Dapoxetine instructions for use, how to take?
This page is an instruction manual for the use of dapoxetine and all generics based on it presented in the GENERICS catalog: Poxet 30, Poxet 60, Poxet 90, Duratia 30, Duratia 60, Duratia 90, Vriligy 60, Dapoligy 60, Stop Ejac 30, Stop Ejac 60, Stop Ejac 90, and others. Their active ingredient is the same — dapoxetine hydrochloride. The mechanism of action, dosages, contraindications, and interactions are identical for all these drugs.
What is dapoxetine
Dapoxetine is a fast-acting selective serotonin reuptake inhibitor (SSRI) developed specifically for the treatment of premature ejaculation (PE). This is a fundamental difference from all other SSRIs on the market: fluoxetine, paroxetine, sertraline were created as antidepressants and are used for PE only off-label, whereas dapoxetine is the first and only drug originally designed specifically for the treatment of PE and has received regulatory approval in more than 60 countries under the trade name Priligy®.[1]
Initially, the molecule was developed by Eli Lilly as an antidepressant, but it was deemed unsuitable for this purpose due to a too short elimination half-life. It is this pharmacokinetic property — rapid absorption and rapid elimination — that made dapoxetine an ideal candidate for "on-demand" dosing in PE. The patent was sold to Johnson & Johnson, and in 2004, an application for registration was submitted to the FDA. The FDA denied registration, requesting additional data, and the drug is still not officially approved in the US. In Europe, Priligy® was approved by the EMA in 2009. Marketing rights in Europe, Asia, and other regions were transferred to Menarini.[2]
In the GENERICS catalog, dapoxetine is available in dosages of 30 mg, 60 mg, and 90 mg from several GMP-certified generic manufacturers: Sunrise Remedies, Fortune Health Care, Centurion Laboratories, Emkay, and Delta Enterprises (India).
Mechanism of action
Ejaculation is regulated by the central nervous system: the ejaculatory reflex is initiated in the spinal cord at the thoracolumbar and lumbosacral levels and is modulated by descending pathways from the brain, including through the lateral paragigantocellular nucleus (LPGi) of the brainstem. Serotonin plays a key role in this regulation: increasing its concentration in the synaptic cleft inhibits the ejaculatory reflex and increases the time to ejaculation.
Dapoxetine blocks the serotonin transporter (SERT), preventing the reuptake of the neurotransmitter into the presynaptic neuron. As a result, serotonin remains in the synaptic cleft longer and has an enhanced effect on pre- and postsynaptic receptors, which delays the onset of ejaculation.[3]
Scheme: nerve signal triggers the release of serotonin into the synaptic cleft → serotonin activates postsynaptic 5-HT receptors → inhibits the ejaculatory reflex. The SERT transporter normally quickly removes serotonin back. Dapoxetine blocks SERT, preventing serotonin from leaving the cleft prematurely.
How dapoxetine differs from conventional SSRI antidepressants: traditional SSRIs (paroxetine, sertraline, and others) must be taken daily for several weeks before a therapeutic concentration accumulates. Dapoxetine works from the very first dose because the onset of its clinical effect is due to an acute, rather than accumulated, pharmacodynamic effect on the serotonin system.
Pharmacokinetics: why dapoxetine is suitable for "on-demand" regimen
- The unique pharmacokinetic profile of dapoxetine is the main reason why it, and not other SSRIs, has become the drug of choice for "on-demand" PE.
- Absorption: after oral administration, dapoxetine is rapidly absorbed. Peak blood concentration (Cmax) is reached in 1.0–1.3 hours when taking 30 mg and 60 mg, respectively. Food has no clinically significant effect on pharmacokinetics — the drug can be taken regardless of food intake.[4]
- Distribution: more than 99% of dapoxetine binds to plasma proteins. The mean volume of distribution at steady state is about 162 liters.
