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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.
| Effect | Description | Changes Observed | Contributing Factors |
|---|---|---|---|
| Increased Online Purchases | Shift towards online pharmacies | Up by 30% | Lockdowns, social distancing |
| Reduced Prescriptions | Some patients delayed doctor visits | Down by 10% | Healthcare access restrictions |
| Stock Shortages | Temporary shortages in some pharmacies | Occurred | Supply chain disruptions |
A high-fat meal does reduce the Cmax slightly, but it is insignificant.
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- Dapoxetine is known for its rapid absorption in the Spanish population.
- The medication is sometimes used off-label for other purposes.
- During clinical trials in Spain, efficacy was confirmed across diverse groups.
- Dapoxetine has a favorable safety profile when used as directed.
- The Spanish pharmaceutical market offers multiple options for dapoxetine.
- Patients are advised to purchase from licensed pharmacies.
- Ongoing research in Spain continues to optimize PE treatments.
Dapoxetine is absorbed and distributed rapidly in the body.
| Product | Dosage | Quantity + Bonus | Price | |
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| Priligy Generic Dapoxetine | 60mg | 30 + 6 Pills | 106.65€ 101.57€ | |
| Levitra Soft Tabs | 20mg | 120 + 8 Pills | 288.52€ 274.78€ | |
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The mean steady-state volume is 162 L.
- In Spain, dapoxetine is prescribed after medical evaluation.
- Common side effects include nausea, dizziness, and headache.
- Dapoxetine's availability varies between pharmacies across Spain.
- It is often part of treatment for men with lifelong premature ejaculation.
- Dapoxetine can be used alone or with behavioral therapy.
- The drug is usually taken on an as-needed basis.
- Price of dapoxetine in Spain varies depending on the pharmacy.
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).
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Since PE is associated with personal distress and interrelationship difficulty, dapoxetine provides help for men with PE to overcome this condition. With no drug approved specifically for treatment for PE in the US and some other countries, other SSRIs such as fluoxetine, paroxetine, sertraline, fluvoxamine, and citalopram have been used off-label to treat PE. Waldinger's meta-analysis shows that the use of these conventional antidepressants increases IELT two- to nine-fold above baseline, compared to three- to eight-fold when dapoxetine is used. [11] However, these SSRIs may need to be taken daily to achieve meaningful efficacy, and their comparatively longer half-lives increase the risk of drug accumulation and a corresponding increase of adverse effects such as reduced libido. [13] Dapoxetine, though, is generally categorized as a fast-acting SSRI.
Cardiovascular safety
It is more rapidly absorbed and mostly eliminated from the body within a few hours. These pharmacokinetics are more favorable in that they might minimize drug accumulation in the body, habituation, and side effects. Dapoxetine was initially considered unsuccessful in its intended use as an antidepressant; however, it has since been investigated as a possible aid to an approach to depression treatment focused on stress reduction, based on an animal model of depression. Dapoxetine should not be used in men with moderate to severe hepatic impairment and in those receiving CYP3A4 inhibitors such as ketoconazole, ritonavir, and telithromycin. Dapoxetine also cannot be used in patients with heart failure, permanent pacemaker, or other significant ischemic heart disease.
Neurocognitive safety
Caution is advised in men receiving thioridazine, monoamine oxidase inhibitors, SSRIs, serotonin-norepinephrine reuptake inhibitors, or tricyclic antidepressants. If a patient stops taking one of these drugs, he should wait for 14 days before taking dapoxetine. If a patient stops taking dapoxetine, he should wait for 7 days before receiving these drugs. The most common effects when taking dapoxetine are nausea, dizziness, dry mouth, headache, diarrhea, and insomnia. [16][17] Discontinuation rates due to adverse effects and costs are very high, as demonstrated in a study in Asia which showed that cumulative discontinuation rates within one year are as high as 87%. 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.
| Year | Number of Prescriptions | Percentage Change | Notes |
|---|---|---|---|
| 2018 | 50,000 | - | Steady growth in early years |
| 2019 | 60,000 | +20% | Increased awareness |
| 2020 | 70,000 | +16.7% | Pandemic impact, more online use |
| 2021 | 85,000 | +21.4% | Marketing efforts, new regulations |
| 2022 | 90,000 | +5.9% | Market saturation begins |
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.
