AVAILABLE MEDICINE FOR Dapoxetine

Overview of Dapoxetine

Molecule: Dapoxetine Hydrochloride

Also Known As: Dapoxetine, Dapoxetine HCl

Category: Selective Serotonin Reuptake Inhibitor (SSRI)

Primary Indication: On-demand oral treatment for premature ejaculation (PE)

Dapoxetine is the first oral medication developed specifically to treat premature ejaculation in men aged 18 to 64. It is a short-acting SSRI, which distinguishes it from conventional SSRIs used for depression.

It is marketed under brand names like:

• Priligy (Europe, Asia, Latin America)
  
  

• Duratia, Duralast, and Poxet (India and other regions)
  
  

Information About Dapoxetine

Chemical Structure & Classification

• Molecular Formula: C21H23NO
  
  

• Molecular Weight: 305.42 g/mol
  
  

• Chemical Family: Phenylpropylamine derivatives
  
  

• Drug Class: Short-acting Selective Serotonin Reuptake Inhibitor (SSRI)
  
  

Dapoxetine is designed to work differently from other selective serotonin reuptake inhibitors (SSRIs), such as fluoxetine or sertraline. Its quick absorption and rapid elimination make it ideal for treating on-demand sexual performance.

Pharmacokinetics Overview

• Absorption: Peak plasma concentration reached in 1–3 hours
  
  

• Half-life: 1.3 to 1.5 hours (initial), 15–19 hours (terminal phase)
  
  

• Metabolism: Liver (CYP3A4, CYP2D6 enzymes)
  
  

• Excretion: Primarily via the kidneys
  
  

• Bioavailability: 42%
  
  

Because of this fast action and clearance, Dapoxetine:

• Works only when you need it
  
  

• Does not accumulate in the body
  
  

• Causes fewer long-term side effects
  
  

Discovery & Development

Dapoxetine was first developed by Alza Corporation, which was later acquired by Johnson & Johnson. It was initially researched as an antidepressant, but in clinical trials, it failed to treat depression effectively.

However, scientists noticed that it had a unique side effect — delayed ejaculation. This observation led to its repurposing as a treatment for premature ejaculation.

This repositioning resulted in Dapoxetine becoming:

• The first FDA-submitted oral drug for PE (not approved in the US)
  
  

• The first globally approved treatment specifically targeting ejaculation control.
  .

Regulatory Approvals & Market Use

Dapoxetine is approved in more than 60 countries, including:

• India
  
  

• Germany
  
  

• France
  
  

• Italy
  
  

• Spain
  
  

• South Korea
  
  

• Mexico
  
  

• Australia
  
  

• Singapore
  
  

While not approved by the U.S. FDA, Dapoxetine has received regulatory acceptance in Europe, Latin America, and Asia. This global recognition is based on multiple placebo-controlled, double-blind studies that have proven its efficacy and tolerability.

What is Dapoxetine Used For?

Dapoxetine is indicated for:

• Lifelong (primary) premature ejaculation: A condition that starts with a man’s first sexual experience.
  
  

• Acquired (secondary) PE: Develops later in life due to psychological or physiological causes.
  
  

• Situational PE: This occurs only in specific scenarios, often due to stress, anxiety, or performance pressure.
  
  

Symptoms Dapoxetine Helps Manage

• Ejaculation occurring within 1–2 minutes of penetration
  
  

• Inability to delay ejaculation during sexual activity
  
  

• Personal frustration or relationship strain caused by early ejaculation
  
  

Combination with Erectile Dysfunction (ED) Treatments

Some men experience both premature ejaculation (PE) and erectile dysfunction (ED). Dapoxetine can be safely prescribed alongside Sildenafil (Viagra) or Tadalafil (Cialis) to effectively manage both issues simultaneously.

Clinical evidence supports this combination:

• Improved control and satisfaction
  
  

• Reduced sexual anxiety
  
  

• Better overall quality of sexual life
  
  

Alternative & Supportive Uses in Research

Dapoxetine is being studied alongside:

• Acupuncture
  
  

• Chinese herbal medicine
  
  

• Neuromuscular stimulation
  
  

• Psychosexual therapy
  
  

These complementary approaches are explored for non-responders or patients who prefer integrative medicine models.