- Elimination half-life: this is where the key feature of the molecule lies. Initial T1/2 is only 1.3–1.4 hours. At the same time, terminal T1/2 is 15–19 hours (after a single dose of 30 mg) and 20–24 hours (after 60 mg). After 24 hours, the concentration of dapoxetine in plasma drops to 3.5–3.9% of the peak, which practically excludes accumulation when taken "on demand".[4] This is a striking contrast to antidepressants: paroxetine accumulates 8 times with regular use, sertraline — 2 times.
- Metabolism: dapoxetine is actively metabolized in the liver and kidneys by several enzymes — CYP2D6, CYP3A4, and flavin monooxygenase 1 (FMO1). The main circulating metabolite — dapoxetine-N-oxide — is virtually devoid of clinical activity. Other metabolites (desmethyldapoxetine and didesmethyldapoxetine) are comparable in activity to the parent molecule, but account for less than 3% of the total concentration.[5]
- Practical conclusion: due to rapid absorption, dapoxetine starts acting at the right moment; due to rapid initial elimination, it is cleared shortly after intercourse, does not accumulate in the body, and does not cause chronic serotonergic effects characteristic of daily SSRIs.
Dosages
Dapoxetine is available in three dosages. The choice of dose is determined by individual response and tolerability.
- 30 mg — recommended starting dose
Official clinical guidelines and instructions for the original Priligy® prescribe starting with 30 mg. This approach allows assessing individual tolerability and efficacy with minimal risk of side effects. If 30 mg provides satisfactory control over ejaculation, there is no need to increase the dose.
- 60 mg — standard therapeutic dose
With insufficient effect of 30 mg and good tolerability, the dose is increased to 60 mg. This is the most studied and widely used dosage. In clinical trials, 60 mg shows a statistically significantly greater increase in IELT compared to 30 mg, especially in lifelong PE.[6]
- 90 mg — enhanced generic dose
The 90 mg dosage is absent in official recommendations and has not been studied in registration clinical trials — this is a commercial decision of generic manufacturers. Shifting to 90 mg on your own without a doctor's prescription is inappropriate: the risk of adverse events increases proportionally to the dose, while the increase in efficacy beyond 60 mg is not clinically confirmed.
The maximum frequency of administration is 1 time per day, regardless of the dosage.
How to take
Time of administration
The tablet is taken orally 1–3 hours before planned sexual activity. Swallow whole, without chewing or crushing — a pronounced bitter taste is felt when chewing. Wash down with a full glass of water (~200 ml). This is important not only for ease of swallowing, but also from a practical point of view: adequate hydration reduces the risk of vasovagal syncope, which is described in more detail below.
Why the "1–3 hours" window? Peak concentration is reached approximately 1–1.3 hours after administration. A wide time window (rather than a fixed "60 minutes" as with PDE-5 inhibitors) provides practical flexibility: the drug can be taken without knowing the exact moment intimacy begins.
Influence of food
Unlike sildenafil, dapoxetine can be taken with or without food — food does not clinically significantly affect the rate of absorption or bioavailability.[4] This is practically convenient: you do not need to plan the intake around dinner.
Alcohol
Concomitant use of alcohol and dapoxetine is not recommended by the official instructions. Although the pharmacokinetics of dapoxetine when taking alcohol (0.5 g/kg — about 2 drinks) do not change clinically significantly, the combination increases sedation, reduces reaction speed and cognitive functions, and also significantly increases the risk of vasovagal syncope.[7] Alcohol and dapoxetine are an undesirable combination precisely because of synergism in reducing consciousness and orthostatic stability.
