Priligy

Priligy contains dapoxetine, a short-acting selective serotonin reuptake inhibitor (SSRI) specifically developed for the on-demand treatment of premature ejaculation (PE) in men aged 18-64 years.

Unlike SSRIs used for depression, dapoxetine is rapidly absorbed and eliminated, making it suitable for intermittent dosing prior to sexual activity rather than daily use.

Premature ejaculation is defined as ejaculation occurring with minimal stimulation before, on, or shortly after penetration, before the person wishes it, over which the sufferer has little or no voluntary control.

In phase III clinical trials, dapoxetine increased intravaginal ejaculatory latency time (IELT) approximately 2.

5 to 3-fold compared to baseline and significantly improved patient-reported control over ejaculation, sexual satisfaction, and interpersonal distress.

Dapoxetine is the only licensed pharmacological treatment for PE in Europe.

It does not treat erectile dysfunction and should not be used concurrently with other SSRIs, SNRIs, or tricyclic antidepressants. The BNF lists dapoxetine under drugs used in premature ejaculation.

Take one tablet with a full glass of water, 1-3 hours before anticipated sexual activity. Do not take more than one dose in 24 hours.

Dapoxetine may be taken with or without food; however, taking it with a high-fat meal does not affect its pharmacokinetics significantly but may delay the time to peak concentration.

Avoid alcohol while taking dapoxetine, as the combination increases the risk of syncope and other neurocognitive effects.

Stand up slowly from a seated or lying position to reduce the risk of orthostatic hypotension.

If fainting or prodromal symptoms (lightheadedness, nausea, sweating) occur, lie down immediately with legs elevated and do not resume dapoxetine without consulting a prescriber.

The recommended starting dose is 30 mg, taken as needed 1-3 hours before sexual activity.

If the 30 mg dose does not produce a satisfactory response and the patient tolerates it without significant side effects, the dose may be increased to 60 mg. Maximum frequency is once daily.

No dose adjustment is required for mild renal impairment; dapoxetine is not recommended in moderate-to-severe renal impairment.

It is contraindicated in patients with moderate or severe hepatic impairment. Concomitant use with potent CYP3A4 inhibitors (e.g. ketoconazole) or CYP2D6 inhibitors (e.g.

fluoxetine) is contraindicated due to increased dapoxetine exposure.

Side effects are from the integrated phase III clinical trial database.

Very common (≥1/10): Dizziness (6-11%, dose-dependent), headache (6-9%), nausea (11-22%, the most commonly reported adverse effect, dose-dependent).

Common (≥1/100 to <1/10): Somnolence, insomnia, anxiety, agitation, restlessness, erectile dysfunction (paradoxical in some cases), diarrhoea, dry mouth, fatigue, nasal congestion, irritability.

Uncommon (≥1/1,000 to <1/100): Syncope and pre-syncope, blurred vision, tinnitus, hypotension, flushing, sinus congestion, abdominal pain, hyperhidrosis, paraesthesia, mood changes.

Rare (≥1/10,000 to <1/1,000): Suicidal ideation (as with all serotonergic agents, though the risk is very low with intermittent dosing).

Syncope or vasovagal episodes have been reported in approximately 0.06-0.23% of patients.

A standing blood pressure and heart rate assessment after the first dose may be considered in clinical practice.

Dapoxetine must not be combined with other serotonergic agents (SSRIs, SNRIs, MAOIs, tricyclics, triptans, tramadol, lithium, St John's Wort) due to the risk of serotonin syndrome, a potentially life-threatening condition characterised by agitation, clonus, hyperthermia, and autonomic instability.

Allow a 14-day washout after stopping an MAOI and 7 days after stopping an SSRI before initiating dapoxetine. Conversely, wait 7 days after stopping dapoxetine before starting an SSRI or SNRI.

Orthostatic hypotension and syncope are recognised risks; ensure adequate hydration and caution with alpha-blockers or antihypertensives. Not recommended in men with significant cardiac disease.

Prescribers should evaluate for underlying psychiatric conditions before initiating treatment.

Priligy is contraindicated in patients with hypersensitivity to dapoxetine or any excipient, significant cardiac conditions (heart failure NYHA II-IV, conduction abnormalities including AV block or sick sinus syndrome, significant ischaemic heart disease, significant valvular disease), history of syncope, moderate or severe hepatic impairment, concurrent or recent use of MAOIs (within 14 days), SSRIs, SNRIs, tricyclic antidepressants, thioridazine, or potent CYP3A4 inhibitors (e.

g. ketoconazole, ritonavir, nelfinavir).