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[18] Unlike other SSRIs used to treat depression, which have been associated with high incidences of sexual dysfunction,[19] dapoxetine is associated with low rates of sexual dysfunction. Taken as needed, dapoxetine has very mild adverse effects of decreased libido (<1%) and erectile dysfunction (<4%). No case dapoxetine tadalafil tablets of drug overdose has been reported during clinical trials. Many men who have PE also suffer from erectile dysfunction (ED). Treatment for these patients should consider the drug–drug interaction between dapoxetine and PDE5 inhibitors such as tadalafil (Cialis) or sildenafil (Viagra).
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In Dresser study (2006), plasma concentration of 24 subjects was obtained. Half of the sample pool were treated with dapoxetine 60 mg plus tadalafil 20 mg; the other half were treated with dapoxetine 60 mg plus sildenafil 100 mg. These plasma samples were then analyzed using liquid chromatography-tandem mass spectrometry. The results showed that dapoxetine does not alter the pharmacokinetics of tadalafil or sildenafil. Alcohol does not affect the pharmacokinetics of dapoxetine when taking concurrently.
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The mechanism through which dapoxetine affects premature ejaculation is still unclear, but dapoxetine is presumed to work by inhibiting serotonin transporter (SERT) and subsequently increasing serotonin's action at pre- and postsynaptic receptors. [22] Human ejaculation is regulated by various areas in the central nervous system (CNS). These signals are passed on to the brain stem, which then is influenced by a number of nuclei in the brain such as medial preoptic and paraventricular nuclei. [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. The cardiovascular safety profile of dapoxetine has been studied extensively during the drug development.
Further information
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. 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.
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This is ideal for exporters planning market expansion. exporters, importers, traders, logistics companies, researchers, and policymakers can all benefit from Eximpedia’s Dapoxetine Hydrochloride exporters database by gaining accurate insights into the global Dapoxetine Hydrochloride export market. See all that you can accomplish with Eximpedia Dapoxetine, sold under the brand name Priligy among others, is a selective serotonin reuptake inhibitor (SSRI) used for the treatment of premature ejaculation (PE) in men ages 18 to 64 years old. [3][4][5] Dapoxetine works by inhibiting the serotonin transporter, increasing serotonin's action at the postsynaptic cleft, and as a consequence promoting ejaculatory delay. [6] As a member of the SSRI family, dapoxetine was initially created as an antidepressant.
Study Locations
However, unlike other SSRIs, dapoxetine is absorbed and eliminated rapidly in the body. Its fast-acting property makes it suitable for the treatment of PE, but not as an antidepressant. Originally created by Eli Lilly pharmaceutical company, dapoxetine was sold to Johnson & Johnson in 2003 and submitted as a New Drug Application to the US Food and Drug Administration (FDA) for the treatment of PE in 2004. [8] Dapoxetine is sold in dapoxetine 60 mg buy online several European and Asian countries, and in Mexico. In the US, dapoxetine has been in phase III development.
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In May 2012, US-based Furiex Pharmaceuticals reached an agreement with ALZA Corp and Janssen Pharmaceuticals to market dapoxetine in the United States, Japan, and Canada, while selling the rights to market the drug in Europe, most of Asia, Africa, Latin America, and the Middle East to Menarini. Randomized, double-blind, placebo-controlled trials have confirmed the efficacy of dapoxetine for the treatment of PE. [10] Different dosages have different impacts on different types of PE. Dapoxetine 60 mg significantly improves the mean intravaginal ejaculation latency time (IELT) compared to that of dapoxetine 30 mg in men with lifelong PE, but no difference is seen in men with acquired PE. [11] Dapoxetine, given 1–3 hours before sexual episode, prolongs IELT and increases the sense of control and sexual satisfaction in men of 18 to 64 years of age with PE.
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