Erectile dysfunction

Active Ingredient: Tadalafil

Indication for Tadalafil

Population group: men, only adults (18 years old or older)
Therapeutic intent: Curative procedure

In order for tadalafil to be effective for the treatment of erectile dysfunction, sexual stimulation is required.

For this indication, competent medicine agencies globally authorize below treatments:

2.5-20 mg once prior to anticipated sexual activity


Dosage regimens

Regimen A: Oral, between 2.5 milligrams tadalafil and 5 milligrams tadalafil, once daily.

Regimen B: Oral, between 10 milligrams tadalafil and 20 milligrams tadalafil, one dose.

Detailed description

In general, the recommended dose is 10 mg taken prior to anticipated sexual activity and with or without food.

In those patients in whom tadalafil 10 mg does not produce an adequate effect, 20 mg might be tried. It may be taken at least 30 minutes prior to sexual activity. The maximum dose frequency is once per day. Tadalafil 10 and 20 mg is intended for use prior to anticipated sexual activity and it is not recommended for continuous daily use.

In patients who anticipate a frequent use of tadalafil (i.e. at least twice weekly) a once daily regimen with the lowest doses of tadalafil might be considered suitable, based on patient choice and the physician’s judgement.

In these patients the recommended dose is 5 mg taken once a day at approximately the same time of day. The dose may be decreased to 2.5 mg once a day based on individual tolerability.

The appropriateness of continued use of the daily regimen should be reassessed periodically.

Dosage considerations

Should be taken prior to anticipated sexual activity and with or without food.

Active ingredient


Tadalafil is a selective, reversible inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5 (PDE5). When sexual stimulation causes the local release of nitric oxide, inhibition of PDE5 by tadalafil produces increased levels of cGMP in the corpus cavernosum. This results in smooth muscle relaxation and inflow of blood into the penile tissues, thereby producing an erection. The effect of PDE5 inhibition on cGMP concentration in the corpus cavernosum is also observed in the smooth muscle of the prostate, the bladder and their vascular supply. The resulting vascular relaxation increases blood perfusion which may be the mechanism by which symptoms of benign prostatic hyperplasia are reduced.

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