Dapoxetine HCL INN 30 mg

Business Unit: Human

Medicine Type: Tablet

Generic Name: Dapoxetine HCL INN 30 mg

Therapeutic Class: Drugs for Erectile Dysfunction

Indication: Extreme is a tablet preparation of Dapoxetine which is a short-acting selective serotonin-reuptake inhibitor (SSRI). Indicated for the treatment of premature ejaculation (PE) in men 18 to 64 years of age, who have all of the following: 1. Persistent or recurrent ejaculation with minimal sexual stimulation before, on or shortly after penetration and before the patient wishes. 2. Marked personal distress or interpersonal difficulty as a consequence of PE and poor control over ejaculation.

Dosage & Administration: By Mouth It should only be prescribed to patients who meet all the following criteria: • An intravaginal ejaculatory latency time (IELT) of less than two minutes; and • 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; and • A history of premature ejaculation in the majority of intercourse attempts over the prior 6 months. Dapoxetin should be administered only as on-demand treatment before anticipated sexual activity. It should not be prescribed to delay ejaculation in men who have not been diagnosed with PE. Adult (18 to 64 years of age): 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 maximum recommended dosing frequency is one dose every 24 hours.

Preparation: 1 x 8 Tablet