Efficacy
Evidence base: 5 Phase III trials, more than 6000 patients
Dapoxetine is one of the most thoroughly studied drugs in urology. Its efficacy and safety were evaluated in 5 randomized, double-blind, placebo-controlled Phase III clinical trials in more than 25 countries involving 6081 men aged ≥18 years. The primary efficacy endpoint in all studies was intravaginal ejaculatory latency time (IELT), measured by stopwatch.[8]
Increase in IELT
In an integrated analysis of two large parallel Phase III RCTs (121 centers in the US, n=2614), the mean baseline IELT was ~0.9 min in all groups. After 12 weeks, IELT increased to 1.75 min in the placebo group, 2.78 min with dapoxetine 30 mg, and 3.32 min with dapoxetine 60 mg (p < 0.0001 for both doses relative to placebo).[9] In a 24-week international RCT (22 countries, n=1162), the mean IELT increased from the baseline ~0.9 min to 3.2 min (30 mg) and 3.5 min (60 mg) versus 1.9 min in the placebo group.[10]
Important: the effect of dapoxetine is manifested from the first dose — a statistically significant improvement in IELT was recorded after the very first drug taken.[9]
Subjective indicators
In addition to objective IELT, dapoxetine significantly improves all parameters of the Premature Ejaculation Profile (PEP) questionnaire: perception of control over ejaculation, satisfaction with sexual intercourse, personal distress due to PE, and interpersonal difficulties (p < 0.001 for all indicators).[8]
Lifelong vs. acquired PE
According to a comparative analysis, dapoxetine 60 mg provides a statistically significantly greater increase in IELT compared to 30 mg in men with lifelong (congenital) PE, whereas in acquired PE, the difference between doses is not significant.[6]
Dapoxetine with concomitant erectile dysfunction
In men with PE who simultaneously have mild erectile dysfunction, dapoxetine is slightly less effective in subjective indicators than in patients with normal erection. In such a situation, it is advisable to consider a combination drug (dapoxetine + PDE-5 inhibitor), which are widely represented in the section on pills for prolongation.
It is important to understand: dapoxetine is a symptomatic drug. It increases the time to ejaculation, but does not eliminate the cause of PE. When the drug is discontinued, the time to ejaculation returns to the baseline level. For a sustainable result in psychogenic PE, dapoxetine is recommended to be combined with behavioral or psychological therapy.
Side effects
The profile of adverse events of dapoxetine has been studied on a sample of more than 6000 patients and is well predictable. Most side effects are dose-dependent, correspond in time to peak blood concentration (~1.3 hours), and last about 1.5 hours.[8]
Very common (more than 10% at a dose of 60 mg)
Nausea is the most common adverse effect: 11.0% at 30 mg and 22.2% at 60 mg versus ~1% in the placebo group. Typically mild or moderate, transient.
Common (in 2–15% of patients)
Dizziness (5.8% at 30 mg, 10.9% at 60 mg), headache (5.6% at 30 mg, 8.8% at 60 mg), diarrhea (3.9% at 30 mg, 6.8% at 60 mg), somnolence, insomnia, fatigue, nasopharyngitis. All these phenomena are usually mild and short-term — in most cases, they coincide with the period of maximum concentration of the drug in the blood.[9]
Serious adverse event: syncope (fainting)
Fainting when taking dapoxetine is vasovagal in nature and is the most clinically significant adverse effect. In the pooled data of five Phase III trials, its frequency was 0.06% at 30 mg and 0.23% at 60 mg versus 0.05% with placebo. In most reported cases, fainting occurred in the first 3 hours after the first dose, often against the background of additional procedures (blood sampling, blood pressure measurement), and was preventable if hydration recommendations were followed.[7]
Prodromal symptoms of fainting include nausea, dizziness, lightheadedness, palpitations, weakness, sweating, and confusion. When they appear, you must immediately lie down, raising your legs above the level of the heart, or sit down, lowering your head between your knees, until the symptoms stop. Do not stand up abruptly. Drink enough water before and after taking the drug.
SSRI-specific adverse events
Unlike antidepressant SSRIs, the long-term use of which is often accompanied by sexual dysfunction, when using dapoxetine "on demand", sexual dysfunction is rare. Erectile dysfunction was recorded in 2.3–2.6% at doses of 30–60 mg versus 1.6% with placebo.[8] Withdrawal syndrome — one of the main risks of chronic SSRIs — is also not a clinical problem with dapoxetine "on demand": chronic serotonergic stimulation simply does not have time to form.
