"Dapoxetine: a new option in the medical management of premature ejaculation". ^ "Priligy is used to Treat Premature Ejaculation".
- For missed dose: if less than 1 hour before sex, take as soon as remembered; otherwise skip.
- Do not double the dose to compensate for a missed one; stay within 24-hour limit.
- Combining with food that is high in fat may delay absorption slightly, but not significantly reduce effect.
^ a b c "Australian Public Assessment Report for Dapoxetine" (PDF). "Pharmacokinetic and pharmacodynamic features of dapoxetine, a novel drug for 'on-demand' treatment of premature ejaculation". "Dapoxetine: an evidence-based review of its effectiveness in treatment of premature ejaculation". ^ "Furiex Pharma gets rights to Priligy, some of which it sells on to Menarini". "New agents in the treatment of premature ejaculation". "Efficacy and tolerability of dapoxetine in treatment of premature ejaculation: an integrated analysis of two double-blind, randomised controlled trials". "Dapoxetine has long-term efficacy in the treatment of premature ejaculation". "AUA guideline on dapoxetine 30mg tablet the pharmacologic management of premature ejaculation".
| Active Ingredient | Dosage | Form | Manufacturer | Approval Status |
|---|---|---|---|---|
| Dapoxetine Hydrochloride | 60 mg | Tablet | Pfizer | Approved in many countries |
| Route of Administration | Oral | Packaging | Various pharmaceutical companies | Approved for premature ejaculation |
| Storage Conditions | Room temperature | Shelf life | Approved by regulatory agencies | Keep away from moisture and heat |
"Dapoxetine: An Innovative Approach in the Therapeutic Management In Animal Model of Depression".
Ethics declarations
Dapoxetine was created by Eli Lilly and in phase I clinical trial as an antidepressant. It never worked out well as a medication for the treatment of depression, though, and was shelved for a while before subsequently developed to treat PE. In December 2003, Eli Lilly sold the patent for dapoxetine to Pharmaceutical Product Development (PPD) for US$65 million. Eli Lilly may also receive royalties payment from PPD if the sale exceeds a certain amount. Research into the effectiveness of dapoxetine was revisited in 2020.
Competing interests
ALZA is the current owner of dapoxetine, but PPD will receive milestone payments and drug royalties from ALZA. If approved, dapoxetine will be marketed in the US by Ortho McNeil pharmaceutical, Inc. Ortho McNeil and Janssen-Ortho Inc, or Janssen-Cilag are all units of Johnson & Johnson. As at 2005, dapoxetine was in phase III clinical trials, pending review by the FDA. Dapoxetine has been marketed and approved in more than 50 countries. "Antistress and antidepressant properties of dapoxetine and vortioxetine". "Dapoxetine for the treatment of premature ejaculation: results from a randomized, double-blind, placebo-controlled phase 3 trial in 22 countries". "Discontinuation of Dapoxetine Treatment in Patients With Premature Ejaculation: A 2-Year Prospective Observational Study". "Incidence of sexual dysfunction associated with antidepressant agents: a prospective multicenter study of 1022 outpatients.
| Product | Dosage | Quantity + Bonus | Price | |
|---|---|---|---|---|
| Priligy Generic Dapoxetine | 60mg | 90 + 10 Pills | 265.64€ 252.99€ | |
| Priligy Generic Dapoxetine | 60mg | 180 + 10 Pills | 494.76€ 471.20€ | |
| Priligy Generic Dapoxetine | 60mg | 20 + 4 Pills | 77.31€ 73.63€ | |
| Priligy Generic Dapoxetine | 60mg | 10 Pills | 47.63€ 45.36€ | |
| Cialis Black | 80mg | 120 + 8 Pills | 264.77€ 252.16€ | |
| Kamagra Oral Jelly | 100mg | 63 + 7 Sachets | 224.18€ 213.50€ | |
| Priligy Generic Dapoxetine | 60mg | 120 + 10 Pills | 341.26€ 325.01€ | |
| Cialis Professional | 40mg | 10 Pills | 65.09€ 61.99€ | |
| Priligy Generic Dapoxetine | 60mg | 60 + 8 Pills | 183.06€ 174.34€ | |
| Levitra Professional | 20mg | 60 + 2 Pills | 223.11€ 212.49€ | |
| Priligy Generic Dapoxetine | 60mg | 30 + 6 Pills | 106.65€ 101.57€ | |
| Viagra Generic | 100mg | 30 + 4 Pills | 60.91€ 58.01€ | |
| Kamagra Gold | 100 mg | 120 + 6 Pills | 330.74€ 314.99€ | |
| Cialis Soft Tabs | 20mg | 10 Pills | 39.03€ 37.17€ | |
| Cialis Professional | 20mg | 120 + 4 Pills | 291.68€ 277.79€ |
Spanish Working Group for the Study of Psychotropic-Related Sexual Dysfunction". "Dapoxetine-A Novel Drug for Premature Ejaculation". "Dapoxetine for the treatment of premature ejaculation: Lack of interaction with ethanol". "Monoaminergic transporter binding and inhibition profile of dapoxetine, a medication for the treatment of premature ejaculation".