Key Benefits of Dapoxetine

• Fast-acting: Begins working in 1–3 hours
  
  

• Flexible use: Taken on-demand — no daily medication needed
  
  

• Delays ejaculation: Increases IELT (Intravaginal Ejaculation Latency Time) by 2 to 3 times
  
  

• Better control: Improves mental and physical ability to delay orgasm
  
  

• Reduces distress: Lowers anxiety and improves self-confidence.
  
  

• Improves relationships: Satisfies both partners, reducing emotional friction
  
  

• Combines well with ED medications: Useful in complex sexual health cases
  
  

Dapoxetine provides a scientifically backed solution for PE — a condition that affects one in three men globally.

How Dapoxetine Works (Mechanism of Action)

The Role of Serotonin in Ejaculation

Ejaculation is a reflex controlled by complex brain and spinal cord circuits involving:

• The periaqueductal gray (PAG) in the midbrain
  
  

• The nucleus paragigantocellularis (nPGi) in the medulla
  
  

• The ejaculatory generator in the spinal cord
  
  

Serotonin (5-HT) is a key neurotransmitter in this network. In men with PE, serotonin signaling is often insufficient, resulting in a faster ejaculatory reflex.

What Dapoxetine Does

Dapoxetine is a Selective Serotonin Reuptake Inhibitor (SSRI) designed for rapid action. It blocks the serotonin transporter (SERT), a protein that reabsorbs serotonin from the space between nerve cells.

When SERT is blocked:

• More serotonin stays active in the synaptic space
  
  

• Stronger signals are sent to the brain to delay the ejaculatory reflex.
  
  

• The brain and spinal centers can better regulate the timing of ejaculation.
  
  

Why It Works So Quickly

Dapoxetine’s short-acting design allows it to:

• Start working within 1 to 3 hours
  
  

• Remain active for 4 to 6 hours.
  
  

• Leave the body within 24 hours.
  
  

This makes it ideal for situational sexual activity without the burden of long-term side effects common with daily-use antidepressants.

Clinical Insight

A large, double-blind, placebo-controlled trial published in the International Journal of Impotence Research found that:

• The average IELT increased from 0.9 minutes to 2.8 minutes
  
  

• Over 60% of men reported increased control and reduced distress.
  
  

• Side effects, such as nausea and dizziness, were mild and temporary.
  
  

This makes Dapoxetine a well-tolerated, evidence-backed therapy for one of the most common male sexual complaints.

Side Effects of Dapoxetine

Dapoxetine is generally well-tolerated, mainly due to its short duration of action and on-demand usage. However, like all medications, it may cause side effects in some users.

Common (Mild) Side Effects

These usually occur within the first few uses and resolve on their own:

• Nausea
  
  

• Dizziness or lightheadedness
  
  

• Headache
  
  

• Dry mouth
  
  

• Insomnia
  
  

• Diarrhea
  
  

Tips to manage:

• Taking Dapoxetine with food can reduce nausea
  
  

• Staying hydrated and avoiding alcohol may prevent dizziness.
  
  

Moderate to Serious Side Effects

Less common, but may require medical attention:

• Syncope (fainting)
  
  

• Fast or irregular heartbeat
  
  

• Blurred vision
  
  

• Mood changes (irritability, anxiety)
  
  

• Palpitations
  
  

These effects are more likely in men with underlying health issues or those combining Dapoxetine with other medications without guidance.

Rare and Severe Reactions (Seek Emergency Help)

• Seizures
  
  

• Severe allergic reactions (rash, itching, swelling of the face/tongue/throat, breathing difficulties)
  
  

• Sudden loss of consciousness
  
  

• Signs of serotonin syndrome when taken with other serotonergic drugs (agitation, confusion, rapid heart rate, tremors)
  
  

Safety & Precautions

Who Should NOT Use Dapoxetine

• Men with heart failure, arrhythmia, or heart block
  
  

• People with moderate to severe liver impairment
  
  

• Anyone with a history of fainting or seizures
  
  

• Those using monoamine oxidase inhibitors (MAOIs) or other SSRIs/SNRIs
  
  

• People on thioridazine, an antipsychotic that affects heart rhythm
  
  

Drug Interactions to Avoid

• Nitrates used for chest pain (e.g., nitroglycerin)
  
  

• Alpha-blockers for blood pressure or prostate issues
  
  

• Antifungals (e.g., ketoconazole), antibiotics (e.g., erythromycin)
  
  

• HIV protease inhibitors (e.g., ritonavir)
  
  

• Other antidepressants, especially SSRIs, SNRIs, and tricyclics
  
  

These combinations can lead to dangerously low blood pressure or serotonin toxicity.