Contraindications
Absolute
- Heart pathology: heart failure (NYHA Class II–IV), conduction abnormalities (AV block Grade II–III or sick sinus syndrome without a pacemaker), significant ischemic heart disease, significant valvular heart disease.
- History of syncope (fainting) — the most important specific contraindication for dapoxetine.
- History of mania or severe depression, or current psychiatric drug treatment.
- MAO inhibitors (MAOIs) — concomitant use or use within the last 14 days. After discontinuation of dapoxetine, at least 7 days must pass before starting MAOIs.
- Thioridazine — concomitant use or use within the last 14 days (risk of QT prolongation and arrhythmias). After discontinuation of dapoxetine, at least 7 days must pass before starting thioridazine.
- Moderate and severe hepatic impairment — dapoxetine is actively metabolized in the liver; impairment of its function leads to a significant increase in systemic concentration.
- Severe renal impairment (CrCl < 30 ml/min).
- Hypersensitivity to dapoxetine or auxiliary components.
- Age under 18 and over 65 — safety in these groups has not been established.
- The drug is not intended for women.
Relative (require caution)
Propensity to orthostatic hypotension or concomitant use of drugs with vasodilating properties (alpha-blockers, nitrates, PDE-5 inhibitors) — all of them reduce orthostatic stability and can increase the risk of fainting.
Mild renal impairment — no special dose adjustment is required, but tolerability should be monitored.
Bleeding or coagulation disorders, as well as taking drugs that affect platelet aggregation (NSAIDs, aspirin, anticoagulants) — like all SSRIs, dapoxetine may increase the risk of bleeding.
Drug interactions
Critically dangerous — absolute contraindication
MAOIs (MAO inhibitors) — phenelzine, tranylcypromine, isocarboxazid, linezolid, methylene blue. Combination with any SSRI carries a risk of serotonin syndrome — a potentially life-threatening condition with hyperthermia, agitation, autonomic instability, and neuromuscular disorders. At least 14 days must pass between the discontinuation of MAOIs and the start of dapoxetine; at least 7 days must pass between the discontinuation of dapoxetine and the start of MAOIs.
Thioridazine — an antipsychotic with a narrow therapeutic window. The combination increases the risk of QT interval prolongation and ventricular arrhythmias. Washout intervals are the same as for MAOIs.
High risk of serotonin syndrome — avoid
Any other SSRIs (fluoxetine, paroxetine, sertraline, and others), SNRIs (venlafaxine, duloxetine), tricyclic antidepressants, as well as serotonergic agents: tramadol, triptans (sumatriptan and others), St. John's wort (Hypericum perforatum), lithium, linezolid. Between the discontinuation of any of these drugs and the start of dapoxetine — at least 14 days; between the discontinuation of dapoxetine and their start — at least 7 days.
CYP3A4 inhibitors — increase dapoxetine concentration
Dapoxetine is metabolized, among other things, through CYP3A4. Potent inhibitors of this enzyme (ketoconazole, itraconazole, ritonavir, telithromycin, clarithromycin) significantly increase the concentration of dapoxetine in the blood and are contraindicated when used together. With moderate CYP3A4 inhibitors (e.g., erythromycin), caution should be exercised and only a 30 mg dose should be used.
CYP2D6 inhibitors
CYP2D6 is another important enzyme in dapoxetine metabolism. Potent CYP2D6 inhibitors (fluoxetine, paroxetine — but they are already contraindicated due to the risk of serotonin syndrome; also terbinafine) can increase its concentration. The clinical significance of moderate CYP2D6 inhibitors is less clear.
PDE-5 inhibitors and other vasodilators
Dapoxetine and PDE-5 inhibitors (sildenafil, tadalafil, vardenafil, and others) do not interact pharmacokinetically — neither dapoxetine affects the concentration of PDE-5 inhibitors, nor do they affect the concentration of dapoxetine.[5] However, both classes can reduce orthostatic stability, so when used together, care must be taken when changing body position abruptly. It is in the form of fixed combinations "dapoxetine + PDE-5 inhibitor" that preparations from the section of pills for prolongation are produced.
