Efficacy and safety of dapoxetine/sildenafil combination tablets in the treatment of men with premature ejaculation and concomitant erectile dysfunction-DAP-SPEED Study
"Dapoxetine for the treatment of premature ejaculation: Lack of interaction with ethanol".
- Sildenafil helps improve erectile response in men with ED.
- Dapoxetine may enhance control over ejaculation for men with PE.
- Combining sildenafil and dapoxetine can improve sexual satisfaction.
- Use sildenafil with caution in patients with heart conditions.
- Dapoxetine has a short half-life, suitable for on-demand use.
- Patients should avoid high-fat meals immediately before taking sildenafil.
- Dapoxetine should be taken with a full glass of water.
- Both drugs are contraindicated in patients with certain heart problems.
"Monoaminergic transporter binding and inhibition profile of dapoxetine, a medication for the treatment of premature ejaculation".
5.4 Hearing Loss
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. The Cmax and AUC (area under the plasma vs. time curve) is dose dependent.
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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. Dapoxetine is absorbed and distributed rapidly in the body. The mean steady-state volume is 162 L.
Allergy warning
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. 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. "Physiology of ejaculation: emphasis on serotonergic control".
- Sildenafil is not recommended for use by women.
- Dapoxetine is approved specifically for men with PE.
- Both drugs help improve sexual confidence and performance.
- Proper hydration can help mitigate side effects.
- Patients with retinal disorders should consult a healthcare professional.
- Use of these medications does not protect against sexually transmitted infections.
- Combining medications without medical guidance can be dangerous.
- Inform your doctor if you experience any adverse reactions.
"Supraspinal site of action for the inhibition of ejaculatory reflex by dapoxetine".
| Product | Dosage | Quantity + Bonus | Price | |
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| Priligy Generic Dapoxetine | 60mg | 10 Pills | 47.63€ 45.36€ | |
| Priligy Generic Dapoxetine | 60mg | 30 + 6 Pills | 106.65€ 101.57€ | |
| Priligy Generic Dapoxetine | 60mg | 120 + 10 Pills | 341.26€ 325.01€ | |
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"Efficacy and safety of dapoxetine for the treatment of premature ejaculation: integrated analysis of results from five phase 3 trials".
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
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. 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.
Why it’s used
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. [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.
Alcohol interaction warning
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". "Dapoxetine: a new option in the medical management of premature ejaculation". ^ "Priligy is used to Treat Premature Ejaculation". ^ "Dapoxetine: a guide to its use in premature ejaculation". "Pharmacokinetics of single and multiple escalating doses of dapoxetine in dapoxetine order online 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".
Disclosure statement
"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. Spanish Working Group for the Study of Psychotropic-Related Sexual Dysfunction". "Dapoxetine-A Novel Drug for Premature Ejaculation". "Selective serotonin reuptake inhibitor discontinuation syndrome: a review".
| Ingredient | Quantity per Tablet | Function | Notes |
|---|---|---|---|
| Sildenafil Citrate | 100 mg | Erectile dysfunction treatment | Active ingredient |
| Dapoxetine Hydrochloride | 60 mg | Premature ejaculation relief | Active ingredient |
| Microcrystalline Cellulose | 50 mg | Binder | Inactive excipient |
| Magnesium Stearate | 5 mg | Lubricant | Inactive excipient |
| Lactose Monohydrate | 20 mg | Filler | Inactive excipient |
"Emerging treatments for premature ejaculation: focus on dapoxetine". "Dapoxetine: a novel treatment for premature ejaculation". "Stereoselective synthesis of (S)-dapoxetine starting from trans-cinnamyl alcohol".
| Parameter | Value | Description |
|---|---|---|
| Absorption Rate | Rapid | Peak plasma levels in about 30-120 min |
| Peak Concentration | 90 minutes | Time to maximum plasma concentration |
| Half-Life | Approx. 4 hours | Duration in system for elimination |
| Metabolism | Liver (CYP3A4 enzyme) | Primary metabolic pathway |
| Excretion | Feces and urine | Removal route |
"Medical Non-Endocrine-Targeted Therapies: Ejaculatory Dysfunction and Immunotherapy".
- Sildenafil is used to treat erectile dysfunction in men.
- Dapoxetine is primarily prescribed for premature ejaculation.
- Sildenafil increases blood flow to the penis during arousal.
