Dapoxetine is indicated for the treatment of-

• premature ejaculation (PE)
• An intravaginal ejaculatory latency time (IELT) of less than two minutes
• Persistent or recurrent ejaculation with minimal sexual stimulation before, on, or shortly after penetration and before the patient wishes
• Poor control over ejaculation
• Marked personal distress or interpersonal difficulty as a consequence of PE

Premature Ejaculation

Male adults (aged 18 to 64 years)

• For all patients, the suggested starting dose is 30 mg, taken as needed 1 to 3 hours before sexual activity. The 60 mg dose of Dapoxetine should not be used to begin treatment.
• Dapoxetine should not be used on a daily basis. When sexual activity is expected, Dapoxetine should be taken. Dapoxetine should not be used more than once per 24 hours.
• If the patient's response to 30 mg is insufficient and he or she hasn't had any moderate or severe adverse reactions or prodromal symptoms suggestive of syncope, the dose can be increased to a maximum suggested dose of 60 mg, taken as needed 1 to 3 hours before sexual activity.
•  The incidence and severity of adverse events is higher with the 60 mg dose.

The following side effects are reported with the use of Dapoxetine-

• Dizziness
• Headache
• Nausea
• Anxiety
• Agitation
• Restlessness
• Insomnia
• Abnormal dreams
• Libido decrease
• Somnolence
• Disturbance in attention
• Tremor
• Paresthesia

Dizziness	Headache	Nausea
Anxiety	Agitation	Tremor (Shaking)

• Only males with Premature Ejaculation who match all of the requirements given in the indications above should take Dapoxetine. Men who have not been diagnosed with Premature Ejaculation should not use Dapoxetine. There is no data on the ejaculation-delaying effects on men without Premature Ejaculation, thus it is not safe.
• Other forms of sexual dysfunction, such as erectile dysfunction, should be thoroughly evaluated by specialists prior to treatment. Men with erectile dysfunction (ED) who are using PDE5 inhibitors should not use Dapoxetine.
• Before treatment initiation, a careful medical examination including history of orthostatic events should be performed by the physician. An orthostatic test should be performed before initiating therapy (blood pressure and pulse rate, supine and standing). In case of a history of documented or suspected orthostatic reaction, treatment with Dapoxetine should be avoided
• Antidepressants, including SSRIs, increased the risk compared to placebo of suicidal thinking and suicidality in short-term studies in children and adolescents with Major Depressive Disorder and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24.
• 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
• Phase 3 clinical studies excluded subjects with underlying cardiovascular disease. In individuals with underlying structural cardiovascular disease, the risk of poor cardiovascular outcomes from syncope (cardiac syncope and syncope from other sources) is enhanced (e.g., documented outflow obstruction, valvular heart disease, carotid stenosis and coronary artery disease). There isn't enough evidence to say whether this elevated risk of vasovagal syncope extends to those with underlying cardiovascular disease.