Alcohol
Alcohol does not change the pharmacokinetics of dapoxetine, but it increases sedation, reduces cognitive functions, and, most importantly, increases the risk of vasovagal syncope. The official Priligy® instructions recommend avoiding alcohol when taking dapoxetine.[7]
Anticoagulants and antiplatelet agents
Like all SSRIs, dapoxetine can affect platelet aggregation. When co-administered with anticoagulants (warfarin), antiplatelet agents (aspirin), or NSAIDs, the risk of bleeding may be increased.
Crucially important: dapoxetine should not be combined with any antidepressant or anxiety medication without consulting a doctor. If you are taking any drugs that affect mood or the nervous system, be sure to inform a specialist before starting dapoxetine.
Special patient groups
Age 18–64 years
It is for this group that dapoxetine is officially approved. Clinical trials included men aged 18 to 77 years, the average age of participants was about 40 years.
Men over 65 years
The safety and efficacy of dapoxetine in men over 65 years of age have not been sufficiently established. Combined with an age-related decrease in orthostatic stability and a higher probability of concomitant cardiovascular pathology and polypragmasy, use in elderly patients is inappropriate.
Impaired liver function
In mild hepatic impairment (Child-Pugh A), no special correction is required, although it is recommended to start with 30 mg. In moderate and severe hepatic impairment, dapoxetine is contraindicated.
Impaired renal function
Mild and moderate renal impairment (CrCl 30–80 ml/min) — additional dose adjustment is usually not required; it is recommended to start with 30 mg. In severe renal impairment (CrCl < 30 ml/min), it is contraindicated.
PE combined with erectile dysfunction
With concomitant ED, dapoxetine as a monotherapy gives a less pronounced subjective response. It is rational to consider one of the combinations of dapoxetine with a PDE-5 inhibitor, which are available in the section of pills for prolongation: Super P-Force (sildenafil + dapoxetine), Super Vidalista (tadalafil + dapoxetine), Super Zhewitra (vardenafil + dapoxetine), Super Zudena (udenafil + dapoxetine), and others.
What to do if...
...the drug did not work or the effect is weak
- Possible reasons:
- A dose of 30 mg was taken, whereas only 60 mg is effective for this patient. Try increasing the dose at the next application.
- Expectations are too high: dapoxetine increases IELT by an average of 3–4 times compared to baseline, but does not provide unlimited control.
- PE has a pronounced psychogenic component that requires psychological or behavioral correction in addition to medication.
- The tablet was taken too late — less than 1 hour before intimacy.
Evaluate efficacy over several uses, not based on the first experience. With a stable lack of effect, consult a specialist to clarify the type and causes of PE.
...dizziness or a feeling of fainting appeared
These are prodromal symptoms of vasovagal syncope. Act immediately: do not wait for it to get worse.
- Immediately lie down, raising your legs above the level of the heart — or sit down, lowering your head between your knees.
- Drink some water if possible.
- Do not stand up until the symptoms have completely disappeared.
- Do not drive on this day.
Fainting with dapoxetine is vasovagal in nature and is usually self-limiting. However, if you fell and were injured or the symptoms do not disappear, seek medical help. In case of repeated episodes of dizziness, reduce the dose to 30 mg or stop taking it and consult a doctor.
...nausea arose
Nausea is the most common side effect of dapoxetine. It is dose-dependent (more common at 60 mg) and usually passes within 1–2 hours, coinciding with the period of maximum concentration in the blood. To reduce its severity: take the drug after a light snack, wash down with a full glass of water, avoid taking on an empty stomach. If nausea at 60 mg is unacceptable, reduce the dose to 30 mg.
