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Dapoxetine, Uses, Dosage, Side Effects, Interactions, Pregnancy

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 an NDA to the FDA for dapoxetine for the treatment of premature ejaculation in December 2004. In October 2005, the company received an FDA Non-Approvable letter from the FDA, at which time they planned to work with regulators to address outstanding questions

Mechanism of Action of Dapoxetine

The drug’s mechanism of action is thought to be related to the inhibition of neuronal reuptake of serotonin and subsequent potentiation of serotonin activity. The central ejaculatory neural circuit comprises spinal and cerebral areas that form a highly interconnected network. The sympathetic, parasympathetic, and somatic spinal centers, under the influence of sensory genital and cerebral stimuli, integrated and processed at the spinal cord level, act in synergy to command physiologic events occurring during ejaculation. Experimental evidence indicates that serotonin (5-HT), throughout brain descending pathways, exerts an inhibitory role on ejaculation. To date, three 5-HT receptor subtypes (5-HT(1A), 5-HT(1B), and 5-HT(2C)) have been postulated to mediate 5-HT’s modulating activity on ejaculation.

Indications of Dapoxetine

An intravaginal ejaculatory latency time (IELT) of less than two minutes

Poor sexual desire
Poor control over intercourse
Erectile Dysfunction
Sexual Dysfunction
Persistent or recurrent ejaculation with minimal sexual stimulation before, on, or shortly after penetration and before the patient wishes; and
Marked personal distress or interpersonal difficulty as a consequence of PE; and
Poor control over ejaculation
A history of premature ejaculation in the majority of intercourse attempts over the prior 6 months.
Very short sexual intercourse
Sexual erectile dysfunction
Inability to sustain a satisfactory erection to complete intercourse
For the treatment of premature ejaculation.
Treatment of premature ejaculation (PE) in men 18 to 64 years of age

Contra-Indications of Dapoxetine

Allergy
Heart failure
Heart rhythm disorders
Bipolar disorder
Loss of consciousness
Kidney Disease
Liver disease
Monoamine oxidase inhibitors (MAOI)
Thioridazine
Selective serotonin reuptake inhibitors
Strong CYP3A4 inhibitors

Dosage of Dapoxetine

Strengths: 30 mg, 60 mg

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Erectile Dysfunction

Dosage 30 mg one to three hours before planned sexual activity. Dapoxetine should only be taken once a day. In the case of inefficacy without side effects, the dosage may be increased to 60 mg.