Active Ingredient: Dapoxetine
Dapoxetine should only be prescribed to patients who meet all the following criteria:
Dapoxetine should be administered only as on-demand treatment before anticipated sexual activity. Dapoxetine should not be prescribed to delay ejaculation in men who have not been diagnosed with PE.
For this indication, competent medicine agencies globally authorize below treatments:
For:
Regimen A: Oral, 30 milligrams dapoxetine, one dose.
Regimen B: Oral, 60 milligrams dapoxetine, one dose.
The recommended starting dose for all patients is 30 mg, taken as needed approximately 1 to 3 hours prior to sexual activity. Treatment with dapoxetine should not be initiated with the 60 mg dose.
Dapoxetine is not intended for continuous daily use. Dapoxetine should be taken only when sexual activity is anticipated. Dapoxetine must not be taken more frequently than once every 24 hours.
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.
If the patient experienced orthostatic reactions on the starting dose, no dose escalation to 60 mg should be performed.
A careful appraisal of individual benefit risk of dapoxetine 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 dapoxetine is appropriate.
Data regarding the efficacy and safety of dapoxetine beyond 24 weeks are limited. The clinical need of continuing and the benefit risk balance of treatment with dapoxetine should be re-evaluated at least every six months.
Dapoxetine tablets should be swallowed whole to avoid the bitter taste. It is recommended that tablets be taken with at least one full glass of water. Dapoxetine may be taken with or without food.
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