On-Demand Use Versus Daily Dosing with Dapoxetine
In addition, five studies9,12,13,14,15 including a total of 3346 patients, we pooled to compare IELT; patients were divided into two groups treated with either 60 mg or 30 mg dapoxetine.
- Prescription only in most countries; requires medical evaluation before initiation.
- A baseline assessment of blood pressure and cardiovascular risk is recommended.
- Regular follow-up every 3-6 months to monitor efficacy and side effect profile.
In the fixed-effect model meta-analysis of the five studies, the pooled estimates were statistically significantly different between the dapoxetine 60 mg and 30 mg groups (MD = 0.39; 95% CI = 0.23–0.56; P < 0.00001; Figure 4).
| Interacting Drug Class | Effect on Dapoxetine | Potential Risks |
|---|---|---|
| CYP3A4 inhibitors | Increased plasma levels | Higher risk of side effects |
| Serotonergic drugs (SSRIs, MAOIs) | Risk of serotonin syndrome | Serious neurological symptoms |
| Alcohol | Enhanced sedative effects | Dizziness, impaired coordination |
| Other PDE5 inhibitors | Possible additive effects | Hypotension |
This pooled analysis indicated that the dapoxetine 60 mg group was associated with a markedly longer IELT than the dapoxetine 30 mg group.
- Psychotherapy or behavioral techniques may complement dapoxetine therapy for better outcomes.
- Partners should be informed about the treatment; shared decision-making improves adherence.
- Discontinuation symptoms are rare; abrupt stop may cause mild headache or irritability.
Three studies9,12,13 including 2950 patients compared the PGIC in dapoxetine 30 mg and placebo subgroups and four studies9,10,12,13 including 3567 patients compared PGIC in dapoxetine 60 mg and a placebo subgroup.
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Dapotime Tablets © ClearskyPharmacy Contraindications Dapotime is contraindicated in patients with a hypersensitivity to Dapoxetine Hydrochloride or any other component of this medication. This medicine is also contraindicated in patients with significant pathological cardiac conditions. Dapotime (Generic Dapoxetine Hydrochloride tablets) is contraindicated for concomitant treatment with monoamine oxidase inhibitors (MAOIs), or within fourteen days of discontinuing treatment with an MAOI. Dapotime Tablets © ClearskyPharmacy Contraindications Generic Dapoxetine Hydrochloride (Dapotime Tablets) is contraindicated for concomitant treatment with thioridazine, or within 14 days of stopping treatment with Thioridazine. Dapotime is contraindicated for concomitant treatment with Serotonin reuptake inhibitors [selective serotonin reuptake inhibitors (SSRIs), serotonin-norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs)] or other medicinal/herbal products with serotonergic effects or within 14 days of discontinuing treatment with these medicinal/herbal products.
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Dapotime is contraindicated for concomitant treatment with potent CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, saquinavir, telithromycin, nefazodone, nelfinavir, atazanavir, etc Generic Dapoxetine Hydrochloride Tablets are contraindicated in patients with moderate and severe hepatic impairment. Dapoxetine HCl SideEffects © Clearsky Pharmacy ➢Dapotime (Dapoxetine Hydrochloride Tablets) side effects occurring in 5% or more of patients are headache, dizziness, nausea, diarrhoea, insomnia and fatigue. ➢The other side effects occurring in 1% or more of the subjects in clinical trials were: Anxiety, Agitation, Restlessness, Insomnia, Abnormal dreams, Libido decreased, Somnolence, Disturbance in attention, Tremor, Paraesthesia, Vision blurred, Tinnitus, Flushing,Sinus congestion, Yawning, Diarrhoea, Vomiting, Constipation. Generic Dapoxetine Overdose ©Clearsky Pharmacy There were no unexpected adverse events in a clinical pharmacology study of Dapoxetine Hydrochloride with daily doses up to 240 mg (two 120 mg doses given 3 hours apart). In general, symptoms of overdose with SSRIs include serotonin-mediated adverse reactions such as somnolence, gastrointestinal disturbances such as nausea and vomiting, tachycardia, tremor, agitation and dizziness.
