How Dapoxetine 60mg Works to Delay Ejaculation

Generic Dapoxetine HCl, given 1 to 3 hours before sexual episode, prolongs intravaginal ejaculatory latency time (IELT) and increases the sense of control and sexual satisfaction in men of 18 to 64 years of age with PE. Dapotime Tablets © ClearskyPharmacy Dapotime Tablets are manufactured by HAB Pharmaceuticals and Research Ltd.

• 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.

(Signature) , India. Active Ingredient © ClearskyPharmacy The active ingredient contained in Dapotime tablets is Dapoxetine Hydrochloride. Chemical Structure © ClearskyPharmacy The structure of Dapoxetine Hydrochloride is given below: Uses of DapotimeTablets © Clearsky Pharmacy Dapotime tablets (Dapoxetine Hydrochloride Tablets) is a medication which increases the time it takes to ejaculate and can improve the control over the ejaculation.

Can premature ejaculation be caused by anxiety or stress?

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. 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).

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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. 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 is used to treat premature ejaculation in adult men aged between 18 to 64 years. Premature ejaculation is a medical condition wherein a man ejaculates with little sexual stimulation and before the man wants. Since PE is associated with personal distress and interrelationship difficulty, Dapoxetine provides help for men with Premature ejaculation to overcome this condition. Dapoxetine, is a fast-acting SSRI and is rapidly absorbed and eliminated from the body within a few hours.

Dapotime Dosage © ClearskyPharmacy ➢ Dapotime (Dapoxetine Hydrochloride Tablets) may be taken with or without food. The recommended starting dose for all patients is 30 mg, taken as needed approximately one to three hours before sexual activity. ➢In case the effect of 30 mg is not sufficient and the side effects are acceptable, the dose may be increased to the maximum recommended dose of 60 mg.

The maximum recommended dosing frequency is one dose every 24 hours. 24 hours must pass before taking your next dose. The dosage of Generic Dapoxetine tablets (Dapotime) is given below: Storage Instructions © ClearskyPharmacy Dapotime (Dapoxetine Hydrochloride Tablets) have to be stored at controlled room temperature i.e. Keep this as well as all other medicines away from children and pets. Warnings © Clearsky Pharmacy Dizziness,disturbance in attention, syncope, blurred vision and somnolence have been reported in patients administered Dapoxetine during clinical trials.

Is Priligy available through the NHS?

The recommended starting dose for all patients is 30 mg, taken as needed approximately one to three hours before sexual activity. ➢In case the effect of 30 mg is not sufficient and the side effects are acceptable, the dose may be increased to the maximum recommended dose of 60 mg. The maximum recommended dosing frequency is one dose every 24 hours. 24 hours must pass before taking your next dose. The dosage of Generic Dapoxetine tablets (Dapotime) is given below: Storage Instructions © ClearskyPharmacy Dapotime (Dapoxetine Hydrochloride Tablets) have to be stored at controlled room temperature i.e.

Data extraction

Keep this as well as all other medicines away from children and pets. Warnings © Clearsky Pharmacy Dizziness,disturbance in attention, syncope, blurred vision and somnolence have been reported in patients administered Dapoxetine during clinical trials. Therefore, patients must be warned to avoid situations where injury could result, including driving or operating hazardous machinery. Combining alcohol with Dapotime may increase alcohol related neurocognitive effects and may also increase neurocardiogenic adverse events such as syncope, thereby increasing the risk of accidental injury; therefore, patients must be advised to avoid alcohol while taking Dapoxetine Hydrochloride tablets ( Dapotime ). Warnings © Clearsky Pharmacy Patientsshould be advised not to use Generic Dapoxetine tablets in combination with recreational drugs as they may lead to potentially serious reactions if combined with Dapotime. Therefore, patients must be warned to avoid situations where injury could result, including driving or operating hazardous machinery. Combining alcohol with Dapotime may increase alcohol related neurocognitive effects and may also increase neurocardiogenic adverse events such as syncope, thereby increasing the risk of accidental injury; therefore, patients must be advised to avoid alcohol while taking Dapoxetine Hydrochloride tablets ( Dapotime ). Warnings © Clearsky Pharmacy Patientsshould be advised not to use Generic Dapoxetine tablets in combination with recreational drugs as they may lead to potentially serious reactions if combined with Dapotime.

