Priligy (Dapoxetine) is one of the newest and most effective medicines used by people improving their potency. This medicine helps to solve the problem of premature ejaculation and does not cause temporary discomfort associated with the cessation of sexual activity. The active substance of the medicine is Dapoxetine hydrochloride. The medicine has passed dozens of clinical trials in different countries of the world and has shown excellent results everywhere. According to the results obtained, regular use of the medicine can increase the time of sexual intercourse 3 to 4 times. Long-term medication intake (from 6 to 12 months) noticeably improves the intensity and, more important, the quality of the sexual life of men. The drug begins to be absorbed immediately when it enters the body, so the effect of the drug manifests itself 2 hours after administration. The desired effect is achieved even after a single use. If the individual response to 30 mg is insufficient and the patient has not experienced moderate or severe adverse reactions or prodromal symptoms suggestive of syncope, the dose may be increased to a maximum recommended dose of 60 mg taken as needed approximately 1 to 3 hours prior to sexual activity. The incidence and severity of adverse events is higher with the 60 mg dose. A careful appraisal of individual benefit risk of Priligy should be performed by the physician after the first four weeks of treatment (or at least after 6 doses of treatment) to determine whether continuing treatment with Priligy is appropriate. Data regarding the efficacy and safety of Priligy beyond 24 weeks are limited. The clinical need of continuing and the benefit risk balance of treatment with Priligy should be re-evaluated at least every six months. Caution is advised if increasing the dose to 60 mg in patients known to be of CYP2D6 poor metabolizer genotype or in patients concomitantly treated with potent CYP2D6 inhibitors (see sections 4.4, 4.5 and 5.2). Concomitant use of potent CYP3A4 inhibitors is contraindicated.
As a member of the selective serotonin reuptake inhibitor (SSRI) family, dapoxetine was initially created as an antidepressant. 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 Food and Drug Administration (FDA) for the treatment of PE in 2004. Different dosage has 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 there is no difference in men with acquired PE. 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. Dapoxetine is a selective serotonin reuptake inhibitor, for the treatment of premature ejaculation. In a phase II proof-of-concept study conducted by PPD, dapoxetine demonstrated a statistically significant increase in ejaculatory latency when compared to placebo. Alza submitted a NDA to the FDA for dapoxetine for the treatment of premature ejaculation in December 2004. In October 2005, the company received a FDA Non-Approvable letter from the FDA, at which time they planned to work with regulators to address outstanding questions.
Clinical Dapoxetine trials and any trials involving new drugs are commonly classified into four phases. Each phase of the drug approval process is treated as a separate clinical trial. Each phase of the drug approval process is treated as a separate clinical trial. Each film−coated tablet contains dapoxetine hydrochloride equivalent to 30 mg or 60. Use of Priligy with recreational drugs with sedative properties such as.