- Dapoxetine 60 mg showed no effect on semen parameters or male fertility in preclinical studies.
- Long-term safety beyond 24 weeks is not well established; periodic reassessment is advised.
- Post-marketing reports include rare cases of angioedema, anaphylaxis, and Steven-Johnson syndrome.
"Physiology of ejaculation: emphasis on serotonergic control".
How to take Priligy
The metabolites of dapoxetine are eliminated rapidly in the urine with a terminal half-life of 18.7 and 21.9 hours for a single dose of 30 mg and 60 mg, respectively. The cardiovascular safety profile of dapoxetine has been studied extensively during the drug development. Phase I trials showed that dapoxetine had neither clinically significant electrocardiographic effects nor delayed repolarization effects, with dosing up to four-fold greater than the maximum recommended dosage, which is 60 mg. Phase III studies in men with PE showed a safety and well tolerated profile of dapoxetine with dosing of 30 and 60 mg. No cardiovascular adverse had been found.
2.2 Mechanism of Action
Studies of SSRIs in patients with major psychiatric disorders prove that SSRIs are potentially associated with certain neurocognitive adverse effects such as anxiety, akathisia, hypomania, changes in mood, or suicidal thought. [30][31] No study on the effects of SSRIs in men with PE has been done. McMahon's study in 2012 showed that dapoxetine has no effect on mood and is not associated with anxiety or suicidality. The incidence of antidepressant discontinuation syndrome symptoms in men using dapoxetine to treat PE has been described by reviewers as low or no different from the incidence of such symptoms in men withdrawn from placebo treatment. [33][34] The lack of chronic serotonergic stimulation with on-demand dapoxetine minimizes the potentiation action of serotonin at synaptic cleft, thus decreasing the risk of discontinuation symptoms.
3.2 Dosage and Administration
Currently, very few methods are used to synthesize (S)-dapoxetine. This novel approach consists of only six steps in which three main steps are shown above. The initial reactant is trans-cinnamyl alcohol, which is commercially available. Sharpless asymmetric epoxidation and Mitsunobu reaction have been used to produce expected (S)-dapoxetine. This method is considered a good choice compared to the known methods due to high yield and easily obtainable reactants. "Supraspinal site of action for the inhibition of ejaculatory reflex by dapoxetine". "Efficacy and safety of dapoxetine for the treatment of premature ejaculation: integrated analysis of results from five phase 3 trials".
Does dapoxetine affect testosterone levels?
[24] Clement's study performed on anaesthetized male rats showed that acute administration of dapoxetine inhibits ejaculatory expulsion reflex at supraspinal level by modulating activity of lateral paragigantocellular nucleus (LPGi) neurons. These effects cause an increase in pudendal motoneuron reflex discharge (PMRD) latency, though whether dapoxetine acts directly on LPGi or on the descending pathway in which LPGi located is unclear. Dapoxetine is a white, powdery, water-insoluble substance. Taken one to three hours before sexual activity, it is rapidly absorbed in the body. Its maximum plasma concentration (Cmax) is reached one to two hours after oral administration.
Generic Names
The Cmax and AUC (area under the plasma vs. time curve) is dose dependent. The Cmax and Tm (time needed to obtain the maximum plasma concentration) after single doses of dapoxetine 30 mg and 60 mg are 297 and 498 ng/ml at 1.01 and 1.27 hours, respectively. A high-fat meal does reduce the Cmax slightly, but it is insignificant. It can be taken with or without food.
