Priligy: Uses, Dosage & Side Effects

What Is Priligy and What Is It Used For?

Premature ejaculation is the most common male sexual dysfunction worldwide, with international prevalence estimates ranging from 20 to 30 per cent of adult men. It is defined by the International Society for Sexual Medicine (ISSM) as ejaculation that always or nearly always occurs prior to or within approximately one minute of vaginal penetration (lifelong PE) or a clinically meaningful reduction in latency time, often to about three minutes or less (acquired PE), in combination with the inability to delay ejaculation on all or nearly all penetrations and negative personal consequences such as distress, frustration, and avoidance of sexual intimacy. Until the introduction of dapoxetine, no oral medicine had been licensed specifically for this indication; clinicians used long-acting SSRIs (paroxetine, sertraline, fluoxetine), tricyclic antidepressants (clomipramine), or topical anaesthetics off-label.

Priligy was developed to address the pharmacological mismatch between conventional SSRIs and the on-demand needs of men with PE. Long-acting SSRIs such as paroxetine require daily dosing for several weeks before reaching steady state and exerting their full ejaculation-delaying effect, and they expose the patient to a continuous serotonergic load with the associated risk of sexual side effects, withdrawal symptoms and drug interactions. Dapoxetine, by contrast, has a short pharmacokinetic profile that confines clinically relevant exposure to the few hours surrounding sexual activity. Peak plasma concentrations occur within 1 to 2 hours of ingestion, the initial half-life is approximately 1.3 to 1.5 hours, and plasma levels fall by more than 95 per cent within 24 hours. This profile enables a single tablet to be taken in advance of an anticipated sexual encounter and avoided on days when no encounter is planned.

The licensed indication for Priligy in the European Union and most other approving jurisdictions is the on-demand treatment of premature ejaculation in adult men 18 to 64 years of age in whom all of the following criteria are present: an intravaginal ejaculation latency time (IELT) of less than two minutes; persistent or recurrent ejaculation with minimal sexual stimulation before, on or shortly after penetration and before the man wishes; marked personal distress or interpersonal difficulty as a consequence of premature ejaculation; and poor control over ejaculation. Priligy should be prescribed only to men who meet all of these criteria and who have been carefully evaluated for medical and psychological factors that may contribute to premature ejaculation.

In the pivotal phase III clinical trial programme, which enrolled more than 6,000 men across multiple international studies, dapoxetine 30 mg and 60 mg taken on demand significantly increased the geometric mean IELT from a baseline of approximately 0.9 minutes to 3.1 minutes with 30 mg and 3.5 minutes with 60 mg, compared with a placebo response of 1.9 minutes. Equally important, patients reported improvements in their perceived control over ejaculation, in personal distress, in interpersonal difficulty caused by PE, and in overall sexual satisfaction. These improvements were sustained over treatment periods of 24 weeks and beyond and were broadly consistent across geographic regions, age groups, and presence or absence of erectile dysfunction.

It is important to understand that Priligy is not a cure for premature ejaculation. It does not address the underlying neurobiological or psychological factors that may contribute to the condition; rather, it pharmacologically prolongs the latency to ejaculation while serotonin is present at the synapse. When dapoxetine is discontinued, IELT typically returns to baseline. For some men, particularly those with acquired PE driven by performance anxiety or relationship issues, combination therapy with behavioural techniques (such as the start-stop or squeeze technique), pelvic-floor exercises, sex therapy or couples counselling may produce more durable benefits than pharmacotherapy alone.

What Should You Know Before Taking Priligy?

Contraindications

Priligy must not be used in patients with any of the following conditions or circumstances. These are absolute contraindications listed in the EMA Summary of Product Characteristics, and prescribing in spite of them is associated with a substantially increased risk of serious adverse events.