Lifestyle Considerations

• Alcohol: Increases the risk of fainting, dizziness, and poor judgment. Strongly discouraged.
  
  

• Driving & Machinery: Avoid until you know how Dapoxetine affects your concentration
  
  

• Elderly Men (65+): Not generally recommended due to increased risk of falls and side effects
  
  

Available Strengths & Substitutes

Strengths Available

• Most men are prescribed 30 mg initially.
  
  

• If well-tolerated but insufficient, doctors may increase to 60 mg.
  
  

Alternative and Supportive Therapies

Always consult a healthcare provider before combining or switching to any therapy.

Clinical Trials on Dapoxetine

Dapoxetine has been the subject of multiple clinical studies and peer-reviewed trials worldwide. These studies have evaluated its safety, effectiveness, and combination with other treatments for premature ejaculation (PE).

Here’s a breakdown of the most important trials and what they tell us:

1. Efficacy of Dapoxetine in Lifelong Premature Ejaculation

Source: WJMH – Global Andrology Forum Guidelines (2024)

This global guideline is based on a meta-analysis of dozens of clinical studies. It concluded that:

• Dapoxetine significantly improves intravaginal ejaculation latency time (IELT)
• Most men experienced greater control over ejaculation and higher sexual satisfaction.
• Common side effects were mild and manageable (e.g., nausea, dizziness)
• Men reported a reduction in personal and partner distress related to P.E.

This consensus supported Dapoxetine as the first-line oral treatment for men with lifelong PE.

2. Combination Therapy: Sildenafil + Dapoxetine in Non-Responders

Source: Al-Azhar International Medical Journal

This randomized controlled trial (RCT) involved patients who did not respond to Dapoxetine alone.

Key findings:

• Adding Sildenafil (Viagra) improved both IELT and erection quality
• 72% of men showed improved results compared to Dapoxetine alone
• Sexual satisfaction and partner feedback also improved.
• Side effects were mild and consistent with each drug’s profile.

Clinical Insight: This trial shows that dual therapy can be a practical approach in patients with PE and ED, or where dapoxetine alone is insufficient.

3. Serotonin Pathway Study: Tryptophan Metabolism & Dapoxetine Response

Source: PubMed – PMID: 38511846

In 2024, this pilot study explored the relationship between serotonin precursors and dapoxetine’s effect in patients with PE.

• Tryptophan is an amino acid used by the body to make serotonin.
• Men with better baseline tryptophan metabolism responded more positively to Dapoxetine.
• Suggests that nutritional or metabolic support could improve drug effectiveness

This study gives insight into why some men respond better than others and may help doctors predict treatment outcomes based on biomarker profiles.

4. Neuromuscular Stimulation + Dapoxetine in PE

Source: PubMed – PMID: 38639594

This study looked at a non-drug intervention (neuromuscular stimulation) paired with Dapoxetine. The aim was to see whether physical nerve stimulation could enhance the drug’s effects.

• Participants using both methods showed longer ejaculation time.
• Reported higher control and lower anxiety during intercourse
• No additional side effects were observed.

This suggests Dapoxetine works well in multimodal treatment strategies, especially for patients with psychological triggers or muscle control issues.

5. Dapoxetine vs. Glans Penis Injection Therapy

Source: PubMed – PMID: 38481413

This 2024 study compared oral Dapoxetine with glans penis injection of botulinum toxin-A (a local therapy for PE).

Findings:

• Both methods improved IELT significantly
• Dapoxetine had the advantage of being non-invasive and better tolerated.
• The injection group had localized side effects (numbness, minor discomfort)
• Most patients preferred the oral tablet for convenience.

This trial reinforced the practicality and preference for oral pharmacotherapy in treating PE.

6. Systematic Review: Silodosin vs. Dapoxetine

Source: AIUA Journal

This Italian review analyzed multiple studies comparing Dapoxetine with Silodosin, an alpha-blocker sometimes used off-label for PE.