- Dapoxetine works by delaying serotonin reuptake, extending ejaculation time.
- Both medications require a prescription from a healthcare provider.
- Sildenafil usually takes about 30-60 minutes to work.
- Dapoxetine is typically taken 1-3 hours before sexual activity.
- Combining sildenafil and dapoxetine should only be done under medical guidance.
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- Sildenafil is marketed globally under the brand Viagra.
- Dapoxetine is marketed as Priligy in many regions.
- Common side effects of sildenafil include headaches and flushing.
- Dapoxetine may cause nausea, dizziness, or insomnia.
- Taking sildenafil with nitrates can cause severe hypotension.
- Dapoxetine should not be used with other antidepressants without doctor approval.
- Both medications may cause dizziness, so caution is advised when driving.
- Alcohol can reduce the effectiveness of sildenafil and dapoxetine.
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12.1 Mechanism of Action
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. 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.
Sildenafil and dapoxetine
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 dapoxetine 60 mg buy online risk of discontinuation symptoms. 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.
Premature ejaculation
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. 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. Product Sertraline Tablets BP 25 mgSynokem pharmaceuticals offers a wide range of products which includes sertraline tablets bp 25 mg. Product Sertraline Tablets BP 50 mgSynokem pharmaceuticals offers a wide range of products which includes sertraline tablets bp 50 mg. Product Sildenafil Citrate Tablets 100 mgSynokem pharmaceuticals offers a wide range of products which includes sildenafil citrate tablets 100 mg. Product Sildenafil Citrate Tablets 50 mgSynokem pharmaceuticals offers a wide range of products which includes sildenafil citrate tablets 50 mg. Product Sodium Picosulfate Oral Solution BP 5 mg/5mlSynokem pharmaceuticals offers a wide range of products which includes sodium picosulfate oral solution bp 5 mg/5ml. Dosage: 60 ml/100 ml/200 ml pet bottle. Product Sodium Picosulfate Tablets 10 mgSynokem pharmaceuticals offers a wide range of products which includes sodium picosulfate tablets 10 mg. Product Sucralfate 1000 mg+ Oxetacaine 20 mg SyrupSynokem pharmaceuticals offers a wide range of products which includes sucralfate 1000 mg+ oxetacaine 20 mg syrup. Dosage: 100 ml/200 ml amber colour pet bottle. Product Sucralfate 500 mg+ Oxetacaine 10 mg SyrupSynokem pharmaceuticals offers a wide range of products which includes sucralfate 500 mg+ oxetacaine 10 mg syrup. Product Sucralfate 500mg+Domperidone 10mg+Simethicone 25mgSynokem pharmaceuticals offers a wide range of hormones products which includes sucralfate 500mg+domperidone 10mg+simethicone 25mg. Product Tadalafil tablets USP 10 mgSynokem pharmaceuticals offers a wide range of products which includes tadalafil tablets usp 10 mg.
What can I do to lower the side effects of dapoxetine?
^ 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".
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"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 the pharmacologic management of premature ejaculation". "Dapoxetine: An Innovative Approach in the Therapeutic Management In Animal Model of Depression". "Antistress and antidepressant properties of dapoxetine and vortioxetine". Manufacturer Anti Malarial Drugs Manufacturer IndiaAntibiotics Injection Manufacturer IndiaAntiretroviral Drug Manufacturer IndiaAntibiotic Tablets Manufacturer IndiaCovid Medicine Manufacturer IndiaGeneric Medicine Manufacturer IndiaMRI Contrast Agent Manufacturer Indiapharmaceutical injections manufacturer in IndiaPharmaceutical Capsules & Tablet Manufacturer IndiaPrivate Label Pharmaceutical Manufacturing India Manufacturer Anti Malarial Drugs Manufacturer IndiaAntibiotics Injection Manufacturer IndiaAntiretroviral Drug Manufacturer IndiaAntibiotic Tablets Manufacturer IndiaCovid Medicine Manufacturer IndiaGeneric Medicine Manufacturer IndiaMRI Contrast Agent Manufacturer Indiapharmaceutical injections manufacturer in IndiaPharmaceutical Capsules & Tablet Manufacturer IndiaPrivate Label Pharmaceutical Manufacturing India Please note: Livealth Biopharma supplies pharmaceutical products in bulk quantities only.