• Hypersensitivity: Known hypersensitivity to dapoxetine or to any of the excipients in the tablet (which include lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate, hypromellose, titanium dioxide, triacetin, iron oxides and other film-coating agents).
• Significant pathological cardiac conditions: Heart failure (NYHA class II to IV), conduction abnormalities such as second- or third-degree atrioventricular block or sick sinus syndrome (unless a pacemaker is in place), significant ischaemic heart disease, and significant valvular disease.
• History of syncope: Patients with previous episodes of fainting due to neurocardiogenic, vasovagal or orthostatic causes are at substantially increased risk of recurrence with dapoxetine.
• History of mania, hypomania or severe depression: Although dapoxetine is not used as an antidepressant, its serotonergic action could theoretically destabilise underlying mood disorders.
• Moderate or severe hepatic impairment (Child-Pugh class B or C): Hepatic metabolism of dapoxetine is markedly reduced in moderate-to-severe liver disease, leading to increased plasma exposure and risk of toxicity.
• Concomitant treatment with monoamine oxidase inhibitors (MAOIs): Including phenelzine, tranylcypromine, isocarboxazid, moclobemide, selegiline, rasagiline and linezolid (an antibiotic with MAOI activity). Priligy must not be started within 14 days of stopping an MAOI, and an MAOI must not be started within 7 days of stopping Priligy.
• Concomitant treatment with thioridazine or within 14 days of its discontinuation, due to the risk of QT prolongation and cardiac arrhythmia.
• Concomitant treatment with other serotonergic medicines: Other SSRIs (fluoxetine, sertraline, paroxetine, citalopram, escitalopram, fluvoxamine), SNRIs (venlafaxine, duloxetine), tricyclic antidepressants (amitriptyline, clomipramine, imipramine), tramadol, tryptophan, St John's wort (Hypericum perforatum), lithium, and certain triptans used for migraine.
• Concomitant treatment with potent CYP3A4 inhibitors: Including ketoconazole, itraconazole, ritonavir, saquinavir, telithromycin, nefazodone, nelfinavir and atazanavir, which substantially increase dapoxetine plasma exposure.

Warnings and Precautions

Several additional warnings apply to the safe use of Priligy and should be discussed with your doctor or pharmacist before starting treatment:

• Cardiovascular assessment: Even men without diagnosed heart disease should have their personal and family cardiovascular history reviewed before starting Priligy. Resting blood pressure (supine and standing) should be measured to detect baseline orthostatic intolerance.
• Avoid alcohol: The combination of dapoxetine and alcohol significantly increases the risk of dizziness, syncope, drowsiness, sedation and impaired judgement. Patients should not drink alcohol on the day they take Priligy.
• Avoid recreational drugs: Recreational drugs with serotonergic or sedative effects (MDMA/ecstasy, LSD, ketamine, gamma-hydroxybutyrate, narcotic analgesics) carry a significant risk when combined with Priligy, including serotonin syndrome and severe hypotension.
• Mental health monitoring: SSRIs as a class have been associated with rare reports of changes in mood, agitation, suicidal ideation and behaviour, particularly in younger adults. Patients should be aware of these possibilities and seek help promptly if they occur.
• Bleeding risk: SSRIs can prolong bleeding time. Caution is advised in patients taking anticoagulants, antiplatelet agents, or non-steroidal anti-inflammatory drugs, and in those with bleeding disorders.
• Mild hepatic and renal impairment: No dose adjustment is required for mild liver disease or for mild-to-moderate renal impairment, but caution is advised. Severe renal impairment has not been studied.
• Driving and machinery: Priligy can cause dizziness, somnolence and reduced concentration, even in patients who feel well. Patients should not drive or operate machinery until they know how dapoxetine affects them.
• Discontinuation effects: Although on-demand dosing minimises the risk, abrupt discontinuation of any SSRI can theoretically cause withdrawal symptoms (dizziness, nausea, sleep disturbance). With dapoxetine taken less than once a day, this is rarely clinically significant.

Pregnancy, Breastfeeding and Use in Women

Priligy is licensed only for use in adult men. It is not indicated, has not been studied, and must not be used in women, including pregnant or breastfeeding women. The pregnancy and breastfeeding subsections of the SmPC therefore state that the medicine is not relevant to women and should not be prescribed for any indication in this population.

Animal studies do not suggest direct or indirect harmful effects on male fertility. Nevertheless, Priligy should not be used by men actively trying to conceive without specific medical advice, and the on-demand nature of dosing means that it should not be present in the bloodstream for prolonged periods.