Conclusions:

• Dapoxetine had a faster onset, shorter half-life, and fewer systemic side effects.
• Silodosin was slightly more effective for some patients, but caused more urinary side effects.
• Dapoxetine was better suited for on-demand use.

7. Electrochemical Detection & Quality Control Study

Source: ScienceDirect

Though not a clinical trial, this research focused on detecting Dapoxetine in pharmaceutical formulations using electrochemical sensors. It ensures that:

• The drug’s quality, purity, and stability can be tracked effectively
• Supports safe dispensing and monitoring, especially in compounded pharmacies or third-party manufacturers

Summary of Findings

Study No.	Focus Area	Key Outcome
1	Global Guidelines	Supports Dapoxetine as first-line PE therapy
2	Dual Therapy with Sildenafil	Effective in non-responders with PE + ED
3	Biomarker Response	The metabolism of tryptophan influences efficacy
4	Neuromuscular Combo	Enhances control in anxious or non-pharmacologic cases
5	Oral vs Injection	Oral Dapoxetine is preferred for convenience and safety
6	Silodosin Comparison	Dapoxetine is favored for on-demand use with fewer side effects
7	Quality Detection & Control	Ensures safe pharmaceutical delivery and authenticity

Patient Guidelines – Storage & General Use

Storage Instructions

• Keep at 20°C to 25°C (room temperature)
  
  

• Protect from moisture, heat, and direct sunlight
  
  

• Keep out of reach of children
  
  

• Do not refrigerate or freeze
  
  

General Use Tips

• Take with a full glass of water
  
  

• Use 1 to 3 hours before sexual activity
  
  

• Do not exceed one tablet in 24 hours
  
  

• Do not split or chew the tablet
  
  

• Sit or lie down if dizziness occurs
  
  

Avoid alcohol and heavy meals before intake

References

1. Giuliano F, Clément P. Serotonin and Premature Ejaculation: From Physiology to Patient Management. Eur Urol. 2006 Dec;50(6):454-66.
   
   

2. Dapoxetine. DrugBank Online. Edmonton (AB): Wishart DS, Knox C, Guo AC, et al. [Accessed 21 Apr. 2024]. (online)
   
   

3. Dapoxetine [International Listings]. Drugs.com. [Accessed 21 Apr. 2024]. (online)
   
   

4. McMahon CG, Althof SE, Waldinger MD, Porst H, Dean J, Sharlip ID. An evidence-based definition of lifelong premature ejaculation: report of the International Society for Sexual Medicine (ISSM) PE Guidelines Committee. J Sex Med. 2008 Jul;5(7):1590–1606.
   
   

5. Al-Azhar International Medical Journal. Efficacy of Adding Sildenafil to Dapoxetine in Treatment of Dapoxetine Non-Responding Mono-Symptomatic Premature Ejaculation. [Accessed 21 Apr. 2024]. (online) 

6. World Journal of Men’s Health. Global Andrology Forum Clinical Practice Guidelines on the Management of Premature Ejaculation. [Accessed 21 Apr. 2024]. (online)

7. NIH PubMed. Tryptophan Metabolism and Dapoxetine Response in PE Patients. PMID: 38511846. [Accessed 21 Apr. 2024]. (online)
   
   

8. NIH PubMed. Neuromuscular Stimulation Plus Dapoxetine for PE. PMID: 38639594. [Accessed 21 Apr. 2024]. (online)
   
   

9. NIH PubMed. Glans Penis Injection vs. Dapoxetine in the Treatment of PE. PMID: 38481413. [Accessed 21 Apr. 2024]. (online)
   
   

10. PagePress Journals. Silodosin vs. Dapoxetine: A Systematic Review. Arch Ital Urol Androl. [Accessed 21 Apr. 2024]. (online)
    
    

11. ScienceDirect. Electrochemical Sensing of Dapoxetine in Water and Drug Formulations. [Accessed 21 Apr. 2024]. (online) 
    
    

12. JCM Case Reports. Chinese Herbal Medicine + Dapoxetine: Study Protocol. [Accessed 21 Apr. 2024]. (online)
    
    

13. McMahon CG. Pharmacokinetics and Efficacy of Dapoxetine in the Treatment of Premature Ejaculation. Expert Opin Drug Metab Toxicol. 2007 Apr;3(2):275–81.
    
    

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