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Generic Dapoxetine Overdose ©Clearsky Pharmacy In cases of overdose, standard supportive measures should be adopted as required. Due to high protein binding and large volume of distribution of Dapoxetine Hydrochloride, forced diuresis, dialysis, hemoperfusion and exchange transfusion are unlikely to be of benefit. No specific antidotes for Dapotime Tablets (Generic Dapoxetine Hydrochloride) are currently known. Generic Dapoxetine DuringPregnancy © Clearsky Pharmacy Dapoxetine Hydrochloride (Dapotime Tablets) has been classified by the FDA as Pregnancy Category C (AU TGA). Dapotime (Generic Dapoxetine Hydrochloride) is not indicated for use by women. Pooled analysis indicated that when compared to the placebo group, there was a significantly higher proportion of PGIC in the dapoxetine group.
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The overall risk ratio (RR) was 2.14 (95% CI = 1.90–2.42; P < 0.00001).
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Generic Dapoxetine Tablets Formore details on Generic Dapoxetine Tablets click here © Clearsky Pharmacy Dapotime Tablets (Generic Dapoxetine Hydrochloride) by HAB Pharmaceuticals and Research Ltd. (Signature), India. Premature ejaculation (PE) is the most common male sexual dysfunction. Dapoxetine hydrochloride, belonging to a class of drugs known as selective serotonin reuptake inhibitors or, was the first drug originally approved for the on-demand treatment of men with PE. We aimed to compare the intravaginal ejaculatory latency time (IELT), patient-reported global impression of change (PGIC) and adverse effect (AE) incidence associated with the use of dapoxetine (30 mg and 60 mg) versus placebo and evaluate the differences in administering 60 mg versus 30 mg as on-demand medical oral therapy for the treatment of PE via a literature review and meta-analysis.
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Relevant randomized controlled trials (RCTs) were identified from PubMed, EMBASE and Cochrane Central Register of Controlled Trials (Cochrane Library) databases. Ultimately, a total of seven RCTs with 8039 patients were included. Our meta-analysis demonstrated that dapoxetine (in the 30 mg and 60 mg subgroup) resulted in significantly higher IELT, PGIC and AE incidence relative to the placebo, with higher proportions observed for 60 mg versus 30 mg of dapoxetine administration. The most common AEs were mild and tolerable. We conclude that dapoxetine (particularly the 60 mg dosage) may be considered a safe and effective drug for patients with PE.
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Premature ejaculation (PE) is the most common male sexual dysfunction with a prevalence of between 20% and 40%1,2. Recently, the International Society for Sexual Medicine has proposed the following evidence-based definition: “PE is a male sexual dysfunction characterized by ejaculation that always or nearly always occurs prior to or within about 1 minute of vaginal penetration; inability to delay ejaculation on all or nearly all vaginal penetrations; and negative personal consequences, such as distress, bother, frustration, and/or the sildenafil and dapoxetine avoidance of sexual intimacy”3,4. In addition, PE affects numerous aspects of a man's life, including sexual confidence, interpersonal relationships and the sexual satisfaction of both partners5. The role of PE on the individual and the sexual relationship is very significant. Thus, it is important to treat patients with PE in order to improve quality of life. The subgroup analysis indicated a statistically significant difference between the dapoxetine (for both 30 mg and 60 mg groups) and the placebo group in
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At present, treatment of PE includes mainly psychotherapy, drug therapy and surgical treatment6. Drug therapy is not only likely to be the most receptive approach for patients, but it is also the most commonly used method. Selective serotonin reuptake inhibitors (SSRIs) have become the most widely used medicine in the world7. Dapoxetine hydrochloride, belonging to the class of SSRIs, was the first drug originally approved for the on-demand treatment of men with PE by seven European countries in 20088. Unfortunately, the efficacy and safety of dapoxetine (30 mg and 60 mg on-demand) has never been comprehensively studied in men with PE.