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Unfortunately, the efficacy and safety of dapoxetine (30 mg and 60 mg on-demand) has never been comprehensively studied in men with PE. 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. This medicine can make you faint or make your blood pressure drop when you stand up. To decrease the chance of this happening take Dapotime with at least one full glass of water and do not take this medication in case you are dehydrated. In case of a history of documented or suspected orthostatic reaction, treatment with Generic Dapoxetine tablets should be avoided. Patients with underlying cardiovascular disease must not be administered this medicine as there is a risk of adverse cardiovascular outcomes from syncope. Dapoxetine HCl SideEffects © Clearsky Pharmacy ➢The other side effects occurring in 1% or more of the subjects in clinical trials were: Abdominal pain, Abdominal pain upper, Dyspepsia, Flatulence, Stomach discomfort, Abdominal distension, Dry mouth, Hyperhidrosis, Erectile dysfunction, Fatigue, Irritability and Blood pressure increased. ➢This is not a complete list of side effects. 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 sildenafil dapoxetine tablets 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. 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.

Similar Trials

Dapotime (Generic Dapoxetine Hydrochloride) is not indicated for use by women. 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.

Study selection

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. 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. ➢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. 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.

4. Safety Profile and Side Effects

We conclude that dapoxetine (particularly the 60 mg dosage) may be considered a safe and effective drug for patients with PE. 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 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.

Exclusion Criteria

Thus, it is important to treat patients with PE in order to improve quality of life. 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. 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. Generic Dapoxetine Tablets Formore details on Generic Dapoxetine Tablets click here © Clearsky Pharmacy Dapotime Tablets (Generic Dapoxetine Hydrochloride) by HAB Pharmaceuticals and Research Ltd.

Author information

Generic Dapoxetine HCl, given 1 to 3 hours before sexual episode, prolongs intravaginal ejaculatory latency time (IELT) and increases the sense of control and sexual satisfaction in men of 18 to 64 years of age with PE. Dapotime Tablets © ClearskyPharmacy Dapotime Tablets are manufactured by HAB Pharmaceuticals and Research Ltd. (Signature) , India. Active Ingredient © ClearskyPharmacy The active ingredient contained in Dapotime tablets is Dapoxetine Hydrochloride. Chemical Structure © ClearskyPharmacy The structure of Dapoxetine Hydrochloride is given below: Uses of DapotimeTablets © Clearsky Pharmacy Dapotime tablets (Dapoxetine Hydrochloride Tablets) is a medication which increases the time it takes to ejaculate and can improve the control over the ejaculation.

Mechanism of action

Dapotime is used to treat premature ejaculation in adult men aged between 18 to 64 years. Premature ejaculation is a medical condition wherein a man ejaculates with little sexual stimulation and before the man wants. Since PE is associated with personal distress and interrelationship difficulty, Dapoxetine provides help for men with Premature ejaculation to overcome this condition. Dapoxetine, is a fast-acting SSRI and is rapidly absorbed and eliminated from the body within a few hours. Dapotime Dosage © ClearskyPharmacy ➢ Dapotime (Dapoxetine Hydrochloride Tablets) may be taken with or without food. (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. 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.

What treatments are available for premature ejaculation?

This medicine can make you faint or make your blood pressure drop when you stand up. To decrease the chance of this happening take Dapotime with at least one full glass of water and do not take this medication in case you are dehydrated. In case of a history of documented or suspected orthostatic reaction, treatment with Generic Dapoxetine tablets should be avoided. Patients with underlying cardiovascular disease must not be administered this medicine as there is a risk of adverse cardiovascular outcomes from syncope. Dapoxetine HCl SideEffects © Clearsky Pharmacy ➢The other side effects occurring in 1% or more of the subjects in clinical trials were: Abdominal pain, Abdominal pain upper, Dyspepsia, Flatulence, Stomach discomfort, Abdominal distension, Dry mouth, Hyperhidrosis, Erectile dysfunction, Fatigue, Irritability and Blood pressure increased.

2.3 Pharmacokinetics

➢This is not a complete list of side effects. 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 sildenafil dapoxetine tablets 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. 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. 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 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.

• Dapoxetine is not recommended for men with severe renal impairment (CrCl <30 mL/min).
• Mild to moderate renal impairment (CrCl 30-59 mL/min) may use with caution at 30 mg max.
• No data for end-stage renal disease; use contraindicated.

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. 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. 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.