SPEDRA tablet (avanafil) is a new medicine indicated for the treatment of erectile dysfunction in adult men . Sexual stimulation is required for SPEDRA to be effective.
SPEDRA is available in 3 strengths: 50 mg, 100 mg and 200 mg.
SPEDRA consists of the new active substance , avanafil , a reversible, highly selective and potent inhibitor of phosphodiesterase type 5 (PDE5) specific for cyclic guanosine monophosphate (cGMP).
When sexual stimulation causes the local release of nitric oxide, inhibition of PDE5 by avanafil results in an increase in the level of cGMP in the cavernous bodies of the penis. This results in relaxation of the smooth muscles and an influx of blood into the penile tissues, producing an erection.
Avanfil has no effect in the absence of sexual stimulation.
Clinical efficacy and safety data
Avanafil has been evaluated in three randomized, double-blind, controlled versusplacebo, conducted in parallel groups for up to 3 months, in the general population of patients with erectile dysfunction (ED), in patients with type 1 or type 2 diabetes and ED, as well as in patients with ED following radical bilateral prostatectomy with preservation of the nerves. A total of 1168 patients received avanafil, which was taken as needed in doses of 50 mg, 100 mg and 200 mg. Patients were instructed to take a dose of study medication approximately 30 minutes before the start of sexual activity.
In addition, a subgroup of patients was included in an open label extension study, in which 493 patients received avanafil for at least 6 months and 153 patients for at least 12 months. Patients initially received a 100 mg dose of avanafil and could, at any time during the study, request that their dose of avanafil be increased to 200 mg or decreased to 50 mg depending on their individual response to treatment. .
In all studies, a statistically significant improvement was observed for all primary efficacy endpoints for all three doses of avanafil compared to placebo. These differences were maintained during long-term treatment.
For all pivotal studies with avanafil, the percentage of successful sexual intercourse attempts was significantly higher for all doses of avanafil compared to placebo, for attempts at all time intervals studied after treatment. taking the product.
For further details on efficacy and clinical safety data, see the SPEDRA VIDAL Product Monograph .
The recommended dose is 100 mg to be taken as needed approximately 30 minutes before sexual activity . Sexual stimulation is required for a response to treatment.
The maximum frequency of intake is once a day.
Depending on individual efficacy and tolerance, the dose may be increased to a maximum of 200 mg or reduced to 50 mg.
If SPEDRA is taken with food (high fat meal), the onset of activity may be delayed compared to taking it on an empty stomach .
Combinations to be taken into account
Co-administration of avanafil with strong inhibitors of CYP3A4 is contraindicated as they may increase exposure to avanafil. These include the following active ingredients: ketoconazole, ritonavir, ataznavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir and telithromycin.
In case of concomitant treatment with moderate CYP3A4 inhibitors (erythromycin, amprenavir, aprepitant, diltiazem, fluconazole, fosamprenavir and verapamil), the maximum recommended dose of avanfil should not exceed 100 mg, with an interval of at least 48 hours between doses.
In addition, other CYP3A4 inhibitors, including grapefruit juice , are likely to increase exposure to avanafil. It is advisable to avoid grapefruit juice during the 24 hours preceding the intake.