...an excessive dose was taken (overdose)
There is no specific antidote. Symptoms of overdose include increased adverse events: severe nausea, pronounced dizziness, sharp decrease in blood pressure, somnolence. Lie down, ensure rest. In case of severe symptoms or suspected serotonin syndrome (agitation, hyperthermia, tremor, muscle rigidity, diarrhea), call an ambulance immediately. Be sure to inform medical personnel about the drug taken and its dose.
...missed a dose
Dapoxetine is taken "on demand" — only when sexual activity is planned, and not on a schedule. The concept of a "missed dose" does not apply to it. Simply take the drug the next time it is needed.
Storage conditions
Store at a temperature not exceeding 30°C, in a dry, dark place, away from direct sunlight. Keep out of reach of children. The expiration date is indicated on the package. It must not be used after the expiration date.
Dapoxetine-based drugs in the GENERICS catalog
All listed drugs contain dapoxetine hydrochloride as the active ingredient. This instruction manual applies to all of them. Differences between brands lie in the manufacturer and auxiliary components; the mechanism of action, indications, contraindications, and interactions are identical.
Dapoxetine monotherapies
- 30 mg: Poxet 30 (Sunrise), Duratia 30 (Fortune), Stop-Ejac 30 (Delta)
- 60 mg: Poxet 60 (Sunrise), Duratia 60 (Fortune), Vriligy 60 (Centurion), Dapoligy 60 (Emkay), Stop-Ejac 60 (Delta)
- 90 mg: Poxet 90 (Sunrise), Duratia 90 (Fortune), Stop-Ejac 90 (Delta)
Combination drugs (dapoxetine + PDE-5 inhibitor)
If both premature ejaculation and erection quality are of concern, it is most convenient to use one of the 2-in-1 combo drugs: sildenafil + dapoxetine (Super P-Force, Super Kamagra), tadalafil + dapoxetine (Super Vidalista, Super Tadarise), vardenafil + dapoxetine (Super Zhewitra), udenafil + dapoxetine (Super Zudena, Udaforce-D), and other agents for prolonging sexual intercourse.
If erection is normal and only treatment for premature ejaculation is needed, dapoxetine monotherapy is optimal. All options are available in the buy dapoxetine section.
The information on this page is for informational purposes only and does not replace a doctor's consultation. Before using dapoxetine for the first time, consult a urologist or therapist — especially if you have cardiovascular diseases, a history of psychiatric disorders, or are taking antidepressants or other drugs that affect the nervous system.
Frequently Asked Questions
Is dapoxetine an antidepressant?
By pharmacological group — yes, an SSRI. But in practice — no: dapoxetine is unsuitable for the treatment of depression precisely because it is cleared from the body too quickly and does not create the accumulated therapeutic concentration necessary for an antidepressant effect. The very same short pharmacokinetics that make it useless as an antidepressant make it ideal for the "on-demand" regimen for PE. Dapoxetine is not intended for daily use and should not be used as a psychotropic drug.
How does Dapoxetine differ from Paroxetine or Sertraline in the treatment of premature ejaculation?
Paroxetine and sertraline are used for PE off-label and require daily intake for several weeks. This creates a number of problems: chronic side effects (decreased libido, anorgasmia, ED in 10–40% of users), withdrawal syndrome upon discontinuation, the need for constant intake regardless of planned activity. Dapoxetine solves all these problems: it is taken only when needed, acts from the first dose, and is quickly eliminated without causing chronic serotonergic changes.
How long does it take for Dapoxetine to start working?
Peak blood concentration is reached in about 1–1.3 hours. The clinical effect begins in the same time window. It should be taken 1–3 hours before intimacy. A wider time window (compared to, for example, sildenafil) gives practical flexibility — you do not need to know the exact time of the start of sexual intercourse.
Does Dapoxetine help with the first dose?
Yes. Unlike antidepressants, which need weeks to accumulate an effect, dapoxetine acts from the first tablet taken. This was confirmed in clinical studies: a statistically significant increase in IELT was recorded after the very first application.[9]
Can Dapoxetine be taken together with Viagra, Cialis, or Levitra?