3.3 Contraindications and Precautions
Most data derived from clinical studies in men with PE are available. The objective of this study was to not only evaluate the efficacy and safety of dapoxetine when used at either 30 mg or 60 mg as compared with the placebo as an oral on-demand treatment in men with PE in routine clinical practice by performing a meta-analytic synthesis of studies, but also to assess whether there are differences in efficacy and safety for PE treatment using either 30 mg or 60 mg dapoxetine. The electronic and manual searches of PubMed, EMBASE and Cochrane Central Register of Controlled Trials (Cochrane Library) databases resulted in 106 references, of which 88 were clearly not relevant to our study. Of the remaining 18 references, 11 were excluded after reading the full text. After a quality validation, only seven studies9,10,11,12,13,14,15 were selected from the literature search.
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The flow chart of the evidence acquisition process is summarized in Figure 1 and the methodological quality of the included studies is reported in Figure 2. Seven randomized controlled trials (RCTs) involving 8039 PE patients met the inclusion criteria. Of these, 2478, 2932 and 2629 patients received 30 mg dapoxetine, 60 mg dapoxetine, or the placebo, respectively. The study included patients aged 18 years or older and the patients were randomized for dapoxetine 30 mg or dapoxetine 60 mg or placebo administration on-demand (1–3 hours prior to anticipated sexual activity). The basic characteristics of the included studies are summarized in Table 1. PGIC (RR = 2.01, 95% CI = 1.69–2.38, P < 0.00001; and RR = 2.26, 95% CI = 1.91–2.67, P < 0.00001, respectively; Figure 5). In addition, data from three9,12,13 studies reporting PGIC compared dapoxetine dosages (60 mg versus 30 mg).
- Dapoxetine 60 mg should be used with caution in elderly men over 65 due to limited safety data.
- Not approved for use in women, children, or adolescents under 18 years of age.
- Safety and efficacy in men with concomitant erectile dysfunction require further study.
These count data were extracted to perform a forest plot analysis, which showed that the use of dapoxetine 60 mg was associated with a
What is premature ejaculation and is it common?
Three of the RCTs selected9,12,13 evaluating dapoxetine versus placebo for PE reported IELT as the primary outcome. Our pooled analysis showed that PE in patients in the dapoxetine group showed a significant improvement in IELT when compared to patients in the placebo group (mean difference [MD] = 1.39; 95% confidence interval [95% CI] = 1.24–1.55; P < 0.00001). Among these studies, we carried out a subgroup analysis based on PE patients treated with dapoxetine 30 mg and 60 mg on-demand oral administration. A statistically significant difference was found in the subgroup treated with 30 mg dapoxetine compared with the placebo-treated group (MD = 1.16; 95% CI = 0.94–1.38; P < 0.00001). The subgroup analysis of the dapoxetine group treated with 60 mg compared with placebo also reporting IELT also revealed a statistically significant difference in patient response (MD = 1.63; 95% CI = 1.41–1.84; P < 0.00001). significantly greater improvement in PGIC than when dapoxetine 30 mg was used (RR = 1.17, 95% CI = 1.09–1.25; P < 0.00001, Figure 6).
- Dapoxetine 60 mg is supplied in tablet form, easy to swallow with water.
- Any sudden allergic reactions such as rash, swelling, or difficulty breathing require emergency care.
- This medication is part of a treatment plan that may include counseling or therapy.
- Dapoxetine is generally well-tolerated but requires medical evaluation before use.
- Use cautiously if you have a history of fainting or low blood pressure.
- The medication should not be used more than once within 24 hours.
- Discuss any past incidents of mood changes or depression with your doctor.
- Always confirm the authenticity of the medication before purchase to avoid counterfeit drugs.