WARNINGS AND PRECAUTIONS

"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". "Dapoxetine for the treatment of premature ejaculation: results from a randomized, double-blind, placebo-controlled phase 3 trial in 22 countries".

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

"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 dapoxetine 30mg tablet Premature Ejaculation". "Dapoxetine for the treatment of premature ejaculation: Lack of interaction with ethanol". "Monoaminergic transporter binding and inhibition profile of dapoxetine, a medication for the treatment of premature ejaculation". "Physiology of ejaculation: emphasis on serotonergic control". "Supraspinal site of action for the inhibition of ejaculatory reflex by dapoxetine".

Condition	Recommended Dosage	Onset Time	Duration of Effect	Additional Notes
Erectile Dysfunction	100 mg sildenafil	30-60 min	4-6 hours	Take 30 min before activity
Premature Ejaculation	60 mg dapoxetine	1-3 hours	1-2 hours	May be taken daily or on demand
Combined Use for Both Conditions	As prescribed	Varies	Varies	Under medical supervision

"Efficacy and safety of dapoxetine for the treatment of premature ejaculation: integrated analysis of results from five phase 3 trials".

What can I do to lower the side effects of dapoxetine?

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".

-Missed Does

^ 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". ^ "Dapoxetine: a guide to its use in premature ejaculation".

Product	Dosage	Quantity + Bonus	Price
Cialis Black	80mg	270 + 10 Pills	502.88€ 478.93€	Buy
Priligy Generic Dapoxetine	60mg	10 Pills	47.63€ 45.36€	Buy
Priligy Generic Dapoxetine	60mg	180 + 10 Pills	494.76€ 471.20€	Buy
Kamagra Oral Jelly	100 mg	90 + 8 Sachets	303.56€ 289.10€	Buy
Priligy Generic Dapoxetine	60mg	60 + 8 Pills	183.06€ 174.34€	Buy
Viagra Generic	200mg	90 + 6 Pills	170.79€ 162.66€	Buy
Kamagra Oral Jelly	100mg	63 + 7 Sachets	224.18€ 213.50€	Buy
Priligy Generic Dapoxetine	60mg	90 + 10 Pills	265.64€ 252.99€	Buy
Viagra Original	100mg	22 + 2 Pills	120.71€ 114.96€	Buy
Levitra Original	20mg	14 + 2 Pills	102.27€ 97.40€	Buy
Super Kamagra	160 mg	152 + 8 Pills	729.11€ 694.39€	Buy
Priligy Generic Dapoxetine	60mg	20 + 4 Pills	77.31€ 73.63€	Buy
Levitra Generic	40mg	60 + 4 Pills	162.37€ 154.64€	Buy
Priligy Generic Dapoxetine	60mg	30 + 6 Pills	106.65€ 101.57€	Buy
Priligy Generic Dapoxetine	60mg	120 + 10 Pills	341.26€ 325.01€	Buy

"Pharmacokinetics of single and multiple escalating doses of dapoxetine in healthy volunteers". "Cardiovascular safety profile of dapoxetine during the premarketing evaluation".

Condition	Explanation	Alternative Approach
Nitrate medications	Dangerous interaction leading to hypotension	Consult healthcare provider
Severe liver or kidney disease	Altered drug metabolism and excretion	Dose adjustment or avoidance
Hypersensitivity to ingredients	Allergic reactions possible	Discontinue use immediately
Heart conditions	Increased cardiovascular risks	Medical evaluation required

"Suicide rates in clinical trials of SSRIs, other antidepressants, and placebo: analysis of FDA reports". "Selective serotonin reuptake inhibitor discontinuation syndrome: a review".

• 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.

"Emerging treatments for premature ejaculation: focus on dapoxetine".

• Sildenafil was first approved by the FDA in 1998.
• Dapoxetine was developed specifically for premature ejaculation treatment.
• Both drugs are available in tablet form for oral administration.
• Use of sildenafil may be affected by certain eye conditions.
• Dapoxetine is absorbed quickly and metabolized mainly in the liver.
• Patients should follow the dosage instructions strictly.
• Avoid taking sildenafil with large quantities of grapefruit juice.
• Dapoxetine has been shown to be effective in clinical trials.

"Dapoxetine: a novel treatment for premature ejaculation". "Stereoselective synthesis of (S)-dapoxetine starting from trans-cinnamyl alcohol". "Medical Non-Endocrine-Targeted Therapies: Ejaculatory Dysfunction and Immunotherapy".

5.7 Combination with other PDE5 Inhibitors or Other Erectile Dysfunction Therapies

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.

Cardiovascular safety

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.

Dosage for erectile dysfunction (ED)

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. Product Salbutamol 1.0 mg+Ambroxol 15.0 mg+ Guaphenesin 50 mg / 5 mlSynokem pharmaceuticals offers a wide range of products which includes salbutamol 1.0 mg+ambroxol 15.0 mg+ guaphenesin 50 mg / 5 ml. Dosage: 60 ml/100 ml pet bottle.

• 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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How long does dapoxetine make me last?

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.

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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 dapoxetine over counter SSRIs in men with PE has been done.

Neurocognitive safety

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 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. 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.

Disclosure statement

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.

Chemical Formula

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.

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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.