Elderly Men and Adolescents

Priligy is not licensed for use in men under 18 or men aged 65 and over. The under-18 restriction reflects both the lack of safety and efficacy data in adolescents and concerns about the potential for SSRI-related changes in mood, behaviour and suicidal ideation in younger patients. The over-65 restriction reflects limited data in older men and the higher prevalence of cardiovascular disease, polypharmacy, orthostatic intolerance and hepatic or renal impairment in this group, all of which increase the risk of adverse effects from dapoxetine.

How Does Priligy Interact with Other Drugs?

Dapoxetine is metabolised primarily by the cytochrome P450 enzymes CYP2D6 and CYP3A4 and by flavin-containing monooxygenase 1 (FMO1). Its pharmacological action increases central serotonergic tone, which in combination with other serotonergic drugs can produce the potentially life-threatening serotonin syndrome. Both pharmacokinetic and pharmacodynamic interactions must therefore be considered before prescribing.

Major Interactions

Moderate Interactions Requiring Dose Adjustment or Caution

What Is the Correct Dosage of Priligy?

Dosing of Priligy is guided by the EMA Summary of Product Characteristics, the European Association of Urology guidelines on sexual and reproductive health, and the ISSM guideline on premature ejaculation. The principles are simple: start at 30 mg, dose only when needed (and not more than once in any 24-hour period), and reassess after a defined trial period to decide whether to continue, increase the dose, or stop treatment.

Adult Men (18 to 64 Years)

Children and Adolescents

Priligy is not authorised for use in any patient under 18 years of age. There is no established indication for premature ejaculation in adolescents, and the safety and efficacy of dapoxetine in this age group have not been established. SSRIs as a class carry a regulatory warning regarding mood changes, agitation and suicidal ideation in younger patients, which is an additional reason for the strict age restriction.

Elderly Patients (Aged 65 and Over)

Priligy is not recommended for men aged 65 years or older. Clinical trial data in this group are limited, and older men more frequently have cardiovascular disease, polypharmacy, orthostatic intolerance, and reduced hepatic and renal function, all of which increase the risk of adverse effects from dapoxetine. If treatment of premature ejaculation is desired in an older man, alternative approaches (behavioural techniques, off-label use of long-acting SSRIs under specialist supervision, topical anaesthetics) should be considered after a careful benefit-risk discussion.

Missed Dose

Because Priligy is taken on demand rather than on a fixed schedule, the concept of a “missed dose” does not apply in the way it does for daily medications. If sexual activity does not occur after a tablet has been taken, no further action is needed; the next dose can be taken before the next anticipated encounter, provided that at least 24 hours have elapsed since the previous dose. Do not take a second tablet on the same day, even if the first dose appeared ineffective; doubling up significantly increases the risk of orthostatic hypotension, syncope and other adverse effects without producing a meaningful additional benefit.

Overdose

Limited overdose data are available with dapoxetine. Reported features of overdose with SSRIs in general include nausea, vomiting, dizziness, sedation, tachycardia, tremor and (in severe cases) seizures, QT-interval prolongation and serotonin syndrome. There is no specific antidote for dapoxetine; treatment is supportive and symptomatic. Activated charcoal may be considered if the patient presents very soon after ingestion. Continuous cardiac monitoring is recommended for significant overdose, particularly when other serotonergic or QT-prolonging drugs may have been co-ingested.

What Are the Side Effects of Priligy?

The safety profile of dapoxetine has been characterised in a clinical development programme that enrolled more than 6,000 men and in extensive post-marketing surveillance since 2009. Most adverse effects are dose-related, occur in the hours after dosing, and resolve as the medicine is eliminated. The frequency categories below follow standard EMA conventions. Frequencies are based on pooled data from pivotal placebo-controlled trials.

The majority of side effects with Priligy are mild to moderate and resolve within 24 hours as the medicine is eliminated. Many of them, including nausea, dizziness and headache, are most prominent with the first dose and become less troublesome with subsequent doses. Counselling at the time of prescription about expected side effects, the importance of drinking a full glass of water with each tablet, the need to lie down at the first sign of light-headedness, and the strict avoidance of alcohol and recreational drugs substantially reduces the rate of medically significant adverse events.