Yes — their pharmacokinetics do not mutually affect each other. Dapoxetine does not change the concentration of sildenafil or tadalafil in the blood, and they do not affect the concentration of dapoxetine.[5] The only caveat is that both classes of drugs can reduce orthostatic stability, so one should be careful when standing up quickly. This combination is produced in the form of fixed tablets: "2 in 1" agents for prolonging sexual intercourse.
Does Dapoxetine cause addiction or withdrawal syndrome?
When used "on demand" — no. Withdrawal syndrome is one of the serious problems of chronic SSRIs because with daily intake, receptor desensitization occurs. Dapoxetine does not create such a picture: taken episodically, it does not have time to cause chronic serotonergic changes. In clinical trials, the frequency of withdrawal syndrome upon discontinuation of dapoxetine was comparable to placebo.
Is Dapoxetine registered in Ukraine?
The original drug Priligy® is registered in Europe (EMA, 2009) and in more than 60 countries, but there is no official registration in Ukraine at the moment. In the US, the drug is also not approved by the FDA. This does not mean that the molecule is unsafe — its efficacy and safety are confirmed by large-scale clinical trials. Generics based on dapoxetine are available through online pharmacies.
Sources
- [1] Serefoglu EC, Saitz TR. New insights on premature ejaculation: a review of definition, classification, prevalence and treatment. Asian J Androl. 2012;14(6):822–829. PMC: 4708110
- [2] McMahon CG. Dapoxetine: a new option in the medical management of premature ejaculation. Ther Adv Urol. 2012;4(5):233–251. PMC: 3441133
- [3] Giuliano F, Clément P. Serotonin and premature ejaculation: from physiology to patient management. Eur Urol, 2006; 50(3): 454–466. PubMed: 16844284
- [4] Modi NB, Dresser MJ, Simon M, Lin D, Desai D, Gupta S. Single- and multiple-dose pharmacokinetics of dapoxetine hydrochloride, a novel agent for the treatment of premature ejaculation. J Clin Pharmacol, 2006; 46(3): 301–309. PubMed: 16490806
- [5] Dresser MJ, Lindert K, Lin D. Pharmacokinetics of single and multiple escalating doses of dapoxetine in healthy volunteers. Clin Pharmacol Ther. 2004;75:P113. [Abstract; cited in McMahon 2012]
- [6] Waldinger MD, Schweitzer DH. Acquired premature ejaculation: neurobiological and pharmacotherapy treatments. World J Urol. 2005;23(2):102–108. — Data on different types of PE based on: Buvat J, Tesfaye F, Rothman M, et al. Eur Urol. 2009;55(4):957–967. PubMed: 19195772
- [7] Priligy® (dapoxetine hydrochloride) Summary of Product Characteristics. European Medicines Agency / Janssen-Cilag. [Data on interaction with alcohol, syncope, drug interactions]. EMA.europa.eu
- [8] McMahon CG, Althof SE, Kaufman JM, et al. Efficacy and safety of dapoxetine for the treatment of premature ejaculation: integrated analysis of results from five phase 3 trials. J Sex Med. 2011;8(2):524–539. PubMed: 21059176
- [9] Pryor JL, Althof SE, Steidle C, Rosen R, Ashby K, Huang Y, International Dapoxetine Study Group. Efficacy and tolerability of dapoxetine in treatment of premature ejaculation: an integrated analysis of two double-blind, randomised controlled trials. Lancet, 2006; 368(9539): 929–937. PubMed: 16962882
- [10] Buvat J, Tesfaye F, Rothman M, Rivas DA, Giuliano F. Dapoxetine for the treatment of premature ejaculation: results from a randomized, double-blind, placebo-controlled phase 3 trial in 22 countries. Eur Urol. 2009;55(4):957–967. PubMed: 19195772
The sources describe the dapoxetine molecule and refer to all drugs based on it — both the original Priligy® and generics.







