Dapoxetine

Source: UK SPC §2/§4.1/§4.2 for PRILIGY 30 MG FILM-COATED TABLETS (PL415490001). §2: 'Each film-coated tablet contains dapoxetine hydrochloride equivalent to 30 mg dapoxetine.' The posology is given in mg as printed in §4.2; the SPC for this 30 mg product prints no tablet count for the 60 mg dose, so none is stated. INDICATION (§4.1): treatment of premature ejaculation (PE) in adult men aged 18 to 64 years who meet ALL of: 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; marked personal distress or interpersonal difficulty as a consequence of PE; poor control over ejaculation; and a history of PE in the majority of intercourse attempts over the prior 6 months. It should be administered only as on-demand treatment before anticipated sexual activity and should not be prescribed to delay ejaculation in men who have not been diagnosed with PE. §4.2 verbatim: 'Priligy should be taken only when sexual activity is anticipated. Priligy must not be taken more frequently than once every 24 hours.' '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.' Moderate CYP3A4 inhibitors: the dose should be restricted to 30 mg and caution is advised; potent CYP3A4 inhibitors are contraindicated. Known CYP2D6 poor metabolisers or patients on potent CYP2D6 inhibitors: caution is advised if increasing the dose to 60 mg. Review: 'A careful appraisal of individual benefit risk ... after the first four weeks of treatment (or at least after 6 doses of treatment)'; data beyond 24 weeks are limited; the clinical need and benefit-risk balance should be re-evaluated at least every six months. Elderly (65 years and over): efficacy and safety have not been established. Paediatric: 'There is no relevant use of Priligy in this population in the indication of premature ejaculation.' Method: oral; tablets swallowed whole to avoid the bitter taste, with at least one full glass of water, with or without food. Before treatment an orthostatic test (blood pressure and pulse rate, supine and standing) should be performed and a history of orthostatic events taken (§4.4); in case of a history of documented or suspected orthostatic reaction, treatment should be avoided. Other forms of sexual dysfunction, including erectile dysfunction, should be carefully investigated before treatment. TRUNCATION: the retrieved §4.4, §4.5 and §4.8 text is cut off at the source-fetch limit (after 'Moderate CYP3A4 inhibitors', 'In vitro studies in' and 'Adverse drug reactions reported in the' respectively); §4.2 is complete.