Brand Names
Dapoxetine is absorbed and distributed rapidly in the body. The mean steady-state volume is 162 L. Its initial half-life is 1.31 hours (30 mg dose) and 1.42 hours (60 mg dose), and its terminal half life is 18.7 hours (30 mg dose) and 21.9 hours (60 mg dose). Dapoxetine is metabolized extensively in the liver and kidney by multiple enzymes such as CYP2D6, CYP3A4, and flavin monooxygenase 1. The major product at the end of the metabolic pathway is circulating dapoxetine N-oxide, which is a weak SSRI and contributes no clinical effect. ^ "Dapoxetine: a guide to its use in premature ejaculation". "Pharmacokinetics of single and multiple escalating doses of dapoxetine in healthy volunteers". "Cardiovascular safety profile of dapoxetine during the premarketing evaluation". "Suicide rates in clinical trials of SSRIs, other antidepressants, and placebo: analysis of FDA reports". "Selective serotonin reuptake inhibitor discontinuation syndrome: a review". "Emerging treatments for premature ejaculation: focus on dapoxetine". "Dapoxetine: a novel treatment for premature ejaculation".
| Common Side Effects | Incidence Rate | Severity | Management Tips |
|---|---|---|---|
| Nausea | 10-15% | Mild | Take with food |
| Dizziness | 8-12% | Mild to Moderate | Avoid operating machinery |
| Headache | 5-10% | Mild | Hydration, pain relief if needed |
| Insomnia | 4-7% | Mild | Maintain a regular sleep routine |
"Stereoselective synthesis of (S)-dapoxetine starting from trans-cinnamyl alcohol". "Medical Non-Endocrine-Targeted Therapies: Ejaculatory Dysfunction and Immunotherapy". Premature ejaculation is a common ejaculation problem. This is when the male ejaculates sooner than he or his partner wishes during sexual arousal and activity.
- Co-administration with strong CYP3A4 inhibitors (e.g., ketoconazole, clarithromycin) requires dose reduction.
- In such cases, maximum dose should be 30 mg due to increased drug levels and side effect risk.
- Moderate CYP2D6 inhibitors (e.g., fluoxetine) also elevate dapoxetine plasma concentrations.
This can happen occasionally and is not a cause for concern!
Dược động học
[39] Dapoxetine has been approved in Italy, Spain, Mexico, South Korea, and New Zealand in 2009 and 2010; marketed in Sweden, Austria, Germany, Finland, Spain, Portugal, and Italy. It has also been approved in France, Russia, Malaysia, Philippines, Argentina, and Uruguay. 784 - Lists of Narcotic, Psychotropic, Precursor, and Other Substances under Special Control] (in Brazilian Portuguese). Archived from the original on 2023-08-03. "Dapoxetine, a novel treatment for premature ejaculation, does not have pharmacokinetic interactions with phosphodiesterase-5 inhibitors". However, if it happens more than you'd like and is a problem, it might help to get treatment. Various psychological and physical factors can cause a man to suddenly experience premature ejaculation.
| Patient Profile | Recommended Dose | Frequency | Special Considerations |
|---|---|---|---|
| Adult Men with PE | 60 mg taken 1-3 hours before sexual activity | As needed, max once daily | Do not exceed once daily |
| Men with Liver Impairment | Dose adjustment or avoid use | Under medical supervision | Liver function tests recommended |
| Elderly Men | Same as standard dose | Monitor for side effects | Increased sensitivity possible |
thyroid problems – an overactive thyroid or an underactive thyroid anxiety about sexual performance (particularly at the start of a new relationship or when a man has had previous problems with sexual performance) Priligy contains an active substance called dapoxetine. It belongs to a group of medicines called selective serotonin reuptake inhibitors (SSRIs) and may also be known as a ‘urological’ medicine. It acts much faster than the other SSRIs used for premature ejaculation and can be used "on-demand". You'll usually be advised to take it between 1 and 3 hours before sex, but not more than once a day. Priligy increases the time it takes to ejaculate and can improve the control over the ejaculation. This may reduce the frustration or worry about fast ejaculation. Priligy is used to treat premature ejaculation in adult men aged 18 to 64 years. Premature ejaculation is when a man ejaculates with little sexual stimulation and before the man wants. This can cause problems for the man and may cause problems in sexual relationships.
- Dapoxetine is not a treatment for erectile dysfunction; separate management may be needed.
- It does not affect libido or sexual desire; action is solely on ejaculation reflex.
- The drug does not interact with phosphodiesterase-5 inhibitors (e.g., sildenafil) in a clinically harmful way.
Dapoxetine is not suitable for all men diagnosed with premature ejaculation. For example, it is not recommended for some men with heart, kidney and liver problems. It can also interact with other medicines, such as other antidepressants. Always take this medicine exactly as your doctor, pharmacist, or prescriber has told you. If you are unsure, check with them. Your prescriber may increase the dose to 60 mg. Only take the medicine 1 to 3 hours before sexual activity is anticipated. Do not take this medicine more than once every 24 hours or daily. Swallow the tablets whole to avoid a bitter taste, with at least one full glass of water.