bladder, improving urinary flow.

• •Co-administration with any form of organic nitrates or nitric oxide donors (due to risk of severe hypotension).
• •Co-administration with guanylate cyclase stimulators (e.g., Riociguat).
• •Hypersensitivity to tadalafil or any components of the tablet.
• •Patients with severe cardiovascular disease for whom sexual activity is inadvisable.
• •Recent myocardial infarction (within 90 days) or stroke (within 6 months).
• •Uncontrolled hypertension or hypotension.

Store in a cool, dry place, below 30°C. Protect from light and moisture. Keep out of reach of children.

In studies of healthy subjects, single doses up to 500 mg of tadalafil were administered, and multiple daily doses up to 100 mg were given. Adverse events were similar to those seen at lower doses but generally more severe. In cases of overdose, standard supportive measures should be adopted as required. Hemodialysis contributes negligibly to tadalafil elimination.

Durevolis is not indicated for use in women. There are no adequate and well-controlled studies of tadalafil in pregnant or lactating women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition, or postnatal development.