Dapoxetine and Priligy Review: Does it Work?

Overall, I found this article on hormonal imbalance to be enlightening and informative. It has increased my awareness about the topic and has motivated me to take better care of my hormonal health. I would highly recommend this article to any man who wants to understand and address hormonal imbalances in their own life. Addressing hormonal imbalances can be an important part of managing premature ejaculation.

There are limited data available on the safety and efficacy of dapoxetine ‘on demand’ for longer than 24 weeks. Treatment should be initiated at a dose of 30 mg and titrated to a maximum dose of 60 mg based upon response and tolerability. http://todoreminder.com/new-study-reveals-promising-results-of-pharma-test/ In men with acquired PE and comorbid ED, dapoxetine can be co-prescribed with a phosphodiesterase type-5 inhibitor drug. To review evidence supporting the efficacy and safety of dapoxetine in the treatment of PE.

Patient-reported outcome-defined level of clinical benefit

The global prevalence of PE is estimated to be between 20% and 40%, making it the most common sexual dysfunction in men. PE causes distress and reduced quality of life for patients and has a negative impact on interpersonal relationships. Historically, it has been treated with cognitive therapy, behavioral methods, and off-label use of selective serotonin reuptake inhibitors usually used to treat depression and other psychological disorders. Dapoxetine is a selective serotonin reuptake inhibitor specifically designed to treat PE. This paper reviews the current evidence for use of dapoxetine in the treatment of PE in adult men. There is substantial evidence that dapoxetine 30 mg or 60 mg taken “on-demand” results in a significant increase in intravaginal ejaculatory latency time when compared with placebo.

• If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.
• In addition, the summary of product characteristics states that a careful appraisal of the individual benefit/risk ratio should be carried out after the first 4 weeks of treatment (or at least after 6 doses of treatment) to determine whether continuing treatment is appropriate.
• Due to the nature of PE, a change in IELT is the only disease-orientated outcome that is regularly measured and reported.
• The 60 mg film-coated tablets are grey, round, convex, approximately 8 mm in diameter and debossed with “60” inside a triangle on one side.
• The incidence and severity of adverse events is higher with the 60 mg dose.
• The 5th study compared dapoxetine 60 mg once daily, dapoxetine 60 mg ‘on demand’ and placebo over a 9-week period.

Symptoms of multiple sclerosis can vary widely and may include fatigue, weakness, numbness, and problems with coordination. Treatment options for multiple sclerosis include medication, physical therapy, and lifestyle modifications. Neurological disorders refer to a range of conditions that affect the brain, spinal cord, and nerves throughout the body. These disorders can have a significant impact on a person’s quality of life and daily functioning. Some common neurological disorders include epilepsy, Alzheimer’s disease, Parkinson’s disease, multiple sclerosis, and stroke. Additionally, psychological factors such as anxiety and stress can have a direct impact on the biological factors that contribute to PE.

Table 1

The recommended starting dose for all patients is 30 mg, taken as needed approximately 1 to 3 hours prior to sexual activity. If the effect of 30 mg is insufficient and the side effects are acceptable, the dose may be increased to the maximum recommended dose of 60 mg. The pharmacokinetics of single doses and multiple doses over 6–9 days (30, 60, 100, 140, or 160 mg) of dapoxetine have been evaluated. Both plasma concentration and area under the curve (AUC) are dose dependent up to 100 mg.

• Neurological disorders refer to a range of conditions that affect the brain, spinal cord, and nerves throughout the body.
• Dapoxetine is unlikely to affect the pharmacokinetics of other CYP2C19 substrates.
• Dapoxetine is not recommended in men with severe renal impairment, and caution is advised in men with mild to moderate renal impairment.
• The prescriber should counsel the patient in advance that if he experiences possibly prodromal symptoms, such as lightheadedness soon after standing, he should immediately lie down so his head is lower than the rest of his body or sit down with his head between his knees until the symptoms pass.
• Grapefruit juice should be avoided within 24 hours prior to taking dapoxetine.

Due to the potential of SSRIs to lower the seizure threshold, Priligy should be discontinued in any patient who develops seizures and avoided in patients with unstable epilepsy. Caution is advised in patients taking moderate CYP3A4 inhibitors and the dose is restricted to 30 mg (see sections 4.2 and 4.5). Patients should be cautioned to avoid situations where injury could result, including driving or operating hazardous machinery, should syncope or its prodromal symptoms such as dizziness or lightheadedness occur (see section 4.8). Concomitant treatment with monoamine oxidase inhibitors (MAOIs), or within 14 days of discontinuing treatment with an MAOI. Similarly, an MAOI should not be administered within 7 days after Priligy has been discontinued (see section 4.5). Priligy is contraindicated in patients with moderate and severe hepatic impairment (Child-Pugh Class B and C) (see sections 4.3 and 5.2).

Alcohol and recreational drugs should be avoided when taking dapoxetine. It is recommended that tablets be taken with at least one full glass of water. Priligy may be taken with or without food (see Section 5.2 Pharmacokinetic Properties). Precautions to be taken before handling or administering the medicinal product. Before treatment is initiated, see Section 4.4 Special Warnings and Precautions for Use regarding orthostatic hypotension.

Alternative medicine

Grapefruit juice is also a potent CYP3A4 inhibitor and should be avoided within 24 hours prior to taking Priligy (see section 4.3). In vitro studies in human liver, kidney, and intestinal microsomes indicate dapoxetine is metabolized primarily by CYP2D6, CYP3A4 and flavin monooxygenase 1 (FMO1). Priligy should not be used in patients with a history of mania/hypomania or bipolar disorder and should be discontinued in any patient who develops symptoms of these disorders. Concomitant treatment of potent CYP3A4 inhibitors such as ketoconazole, itraconazole, ritonavir, saquinavir, telithromycin, nefazadone, nelfinavir, atazanavir, etc. (see section 4.5). Concomitant treatment with thioridazine, or within 14 days of discontinuing treatment with thioridazine.

For example, men with erectile dysfunction may find that combining Priligy with other medications, such as Viagra, improves their overall sexual performance and satisfaction. Priligy can also be helpful for men with underlying psychological conditions, such as anxiety or depression, which may contribute to their premature ejaculation. Priligy is a medication that is specifically designed to treat a particular medical condition known as premature ejaculation. Premature ejaculation is a common sexual dysfunction that affects men and can cause significant distress and frustration in their relationships. This condition occurs when a man ejaculates sooner than desired during sexual activity, often within one minute of penetration.

The increase in CYP3A activity may be of clinical relevance in some individuals concomitantly treated with a medicinal product mainly metabolized by CYP3A and with a narrow therapeutic window. Multiple doses of dapoxetine (60 mg/day for 6 days) followed by a single 50 mg dose of desipramine increased the mean Cmax and AUCinf of desipramine by approximately 11% and 19%, respectively, compared to desipramine administered alone. Dapoxetine may give rise to a similar increase in the plasma concentrations of other drugs metabolized by CYP2D6.