If you experience any adverse effects while taking Priligy, even if they are not listed here, you can report them to your national pharmacovigilance authority (for example, the MHRA Yellow Card scheme in the United Kingdom, the EMA EudraVigilance system in the European Union, the TGA Black Triangle scheme in Australia, or the corresponding system in your country). Reporting helps the ongoing safety monitoring of medicines.

How Should You Store Priligy?

Priligy film-coated tablets are stable when stored under ordinary household conditions, but a few simple precautions ensure that the tablets retain their full potency until the expiry date and that the medicine cannot be accessed by people for whom it is not intended.

• Temperature: Store below 30°C (86°F). Avoid storage in places where temperatures may exceed this limit, such as bathrooms, glove compartments of vehicles in summer, or near radiators.
• Moisture: The aluminium-foil blister provides the primary moisture barrier. Do not transfer the tablets to alternative containers, pill organisers or unblistered packs, as this exposes them to humidity and can degrade the medicine before the printed expiry date.
• Light: Keep the blister inside the outer carton until use, both to protect from light and to retain the patient information leaflet for reference.
• Original packaging: Always keep tablets in the original blister with the lot number and expiry date intact. This information is essential if a recall is issued or if a side effect needs to be reported.
• Child safety: Keep all medicines out of the sight and reach of children. Although Priligy is licensed only for adult men, accidental ingestion by a child or by an unintended adult could cause significant adverse effects, including syncope and serotonin-related symptoms.
• Discreet storage: Many users prefer to store medicines for sexual health discreetly. A locked cabinet or drawer is appropriate; avoid leaving tablets visible in shared spaces.
• Travel: When travelling, keep Priligy in the original blister and carton in your hand luggage, with the prescription label or a doctor's letter if travelling internationally. Some countries have restrictions on the importation of prescription medicines, particularly those affecting sexual function; check the regulations of your destination.
• Disposal: Do not dispose of Priligy in household waste or down the toilet or sink. Return unused or expired tablets to your local pharmacy, which will dispose of them safely in accordance with national pharmaceutical waste regulations.

Do not use Priligy after the expiry date (“EXP”) printed on the blister and the outer carton. The expiry date refers to the last day of the stated month. Expired tablets may have reduced potency or altered chemical properties and should be returned for disposal.

What Does Priligy Contain?

Active Substance

The active substance is dapoxetine, present as the hydrochloride salt. Each Priligy 30 mg film-coated tablet contains 30 mg of dapoxetine, equivalent to 33.62 mg of dapoxetine hydrochloride. Where the higher strength is marketed, each Priligy 60 mg film-coated tablet contains 60 mg of dapoxetine, equivalent to 67.24 mg of dapoxetine hydrochloride. Dapoxetine is chemically (S)-N,N-dimethyl-3-(naphthalen-1-yloxy)-1-phenylpropan-1-amine and was specifically developed for the on-demand treatment of premature ejaculation rather than as a treatment for depression or anxiety.

Inactive Ingredients (Excipients)

The inactive ingredients in Priligy serve as binders, fillers, disintegrants, lubricants and film-coating components. The typical composition is:

• Tablet core: lactose monohydrate, microcrystalline cellulose, croscarmellose sodium, colloidal anhydrous silica, magnesium stearate.
• Film coating: hypromellose (hydroxypropylmethylcellulose), titanium dioxide (E171), triacetin, iron oxide black (E172) and iron oxide yellow (E172) for the 30 mg tablets, with a different shade for the 60 mg tablets to allow visual differentiation between strengths.

Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption should not take this medicine because it contains lactose. Always check the patient information leaflet (PIL) of the specific product you are dispensed for the exact list of excipients in your local formulation, as inactive ingredients may vary slightly between manufacturers and markets.

Product Appearance

Priligy 30 mg film-coated tablets are typically presented as approximately 6.5 mm round, biconvex, light grey tablets debossed with “30” inside a triangle on one side. The 60 mg strength, where marketed, is presented as approximately 8 mm round, biconvex, beige tablets debossed with “60” inside a triangle. Tablets are supplied in PVC/PE/PVDC-aluminium blisters in carton pack sizes of 1, 2, 3, 6 and 9 tablets. Pack sizes available vary by country.